Q4 2021 AngioDynamics Inc Earnings Call
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Okay.
Good morning, and welcome to the Angio, Dynamics' fourth quarter and fiscal year 'twenty 'twenty 1 earnings call. At this time, all participants are in a listen only mode.
Question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero from your telephone keypad.
As a reminder, this conference is being recorded.
The news release detailing our fourth quarter and fiscal year 'twenty 'twenty 1 results crossed the wire earlier this morning and is available and the company's website.
This conference call is also being broadcast live over the Internet at the investors section of the company's website at Www Dot angio and dynamics Dot com and the webcast replay of the call will be available at the same time same site. Shortly after the todays investor and technology day presentation, which will begin at 930, a M eastern time.
Before we begin I would like to caution listeners that during the course of this conference call. The company will make projections or forward looking statements regarding future events, Inc.
The statements about expected revenue adjusted earnings and gross margins for fiscal year, 2020, 2 as well as trends that may continue.
Management encourages you to review the company's past and future filings with the SEC, including without limitation. The company's forms 10-Q, and 10-K, which identify specific factors that may cause the actual results or events to differ materially from those described and the forward looking statements.
The company will also discuss certain non-GAAP financial measures during this call.
Management uses these measures to establish the operational goals and view of operational performance and believes that these measures may assist investors in analyzing the underlying trends and the companys business over time.
Investors should consider the these non-GAAP measures in addition to not as a substitute for or is sort of.
Superior to financial reporting measures prepared in accordance with GAAP.
The slide package offering insight into the company's financial results is also available on the investors section of the company's website under events and presentations.
This presentation should be read in conjunction with the press release discussing the company's operating results.
Initial performance during this morning's conference call.
I'd now like to turn the call over to Jim Clemmer, and your dynamics, President and Chief Executive Officer, Mr. Clemmer.
Thank you, Rob and good morning, everyone and thank you for joining us today for Andrew dynamics fiscal 'twenty 'twenty, 1 fourth quarter earnings call.
Joining me on today's call and Steve Trowbridge, Andrew Dynamics, Executive Vice President and Chief Financial Officer, who will provide a detailed analysis of our fourth quarter and full year financial performance and our FY 'twenty 2 guidance.
The fiscal 'twenty 'twenty, 1 was a unique year that presented a number of external challenges and I could not be more proud of the entire Andrew of dynamics team for their continued demonstration of perseverance passion dedication and performance.
During the year that was continually disrupted by the COVID-19 pandemic, we made significant progress and our transformation into a customer focused technology driven growth oriented company.
From the onset of the COVID-19 pandemic, we were determined to maintain our focus on disciplined investments and our people and the technologies that will drive revenue growth for our company and large fast growing highly profitable markets.
Despite the disruption from COVID-19, we ended FY 'twenty, 1 with more people employed and the Andrew dynamics family and we had pre COVID-19.
During the year, we initiated and executed our strategic research and development and sales and marketing investments in our growth platforms.
These investments drove growth in FY 'twenty, 1 and are poised to facilitate accelerating topline growth into FY 'twenty 2 and beyond.
Before I get into our performance I'd like to remind you that year over year of comparisons of our results are significantly impacted by the COVID-19 pandemic.
Particularly the particularly the acute disruption that occurred during our fourth quarter of FY 'twenty.
As a result this morning, I'll also be referring to sequential growth over our fiscal third quarter. As we believe this is a more accurate indicator of the current momentum and our business.
Additionally, as you'll hear more about during our Investor and Technology day later this morning.
Going forward, we will be referring to our key growth platforms.
John.
Mechanical thrombectomy.
And and nano knife as our med tech businesses and the remainder of our portfolio as our med device businesses.
With that and mind strong performance from our med tech platforms as well as our more mature of med tech businesses drove solid fourth quarter and full year results.
We ended FY 'twenty, 1 with full year revenue of $291 million representing growth of 10, 2% year over year.
We completed our fourth quarter with revenue of $76.8 million, representing sequential growth of 8% over the third quarter, reflecting the momentum we are building as we head into FY 'twenty 2.
I'm encouraged by the continued improvements and our and markets.
And believe our results demonstrate that we are well positioned to drive further adoption of our differentiated platforms.
The procedural volumes normalize coming out of the Covid pandemic.
We broke even on an adjusted EPS basis during the quarter.
As we prioritize certain strategic investments and research and development and sales and marketing including.
Including investments and preparation for our anticipated launch of the Alfa Vac mechanical thrombectomy system.
While continuing to balance near term cash and expense management.
For FY 'twenty, 1 we generated 5 cents of adjusted EPS as we made purposeful and strategic investments throughout the year and research and development and sales and marketing focused on supporting our med tech platforms and generating future growth.
Diving deeper into our performance in the quarter.
The positive trend within our Oregon business continued into the fourth quarter.
With revenue of $4.6 million.
And total FY 'twenty, we on ARIA and revenue to $11.1 million.
Are you on continued its sequential growth as well.
Coming off $3.3 million of revenue and the fiscal third quarter.
For FY 'twenty, 2 we expect Oregon to continue to grow meaningfully and generate revenue and the range of $18 million to $22 million.
We continued to see strong growth from our angio of Vac platform.
And as evidenced by the record number of procedures performed in both fiscal <unk> 'twenty 1 and.
And for the full year.
Andrew of Vac platform revenue increased 14% sequentially and the fourth quarter with year over year of growth of 47% and FY 'twenty 1.
Additionally, we are thrilled about the recent 5.10-K clearance of alphabet.
Our new multipurpose mechanical thrombectomy device.
This device expands the breadth of our age of Vac platform.
And will allow us to serve a much larger segment of.
Of the venous thromboembolism market, which we all of which we will discuss in more detail during our investor and technology day later this morning.
We also believe that our current on circuit Angio of Vac system will continue to drive strong growth and the complex right atrium and focused market.
Together and.
And you're back and Alpha Vac comprise our mechanical thrombectomy platform, which.
Which we anticipate will grow approximately 30% year over year and FY 'twenty, 2 and inclusive of the Alpha Vac revenue following its anticipated launch towards the end of calendar year 'twenty 'twenty 1.
Net of knife probe sales were strong and the fourth quarter growing 14% sequentially worldwide, and 19% sequentially and the United States.
As anticipated capital sales and the quarter declined 77% year over year.
As we were coming off of strong prior year quarter due to the launch of our and Internet 3.
3 point O generator as well as of challenging capital environment.
And the end of life probe sales for FY 'twenty, 1 grew 13% year over year worldwide and.
And 38% in the U S.
The continued positive momentum and the U S is a direct result of 2 main drivers.
First our increased capital base that we established last year.
And second increased awareness of <unk>.
Austin by the direct study.
We remain focused on investing and the nano life platform as we progress towards expanding potential for new indications and improving O U S environment in the future.
We anticipate continued strong probe sales growth and FY 'twenty 2.
On the internal R&D investment front we.
We continued to strategically invest and growth initiatives during the fourth quarter.
As we supported our med tech platforms already and the market.
As well as products and our development pipeline.
It's worth noting that over the past 3 years, we have of grown R&D spend.
And of greater than 10% CAGR and are now starting to clearly see the results of that investment.
Throughout FY 'twenty 2.
We plan to continue to strategically invest and to further advance our current portfolio.
And expand into larger faster growing addressable markets.
M&A remained on the back burner during the fourth quarter as we continued to focus on balancing growth and profitability and the face of Covid related challenges.
However, our strategic and tuck in M&A remains a key piece of our long term growth strategy and we continuously monitor the landscape for these opportunities.
And the near term, we anticipate and maintaining our disciplined approach the capital allocation and expense management.
Turning to our clinical progress.
Subsequent to the end of the fiscal year.
We received approval from the FDA for our 100 patient and then a knife prostate I D E study preserve.
And we're excited to begin this study and.
As we seek to prove the clinical benefits of men of life for patients suffering from prostate cancer and look forward to updating you on our progress as we pursue this expanded indication.
Consistent with where we were at the end of our fiscal third quarter. We currently have 26 active sites and our direct study.
And are encouraged by the overall execution of the study and the current environment.
With that I.
I'd like to turn the call over to Steve Trowbridge, Our executive Vice President and Chief Financial Officer to review the quarter and more T tail Steve.
Thanks, Jim and good morning, everyone.
Before I begin I'd like to point you to the presentation on our Investor Relations website summarizing the key items associated with our quarterly results.
As Jim mentioned, our year over year comparisons for our FY 'twenty, 1, particularly our fourth quarter results are significantly impacted by the COVID-19 pandemic related disruption.
Our net sales for the fourth quarter of FY 'twenty, 1 increased 31, 7% year over year to $76.8 million.
Our growth was driven by continued sequential growth and our Oregon Atherectomy business strong angio Vac performance net of knife probe growth and solid performance from our med device businesses.
During the fourth quarter, we saw continued sequential improvement and case volumes and we are encouraged that we're trending towards a more normalized run rate as we enter fiscal 2020.2.
Our total Endovascular therapies business, which was formerly named our Vit business increased 72.3% year over year to $38.1 million.
And this increase was driven by the greater impact of COVID-19, and the prior year period, and the continued strength of 2 important growth products angio back, which grew 108% year over year and Oregon all.
Alright, I'm contributed $4.6 million and revenue during the fourth quarter building upon the momentum that we saw following the product's official commercial launch and the second quarter and strong performance and the third quarter.
Total fiscal year 'twenty 'twenty, 1 revenue for Oregon was $11.1 million.
And remains a key growth driver as we continue to invest and the platform build out our commercial infrastructure and generate clinical evidence.
As Jim mentioned for FY 'twenty, 2 we expect already on to generate revenue in the range of $18 million to $22 million.
Vascular access revenue increased 3.2% versus the prior year period, driven by growth and ports, which offset a decline and picks as.
As we previously discussed the fourth quarter of FY 'twenty included approximately $1 million of sales related to a 1 time order from NHS through our distribution partner.
Additionally, picks and Midlands, where 2 of the few product groups, but did not suffer significant disruption during our fourth quarter of FY 'twenty FY 'twenty due to COVID-19, hence the lower year over year growth relative to our other businesses.
Revenue from our oncology business increased 14, 2% during the quarter as compared to prior year, driven by a 42% year over year increase and nano and I have disposable sales as well as strong results and both biosurgery and microwave disposables.
Oncology revenue growth was partially offset by the tough comp and continued weakness in capital and markets as well as the challenging APAC region, where many of our businesses continued to be impacted by the COVID-19 pandemic.
Moving down the income statement, our gross margin for the fourth quarter of FY 'twenty, 1 was 55, 1% and increase of 330 basis points compared to a year ago, and an increase of 100 basis points sequentially from our third fiscal quarter.
The improvement was largely due to sales mix, though this was partially offset by continued staffing pressures and anticipated ARIA and startup cost and we continued to reduce inventory during the fourth quarter ending at $48.6 million.
We do expect that gross margin will expand over time as we continue to execute on our strategy of driving growth and our high Tech high margin platforms of Aryan mechanical thrombectomy and nano nice.
And however, during the back half of FY 'twenty, 1 and a number of external pressures resulted in gross margin headwinds that we anticipate could extend through the next several quarters.
Many companies have discussed staffing challenges during the first half of calendar year 'twenty 'twenty, 1 and we have faced and continue to face challenges and fully staffing our Queensbury New York facility.
And this tight labor market and has resulted in higher labor and manufacturing cost in.
In addition, we've experienced significant freight cost pressures and we observed what we believed to be the beginning of raw material inflationary pressures.
And we are of talented and dedicated operations team that is focused on labor and service efficiency material pricing opportunities and make versus buy analysis. However, the external factors I mentioned and the ARIA and pricing dynamics stemming from the increased OBL mixed that we previously discussed will impact the pace at which our sales mix drives gross margin leverage.
Through FY 'twenty 2.
The net result is that for FY 'twenty 2 we expect gross margin of approximately 55 per cent.
Our research and development expense during the fourth quarter of FY 'twenty, 1 was $9.1 million or 11, 8% of sales compared to $7.2 million or $12.4 per cent of sales a year ago.
We continue our strategy of disciplined investment and R&D focused on driving our key technology platforms.
For the fiscal year R&D expense was $36.4 million or 12.5 per cent of sales.
For fiscal year 'twenty 'twenty, 2 we anticipate R&D spend to similarly target, 10% to 13% of sales.
SG&A expense for the fourth quarter of FY 'twenty, 1 increased to $33 million, representing 42, 9% of sales compared to $26.4 million, representing 45, 3% of sales a year ago.
For the fiscal year SG&A expense was $117.2 million or <unk> 43 per cent of sales.
We're pleased with our ability to control general and administrative spending amid COVID-19 related disruptions and remain committed to disciplined expense management and managing our cash while investing and our key technology platforms, including investments and our sales organizations.
Accordingly, we anticipate FY 'twenty, 2 SG&A spending to approximate 40% to 45% of revenue.
As we previously mentioned SG&A spend and FY 'twenty, 1 was positively impacted by reduced travel associated with the ongoing COVID-19 pandemic, we do expect travel costs, along with our ongoing investments and our sales organizations to increase in FY 'twenty, 2 as the global environment improves and restrictions ease.
Our adjusted net loss for the fourth quarter of FY 'twenty, 1 was 100000 or breakeven on a per share basis compared to an adjusted net loss of $2.1 million or 6 cents per share in the fourth quarter of last year.
For the fiscal year adjusted net income was $1.9 million or income of 5 cents per share compared to adjusted net income of $3.5 million or 9 cents per share a year ago.
As a reminder of third quarter of FY 'twenty..1 included a benefit from the cares Act.
Adjusted EBITDA and the fourth quarter of FY 'twenty, 1 was $4.5 million compared to point 6 million in the fourth quarter of FY 'twenty.
For the fiscal year, adjusted EBITDA was $19.5 million compared to $18 million in fiscal 2020.
Turning to our balance sheet, we began the quarter with roughly $54.5 million and cash and cash equivalents and we generated free cash flow of $3.1 million.
And at May 31, 'twenty 'twenty, 1, we had $48.2 million and cash and cash equivalents and 20 million and debt outstanding having repaid $10 million of our outstanding debt during the fiscal fourth quarter.
Turning now to guidance.
We anticipate that FY 'twenty, 2 net sales will be and the range of $305 million to $310 million and full year adjusted earnings per share will be and the range of zero to 5 cents as we continue to invest and research and development and sales and marketing for our key med Tech platforms.
Our guidance range contemplates topline growth of 5% to 7% over FY 'twenty, 1 which included approximately 5 million of revenue related to that 1 time sale to the NHS through our distribution partner.
And we look forward to providing you with our longer term financial outlook as part of our Investor and Technology Day later this morning.
With that I'll turn it back to Jim.
Thanks, Steve I'd.
I'd like to again say, thank you to all the members of the engine of dynamics team for the continued hard work and dedication to our mission.
I am very pleased with the progress we have made with our 3 key technology platforms, and Youre Vac, Oregon, and then of life, including the recent 5.10-K clearance of the alpha vacuum mechanical thrombectomy system.
We view this as the first step and our market expansion strategy as we continue to make focused investments and larger high growth markets.
I'm excited to discuss these and other parts of our portfolio at our Investor and Technology day presentation, which will kick off at 930 Eastern this morning.
With that I'd like to turn the call back to the operator and open the line for questions.
Bob.
Thank you well now be conducting a question and answer session.
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1 moment, please while we poll for questions, what's going on and Star 1 to ask the question today. Thank you.
Yeah.
Thank you and our first question is coming from the line of.
Matthew of mission with Keybanc. Please proceed with your question.
Great and thanks for taking the direction of the guys and congratulations on the revenue momentum here.
And I think first from me could you give us a sense of the type of procedures. The debt Ori on is is sequentially growing in.
Hi, Matt Good morning, it's Jim.
Matt I will give more detail later, but we're really seeing you know of.
And of above and below the knee.
Initially we thought that our users of it would be more comfortable with the above the knee procedures and I think the other laser that's been in the market is used more and that that phase. So I think the users initially started with above the knee, Matt and now we're seeing a trend where they're getting very confident in our technology and then taking it below the knee through what is usually more challenging procedures and there's probably only.
And 1 of the other companies that do that well. So I think we're now becoming a really key and trusted partner and that so we're seeing our blend really go closer to a 50.50 split above and below the knee, where we're also seeing that too as we said earlier more than we expected and the Obl's I think part of that is due to the COVID-19 effect, where a lot of the care is delivered in the past year in the Obl's They will see a blend of getting.
Back to of a hospital OBL mix.
Bob Little more favorable over the course of this coming fiscal year.
And then Jim as you've seen the sequential improvement the that's been there's been fairly linear at this point.
And how many of those share it is there a way to parse out how many of those sales are.
Increases in the installed base and original waters first is you've you've already installed the oriented device and 2.3 quarters ago, you've gotten through the initial orders and now you're starting to see the the sites.
<unk> increased the revenue per site increased procedures per site.
And you hit the nail and the head Matt we're measuring all of those effects. So exactly what you asked is the way. We're measuring this you know again you know this is really of startup business within a mature operating company and when we are and it would be really careful as we took on this marketplace. Our initial moves as you know of supply getting our supply chain robust, making sure we get the quality we need on our hardware first the capital.
The second owner or disposable catheters, so right now I'm, Matt we're doing everything you said every time, we place the new laser and now we have a good trend we know how long it takes for the users to get confident and comfortable with the device. We can expect the.
Catheter usage to increase and a monthly basis. So we're measuring the the metrics you gave us plus about half of dozen more as we get this of this business off the ground and we're really pleased with how the business of started we've got really great people and the field supporting our users, but Matt the metrics you mentioned and a bunch of more we're gonna measure diligently and we'll report back to you.
And kind of wherever you'd like to see over time as we expect this to be of growth driver for a long time for us and.
And I and I think I think people generally understand the the the startup cost associated with this and then the fact you have to build inventory before you launch and how should we think about sort of.
Think about the mix of the oriented revenue versus the company average gross margin as you get the scale.
Yeah, Steve and kind of yes, we get the scale, Matt, we certainly expect ARIA and standard margin to be accretive to overall corporate margins and as you mentioned, we have those start up costs and they're going to impact the the margin profile of that business initially, but as we were exiting Q4, we were really pleased with the trajectory that we were on and we expect as we.
Head into 'twenty, 2 and certainly beyond that that the overall margin profile that that Oregon is giving us is gonna be accretive the overall corporate margins.
And last question on Angi of Vac.
Comps are a little wacky this quarter for you and given what occurred last year, but if you. If you look at a 2 year stacked basis. It does look like youre seeing and acceleration of growth in the angio back and and kind of what do you think is what do you think is driving that.
So a couple of things if you remember in fall of 219 near the end of the calendar year of 219, we launched our and your back 3 point all of which we really incorporate a lot of user feedback into that design and development of that launch. So we've got good momentum right as we launched it then the pandemic hit in March.
But we are confident 2 things are happening that we of new users using the product that didnt use the old version and then second users using the product and now try and get more and more cases as they gain confidence and the great outcomes are saying so it's a blend of both of our job again is to keep talking about why this technology is very different than everything and the market getting users comfortable and com.
And to try it and once they try it we think the results of speaking for themselves and they're getting confidence and using it more often and so it's really the combination of both new users and the same users using it more often and then.
The thing I would add to that Matt is you know as Youll see more through our Investor day presentation. This morning, we're really excited about the upcoming alpha of <unk> launch and what you'll see is that those 2 products alphabetic and Angela of ACA really complementary. So we're going after the overall DVT market from mechanical thrombectomy, but we feel both of those products have a role to play and.
So we're not expecting significant cannibalization to come from the Angio Vac side. Once we launched Alpha Vac and so we think that there's great runway with the angio back the as you've continued to see and as you pointed out earlier and your question and then we expect that to be incremental with alphabet and once we launch that towards the back half of this calendar year.
Okay, Great look forward of part 2 at 930.
Thanks, Matt.
Thank you. Our next question comes from the line of Jason Bedford with Raymond James. Please proceed with your questions.
Good morning, just I guess of few questions just given your ear corky fiscal year, and there's always I think attention on the intra quarter trends wondering if you could just comment on on trends and in April and May.
Hi, Jason you know as you know weird and measuring kind.
Kind of same store sales as we've talked to our investors about during the course of the year and we're watching those trends get better and closer to normal during the course of the year and as we looked at the the the timeline you gave the April may were closer, but that's the 1 last year, we had a falloff as well so it's really tricky.
What we tell Jason between the metrics, we have hard metrics and side and just gut feel from our our sales reps talking to customers. We're not back to what we would assume was of normal operating environment, whereas close and it's been and the last 6 months or so, but we still feel there is not 100% alignment to where we would call normal treatment occurring.
Okay.
In terms of fiscal 'twenty 2.
It's embedded in the guidance for per segment growth between.
Between the Endovascular vascular access and oncology business.
Yeah, So Jason and as Jim mentioned, you know the what we wanted to focus on when we gave the revenue guidance. So we're guiding 305 to 310 million for FY 'twenty 2.
And you're going to see 18 to 22 is going to be coming from Aryan as we talked about a 30% growth year over year for the mechanical thrombectomy.
Port foot platform, together, which is angio vac alphabet once its launched as well as units use.
And then you know 20% growth in terms of probes for nano and life. So the rest of the business. We're expecting the hold its own you can think of it and that kind of 1% to 3% range for the device segments with the growth coming from those med tech platforms that I just went through.
Okay, and just maybe Steve on on nano when does the capital churn, meaning you had tough comps this year, which makes for easy comps next year and fiscal 'twenty..2 do you see a lift and capital at all.
So we're we're planning about to be flat in 'twenty 2 to 'twenty 1 when it comes to the capital sales. So you know 21 was about half of what we saw in 'twenty and that's not surprising that's when we launched the nano and I 3 point of system, we're expecting 22 to be roughly similar to 'twenty 1 from.
From a capital placement perspective, but we are expecting to see that continued growth and the probe sales coming from as Jim mentioned direct as well as the increased installed base that we've seen.
And then focusing on you know getting up and running and launching the the prostate trial that Jim mentioned earlier today.
Okay.
And then I apologize if I missed this but.
The the ROM trombone business, how big is it meaning the 30% growth what's the baseline we should we should use for growth.
Yeah, So angio vac the ended up at the end of the year right around 25 million and then you can add in.
The the about $5 million or so of of our unifi and so those 2 together are comprising the mechanical thrombectomy base right now and then as we launch out of that towards the end of the calendar year that'll get added into that section.
Okay helpful. And then maybe Steve Pruett for Ya Lastly, on gross margin is there any way you could break out the the weights on margin between.
The startup costs the increase in raw materials Labor and then I'd also love to know what do you think the exit rate is for gross margin in fiscal 'twenty 2.
Yeah, No we were looking at all of those things. It's a great question. So if you do your work from 'twenty to 'twenty..1 you know the Oreo and startup costs, you can think of and the range of 100 basis points or so when you put together the inflationary pressures that we're seeing including freight costs, you're you're over another hundred basis points.
And then just the Covid impact with that we saw on our absorption is even another hundred basis points. Now we think some of those inflationary pressures are going to keep going as we head into FY 'twenty 2.
We're not and in a different situation than what you've heard from a lot of other companies. So there's going to be that drag as we move forward. You know we were exiting the year in that you know north of of 56%, but youre going to see a little bit of of a pullback as as those inflationary pressures put pressure start to accelerate so that's where we get to our guidance of approximating 55 per cent for FY <unk>.
The 2.
Okay, and sorry, Steve at the 50.
The 6% exiting that's exiting 'twenty 2 or were you referring to exiting 'twenty 1 before some of these wait I'm sorry exiting 'twenty 1 before you get some of these increasing accelerating weights.
Okay, but we can assume that gross margin Doug.
Cash margin trend higher throughout fiscal 'twenty 2.
That's what we expect we accept we expect to see that ramp as you continue to get the benefits from the sales mix with the growth products that we've talked about but that's going to be mitigated by these inflationary and other cost pressures that you're seeing so we're targeting that 55 for the full year I would expect to see the upward trend as you get through the full year, you're going to have.
Of your normal peaks and valleys as you go through the the year, though.
Is the expectation that you place more Oreo and boxes in fiscal 'twenty..2 then in fiscal 'twenty 1.
I don't think the expectations that we'll place more in 'twenty, 2 and in 'twenty, 1, but we're going to continue at a good pace as we find the right accounts to open up so we will continue to be placing boxes.
I think the right way to think about it would be think of 'twenty..2 is very similar to 'twenty 1 in terms of placements.
Okay.
Alright, I'll leave it there thanks.
Thanks, Jason Thanks.
Our next question comes from the line of Bill Plenty of Inc. With Canaccord Genuity. Please proceed with your question.
Great. Thanks, good morning.
Just a little more color on the question for procedures.
And how that looks intra quarter again, given your may and quarter.
You know each quarter, if he could give us a little more detail geographically is there any nuances that we should be kind of aware of if you look around the globe and relative to the COVID-19 impact on procedures and connect where you think you are today and he said you're you're not all the way there are we 95% and if so.
And 90% and when do we expect to get the 100% and just a little more granularity relative to the geographic.
The segments. Thanks.
Sure Hey, Bill of Jim I'm, you know, what we saw and the last I'll call. It 60 days or so that the April may time line was at least in the U S. If you look at the U S. As a region more normalization and the U S where earlier that we had even regional pockets of the U S that were spotty are of different but we saw some of that normalize during the the last 60 days of.
Our fiscal year of the April May time line, but we look at other spots you know our Latin American business was affected very much. So and still is you know by the pandemic, obviously and Europe, we have pockets. So I think what we see these pockets in Europe are more unstable. They are and you asked and I said you asked the stabilized a bit more and we'd been challenge all year in the Asia Pacific.
And our business and maybe the mix, we have and we have a hell of lot of our oncology business and the APAC region and a lot of those procedures were on hold during the course of the year. So we haven't seen those come back yet or the confidence that it'll come back of the rate that we expect at that point. So we're still saying that we'll try to give you a good good a look at that but it's getting more normal but I can't.
Tell you its where we would expect normal procedure volumes to be and at this point.
Okay. That's helpful. Thank you and then in terms of the area and guidance you know.
You did $4.6 million and you're guiding 18 to 22.
Matt says 4.6 million is a little above the low end of that range and just wondering is there is there something you are shifting more of new disposable and less capital.
Or why wouldn't we see a little higher growth.
Good question, we I mean, we had a great start to the you remember we launched this product tactically in September of last year and it was of great launch, but a couple of things we're going to see we think the mix will also shift a little back to the in the hospital mix that we originally originally expected bill. So we had a lot of OBL business right out of the gate because they'll be all of it.
Doing procedures hospitals weren't and we're going to focus on really serving no matter, where our customers are located.
And let us try to continue that momentum. The Q4, we knew we had good momentum I'm not sure. If we expected it to be of strong as it was but it's a great way to end the year. So we feel good about the guidance range, we've given and we'll do our best to try to hit that range for you guys and see what happens from there.
Okay and then last question is you've made a lot of investments it seems you're you're signaling that the with the with the new terminology of the metal technology versus the medical devices that really focused on the 3 product lines.
When you've made a lot of investments, but when should we expect to see you start harvesting those investments and and leverage that into the model in terms of cash flow and earnings.
And maybe that made the maybe the engineered and Investor day question, and we can pay for that as well.
We can answer it twice and can you give the quick answer now we can answer a little later in the morning, when you see our presentation coming up soon but but but honestly what you'll see is what we've talked about now when I mentioned, our investments against the happening in 2 major areas first as our investments in our technology and our portfolio expanded new product iterations from our current platforms and new areas that we can sell into.
Meaning where we're supporting data collection and proof of our of our science second also adding onto our selling and marketing and clinical research teams. So those are both 2 large expenses. We're taking so for the next couple of years, we're going to focus on those to accelerate growth.
At that point, you know at some point, we'll show you as we get closer al will start leveraging that and leveraging that towards operating profit. As these are all categories that are accretive and gross margin. So the profitable categories. The.
Overtime of our vessels of pay for Steve and Bill I think Jim laid it out perfectly you know there's the 2 main categories of our investments R&D, and then sales and marketing and as you'll see through our Investor day presentation. We're really excited about the platform aspects of our 3 growth driver products peripheral atherectomy mechanical thrombectomy and analyzed and we think Theres grew.
Opportunities and the short medium and long term for those platforms. So our R&D investments, we expect to continue to be very disciplined but make the right investments to drive topline growth there and as Jim mentioned, we're certainly investing in sales and marketing and what we did with Oregon's of Great example, we invested ahead of the curve with the sales force to make sure that we could support those top.
The line growth initiatives that we had we're going to continue to do that and 22 with Oregon as well as our alphabetic and angio back So you know.
As you get out of the shorter term theyre going to see leverage from those sales investments.
But that we expect to continue to have those R&D investments go into our platforms to drive topline growth over the medium and long term. So I think that's the way to think about it.
Great. Thank you for taking my questions.
Thanks Bill.
I'd now like to turn the call back over to Mr. Clemmer for any closing remarks, Mr. Clemmer, Thanks, Robert and I. Appreciate your time. This morning on the call and we hope you can join US at 930 Eastern time for our Investor presentation I'd like to say, Thank you again for the age of dynamics employees and their dedication to our mission working tirelessly throughout the pandemic learning new ways to do our job.
<unk>, new way to serve our customers and keeping all of our thoughts on the outcomes of our customers deserve and arc products drive when they're using the hands of talented caregivers worldwide, our quality and operations team made sure we had adequate supply of quality of products. During this challenging time, and we're really pleased with their efforts and the results.
Thanks to each of them Rob. Thanks again for your time this morning.
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And the dynamics of Investor Technology day.
And I'm, so glad that you could join US this morning, 1 of them.
Stephen Trowbridge and I'm, the executive Vice President and Chief Financial Officer, Andrew of dynamics.
With the company for over 13 years, and I'll tell you I have never been more excited about our future opportunities and I am too.
Day. So we're really excited to tell you about our products and the markets that we're willing and true and our strategic transformation.
And today and many members of our team and the other thing the opportunity to talk about the fast growing high margin markets that we're going to be taking our products into 1 of the joined by Jim Clemmer, <unk>, President and CEO, Jim kind of talking about the strategic transformation that answered and that ex has undertaken and how we're going to be looking at sweeny and growth drivers and we call.
And Ah Med Tech products and those of course all of those are gonna be mechanical thrombectomy peripheral atherectomy and the net of LIFO vegetable extrapolation product. It was 1 of my Scott Santi Scott as our senior Vice President and General manager of the Endovascular therapies business Scott.
The first walk us through the excitement of the NGL Vac platform and talk about the successes that we've had through fiscal year 'twenty, 1 and the successes, we will have to fiscal year 'twenty, 2 and through 'twenty 4.
Scott and then also going to be very excited to talk about the launch and unveiling of our alphabetic product 1 of the most exciting launches that we have coming up and this fiscal year and I'll go back of our multipurpose mechanical aspiration device, which was the major player and 1 of the most exciting hottest growing markets in med Tech today Scott.
And then also talk about our Ala and <unk>.
Or are you on was our peripheral atherectomy device that we launched last year.
Please with the performance we saw in fiscal year 'twenty, 1 and we're very excited about the prospects and.
Moving to 'twenty, 2 and beyond.
And we've done the Jake Bumbaugh.
Many of the amount of life platform at the World.
Excited to share with you the mechanism of action of this very unique technology and you talk about what we think of some great opportunities and treat patients in the oncology space.
Campbell will join US chatter of senior Vice President and general manager of a vascular access business.
And I'm going to talk about how he has driven that business over the last several years and turned it into and engine to provide investments for the rest of the businesses that we've talked about today of the NGL.
Juan Carlos and I will join US Juan Carlos of our senior Vice President for Science and clinical Affairs, Mark also going to talk about the data generation and evidence based approach and we're gonna be supporting all of our growth businesses.
Joining the wind up church of ice.
And then from global Health care Economics.
And I will talk about the health care economics cash needs and the bulk of the important initiatives. We are undertaking the secured market access for our technology platforms and.
And throughout today.
Joined by some of the nations.
Tuitions and they talk about the disease state and the unmet patient needs that the engine dynamics products are aimed to address prior to becoming Andrew and then.
CFO I wasn't general counsel for a number of years here. So I am really excited to remind you that the most presentation will contain forward looking statements as defined under the private litigation Securities Reform Act of 1995 of these forward looking statements are not guarantees of future performance and are subject to risks and uncertainties.
And we encourage you and connection with the presentation to also read all of the injured and Amex public filings, including without limitation of our annual reports on 10-K, and our quarterly reports on 10-Q and in addition during this presentation moving to the.
And from some of the nation's leading from opinion leaders chemical and moving paid consultants the banjo dynamics.
It was and the opinions expressed by the camping and neighbors, all around and do not necessarily reflect the news and the penguins of Android genetics.
Now I'd like to welcome and Jim Clemmer.
Thanks, Dave and welcome Thanks for joining us today.
Today, we will share with you the transformation of the age of dynamics the transformation of our portfolio and how we'll be coming of medical technology company.
And let me tell you how we started.
So as we move and though we started as of catheter company and upstate New York.
And then once known as catheter valley of lot of companies started here and new technologies were spun off.
Overtime and became a trusted partner to the interventional radiology community by providing high quality tools and devices that they trust and for care for their patients.
We're doing all the journey, we added to our portfolio.
Kim of more complex company, but certainly the look back over the past couple of years, we've made some decisions from.
Now of our portfolio and focus it.
So in 2019, we actually sold our largest single business or mimic fluid management business and then.
And where do I don't know from that technology.
We're going to continue to change the portfolio.
Areas, where we can compete with our technologies and have competitive advantages.
All of these drive those outcomes that can be measured by physicians and change physician behavior.
When you look at the company today.
2 different portfolio of approaches the.
The first and the 1 here and the most of it out today is on the.
Medical technology portfolio.
Our mechanical thrombectomy products.
Our atherectomy products and our non thermal I, our ablation tools.
Each of these products are foundational technologies that we believe we can iterate from and build new technologies on the.
And I'll also create opportunities for our portfolio of expansion over time.
And we think that each of these platforms create opportunity for growth driven by the unique science and technology behind these products. So they will learn a bit more about those so we're gonna change of portfolio based on flu and pulling the levers.
Research and development.
We've already seen new product launches from us and utilizing our R&D process, it's really good.
We are investing 50% more in R&D and media.
Years ago.
That's an important driver for us and we're seeing the outcomes of the new product launches through our process.
Second.
And what we call clinical and regulatory pathway expansion opening up new areas and new pathways for us and 1 of the technologies to treat patients in need of care.
And the pipeline has 2 important aspects.
First of all the new products and will launch over the next 3 to 5 years.
And second of the popular the opportunities that we're investing in and a pathway of expansion approach.
And the final leg of it the M&A.
Utilize M&A in the past technology.
Technologies to our portfolio 2 of them.
And even though we're the only about half the size and so we are today and the market. So we compete.
Well the thing there so now the double that again, so it's really important for investors to know our technologies drive the outcomes, so unique and special and we're also competing in the areas where the markets are larger and the growing much more rapidly ease of.
Part of the journey to value creation.
And we're excited today to share with you more details about our technologies and our products we.
And you'll see from us and what they are and how they work and why they matter.
Also here and some global Kols and why they matter of from their perspective, and how our technology is making a difference and how they treat patients in need of care and the need of wellness. So we're really proud of the portfolio of Blue belt.
We're excited about our future and we'll continue to invest in the portfolio and add ons and new opportunities for growth for our company and the opportunity for value creation for our investors so and.
Now let me welcome Scott Santi, who will walk you through our mechanical thrombectomy business.
The first look and I know alpha backed product.
Thanks, Jim.
Scott from P. M. The senior Vice President General manager of of Endovascular therapies and as he'd adhere.
And your dynamics and I'm extremely proud and privileged and excited to share with you the offering that we are creating and expanding upon and a promise of her.
The old to better address and meet the needs of patients.
And both of them. So what are the started there but part of it.
The meat of the presentation and I think what's the level of fan and talk a little bit of about the disease state of itself.
And all of them further means also the referred to.
And somebody said, it's comprised of both of them.
And 1 of the Pea and the matter of fact and those patients that have the AP.
From day, 1 until they actually have D. G. So let's start there.
And from both is 1 of them.
The cumulation of blood over time and as vessel the critical of.
Blockage on the Cleveland and if left untreated can actually break off from the buffet ranked us becoming and emphasis on and the lie.
The right when it gets from.
The right heart and become the clock the in transit.
The forward and developing until the economy and.
And going into the pulmonary arteries and you can see this as of third leading cause of death by behind the heart attack and stroke.
And up until recently most of the therapy and the way with the retreat.
And with patients with all the more conservative.
And I'll show you a little bit about those 2 options and more importantly, how physicians of true pushing explicitly and how we live and dynamics are starting to true black those device innovation.
And 1 of the 2 different segments, we look at but if the procedure type from simple to complex of a death. So we're looking at.
And both what of those therapies.
And what was the non Medicaid therapy from them.
And quite a bit of everything that the patient and that high.
With the developer.
And so on and it Craig.
And it's something that from the blood to help the leg clots from even occurring now if the clock push up the.
And well talk a little bit more of low selling everything else.
Call kind of directed from the library.
And the liver of letting English.
And of the clock now it's been proven and effective but they also come with somebody here and.
The profile of toilet tissue and monitored due to COVID-19.
Potential of interest blini now from food.
And then kind of shift to the right.
And similarly, with the Boston scientific.
Which of the pharma co mechanical and <unk>.
And the chemical asphalt and there were some components along with the.
The health is I'll break up the escalating the clot out and what's happening now.
Now to go non lip and face that's 1 of the risk of Blue and for some of these patients and the control of we're moving the clot with the promise and its entirety and we call the mechanical thrombectomy system or the mechanical installation and the last but not lose the all of them to the right a little bit of more than any of the senior a complex procedure.
And she reports back the Buda, we called this and your Iraq and before I talk a little bit about earlier that I wanted to mention of those Jamba Inc.
Gotcha Moriarty.
It's a I'm sure when the hours out of the University of California, Bob.
Some of them from a little bit more.
The boost the itself as well as some of them and competition and or challenges that physicians have with and the patient.
Population John.
Scott and the doing the things we do here of a few of today.
And being able to the true.
And I'm very passionate about half of which is cash.
Interesting.
Mhm and Brian Howard Strombus removal.
It's 1 of the team.
Thanks.
The maintenance director and director of the PD response team and.
And the service of UCLA, and so it's a pleasure to be able to discuss the sum of.
I hope there will be an interesting sort of a few minutes on the.
The T therapy, so women per se.
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He took the comps within the range.
The either Stephen Lang.
The or move somewhere else either to the hardcore Reinhard from the order to the longest cookie and of course.
Altogether that James.
The <unk> venous thromboembolism and this is extremely common in some more of his health burden and arch.
System and 900, thousands of Americans are going to experience the VT events and this year and.
These patients are debilitated and buyers.
And our risks and benefits from it.
And indeed of the third most common cause of cardiovascular mortality after and I.
And the stroke and when we know what the seamless and.
Matt and.
Myocardial infarction or heart attack.
Very comfortable range and.
The provision and the huge resource towards the last week.
A copy of on time, we dedicate novel Therapeutics like drug Eluting stent thrombectomy and devices.
Thank you Emily.
And.
And it basically means of removing the problem.
All of them.
And we are doing the same when it comes the GBP treatments and so we're really seeing the changes and happened and it is true and in cardiac disease and being a little bit of deposits.
And we see things going with DVT.
Most of the patients who were harmed.
T D.
D D or range.
Moving to some sort of imaging, whether its an ultra of interest.
And then go into a basket of the specialist and.
The only way that these basket of essentially similar to some other areas of.
Last quarter mentioned is the stations and gains from the spreads will go that can be of cardiologists and vascular surgeons and interventional radiologist, depending on just the army.
Most of the different types of the divisions of involved and.
Thanks for that.
I will note is that there was still sure.
And the homogenous nation.
Lots of different repurchase plans and then I think.
The window down over the next day.
So as we defined cash.
The world trade and Bridgeport and wish to biases.
1 of the way and so we've seen sort of it.
And the last decade, and there are still ahead of us being the move from a pharmacologic therapy, only and the rules where people not getting drug therapy at the day in day 1.
David Jones Coumadin.
And with the whole range of and go Act therapies.
The 2 moving towards a far more of patient centered approach, which involves in dimension and these and dimensions.
But the 1 typically in the hospital arena and the Cath lab.
The per licensed copyrights and dissolve the Bob.
Now how does expand the hugely in utility and.
So over the last few years.
The volume of cloud based catheter directed lysis brings the total of risks these and predominantly of around 2 things 1 would be the risk of bleeding from the patient.
And the cost of service.
And in the patients in hospital with the.
And the Asia, and the kind of injected licensed stores and over a period of usually 24 to 48 hours and these patients from being an ICU and for that length of time, so any of those units.
And of those 2 main things.
And the movement towards the risk.
Fashion inspiration from that to me has been a huge over the last few years.
And David.
Turning to the patients that previously had been going to the ICU for a few days and to someone who maybe into the home and the same day as well and hoping Chuck in the breaking out the moving the blood draws and that's in there and.
When the time so that the.
Needs to give the mic composting, Doug that concludes the bleeding is far far far less and the history.
And so.
And this kind of natural extension going is the similar to what happened with stroke and with hundreds of <unk> is that what you're seeing the who engage heart attacks and true medications and then we gave them a medication directly into the macro and Maryland.
And our snack and still began moving prospects closing of the problem directly and <unk>.
And during the same way with DVT and BG each.
And the direction Okay.
Bob that's there.
And there'll be a couple of devices that have really changed the way the we have approach.
And then I'm going to remain stuck and at least.
The robots.
And there are these devices the regionally.
And kind of bastardized from other areas of intervention of Medicine and for example, they were used and the arterial system to remove the bumps and then.
And moved into the beans.
And given the change to the device, but over the last 5 years 10 years, what we're really saying is.
Our bespoke devices.
Dedication to the needs of the day in the system and therefore.
And I believe are significantly better.
But we used to have and until the results of a master of the patient experience and better.
It's sort of members from the invention of point of view because of the Doctor would you wanted David do you want to get the right device first time and so the blue of each of June.
This range of that patients and.
Thanks.
And each of the into the patient safely remove the globe Bob.
And then move on is really critical.
And the areas that I think we've seen the income statement and the fact of this is.
Thanks.
Particularly with the with the removal of very large volumes of frost from the right Howard.
And the ITC, which is as you know.
The main blood vessels and the things the thanks to the higher.
And Jim.
And why you kind of a lifetime of getting intervention of therapies.
The huge change where some of these patients would be 9 days of down a bit of open heart surgery.
And the corporate in the chest.
And the ease of ICU admission and surgery.
And the substantial morbidity and the long recovery.
Thanks, Jim and building boom.
And so I think these.
For example of using actual mood of coffee and Lucian within the right Howard.
And the return.
The senior into 1 of the is over and done with moving in and our 2 indications and the has the advantage over the network and.
And as Bruce again, I think the transformative change and it is normal.
And the field to be extremely excited of bias.
What we can do now but also of what we can do and the future Jim can be 1 tool that shapes and everything, but rather and youre getting 1 kind of a range of devices during March 2 and 3.
And so.
The <unk> thousand to try and keep the removal of the bottom of the IV.
And the 20 to 180 from the removal of the positives on the.
The right Howard.
Moving on.
And I think important changes and we're going and Youre seeing Doug.
Need us to be able to deliver care to more of a patient.
Most of the patients that we and we actually have.
And this is also being backed up by the data that has.
And I come to fruition over the last few years and some of that has come by Ash multicenter trials registries and some of it is still ongoing and his team is going to come to fruition over the over the next few years, both David and his new iterations of my mind that D. C. J.
Thanks.
Moving from a purely drug based therapy into London, and personalized and interventional to get all the patients better faster and also deliver better loan from results is the undoubtedly 1 that's going to continue over the I think the years and decades.
Thanks.
The news.
The international P marketed intervention of array Mark Thomas Merton and dimensional of DVT market I think there's only kind of expand and.
As we see improvements and patient outcomes, we're seeing drivers for that expansion coming not only from physicians and the location of the patients themselves and it is extremely common way of buying gas.
Email and direct messages from patients who are searching and.
Bob.
The resort and the 1 youre getting the just medications and they want to go to some of them or.
What do they have access to beans, and high end devices, and therapeutics and hopefully high and consults.
So thanks.
A brief run through 1 of them.
I think he is 1 of the most interesting and in fact, the areas of medicine at the moment, which is D day therapeutics, and where things are going and I look forward to the journey and we're gonna see over the next little while.
And we improve our patient slides with the with these devices and whatnot and thank you very much.
Got it and Moriarty you are an important voice and we appreciate you sharing your insights around not only of the disease state, but the innovation that is needed and better treat those patients. So 1 of the devices that he mentioned that he has a relationship with of our and get access to them and let me just unpack the.
It's a little bit more share from some of the details and more and probably be advantages of the anda back offers physicians and more importantly, the patients per day, 1 of the biggest differentiator is about age of axis is a fun.
Hello.
Well the rest of the 20th Thanks, Tyler the funnel actually opens up to a 42 fresh items.
We're able to better true and in an efficient manner of grabbing that cloud and I promise as a matter of fact I had the physician tell me natural and well you can imagine as and Anaconda eating of goat, which kind of paints the picture for the right there and additional to the finals and the Engulfs, the which became the Lidar and then.
The continuous aspiration system for that powerful and of course yet.
The clot removal, while simultaneously moving and the blood back to the patient and so there was no risk of additional blood loss now all of the great benefits that help the position with the range of that system.
And it is more of an advance of a complex procedure. So that you have.
At the half perfusion and support to be wanting the centrifugal pump so being led by physicians and listening to them and hasn't been pallets and would love of the benefits of the end of that system more and the control of our hand without the need of a per P. S and the world. We took all of that and I'm extremely excited to introduce here for 1 of the first time.
Our next generation and you're back system, which is what we're calling the alpha vac.
And so for me most of them the best.
Mechanical of aspiration Tonight, and we also have access to the.
The answer is that right.
The range of proprietary technology that would be outside and inside.
But the most of the measurement.
Best of mechanical and aspiration, but I took the helm.
And the eliminates the need for profusion of support from all of them.
No Jim.
Thanks.
The answer of that came with it.
And so the non surgical removal of eschar, Mike and black.
From the venous system.
[music] the answer Matt Hewitt.
And just the bathroom choice for many of them.
And the best mechanics of the aspiration system.
[music] the onto that system of in terms of the vehicle.
And I think the advantage of not seen in the market today.
And the answer that the system incorporating type of house 90, some of the central technology.
I think the economically designed alphabet aspiration and the.
And 1 central procedure, Mcdonald's and election.
And so we set the vacuum.
And the loaded you remember it sounds like the correct.
Purina control and Lindsay the and the handoff.
The operation of hand, I'm sort of aspiration.
First of all of them eliminate suede and heard of and minimize the blood loss and while navigating the team and hunting for Scott.
Okay.
And the vacuum locking mechanism allows the negative pressure can be maintained the freeing up and he says.
The Orange bar of the maturity of has been upgraded to the canyon.
[music] the answer about the test and can be used from amendments.
And in the in theory, the and it came back and disappearing and relocate.
And so I didnt transition of the Jennie O and the rate hike.
And that's just an <unk> of 19, 1 and I'm sure I've kind of thing.
And then left and right.
And that's another loan or the NASCAR rights Summer day.
And the Canyon and that comes with either of them 20 degree 180 degree it sounds like sand and I must say limestone Kim.
Listen all of you and bodies and mountain and framework to establish consistent predictable and the fishing deployment of the aspiration.
And most of the anatomical locations throughout the last 1 of 2 items.
[music] upon the last navigator and the desired and chemical location with material kind of thing.
Total net income mainly 10 day with the material.
And once the mcmillian and they can gain.
And then moving from the last spring and moving the handoff the 30.
See the setting and engage the.
The back to and Roc mechanism and maintain maybe from Russia to ensure all the material.
Let's go and that's kind of.
Minimizing deadline.
And the material events section and the canyon to release the range now and into the trends.
And I suppose back making sure the vision of a measure of how much Brad and the county hours from the Eaton.
[music] the answer that.
And the assumption for a large part of material and the bema and system.
The confidence.
Jim.
[music], it's powerful it's controllable by the end of the or the physician and it's worth a total of being able to be used as the first line treatment by total them into account all of the benefits of the ends of it.
And that kind of off the funnel take shape the angle of it which we have but putting that entre of mechanical mono of handle to give more control and reduce the risk of some of the challenges associated with treating and the type of patient and the start of the handle because this is where a lot of thought and attention by our physicians went into the.
Well listen to them and said and what are some of the challenge and we're having 1 of the and risk associated with it and this 1.
The simple the real true of device.
And after the last to be able to remove the most amount of clock and the least amount of time without having a lot of blood loss first of all the start with the volume and limiting switch where all of the switch on the handle itself that with all of them between of Timothy I Love the.
Aspiration or pool that we're pushing.
And from a physician is that and they are tracking ahead of the hunting for the clock. They can pull back from since he is without a bolus of blood and whats the onto the cloud and they will do of tactile flow that will allow them to alert them and they had been there but the museum.
And then between of Tennessee over to a third of something to be able to pull more of that powerful aspiration back into the handle itself that once they are there and we talk about the consumer with aspiration with the underlying all of that have to do the block The act.
And the handle and place and now all of the sudden get the.
Continuing the aspiration and unlock the removal of the claw back into the cannula, and then finally and really important that thanks.
And it completely and closed system and what I mean by the out of the mill.
All of the clot from the pension and the <unk>.
And I'll start and stop for every actuation and actually moving that into a little stag and a computer and a close system. So there was none of them studying over the term.
And we're studying and with the land of dumping and on the back to the within the lab.
It's controlled it's simple, it's intuitive and more importantly, it's powerful.
As discussed and venous thromboembolism is not convinced from 2.1 area of the body of vessel that can happen and a car from your neck kidney and everywhere in between and amongst all of us.
We are trying to navigate tortuous anatomies with catheters and cameras and devices that are purpose built the varying vasculature, which as wide a range of dynamics will be watching.
Watching our portfolio of restore the flow of the therapy products, but with the answer to experiment and to the back line and all circuit and trying to the non rhetoric of first line and mechanical thrombectomy market. So the Ah ha.
And if you will of coupled with a unique on the sizes.
The pain of links Mark ratios and final allowed us the Russia to choose from a comprehensive suite of devices. The best treat the patient population and as.
And sort of assumed of 5 P and K class, while the first 2 alpha that products are F 'twenty through 'twenty and F 'twenty to 180 <unk>.
22, representing a total of of French size, and 100, and Amy referencing the trip angle of the degree of both.
The much matter and treatment.
M P.
And as a flip of angles are available and both are and who Iraq and alphabet platforms. When most of them soon after that will be all day.
The <unk> 85 alphabet.
Which was developed with and 85, the Greens with angle to better select the pulmonary arteries, what's on the market and we're moving.
And through our <unk>.
And for product indication and lapham, well the size of the tender or catheter of Camden, and limiting our roots and first of them to the lower extremities with true commonly reside and will come and working on the next the alpha and rack of 13, which were a loss of vision.
Sales of our Aframax system with a follow up the cannula and the lower extremities, all the sort of keep you updated with our progress of that fine. So I had the pleasure of walking you through all of our R&D investments and now I had the pleasure of introducing 1 color of our senior VP of scientific and clinical affairs.
And through the important because 1 of the investments, we're making on the clinical side of all things and the promise of management.
Thank you Scott.
And part of our advantage of backing off of that products will continue to make investments to develop clinical data that demonstrates the unique science and outcomes that our products enable we are committed to developing the data sets that will allow us to get regulatory approval and get payer access for patients and rent and the market by having competitive data.
And remember, we announced the safety and efficacy results from a rapid study results for share by principal investigator Dr. John Mariotti. The registry was designed to evaluate the patterns of use safety and efficacy of the and you back system and the bulk of them Louisville of undesirable intravascular of material there.
Registry and while 234 patients across 21 sites, surpassing 200 patient enrollment goal among enrolled patients, 49% had masters and the right heart, the only 6% of cables around by 9% and had catheter related from buy and approximately 2% had a pulmonary embolism.
And in fact system, 70% to 100% Columbus of mask removal was achieved and the vast majority of patients and what the weapons registry data and demonstrate is that the envy of access and can safely and effectively remove vascular that's run by and cardiac masseuse across a broad range of patient populations.
And we're also validate our belief that physicians on that side of the high with the current treatment options for P. E and are starting to explore the possibilities and use them.
And he of X systems and patients with Pes.
And P E R M.
And those have lessons from our customers and I have developed the F 18, and 5 P. E device, Scott and just announced the FDA will require a clinical study to support that indication.
And very collaborative and pre submission process with the FDA, our clinical and regulatory teams feel very prepared to submit that trial from I D. Approval. Later this year lastly to learn from the initial launch of the Alfa that F. 'twenty 2 product family, we intend to launch a new study to capture of real world experience.
And with the new off circuit the device.
And I agree and venous anatomy, which includes quite and transit and the right heart peripheral vasculature and proximal Iliofemoral tvt's.
Recognize the importance of validating our technology through data collection that can help guide payers and physicians to better treat their patients.
Back to you Scott.
And thank you Juan Carlos well said as always.
And talking about our technology, and the innovations and our product portfolio, and specifically alpha vac and ever mindful and share with you the tone of the draft from the market to witness the devices and will need not only of the move of our physicians, but more importantly, the needs of the patients that are suffering from being a problem of embolism.
Although that some of them will be lots of them and technologies and expanding indication and intentional timeline that will strategically unlock access to more clinically effective and larger patient population and the need of improved innovation and advanced personal care and wellness and.
And I wish I know and well I intend is to offer 1 of if not most.
And those comprehensive thrombus management portfolios and the market, which will ultimately considered the help drive angel dynamics of transformation, which I'm incredibly proud to be of part of back to you and Jim.
Thanks Scott.
You can see why we're so proud of the design and the development work and went into a new alpha Vac and mechanical thrombectomy device.
Listen to the users of Asia back and listen to as to why the thought it was unique and special.
And we incorporated the voice and the feedback into the design of Alfa Bank.
We believe it will be part of the confidence that you will need to treat more people with different types of <unk> from using mechanical thrombectomy tools.
And we look forward into growing the segment.
Now let me welcome Scott back to speak to about <unk> of <unk>.
And the device.
Thanks, Jim.
And the first 2019 when he gave me an ex first announced its acquisition of XOMA medical and technology, the xylem true patient suffering from peripheral arterial disease or as we refer to IPD and and the 21 Central and then Dizzy the team now.
And now known as <unk> and has been the living will focus on.
Executing a thoughtful and strategic commercialization plan.
Sales team of experienced professionals, who are ready to partner with physicians to provide best in class service and security and scale our supply chain to ensure that we can meet our customers demand.
And last our technology during period of the awareness month in September of 'twenty, and 'twenty during and unpleasant rainy period and.
The 1 not only of the challenges.
Challenges to overcome and a new way of thinking to meet the needs of our customers. So that's still true today and looking back on what the team accomplished during its first full year of product availability and income.
None of them and proud of all the work and I felt that the estimate and true function all of them.
And the rest of our technology and more importantly, the innovation under the law.
Growing up the partner with some of the most the experience and knowledge of both physicians and the world to help advance patient care and wellness.
And let me go back to the beginning of share a little bit about why we made the decision to acquire the next generation.
Technology known as already on the.
Starting with the most of its rate of 8.
And the American over the age of 50 have peripheral arterial disease and the same patient are 6 times more likely to have a heart attack and if left untreated for a long period of time can move the limb or unfortunately the life.
The road, it's an incredibly large patient population, who continue to of why on the care and the potential of physicians and more advanced and and technologies to help prevent and true with devastating disease.
And the promise of volume of the disease. So lets can range from lifestyle modification to medical management to Endovascular procedures like atherectomy and can help open the blockage and the vessels and an effort to preserve ones and save lives throughout the rest of the procedure alone is currently of 600 million dollar market growing at 16.
And the person who every year from them.
And the move from better treatment technologies within the patient population and a growing and substantial market. It moved from the very compelling acquisition opportunity and although the market with southwest convincing the list of technology, but ultimately demanded and yet the inc.
During our time together to day closer and work at the technology and share with you have the winning the change everything.
That said, it's my pleasure and so now introduced I could total das and interventional cardiologist from there.
The little higher income food, and Dallas, Texas, and so they're really not familiar with the batch of dos and 1 of them at the spring with the prominent figures.
And the treatment of peripheral vascular disease and win.
1 of the first cardiologists to the board certified and Endovascular intervention for peripheral vascular disease and as.
And thank you very much from that kind of introduction Scott. My name is launch of turned out from the intervention cardiologists and practice here in Dallas, Texas and all.
And from Congress, and the cardiology and I was actually the Endovascular of large company intervention and I've been involved with and a multitude of clinical trials as either the primary investigator of some investing and Polish lives are widely and the seals and also because of our lasers and have since 1997 and facts.
It was.
Trained with the original part of our lasers and gene called the immuno and Germany and learned of the technique and the technology of of.
The total occlusions and therapy et cetera, with him and using lasers and per published on that sales and things of that done.
Doug.
Of cases, including Euro PCR TCG and others for many years and I'll just talk to you know moving over the next few minutes about my background and.
And about what I think that the sorry on laser can do and it capabilities and also some of the uniqueness to the device itself and the strength.
As Scott has mentioned previously and I think.
The folks on this call understand and patients and see how much has been completely exploding. The vascular space itself is the high prevalence and the interventions to improve outcomes reduce the end loss and from there.
And looking for therapies that are beneficial in the space.
Think about the laser and unique properties and 355.
Nanomole nanometers at the very specific wavelengths, and we know how of the different wavelengths of lasers and they treat the plant differently.
Wavelengths around the 355 and he has the ability to act on and soft plaque and hard plaque and the large quantity and ways that are very safe effective and allow us and mechanical and sort of chemical and check on the plaques and what does that and that means that when you are evaporating.
Built up and the arteries and share awesome, creating and and just seeing what the underlying vessel.
And makeup is an iconic uncovering the lesions and when.
Of these type of devices and the ability some true.
Thanks, very effectively and.
And the ability to have of Catherine and also as aspiration, you can actually talk out of and pull out of some of that cloud of material, which is part of the plant make up the other thing.
And we look for when we're adopting the technology does is it easy to use the spectrum that ex laser which is down and some of those laser and a long and setup time and it's a very heavy device.
Compared to the argon lasers, if you think about the ease and.
Procedure.
And you want to be able to plug in the catheter.
System and be able to easily immediately. So this device is a solid state devices as opposed to excellent of laser basically be exciting guy and I wish the spectrum. Thanks laser has gases that are inside of very large.
And Dubai.
And the push around and takes 5 to longer minutes to be able to set up business.
And the majors and media and plug and play and.
And there's really no setup time, which is actually advantageous to us English and he does aspiration, so kind of in the call.
And that blackout and thank you very important Doug.
And when we look for companies that have and great relationship with <unk>.
And physicians, who want to improve the technology and things.
And I was very impressed with is the desire for the answers and age group and particularly Scott and his team to reach out to users and so we're going to do a trial kind of path.
And we want to pick 10 sites that have experience with these type of devices. Every 1 of those of you like where does the saying 1 of our and did not work. So we embarked on the trial together and where you all enrolled 10 and 12 patients.
And after and learning.
The 100 patients I think we learned how to do.
And the tremendous capability and the ability to visualize Blackberry and unique way.
The company Who's listening and we said there are certain things that need improvement on like the end of the catheter meeting a little bit more and take or pay.
Changed and we said we need each other.
And we're working on them, so I think that the.
The collaboration between the company and the and the users is very high.
So it's a space where there is the name from each of those 2 and it's been proven in the past 2 years and really improved outcomes and how can we have the company is willing to listen to the operators and users and then.
And could you and trying to make this and useful and think of all of those things make it quite unique and our space to add and collaboration like this because we think that these tools and continuing to evolve and as they evolve and I'm going to get better and better and to be manpower and patient. So I, just want and thanks and your dynamics and.
To be able to help us.
And the outcomes of having devices like this and listening to operators.
The significant amount of experience and be able and should work together and trying to make better device. So when that and thank you very much. So thanks.
Very well said I appreciate you sharing your insight and discussing the overall of the real estate the true.
Volume is that physicians are continuing and the first with and how the technology has proven to address the challenges and help advance patient care and I wonder if the taken opportunity to unpack some of his comments and provide some additional details that make the all of that system, Sydney and special and how it's changing the way of patients are being treated with our device.
Let's start with the basics of the nuts and bolts of the leader of system. That's the most.
Good morning, Betsy with the rest of them and moving to often and she's dynamics and why.
And the really important and know how.
You can visualize the mechanics of how the little of it works within the Russell portion of the quick video.
[music] and the ion system, if the next day.
Thanks, and on peripheral atherectomy and technology.
Third from size of to choose from.
Catheter designed to share the first batch of my career.
And.
[music] the cash.
And so it might be the ability to treat most of the bonds the labor.
All of them.
And I were below the line.
[music] the I am for some of the best technology.
And so true.
Jim.
The system delivers a lot of them with an optimized way later.
This win.
And so the dominion of greater power.
And without sacrificing safety.
The netting of dealing with the looser and let us remember.
The weighted.
And how does the type b.
And so if that much and clinically proven the model.
Type of income.
Okay.
The license.
Thanks.
Most of the part that is true.
Procedure.
Relative to the efficiency would be OEM system.
The central capability.
And I took a bunch of years.
And the impact of the.
So listen and learn and beyond.
And so it's not in the office building and the aspiration.
Of the Who's got the embolization.
And I did and biological reactions are utilized.
Thanks, a lot of corporation.
[music] Kimball.
And of the filings the bulk of it.
Howard.
So and and Christmas.
And the ion systems of both technology and it does cause.
Some of the other income and Joseph.
[music].
On the road.
The first go live every day.
Thanks.
As a reminder, all of you on a very solid.
All of the rule that requires no toxic gas or continuous calibration is small.
The lightweight and has lived with and intuitive touch screen for optimizing the experience the spend.
And it and convenient power source of allowing the customer to plug into any 110 volt power outlet.
Without requiring the neutral of retrofit and existing office based lab or hospital with a special outlets like the Philips laser requires.
The food system of equipped with afterwards from capability and the need.
And with our 2.5 of our 2 pointed out the disposal of 5.
And it helps from the Bristol mye from occurring during the procedures.
Although as much of that of like the physical features of our capital and our system.
And the wind side that matters most and.
And I want to walk you through the science of all of our technology and more importantly, how of changing the way for this and we're able to treat their patients and.
Most importantly, how patient outcomes are improving as the wall.
The audio system of design can deliver and optimize wavelength impasse with that increase the amplitude to remove the multifamily and tight while preserving the vessel wall endothelium simple and quick.
The work across most of our follow the rules and without harming the mood of muscle wall. The.
All of the system and tell just by changing the game across all of them of their science, which includes providing a moving.
Paul Smith, and amplitude and the treatment options for <unk>.
Starting with the 55 net of them.
Suffocation the Ali.
The gun system and everything.
The length of systems with the moving of the energy to be hard on calcium and Scott on vessel wall.
And I would say more of a shallower depth and shorten the range was often and lower photon energies.
This concludes the lives of a sharp enough to penetrate the plaque but small enough that could damage the vessel wall.
So we're looking at the cost of goods.
And amplitude.
And the audio system is developed and deliver optimal amount of energy the effective treatment, but without compromising the really.
The range of fiber up and come up.
No 1 has been able to deliver the we're not in any of them 2 of fiber without the catheter with the weighting to a point of failure. Its the difference and the path with the close of the optimal amplitude the plan.
<unk> modification and then.
From 1 level of income from this point, because it's important our share.
And the pathway allows all around to the part of any of them quickly and the appeal to me the income faster than the competition.
And the contact and the literature, the Russell role of so short at the little kind of damage the mill there.
Sure.
So a little bit of all of them here.
And actually need why shouldn't and care.
Transition of care because of the audio system hasn't been moved from moving technology and allows them to treat.
And of physician and counters all of the single device from a smaller footprint of small portable and convenient of power source to a broker and aspiration, coupled with a comprehensive line of Katherine well above the knee and below the knee applications, including our instant restenosis indication the.
And so it's kind of Inc.
2 of them.
How's the worst neutral proven safe and effective technology for any of them.
And the patient.
The talk more about the first day of ion and the compelling body of evidence with the system and 1 of the world.
Apple solution.
Moving to move 1 call of senior Vice President of scientific and clinical Affairs Juan Carlos.
Initially announced preliminary interim results from the past finding of registry the path.
The final regulatory and prospective multicenter single arm I'll come to the registry to evaluate the use of the ARIA and laser and a real world setting to treat and novel and we used the Nordic and ISR legions of peripheral arterial disease patients. The study enrolled 100 and for patients.
Preliminary data show the high procedural success, despite a variety of challenging lesions, including the long occlusions severely calcified lesions and ISR and.
The primary endpoint of successful vascularization of the target of vessel defined as 30% residual stenosis and the index lesion.
The ion and find out of adjunctive treatment as evaluated by Angiographic core lab.
Rare to have the registry study called out of adjudicated Jill we thought it was important that the first real world data available from our unique laser the independently verified.
And the safety profile is also work and promising and the primary safety endpoint is the percentage of subjects with freedom from per pushing the major adverse events.
6 months results of I expected by the end of 2020.1.
And your study.
And generally of the addition of hypothesis of the acquisitions are eager to explore the civic and shows has been express and the below the knee application of <unk> and we will continue to listen to the physicians, who guide us as they consider the best treatment options for their patients and we will continue to invest and datasets that quantify the unique.
Outcomes of our product not only from regulators prefer patients payors and providers.
Scott back to you.
And thank you Juan Carlos so right.
And Mike We started this turning 20 months ago.
And that's the real customers real inventory and really the sales, but they started with 1 amazing technology.
37 from dedicated commercial representative with cash over 5000 procedures above and below the knee and we have over 132 customers that contributed over $11 million of revenue during 1 of the most challenging and I'm proud of it and tie in and our sales history.
In terms of live and over in fact, it's just beginning.
We saw the tremendous amount of and growth and upside of the meeting the increased demand of a practicing physician.
And while listening to our advisers and our customers to capitalize on the experience and to optimize our technology bill rates and in turn by the address the needs of the patient suffering from the 80.
And lastly, beyond rest of the atherectomy and actively working on pursuit of new markets with the <unk> technology, and the meantime, I'm incredibly proud and honored to have the opportunity with our teams the place with technology and the hands of skilled physicians from across the country together with our technology and the clinical expertise will help.
And the advanced care and wellness the pollution could avail of improved treatment options and the.
The process, helping drive our organization's transformation.
You go back to you Jim.
Thanks Scott.
Really appreciate the team at ARIA and how they've taken this amazing technology to the marketplace over the past year.
And good here the indicative of how we're going to invest and our businesses over time and range of dynamics and gone to investing of based technology and the science behind that as you saw and the presentation and now we are investing in the clinical and regulatory work and necessary.
And the added room rate selling and marketing people to support our customers and.
And that's why when I talked to you about the investments that we'll make it covers each of those parts of respect of each of those are important and grow our businesses and now let me walk and James from boss to speak to you about and then on items.
Thank you Jim.
My name is J from a senior P. M of the net and I portfolio and I look forward to this opportunity to speak with you about our business and and another amazing and the dynamics technology, the man and I system. The.
The end of oncology is at war with the complex group of diseases.
Physicians are continuously seeking out novel therapies to provide comprehensive and personalized care for their patients.
Unfortunately, the local treatment for solid tumors come with substantial tradeoffs traditional methods.
On mechanical energy that the strength is everything and its path, including the underlying structure of tissue known as the extra cellular matrix.
So the physicians most nonspecific destruction is a problem.
Can limit the patients that they provide treatment for and for those that they do treat Kim damage too much and reducing their quality of life.
The name of my system solves these problems.
Of non thermal energy.
So it arises target of tissue and lose the extra cellular matrix and damaged.
This preserves the body's ability to regenerate functional vascularized tissue, including blood vessels and nerves inside the treatment area empowering physicians to provide a local treatment, while maintaining their patient quality of life.
Today, the man and I system, and revolutionizing the way and physicians provide local treatment.
By creating more opportunity to provide care to more patients.
The other thing new markets that our competitors are unable to access.
To better understand why our physicians are choosing the man and I system, more often and let's take a closer look at the science behind this technology.
Thanks.
Thanks, Jim honestly.
Moving to inflammation.
And can you just talk disease tissue.
Jim.
[music] and basic needs.
The physician.
And the disease tissue and losing them.
Cynthia.
[music] voltage cruises and deliberately to Wilmington.
And being able to get into the leases.
And so the need is.
And of course of a menu board.
And of membrane.
[music] seamless and Jason.
Thanks.
The 1 thing and that kind of interpretation of the tissue.
The net configuration.
Thanks.
And so they can take the <unk>.
The removal of the cellular debris.
And any of them.
In terms of the contribution and the extra cellular matrix.
Jim.
The presentation of earnings from <unk>.
Elimination of though the CDK.
And the histological functional regeneration.
Treatment.
Thanks, Jim.
And so moving from the peak.
Thanks.
The increasing the vision.
And most of the team.
Sure.
Okay.
Incidents.
Precision empowered preservation redefined and versatility protected the nano and I system will imagine localized therapy for our physicians by enabling them to treat at times and locations previously unavailable to them.
And we're able to develop new markets and the treatment of solid tumors.
Now today, the nano nice system is indicated for the surgical ablation of soft tissue and.
And is used and many organs throughout the body, including the pancreas and liver.
But we'd like to talk to about our next opportunity they.
And the use of the and analyze system for prostate tissue now of prostate cancer is the most commonly diagnosed solid tumor from American men.
In 2021 and is estimated at 238000 men and the United States will be diagnosed with prostate cancer.
Now on a patient and diagnosed with prostate cancer.
The 2 available options.
1 they can go on active surveillance, where there'll be continuously monitored until the time of treatment might be required.
Many of these patients may never actually receive treatment for their prostate cancer.
The other option is the patient where immediate and qualify for whole gland therapy.
This is a radical surgery or radiation of the entire prostate.
So the gland treatments can have a significant impact on a patients urinary and erectile function.
This means that prostate cancer is the most solid tumor where the local treatment is not part of the standard of care for eligible patients.
There has been a growing consensus that prostate cancer has a single dominant lesion that exhibits life threatening behavior and.
Imaging patient staging and physician technique improves.
The local option to treat that solid tumor and growing and popularity.
This is known as focal therapy and can be used to delay the need or even remove the need for a whole gland therapy, allowing patients to preserve the quality of life for as long as possible now it has been estimated that 38% of prostate cancer patients qualify for of focal.
Option.
100000 men and the U S. Each year.
Despite patient and physician interest.
Less than 5 per cent of land actually received this treatment.
This means of a big gap between patients that qualify and patients that are treated.
And that is the 2 specific reasons.
1 the current technology of less than ideal outcomes.
Still has a negative impact on urinary and erectile function of many patients.
2 the current data supporting focal therapy is less than optimal as it often includes patients with Louis disease within the study cohorts.
It's Andrew dynamics is going to bridge that gap and develop the prostate market.
To provide a unique product that maintains a patient's of urinary and erectile function and.
And we can do this by preserving the nerves and blood vessels within the treated area.
We also need the performed rigorous and data collection on the right patient population.
And as men with intermediate risk disease.
If we can execute those 2 goals, we will be 1 of them.
Develop the largest solid tumor market and the United States.
Now I'm going to pass it over to Juan Carlos who will walk you through our clinical strategy for both pancreas and prostate thinking Jake physicians have used manulife and its unique mechanism of action and patients with various tumor is unsuitable for surgical resection.
Art and conclude the kidney and liver pancreas and prostate 2.
And who are targeted the pancreas and the prostate to sort of considerable investment and data development not only for regulatory approval, but to address data requirements from patients payers and physicians.
We've made considerable progress on enrollment and our direct study. This unique study design, including the randomized control trial and of real world prospective trial to obtain the highest level of evidence and real world evidence to confirm that the initial results published over the last several years of.
Transferable to a broader use of the technology.
We are pleased that world class institutions, such as the NYU, Miami cancer, Mayo clinic, and northern healthcare UCSD and many others have chosen to participate in the study by the company with a recent of ICD 10 codes specific to U S and the liver and pancreas. We believe that this is in the sense.
You'll start to expanding patient access to our unique <unk> technology.
And another significant investment and data and generation surrounds our prostate initiative. We are also excited to announce that FDA has granted us an IDE approval for a prospect of 100 patient study of nano knife and intermediate risk patients.
And partnership with the society of Urologic oncology will be launching of multi set of 100 patient study to demonstrate the safety and efficacy of net of knife and intermediate risk prostate patients. We are honored to have 2 P is that will scare of the study the I gotcha.
And Jonathan comment at Memorial Sloan, Kettering, and Doctor oven, George at the University of Michigan.
And we anticipate having 15 sites and the U S and rolling patients starting early next calendar year, Chris and planned study along with our recently announced CPT 3 code will be and essential milestone tuning share patient access to our unique technology.
The variety of and investigator initiative studies further support the sponsor studies. These include the Pan fire through study investigating the use of IV for pancreatic cancer in combination with immunotherapy, the Crows and Multicenter Society run 500 patient prostate registry and many others that.
And will further validate the value of our technology.
And 1 of the Iot is prostate cancer specialist professor felt the Stryker and <unk> pioneered the use of gamma knife and Australia. He joins us today to share his experience with the use of nano knife.
1 of them.
Thanks.
The incidence and Sydney and.
And the Institute of research.
And in prostate cancer research.
I have and immune the seamless.
And thirdly by the clinical and preclinical.
And after.
Explain my experience theme, none of our noncore items.
The first question and as well I would say.
Emission and patients went ahead and cycle.
None of our notwithstanding and I think the range and why because number 1.
And sort of trailing revenue the whole gland therapy cause quite a lot of side effects, such as interim Kim compliments director of damage.
And often we seem to be unnecessary and out of the truth, whereas total therapy, such as used Mcmahon and amount of therapy.
Of course is much less side effects, maybe mark no in the continent, definitely and a rectal damage and moving more intense and so and that's the day pursuit of just a request and basin.
It's the various site technology.
And the.
And my experience having years many of the other technology proof of this thing and find that the best of the available technologies to true.
Localized prostate cancer.
The way and things of that is 1 of insights true.
Tourism to be highly effective and reliable and killing tumors.
As volume and that's the nature of the tissue.
And number 3 it can be used and taken.
Net of the cross site and engage the public stumbles and number of pool, even if the.
The styles.
And 2 attempts salvage treatment such as surgery and radiotherapy so cost of goods. So no no breaches of the birds.
So our guidance the same shack sales.
Reliable.
Particularly in the group of people that are recommended by the consensus as of yet.
Does the intermediate grade cancers with seem to be a logical progression sales.
And I've done about 400 cases of the setback since 2000, and surging and try and the number of units and in Melbourne and Brisbane.
And now more recently and Blue Mountain States of Europe.
The results from buildings like the 97% clearance of Ciena.
And about a 15% recurrent and the rest of the cost side, which is the main of both the broker and if necessary.
Alright, Thanks, Bob.
David.
There've been no major complications and a literature and then in addition to that and you'd have less than 5% incidence drives and.
Zero Cassandra.
And <unk>.
We've used the back of radiotherapy thousands grow and then David about the publish items of about charge and by a job.
A randomized trial is about to me and some strength.
Okay.
Super Boston.
So in essence, this is a very safe and reliable.
I've been doing it now.
And 400 cases and.
And more interest at the time, rather invest in price and it's been the subject of.
And the complications from AD units.
The market size is enormous.
And then came and 20% or all of primary diagnosis of prostate cancer would be amenable to it.
And Bruce a question as to the.
And so I'll just go and into the website cancer of suitable thanks.
As we get better and selecting those patients may be with new markers and in addition to the excellent mountain and.
MRI and possibly pet scan will become better and selecting the spoon.
So moving forward I think manner and not as the best technology that are saying per trade and type of therapy I think of features very bright and doing.
And even has the potential to stimulate the immune system the ones James So I.
And the later.
And a strong supporter of the chip.
Allergy and on and the scientific results that have been added to the true.
And if you have the Louis Jim.
Jim.
The Doctor Stricker is cool and important voice and I'm excited he had the opportunity to share his experience treating prostate cancer now.
And as you've heard many physicians around the world continuing to refine and develop techniques for focal therapy.
Some physicians outside of the United States have added the men and I system to the toolkit to further investigate its use and prostate tissue and.
And we have been excited by the results.
This data is coming back as positive and promising showing that the mineralized system can provide a complete ablation of prostate tissue, but still preserve the erectile and urinary function of man and you see we are so excited by the men and our system because it is able to deliver a complete ablation with precise treatment margins.
Yes.
It can destroy tissue, but preserve the extracellular matrix, which leaves the functional regeneration.
<unk> and blood vessels and it can be used confidently and all segments of and Oregon.
And this is what makes it an idea of technology for focal therapy.
We believe the footprints we made today will be the travelled path of tomorrow by providing a new treatment option to help our patients who have happier and healthier lives.
Thank you again for the opportunity to discuss such an exciting technology.
Back to you and Jim.
So I'm glad you got the C. Our approach to minimize the wawa and making us a really valuable business opportunity.
Let me welcome Chad Campbell.
So you our vascular access business and why.
Total value creator for our company.
Thanks, Jim Hi, I'm, Chad Campbell, Vice President and general manager of our vascular access business and.
Today I wanted to take some time and talk a little bit about our medical device portfolio.
Each 1 of these portfolios of differentiated products and serve our patients a day in and day out.
If you look at this group of markets and portfolios, the really strong and have been integral and the transformation of the angio dynamics.
These products drive a lot of earnings from the company that help us invest and our med tech portfolio.
Today, I want to focus a little bit on our vascular access business.
And vascular access we're really proud of the role that we play and helping nurses and doctors faithful day moving medication worldwide.
We've had some growth in vascular access.
Really proud of and.
And there's 3 main reasons or imperatives, why that growth is coming out of business.
First is our portfolio.
Second is improved market access.
And third is our performance so let me rewind back to our portfolio.
And in the past 2 years, we've launched a number of products and our portfolio and helped us better serve our patients and customers.
We've done that from research and development.
Clinical and regulatory pathway of expression.
And M&A.
First we have the value line of deadlines and picks which had been of great balance to our bio flow portfolio.
Second we acquired I still true tip location and asset that has helped the nurse's safely deliver picks without and X ray.
And that's been a game changer for us because that enables us to put more of bile flow picks into our clinicians hands to serve patients.
And third we've launched our family of Smart Port plus and smart port plastic ports.
Which marries our vortex technology with our bio flow catheter.
And very well received by patients and clinicians around the world.
Second is market access and we've been able to improve our access to clinicians and patients by some of the product changes that we made and our portfolio.
Second is our 1 differentiator and that's our Biopharma technology that has given us more access to patients around the world.
And third our corporate accounts team has done an amazing job, earning came in and contracts.
And what we've learned is the improvement at our portfolio and combination with a buyer for the story.
It allowed us to contract more effectively not only at the local level with the hospitals, but also.
And that cover a large groups of hospitals.
And third is our execution.
And our teammates across the regions have done in our meals and job with our commercial discipline.
Our sales and marketing plans have been executed by all of our teammates and really helped us bring value and growth to the company.
Really proud of and vascular access and the growth we've achieved over the last 3 years.
Positioned to win the day and in the future and we'll do it by the same way that we got here portfolio improved market access and strong performance Jim back to you. Thanks, Chad you and your team have done a great job managing the vascular access business.
Now let me welcome Linda Upcharge.
She and her team lead our healthcare economics and market access team to help to ensure that all the devices and technologies and reach the patients the immune balance.
To ensure that the caregivers and get adequate reimbursement from the care and they deliver.
Under.
Thanks and again.
And you've had the opportunity.
Technology and the investments, we're making with all of the clinical data that can support us the Russian patient and Paris, and select the right technology, the right patient and the right.
Selling alongside.
Alongside those investments, we can tell me the make meaningful progress and market access.
First net 1.
And of the critical investments to interact and index is made up of the past due and yes.
Thanks.
Commitment to without a lot of world class health care economics and market access.
We now have the team with experience from public policy Health care economics.
And I'll, let you assessments.
At the same patient advocacy and society relationship Covid.
And market access across our product portfolio.
Example, we can tell me Kim with all of our customer facing tools and move towards to assure the customer of ours.
I understand how to accurately and efficiently and they all kind of services they provide with our products.
The support those tools, we now have the staff available to answer questions or provide weapons and there's 2 I'll provide us and my staff.
Last and we had the market access models to demonstrate the clinical and reimbursement opportunity how can the position and the value of analysis departments and hospitals I understand how all of them all.
Joseph can fit into their clinical offerings.
In addition to the customer facing tools, we've made great strides and working with our partners to develop new COVID-19 specific to our product.
Simple and October 2018, Medicare activating the ICD 10 code the payment at the.
Of all electroporation, and the liver and pancreas.
Provider than inpatient or hospital setting.
In addition, if Medicare payment, we've heard from our customers the most private payers and that's a nice and stuff.
Part of it.
All of the flu, but now the right patients have access to the right technology and the right setting.
In July of 2020 and feelings of the category 3 CPT code specific that's part.
And I would like to place on the payment after the first.
Louis and billing.
And that's where the first thanks.
And.
Notably the kinds of agnostic to all day.
And these kinds of align well with the interventional radiologists piece of all of them.
Some of our prostate initiative and that's the fact that many physicians will choose to move.
And the outpatient setting.
Colin place and we're now just the player.
And I'll spell electroporation and requested and championed by the Society of America.
Allergy and partnership with the American College of Surgeons.
These professional society.
And so the priority recognize from the clinical value of this part of that.
And wanting to say that the member they had the mechanism to the Finch.
David.
And what's the most of the TK.
And the approved by the American Medical Association Central to the panel.
Each of you and chose to prepare the inclusion of these codes and LPC and corr.
Our ambulatory payment classification.
And the tour of payment classifications, and the government's method of paint facility, the outpatient services and the Medicare program.
The purpose of carried until the final rule.
The codes were assigned to an ERP and the outpatient.
Outpatient hospital setting.
And that's consistent with Cryoablation and higher than other ablation of modalities.
Because of the also assigned reimbursement.
The <unk> totally setting.
And this progression and take care.
Okay. Thanks.
Set the stage the increase access to the army.
And the outpatient setting.
We're very grateful to have the American college of Surgeons and the society of interventional radiology for printing.
And motion.
And just sort of and highlight significant progress Pacific command and ice, but the work of happening and momentum is building across of Empire and sort of dynamics portfolio.
The Vac already said that all of this thing called family and thanks feature and its like the patents and funnel per drive market with the Axa well.
Possession of ion.
And the impressive market growth with that product, 1 day, and identify and market access opportunities and challenge for the P O the market as well as adjacent spaces.
The loose in the future.
And I look forward to share more on mezz funds and the near future.
Lastly, I want to emphasize the partnerships with the valve.
And that the professional societies and patient organization.
At the heart of what we'll do it and say the dynamics of the patient.
And there's a lot of the improved extend and because of all the devices and products and the.
Physician, it's Scott.
And to identify the right therapy, and the right sort of for each individual patient and mark.
Sure.
Likeminded professional societies, CT every day too fast and ability.
And I remembered and provide innovative and lots of thorough care to patient.
And we're proud to partner with them to the belt through thick and public policy.
Thanks, Jim.
Thanks, Linda we appreciate the work doing the teams have done here.
The group that will the leads is an example of the investments that we're making and of.
Our portfolio and the <unk>.
<unk> ended up.
Adding new capabilities to age of dynamics.
Now, let me bring Steve Trowbridge back and talk to you about our financials and our outlook.
Steve.
Thank you Jim.
And thank you for joining us this morning.
The Angela and ex management team really appreciate the opportunity to discuss the transformation that we've embarked upon.
You've heard about many of the exciting investment opportunities in front of us and we continue to focus on our med Tech platform technologies, and it's a fast growing high margin markets and which we have the technology advantage and that can drive both improve patient outcomes and overall shareholder value.
And you've also heard about the more mature and medical device businesses and how they provide the engine for investment and our growth drivers.
This morning during our fiscal year, 2020, 1 and fourth quarter earnings call, we discussed our guidance for the upcoming fiscal 2022 year.
We expect revenue to me and the range of $305 million to $310 million representing growth of 5% to 7% over fiscal year 'twenty 1.
As a reminder of fiscal year 'twenty, 1 included approximately $5 million from of onetime NHS order.
Excluding this order our FY 'twenty guidance implies a growth rate and greater than 7%.
And this revenue growth will primarily be driven by a med tech platform technologies ARIA.
And we're backing off of that and then of life.
And we improved the end of FY 'twenty, 1 for the $11.1 million and revenue per hour and we expect the ion to contribute $18 million to $22 million of revenue in FY 'twenty 2.
Driven by increases in both new customers and existing customer utilization.
Our edge of that platform grew 47% during FY 'twenty, 1 representing solid performance.
That's why the 'twenty 1 comparisons are somewhat skewed by the impact of the COVID-19 Global pandemic, we expect our mechanical thrombectomy businesses, comprising both Andrew <unk> and Alpha Zach the new growth driver and FY 'twenty, 2 delivering greater than 30% growth.
And we finished FY 'twenty, 1 with strong sales of me and I'll, let disposables and we expect manner of that probe sales to grow approximately 20% for FY 'twenty 2.
And we expect adjusted EPS for FY 'twenty, 2 to be between zero and 5 sets and.
We have discussed throughout today the answer there.
And he was an investment mode, we have identified and prioritized significant investments and our med tech platforms, and we are committed to making the necessary investments to drive top line growth as illustrated throughout all of FY 'twenty..1 we will continue to prioritize these exciting investments while being good stewards of the bottom line.
And we expect gross margin and FY 'twenty 2 to be approximately 55%.
And this would represent an increase of 110 basis points, moving where we ended FY 'twenty 1.
The increase will primarily be driven by sales mix of.
The gross margins do face the number of external and structural headwinds and mitigate the pace at which our strategic transformation can drive gross margin expansion.
We do expect the gross margins will expand over time, and we continue to execute on our strategy of driving growth and our high margin low tech platforms.
During the back half of FY 'twenty 1 of them.
And of external pressures resulted in gross margin headwinds and we.
We anticipate could extend through the next several quarters.
The tight labor market has resulted in higher labor and manufacturing costs and in addition, we've experienced significant freight cost pressures and 1 of them.
And we believe to be the winning of raw material inflationary pressures.
And many companies have discussed staffing challenges during the first half of calendar year, 2020, 1 and we're no different as we faced challenges and fully staffing our Queensbury New York facility.
We've got a talented and dedicated operations team that is focused on labor and service efficiency material pricing opportunities and make versus buy analysis.
And the external factors I mentioned and the eye on pricing dynamic stemming from the increased OBL index that we previously discussed.
It will impact the pace at which our sales mix drives gross margin leverage through FY 'twenty 2 and beyond.
So as we move into FY, 'twenty, 3 and FY 'twenty 4.
The move and the investment mode, and we continue to advance the strategic transformation that Jim talked about.
For our FY 'twenty, 3 we expect revenue growth to be and the range of 7% to 9%.
330 million to $336 million.
By FY 'twenty, 4 and we expect the Andrew dynamics to be of 10% to 12% revenue growth.
The projected revenue and the range of 360 million to $375 million.
As we've discussed throughout the morning. This revenue growth is predicated upon our med Tech platform technology is of Oregon, mechanical thrombectomy and men of life.
Becoming an increasingly larger contributor to our overall revenue base.
Throughout the planning horizon from FY 'twenty 2 through FY 'twenty 4 we expect our med tech platforms to provide a compound annual revenue growth rate of 30 to 35 per cent.
And we expect that more mature medical device businesses to provide a compound annual growth rate of 1% to 3%.
And we started FY 'twenty, 2 and med tech platform contributes less than 20% of our overall revenue.
By the time, we complete 2024.
And that those platforms will contribute approximately 35% of our overall revenue base.
Revenue growth and sales mix will drive gross margin expansion and while we do expect to see some expansion during all of FY 'twenty 3 and 'twenty 4.
We expect the headwinds I just discussed the par.
We offset the product mix benefits provided by this revenue growth.
The front of store I FY 'twenty, 1 that we discuss this morning, and our guidance for FY 'twenty..2 is a direct result of the focused and targeted investments that we've made and our growth drivers.
We will continue to grow and this investment mode through 'twenty 2 to 'twenty 4.
And we'll continue to invest and internal R&D and now we've had some great successes come out of internal R&D, including the angio, Vac and Dan and I 3 point of our product launches.
And we're looking forward to the exciting Alpha bank launch planned for this calendar year.
And we're absolutely committed to the mood of generation initiatives. The 1 Carlos sort of walked you through today, including our Pathfinder study the <unk>.
Canticle Thrombectomy pain studies.
Our direct pancreatic cancer study.
And the more of the prostate study the.
Approval of which we announced this morning.
Data is imperative to articulate our medical tech platform technology and value to physicians and <unk>.
<unk> and Payors.
And just as important as investments in R&D, and our investments and our sales and marketing organizations.
Throughout FY 'twenty, 1 we discussed how we were investing ahead of the curve to support our all of our launch.
We'll continue to do just that as we head into FY 'twenty, 2 and beyond and support of both our ion platform and.
And our mechanical thrombectomy platform.
Administrative throughout FY, 'twenty, 1 and we're committed to making the necessary investments and our business to drive future growth.
Which tempers, our operating leverage expectations, even as revenue growth accelerates over the next 3 years.
We will be good students of the short term bottom line, but we're also prioritizing the investments we discussed today to drive sustained long term profitable growth as we move into FY 'twenty 4 and beyond.
All of the out of the very challenging environment created by the COVID-19 global pandemic.
And as we sit here today, we're in the net cash position and we will.
And the very strong banking group, providing us access to a revolving credit facility.
We're confident that when the support all of the investments to drive our business through internal operations with 1 of them.
Any plans for the equity raises sort of a permanent debt on the capital structure.
And we'll remain opportunistic and disciplined and our approach the external M&A.
And look for tuck in acquisitions.
Support on the tech platforms.
And very pleased with the performance we disclosed this morning for our FY 'twenty 1.
We're proud and humbled by the perseverance and dedication and performance that everyone in the range of dynamics family exhibited.
And we're gonna take the same principles as we move into FY 'twenty, 2 and beyond and as we complete our strategic transformation to become a double digit top line grower and large fast growing high margin markets and which we have the technology advantage that drives patient outcomes.
And I said earlier this morning, I have never been more excited about edge of dynamics future than I am today.
With that I'll give it back to Jim.
Thanks, Steve and hoping you get a chance to see our company's transformation and Dr.
The C. How important the products you saw what they are how they work and why that matters to our customers will see that the basis of our transformation and as our portfolio.
But beyond that.
We're in investment mode Board and the dynamics, we are investing to grow our company and whatnot.
And just investing in our portfolio, we're also investing and the pathway of expansion.
Alex moving to get to market.
And the talent and capabilities of the people that drive our products and drive our transformation.
And joining us today now, let's move to the question and answer period.
Thank you.
And that would be conducting the question and answer session. If you'd like to ask a question over the phone. Please press star 1 from your telephone keypad and of confirmation tone will indicate your line is and the question queue.
You May press Star 2 of few late you move your question from the queue.
For participants who are using speaker equipment may be necessary to pick up your handset before pressing the star keys.
1 of my own police and while we poll for questions.
Thank you and our first question comes from the line of Jason Bedford with Raymond James. Please proceed with your questions.
Hi, good afternoon, and good morning, guys can you hear me okay.
Jason and thanks.
Uh huh.
Okay, and maybe just.
I'd like to hit on a few of the the key products here.
First on <unk>.
You mentioned 2 forno enhancements can you just detail a little bit on kind of the new features of the enhancements.
Also talk through some of the expanded indications that you alluded to and then finally, you mentioned adjacent spaces from Oregon, and I guess can you just comment on your plans for the coronary indication.
Sure Jason So 2 point of project really started when we first got the product in front of our users and our customers. They started to engage with it and treat people. So we're able to collect a lot of feedback on what they liked about the first design and what enhancements I'd like to see so I'll have Scott really give you a couple of details about what we're looking to do.
Thank you, Jim Yes, and the topics on the Doc mentioned you know we've been listening to the physicians from the very beginning of us implementing the technology into their hands and with their experience and 1 of the thing and it's really around the deliverability of the catheter itself.
We've made some enhancements to the tip to round it out a little bit more to get help get up and over the bifurcation and then in addition to more of the near term changes that we're going to be making around maybe a hydrophilic coating just again help with the advancement of the catheter itself.
And Jason asked about expanded indications and other areas that we're considering yes, much like what we've seen with the existing laser and the market right now with the the the Philips laser we know that they are and the coronary space. We're looking at obviously the benefits that we get with the $3.55 nanometer laser and the coronary.
The space based on the safety and the efficacy. So we're looking at that and we're looking at some other adjacencies as well from a from back to meat standpoint, again being led by the physicians trying to help guide us to where this thing can actually.
Play, even better than some of the existing technologies out there.
Okay.
Maybe for Alpha of Act.
Do you and do you plan on having some data before the fiscal 2 Q launch and if not when and when can we expect to see some data on the device.
Sure Scott.
Yeah. So we have some of the day to that we've collected already through the rapid registry, which I know John Moreira of Dr. Moriarty talked a little bit about and the and the last presentation, where you weren't utilizing some of that based on the advantages of the and you of that platform and then of upon immediate relief and launch and use of the Alpha Vac device we.
We'll be entering into a registry to further capture some of the clinical data and the results that we know are necessary to further confirm and validate what we believe this thing or this the alphabet system will be able to accomplish and Jason you can look at what we did when we launched the Oregon is a good example of how we will handle the alphabet launch as well so we won't have.
At the time of the launch will be doing a limited market release once that product is ready, but we will as Scott said the entering into a registry will be collecting that data listening to our physicians understanding what data gaps they may see to help us drive commercialization and the future.
Okay.
And then maybe a couple of others on the alphabet and I'll, let someone else jump in can you just speak to the call point here.
And the sales force.
And then expect to expand the sales force for this initiative and then also can you just comment have you filed for the 18 French device yet.
Sure.
Yeah, and so to answer your first question, Jason It's a good 1 right now with our restored of flow therapies of Venus sales team that currently sells and.
And and represents the and you back platform. The majority of our physicians that we're calling on today with that device is interventional cardiology as well as cardio thoracic surgeons and the benefit that we get with our core portfolio, our angiographic catheters, which is also and that same portfolio and.
It's really coffee with the intervention of radiologists as well as the vascular surgeons, where the they are predominantly doing the majority of these mechanical thrombectomy devices. So we have an existing relationship already with that specialty and the sales force will be able to re engage with them or further strengthen those relationships with the introduction of the of the alphabet.
I'm sorry, if that's true.
And I'm sorry can you remind me your second question.
Yeah. The second question is have you filed for the 18 French device yeah yeah.
Yeah, So where we are just about the file for that right on the heels of US obviously, just getting the the the 5 P and K clearance for the F 'twenty to 'twenty and the F..22, 180 degree cannula. So we'll be following for that indication within really the next month or so and we hope to have and approval on that very soon.
Okay, and just start getting back to the other comment.
Which physician some specialty do you envision using alpha back the most.
It's really going to be and the intervention radiology as well as the vascular surgeon call point again, as you know, Jason and 1 of the 1 of the challenges that we have are the limiting factors with age of Vac is just the access to perfusion and interventional radiology and in fact, the surgeons are really that first line and sort of the treatment. So they want something where they have.
Troll, they don't have to worry about the scheduling and the production of event and so we see that the alpha Vac system will play very nicely and that space of long wear and the Oriental and number of currently playing as well.
Okay. Thanks.
Okay.
Our next question is coming from the line of Matthew of mission with Keybanc. Please proceed with your questions.
Great and.
And again.
The Big picture question for you guys and when you look at the organization and I feel like you've always had technology and and larger tans.
But we're never ever really fully realize the opportunity. It seems different this time because of what are the more the most important changes kind of you've made with the organization.
And that investors should notice of they they have more confidence you can execute on these important launches.
Yeah. Good question of Matt. So a couple of things if you saw today the Tam development on the slide we put forth you'll see we're actually competing in larger markets than in the past, but youre right. We are still in large markets before Matt, but we took a look inside structurally and how we do business. So we tried to align changes to our structure when we made the investments and the products.
And then and the regulatory clearances that wed like to seek so we look at the company now that has the bulk of its resources deployed towards these devices and the larger markets. So we've done some shifts and the internal resources, whether they were R&D resources clinical resources were selling and marketing and customer service resources. So we've kind of shifted along the way he tried to time those sure.
<unk> with the deployment of all of these new launches and these spaces, Matt. So it will be really well resource to these areas with the larger Tam and the faster growth rates. So we can be prepared to take advantage of those.
Yeah.
And then as I look at Oregon, and I remember when you acquired the device. The goal. The goal was to get up to about 10% market share, which I guess, what it would be around around $60 million.
Are you far enough, along where where that may be the most most realized where that is of realizable share target.
And is that something you can do you think you can do with within the timeframe of of of.
Your 3 year L RP.
Yeah, you know, Matt you're right when we talked about the worst acquiring the product I think we've mentioned the 8% to 10% was a realistic we thought 3 year goal and I think that's still a good range to look at now we know so much more about of device and the feedback we've gained from our users had been really positive. So we still think that's a good range. If you look at what we did and you're 1 which really the launch wasn't.
September so part way through our fiscal 'twenty..1 you saw the guidance. We gave this morning for this coming first of all year I think we're still in the same range. We identified early on and if we see more of their will adjust with you.
Matt we're very pleased with what we saw in 'twenty, 1 for ion and remember as Jim said, we Didnt officially launch it until September and we were doing it in the year that clearly had a lot of impacts remaining from the COVID-19 pandemic. So we were happy with with the performance that we had and and additional part of that COVID-19 disruption is the fact that there's been a very big shift out.
Of the hospitals to the OBL, so as we talked about before about 60% of atherectomy, there's the ethnic and procedures used to be done in hospital about 40 per cent and the obl's over the last year, we saw that completely shift around and the broader market. The we're about 60 plus percent and we're being done and the OBL and for our business more than 90% was being OBL base. So were looking.
Forward to this year, where we think hospitals are opening up and we can start to shift a little bit as we said, we expect that shift to be sticking to a certain extent is not going to go back to where it was pre pandemic levels, but it's another opportunity for us to continue to drive this business throughout our planning horizon.
And when you look at that market and you broke it out by laser versus versus mechanical to get to that 8% to 10% share.
Are you are you is it is it taking taking the laser share or are you actually converting some mechanical too as well.
So you look at where and a large market is growing already itself. So theres market growth occurring as people are trusting atherectomy is and overall treatment of choice. So we're going to see that dynamic occur and Scott today and the presentation focused on our laser of science and how it's different than the other laser and the market, but when you look at the adoption of our products now and how it can work.
Above and below the knee, we're not targeting any 1 of our competitors, we're letting our customers lead us to where they have confidence. So really we think we'll gain share and the market takes share from the current players and also be part of the market development, that's occurring and the comment Scott Yeah. Thank you Jim I think 1 of the additional comments I'd like to make is and the beginning right I think the customers of that.
We're attracted to our young and we're already the laser established customers and what we've seen over time based on the efficacy the safety and the results that we're getting with all of you on going after that and mechanical application.
We're seeing a lot of growth in that area as well so not necessarily just taking the laser of share, but when we get into the below the knee more complex lesions and highly calcified lesions what physicians.
I've told us that they enjoy most of the safety profile that they get with the laser technology, but the efficacy of that orbital rotational device that you've seen some of those other competitive devices working as well with our laser system and and I think that's what gives US you know of.
A lot of confidence going into not only this year, but the years to come.
And the last question and then and I'll jump out around Alpha Vac, just which of those features do you feel are our most unique and and most of them protected from competition over overtime.
Yeah, so starting with obviously, the Andrew back system and some of those benefits of the proprietary funnel tip design that we're taking advantage of and attaching to the alpha Vac and mechanical manual App applicator.
That and in addition to the 10 of the 30 C. C. You know a switch so that the physicians themselves have more control over where they are going and looking to deliver or actually remove the clot from that area. So once they get there they're not removing a lot of blood. They can toggle between 10 and C. C and then over and of 30 theses the other.
A key feature is the tactile response I think when you talk to a lot of interventional, our interventional and they love to use their hands. They look for some sort of response and the devices that they are using this 1 gives them that so they know that there and where they need to be to be able to remove that clot and then when you put the vacuum lock on there the continuous aspiration that we.
See with and you are back now coupled with alpha that to get that same sort of modality and mechanism of action is what we're going to see hopefully some really exciting results.
Our goal is to be able to remove the most amount of clot and the most efficient manner, while reducing blood loss.
Matt We did a lot of voice of customer work and the design and development phase of the alphabet and the thing we kept hearing from from our users with a loved the funnel tip design and the control that we gave them with angio vac, but they said if you're going to develop and off circuit product, which of the Alpha Vac became they wanted more control at their hands and these are still skilled and talent.
And physicians with incredible knowledge and he said, let us use that give us the tool that we can use our skill. So you see the design elements and we showed you today of the alphabet and that came right from their voices to our design elements and our products. So we think there's a lot of features that'll be well received when the product gets the market with these customers.
Alright, Thank you all set guys.
Our next question coming from the line of Bill plan of it with Canaccord. Please proceed with your question.
Great. Thanks, Good morning can you hear me okay.
Yes.
Great. Thank you.
I'm going to hit it on the 3 med Tech first just start out with the nano Jim.
Can you eat and.
And this is driving the future.
What give us a ballpark for the 2021 fiscal 2021, and what revenues for nano and then how is that.
What's the mix between capital and disposable just so we have a good base to build off us.
Yeah, so the mixes and capital and disposables, primarily we were we were driving disposables as we got through our FY 'twenty 1 of our Q4, we talked about about $3.5 million for Fernando knives. So we were closer to that that 15 number for the full year.
Primarily driven by disposables as we talked about FY 'twenty was the big capital year for us even pre pandemic coming on the heels of the launch of the nano and <unk> 3 point O and we've talked about this year, we expect capital to be roughly in line with 'twenty..1 so the focus for US is driving disposable growth. We think that we can get disposable growth continuing at the 20 plus percent grew.
Both rate as we head through FY 'twenty, 2 driven by as Jim said earlier on today's earnings call increase the awareness coming from the direct study, but also increase the utilization coming from that installed base of the capital that we talked about.
Okay, and I'm, a little slow here. So total nano knife was $15 million for the year and what what percentage of that was the capital.
So the capital percentage would be of nano let me just get my numbers right for you and it's it's it's yeah, just just north of 10%.
Yeah.
Okay great.
That's very helpful. Thank you and then.
It is we look at the ARIA.
You know as you get into that market and that product comes out.
And today just.
Atherectomy is.
It has very low penetration rate and given the data you're seeing or at least the features and benefits of the improved safety and outcomes for this technology. Initially just curious as to what Youre seeing in terms of market share versus market penetration into the procedural opportunity and kind of where do you.
And you see that headed.
Yeah, It's a great question and I think early on obviously this is a pretty well established market already with some of the you know the 4 big players that came before us and a large market. So initially it was this market share shift away from those devices over to the Oregon system and now what we're saying is based on what you just said the safety the efficacy where.
Actually seeing more and more physicians looking to treat differently. These patients before again through less medical management and more intervention of our percutaneous intervention with atherectomy, allowing them to be able to treat more of these patients with again, the confidence of having that faith as well as effective procedure.
Okay and as you look at the just given your.
Your per each and you see the features and benefits of this technology I think the penetration rate today for atherectomy is about 5% you'll do you see this is expanding the market and if so to what level.
Yeah, I definitely see and expanding I I don't have numbers that I can quote at this point based on where we're seeing and what we're driving because of lot of our share right. Now is early on has been just that market share shift away from the competition over at sort of technology, but as I stated a moment ago. What we are seeing is more and more physicians as they move into obese.
All of which is what we're starting to see some of that transition or the care of our delivery of care moving towards we are seeing physicians what the treat these patients maybe differently than they have before and with the Ari on device, we're making sure that they're well aware again of the safety profile as well as the versatility and allows them to treat both above and below.
Oh, the knee and including instant restenosis, so how big of that 1 stop approach.
For these patients I think will be critical as we move into those markets even further.
Great and then just on the Thrombectomy segment.
A technical question, but you know as you launched the cannula is with the alpha of that product and the similar features that you see with the anti <unk> are those interchangeable kidney loser. They each specifically designed like alphabet has its own set of Cumulus and angio back as its own.
And said.
And Bill we took a lot of the design elements from Asia of that because we spoke earlier during our design and development process, but as we develop the off of Vac. We saw there of so many new features we wanted to add to listen to our customers. We really have 2 different platforms here. So angio vac gave us some of the funnel tipping obvious the large bore.
Parts, but really those design elements were brought over by the alphabet is really of new product.
Okay, and then just glass and pricing as you look at the market I mean, that's been and it's been Super fast growing market and as we see different players come in and how do you think about pricing versus of the features and benefits.
Well again Theres a couple of really good products on the market today, we think we're going to add and.
Give people users' choice as Dr. Mark I already said and our video earlier give these physicians confidence the treat more people utilizing this approach towards this disease. So we're going to price this product today, where the market sits at today. We think we have great features of benefits. We think the market pricing is about where we should be.
Okay great.
Great. That's all I had thank you very much.
Okay.
Our next question is a follow up from the line of Jason Bedford with Raymond James. Please proceed with your questions.
Good good morning, just a couple of follow up questions first and I'll come back and I apologize if I missed this but are you increasing the size of the sales force just 2.2 to 2.
To support the alphabet launch.
And we may have not answered it for you Jason So we did and we moved from people from other sales forces I spoke earlier question was raised about how we're going to address these larger market. So I mentioned about resource deployment internally. The first thing we look at this resource deployment. The second is expansion we talked to you about the investments we're making so we have added to the sales force as Scott described and we will.
Still look to continue to add once we launch the product and get more feedback from our users and will keep you and the loop as to how we do those additions and the future.
Okay, and then just a quick quick 1 on nano. The preserve study does this result, and a dedicated level.
Sorry dedicated label or is this study kind of bridging to another study that leads to a label.
Yeah. Thanks, Jason No. We expect the preserve study to be in support of a label for the treatment of prostate tissue as we've talked about before the FDA came out with guidance last year, where they were treating focal treatment of the prostate a little bit differently than they have some other cancer related indications. So we agree with them, we think that they're approaching it right and this is the study.
And that would then lead to an indication for the treatment of prostate tissue.
Okay. Thank you.
Thank you.
And there are no further questions on the phone I'll now turn it over to the angio dynamics seem to take questions that were submitted through the webcast.
And our first question and understanding the intermediate and high risk DVT market can you frame the mechanical penetration into the market.
Sure Scott Yeah, I think when you look at and the overall total addressable market with V. T. E. Those are all of these combined obviously with the pulmonary embolism as well as D V T.
The addressable market, if you reference our slide 18, and the and the presentation, we've actually taken that 1 step further we're segmenting those out and.
And we did so intentionally because of the cadence of which we are launching our products. So as you know our F 18, and 85, although it was designed purposely for pulmonary embolism and it will not carry that indication of what is the originally lots. So we just wanted to make sure. We're clear that our adoption in that space will be limited until we get that indication moving over to the DVT.
Side right. If you look at again Clarke and occur from NEK the knee, but we also know that we're somewhat limited just based on the size. So as you go more distal into the lower extremities.
Where were challenged a little bit with the size and with our F. 'twenty to 'twenty and our F. 'twenty to 180 <unk> at the 22 French device. So we're targeting that I V. C. S V C space to primarily be our entry into the mask and mechanical thrombectomy market from of DVT perspective, but we know that physicians are going to take.
And even outside of that probably into the early acts and maybe even further distal until we get our F 18.85 on the market.
Yeah.
Our next question what characteristics of product families, but you'd likely target when looking at tuck in M&A opportunities.
So really we love of the free platforms. We have today, we talked to you about how we're looking at our company differently and if you look at some of the support data. We gave you. This morning and the slides will give you a way to look at our company and kind of 2 portfolio of approaches with our medical technology portfolio that we spent the bulk of the time with today and our medical device portfolio.
And each of those would be resource differently and will approach our go to market strategies differently and even our strategic additions to the portfolio. So we love the 3 platforms, we talked about today with our Oregon or age of Vac and alphabet and are net of life, what I think you'll see from us of maybe smaller tuck ins or iterations that could help support these products with.
Our customers, but sometimes the customers are looking for ancillary products to use and addition to these devices. So right now we're really focused on getting these 3 products to grow and the marketplace and drive growth for Angio dynamics I don't think you'll see a major M&A move here of transformative move we've got the company that we're building internally that we have today, we like.
We liked the foundations and what you'll see that we'll probably add will just iterate from there.
Okay.
Thank you that concludes our questions submitted online right I want to thank you for joining US today, hopefully you get a better feel for the technologies behind our company, what we're doing with these amazing technologies and amazing people that work here the drive value and make sure our customers are aligned with our thinking and they can support the use of these products with the talented caregivers.
To make sure people can get care and wellness.
Thank you for joining us today.
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