Q3 2019 Earnings Call
Good afternoon, and welcome to Trust third quarter 2019 earnings Conference call. At this time, all participants are in listen only mode.
We'll be facilitating a question answer session towards the end of today's call.
Reminder, this call is being recorded for replay purposes.
I could turn to cold delivery service level, that's from become working group for your feet introductory comments.
Thank you my nine Should've received a copy of the earnings press release. If you have not received a copy. Please call 513 75, five more with respect to happen emailed to you.
Speaking today, let me remind you that the company for Mark include forward looking statement.
Forward looking statements are subject to numerous risks and uncertainties, many but your beyond stricter control, including risks uncertainties described from time to time, you need to true up you'd be filing. It occurs results may differ materially from those projected a bigger undertakes no obligation to publicly update any forward looking statement. Additionally, we refer to non-GAAP financial measure.
Typically revenue reported on a constant currency basis, adjusted EBITDA and adjusted loss per share reconciliation of these non-GAAP financial measure most directly comparable GAAP measures, including in our press release, which is available on our website with that I'd like turn the call over to Mike Carroll, President and Chief Executive Officer, Mike. Thanks.
Good afternoon, and thank you for joining us today.
We're continuing our strong momentum from the first half of 2019 total revenue in the third quarter of approximately $57 million or 28 consecutive quarter of double digit revenue growth.
Our topline performance was again driven by strength across our U.S. franchises.
With this strong momentum, we're raising our revenue outlook for 2019, which we now expect to be in the range of $227 million to $229 million.
This range corresponds to grow 13% to 14% for the year.
The third quarter was a very exciting quarter in transforming important for us here nature.
As highlighted by the strategic acquisition of Center heart paving the way for our direct entry into the electrophysiology market.
As we discussed August call announcing the transaction center or develop the Larry device, which is a percutaneous suture based approach to close the last April appendage.
This is particularly important given the ground support and acceptance of managing the left atrial appendage in the treatment of a fan and the growth potential within the EPA market.
The words device is currently being studied in the amaze clinical trial.
So what are your product is I'm working today in the U.S. under a five 10-K and in Europe . However, we expect very few devices to be sold outside of the amaze trial. Our top priority is to complete enrollment in this trial and we have made meaningful progress since the acquisition in August .
As of today, we have enrolled 579 patients and on track to reach for enrollment of 600 patients in the first quarter of 202020.
With the converge.
Deep.
And amazed trials, we are the only three clinical trials addressing the most complex and advanced form of a fad.
Strategically, we expect malaria technology to advance our position in the EPA space that is complimentary to the endocardial catheter ablation procedures and multi disciplinary approaches such as converge indeed.
Each of these therapies, obviously valuable treatment option for a fit patients and the total addressable market for a conversion deep and amaze procedures is well into the billions using conservative estimates.
Turning now to reporting results, we continue to execute and are seeing the benefit of our broad portfolio and robust pipeline.
Specifically in our U.S. business in the third quarter. We saw continued strength in our appendage management franchise, driven by our open and minimally invasive atriclip products. We again had meaningful contribution for a minimally invasive April pro two and a pro be devices as well as from are open chest ATRA club flux be device.
With that are open ablation platform, we remain focused on innovation education and training to address this large still underpenetrated market.
We are progressing with our plan to launch a new open clap in 2020, which we believe will be attractive to physicians were seeking a simpler and faster approach to bleeding heart in open procedures.
Well, we anticipate broad market appeal, we expect to be particularly resonate with the Cabot surgeons in the open can comment space and to be accretive to our open ablation revenue.
In addition in the third quarter, we received FDA clearance for expanded labeling claims for each of whats family devices.
We were able to demonstrate some clinical evidence that eight your Clint devices, both exclude and electrically isolate the left atrial appendage. This expansion of the Atriclip labeling is important because of course <unk> exclusion.
The appendage has multiple benefits over the past several years, we've invested in our Asia <unk> portfolio with innovative new products and the evidence to support increasing adoption.
Physicians continue to recognize the benefits.
What future appendage management and how the Atriclip line of last April appendage management devices conserved their needs in a variety of different ways.
The pilots here broke our dedicated device for managing post operative pain in cardio thoracic surgical patients also contributed to our strong U.S. results in the third quarter.
Well, it's still early and overall revenue contribution is still relatively low we're seeing this therapy performed well and our account base continues to build.
We are seeing we're steadily bolstering our small dedicated traffic team with critical resources to support cases in select markets.
Our approach is focused on death, rather than Brad as we first identify accounts that we believe in a comprehensive an innovative pain management program for their patients and then we go deep adding resources support case volume as a business built.
We are encouraged by our results and expect the traffic pain management market to offer significant opportunity over the long term.
Transitioning towards my assimilation business U.S. revenues were up 14% mcwhorter rebounding from year to date growth of approximately 1%.
This is consistent with quarterly fluctuations, we have been experiencing and this franchise and the variability that we expect to continue until we see received FDA approval of our Epicentral system using that conversion approach in treating symptomatic persisted for patients.
As it relates to the convert SRO I want to take a step back and review our timeline and expectations again.
The last patient in the study was treated in August 2018, and one your follow up was completed recently.
Our clinical team is working through the data and are on track to submit the final Camay module.
Including training protocols and other details by the end of this year. The conversion procedure is a novel therapy for patient group for whom there is no products within approved label for Standalone treatment of persistent and longstanding persistent a bit.
With that mine, we're expecting the f. data can be a panel.
We anticipate that we were at least the data in 2020, along with our submission in preparation for the panel based on this timeline, we're optimistic that we could receive FDA approval toward the end of 2020. Although this is clearly dependent on the process within the FDA.
Internationally third quarter results were up modestly with strength driven by our open and appendage management businesses.
We recently received CE Mark for Asia, Flex, the and probing devices and look forward to their contribution in the year and European market in the future.
Broadly speaking, we continue to see steady growth prospects in the end user markets in which we operate outside the U.S.
In summary, we are excited about our broadening portfolio and channels. This quarter and are extremely pleased with our track record of sustained double digit top line growth.
Now I'll turn the call over to Andy Wade, Our Chief Financial Officer to review, our financial and the outlook and war and will return for closing comments.
It's Mike for the third quarter of 2019 worldwide revenue was $56.6 million representing growth of 13.4% on a GAAP basis, and 14% on a constant currency basis.
Revenue from U.S. product sales was $46.1 million, an increase of 16% from the third quarter of 2018.
You asked open ablation revenue increased 10.1% to $19.8 million.
The addition of the KRYPTOSPHERE probe in early 2019 is creating continued momentum in our open ablation franchise, along with steady contribution from open claims.
U.S. sales of products used in minimally invasive procedures increased 14.3% to $9 million in the third quarter of 2019.
The improvement from the prior year is due to comparison with relatively soft third quarter minimally invasive sales in 2018.
As we have discussed on past calls, we anticipate quarterly volatility from this business.
You asked sales of appendage management products, which now includes delirious system were $16.9 million during the third quarter of 2019, an increase of 25.4% driven primarily by Atriclip products.
We again realized very strong growth from the Atriclip flex via device along with volume increases in the minimally invasive elie exclusion system devices.
We remain confident and sustaining growth rates for our appendage management products.
International revenue was $10.5 million.
Up 3.1% on a GAAP basis, and 6% on a constant currency basis as compared to the third quarter of 2018.
Open ablation and appendage management products are driving our international business this quarter offsetting a decline in revenue for minimally invasive ablation products.
Turning to specific markets, we continue to see growth throughout Asia and had solid performance in several key areas in Europe , notably the UK, Turkey, and France, with some weakness in Germany, and the Netherlands.
Gross margin for the third quarter of 2019 was 73.8% as compared with 72% for the third quarter of 2018.
This improvement is due primarily to a decrease in share based compensation from a onetime charge of approximately $500000 in the third quarter of 2018, driven by the retirement of an operations leader.
In addition mix was slanted to the U.S. business, which carries a higher gross margin.
We continue to see improvements to operations and lower costs, making strong progress toward our long term goal of a consistent 75% gross margin.
In the third quarter of 2019, we had an adjusted EBITDA loss of $2.2 million compared to a loss of approximately $500000 for the third quarter of 2018.
During the third quarter of 2019, we modified our definition of adjusted EBITDA to exclude acquisition costs due to their nonrecurring nature.
Approximately $3.6 million of acquisition costs were recorded for the Central Heart acquisition in 2019.
Our operating loss for the third quarter of 2019 was $8.6 million compared to an operating loss of $6 million for the third quarter of 2018.
Our net loss per share was 25 cents for the third quarter of 2019 compared to a net loss per share of 22 cents for the third quarter of 2018.
No that a 3.1 million dollar noncash credit to operating expenses was recorded this quarter related to the change in contingent consideration liability.
Without this noncash credit to operating expenses, our adjusted loss per share for the third quarter of 2019 was 33 cents and our operating loss would have been $11.7 million.
Similarly, a $780000 noncash credit to operating expenses was recorded in the third quarter of 2018 for the change in considered contingent consideration liability.
Adjusted loss per share for the third quarter of 2018 was 24 cents and our operating loss would have been $6.8 million.
Adjusted EBITDA results for all periods exclude noncash adjustments related to the can contingent consideration liability.
Excluding the impact of the noncash adjustments to the contingent consideration liability operating expenses increased approximately $10.7 million from 42.8 million in the third quarter of 2000 $18 million to $53.5 million in the third quarter of 2019.
Research and development expenses, which include clinical and regulatory activities were $10.2 million for the third quarter of 2018 or 18% of sales.
Increases in personnel costs clinical and consulting expenses and amortization contributed to the 1.6 million dollar total increase in research and development expenses.
SDMA expenses, excluding the noncash adjustments previously described increased approximately $9.1 million from the third quarter of 2018 to a total of $43.3 million for 77% of sales.
The increase.
Results from the central hurt.
Acquisition costs and higher personnel costs from our continued investment in the commercial organization worldwide as well as incremental Tradeshow and training activities and increases in share based compensation expense and other operating costs.
We ended the quarter with approximately $100 million in cash cash equivalents and investments down approximately $3.6 million from the second quarter.
Lastly, we are updating our guidance for 2019, we now anticipate topline revenue growth of approximately 13% to 14% year over year more approximately $227 million to $229 million on a GAAP basis.
We continue to anticipate gross margin will be approximately 73% to 74% for the year the absorption of central heart operating costs put some pressure on gross margin. However, we believe this is a small tailwind against the improvements to gross margin that we have made throughout 2019.
As a result, we're maintaining our guidance range for 2019.
As we've stated many times, we are still marching toward our goal of 75% gross margins and continue to make progress on this front.
We expect R&D expenses to be 18% to 20% of sales for the year investments. In this area include the amaze ice age Afib and deep AF I'd trials growing clinical science activity and R&D pipeline development.
We expect SGN, a expenses to be approximately 69% to 72% of sales in 2019, which includes noncash adjustments to the contingent consideration liability recorded this year.
The increase in SNA expense is driven by thoughtful expansion of our worldwide sales team investments in training and education absorption of Central heart operating costs, along with heavier legal and acquisition costs.
We continue to expect an adjusted EBITDA loss for the full year 2019 to be in the range of $7 million to $9 million after absorbing the operating costs of central hard since the acquisition.
This adjusted EBITDA range for 2019 translates to an adjusted loss per share between one dollar and seven cents and $1.14 cents.
At this point I'd like to turn the call back to Mike for closing comments.
Thank you Andy before we open for questions I want to take a moment of knowledge in September March national anthem awareness month.
This is a critically important time in which we work to raise awareness for his life threatening arrhythmia by helping the public become more familiar with the symptoms warning signs and available treatment options.
More than 33 million people are affected by if theyve worldwide and the majority of those are not addressed by standard of care through our social media channels, we showcased our white treat campaign and provide an educational information about a five each appears roll uniting patients with physicians in closing our continued performance reflects our.
Commitment to clinically differentiated products the diversity of our business and the overall strength of our organization. We believed that the addition of central art will serve to accelerate our strategy and will allow us to treat more patients with a fit thus expanding our total addressable markets in a meaningful way.
We're looking forward to a bright future shaped by growth prospects created by our many business catalyst such as converge amazed crowner block and several more over the next several years, we'll now open it up to questions.
Ladies and gentlemen, if you have a question at this time. Please press. This story and then the number one key on your Touchtone telesales.
Your question is been answered if you wish Jim we grew so from the Q. Please press the pound.
Your first question comes from the line Robbie Marcus from Jpmorgan. Your line is open.
Oh, Thanks, guys and congrats on a really nice quarter.
Thank you sorry.
I was hoping you could start out with sort of the early feedback after the lariat acquisition or center hard acquisition, what's been the.
Gushan.
Are you starting to see moving in with the EPA is that's that relationship starting to build ahead of converge next year any feedback you could give early on would be great. Yeah. It's obviously early but the integration has gone really smoothly on many different fronts I mean first.
More and more excited about the strategic nature of our that we've built great relationships for the piece on our side, but also they are introducing us into new IP that we didnt have they're doing a great job with their trial.
Little bit nervous when we bought them with that with the enrollment slow down and in fact, instead, it's actually accelerated and actually increased and done very well on that front.
Personally made visits to pretty much all the K wells that they were working very closely with and got very positive reception again, they're very excited about the amaze trial. The focus is on that trial. They want to make sure. We're committed to at clinically and then bringing that product to market.
Through obviously, great education, and training that we will kind of bolster the team with I've also been really impressed with the team at Central Heart just.
Top notch professionals across the board both in the field team that is supporting the cases onto the clinical team to the back office. There just wonderful people with a great culture focused on the patient they fit really well I mean, you go through these and you're not 100% share because you don't meet everybody when you're going through an acquisition.
And the people that are have just been fantastic benefit in really well and blended and great conversations are going on already in the field I'll say that but at the same time, we're very focused on the amaze trial, we're making sure that our teams are focused on that that were not diluting their attention from that and getting it kind of integrated out in the field quite.
Yet it's more been introductions.
And beginning to kind of create awareness, but we really want to make sure. We get that trial done we get an enroll and we're really going to hit the ground running.
Next year as well so.
It's going great I couldn't be happier with the acquisition and a more excited today than it was two months ago.
Great and then a follow up here are the two line items that stood out to me. This quarter were open heart ablation and HR Cliff I know this is not a new topic with outperformance.
In both of those segments, but was just hoping you could give a little color, particularly in third quarter, what you're seeing where the growth is coming from is is there any change in fundamentals or or improvements that you see that would be helpful. Thanks a lot.
Yes, I wouldn't say that there's any change per se on the open cetera business. It comes down to two different pieces, we can as I mentioned near here at the end, we're really pushing hard on this eighth of awareness in the treatment can comment only.
As you probably well know we've invested heavily to improve the penetration in the open space over the last seven to eight years since we.
Got ourselves the pmean that space and we've more than doubled the number of patients every year around the globe in the us in particular, there actually getting treated that being said, it's still only 25% of the patients that are on the table are getting treated dr. Mccarthy just came out a paper on that.
He actually analyze all the CMS data looked at it and demonstrated that there are so still 75% of the patients that have a fab that are getting operate on are not getting treated and so we've got a big underpenetrated market in front of us with that I think you see some of that that we will continue to have that with our training and education the programs that were running.
On top of that I would the other part of the open side of our businesses that we did get benefit in craft beer in the ground nerve block team as well. So we get a couple of points from that because that team is doing very well. It is small numbers, but it can impact that growth a little bit as well and kind of give us some good kind of behind the scenes numbers from there without giving specifics on the age.
For franchise it actually plays off of that opened business quite.
Extensively because a lot of eclipsed our the flex the clubs that are going in.
End of those open cases people just love that product spend on the market now for about a year and people are they're using it is easy simple its.
It doesnt cause them any kind of a t. when they actually placed the clip. It's a smaller profile. So I'd say that that innovation is continuing to kind of build steam and momentum in that opened business in particular, and then on the other side of our business on the M&A aside the strengthened my asked kind of helps off on that because its concomitant typically with that.
Your next question comes from the line of David section from.
Your line is open.
Okay, Thanks, Mike and Andy.
I guess just a quick.
One can you.
Let us know how much center heart.
In the quarter.
Very it was it was almost nothing I mean, it was a very very very small number was in this quarter.
Bottom on August 13.
Yes, when the focus as we were really focused on the trial. So it's very little bit of revenue in this quarter.
Okay, Great and then I'm just looking at the box client.
Can you can you talk about kind of how it's going to be priced and.
Maybe your thoughts on the pace of adoption once you onto it.
Yes, I think you're done with the new plant that we're looking at.
Or kind of the open part of our business.
And.
We're looking to kind of have that sometime next year, the pricing will be above what we're charging for the price of our product today likely we haven't set on a specific price at this time, but we do anticipate that it will be it will be far north of what you get with regular plan today, it's more sophisticated.
And it's actually obviously attacking the heart and making a lot simpler and easier for these physicians to get better and broader relations.
Great and just lastly, how are you progressing with higher and clinical support in advance of converge.
Great question.
We've been actually building out that team for the last several years and so it's.
Both on the clinical side, but also on our minimally invasive team to kind of get them up to speed I understand.
That product line. So we are progressing very very well, we've got I believe about 15 or 16 minimally invasive managers that are out there today and we've got about five or so on the clinical side. We anticipate that we will continue to extend and add more to that team.
And we found just wonderful people in those roles they have been a great fit and and they get up to speed very quickly.
Thanks, Thanks, David.
Hey, good afternoon, guys. Thanks, so much for taking my question congrats on another really solid quarter.
Thanks.
Is it feels like maybe it's closer to a low double digits, but just curious on your view that based on the of that based on the recent outperformance one and also too.
Yes, I'll really good questions I'd say that we are excited about what's happening in the open business. We continue to feel like theres going to be strength, there for a long time.
I don't want to get ahead of ourselves to the numbers that you're talking about.
Consistently on that basis that being said, we also the crown nerve block is a big upside opportunity for us really as we enter into 2020 and 2021.
As those that team becomes more mature we get more coverage around the country that definitely will help bolster and.
And help out there quite a bit and we do feel like there's a huge opportunity. It open but I don't know that I would get too far ahead of myself at this point relative to just to those growth rates on that front.
And then ask another question.
So yes, Miami the question Bob is that the impact of however, low risk on the aortic valve business seems like theres not much if were based on the numbers you put up but.
What you're thinking.
I think it's consistent with what we've talked about before which is obviously is having an impact on overall aortic volumes per se, but the penetration continues to be low and patients that have a favor our diagnose what they have been advance many of those patients are not getting treated with attached or they're basically saying you know what we know these patients do better there are paid.
Is that are out there showing that if you actually if those patients have a fan they do do better if you treat them surgically with the than just going in and doing the tablets I think there's more data that's out there we're getting the benefit of that.
And we're not necessarily seeing and are part of the order business, but there is pressure on aortic side, you're probably hearing that on probably a lot of l. company sides as well, but in terms of the pressure for us because the penetration so low and the benefits of treating that exhibit the same time.
It's not really affecting us at this point.
Got it and then quick follow up question for Andy just on the on adjusted EBITDA. Appreciate your guidance for this year.
Come in better than we had expected in the quarter and just wondering if you can comment on how you're tracking towards adjusted EBITDA.
Positive.
Profitability. Thanks, so much.
Sure. So the guidance we gave at the time of the deal back in August was that we would lose seven to 9 million.
EBITDA line, we still feel comfortable with that range of guidance as we said a couple of months out we're as Mike said, we're doing well and the integration front, but we've absorbed the cost of running the trial any infrastructure in which to make that successful so.
Just just feel good about the seven to 9 million, which is why we reiterated the guidance so nothing else really on that front.
Okay. Thank you.
Yes.
Your next question comes from the line of Matt O'brien from Piper Jaffray. Your line is open.
Hi, it's Adam on for Matt Congrats on the quarter and thanks for taking the questions.
My first question is on a true.
Growth, which was strong again against a tough comp.
Just wondering have you seen any impact or benefit from the labeling changes that came in late August .
This is helping shape conversations that your reps are having in the field than that I had a follow up.
Yes.
I'm going to kind of reverse the answer that were done it's definitely shaping a lot of conversations because there is more and more activity as and when talking about the benefits of doing electrical isolation in fact, the leery of product that we just bought.
That is exactly what is doing and thats, how its reducing the afib and the amazed trial. So it does engender a conversation allows for that and Thats really been rich intellectual good discussion that we've been able to have as a result of that people are excited to have that conversation and look at what the data was that supported it I don't know that is driving our revenue.
In the short term eminent and really if you know our business well, we're kind of that would that player that we're here for long haul we have conversations and eventually we do think that kind of the combination of that with the 20 other things that we've done over the course than last four or five years with new product introductions and other data that comes out is really kind of.
Continuing to improve the adoption of the let the journal appendage products have but I wouldn't say this specifically drove anything in the last six weeks.
That's helpful. Thanks, and then.
Just wanted to ask a question on the Q3 performance just was hoping you could parse out the U.S. and.
You asked dynamics, a little bit more U.S. came in better than we are expecting law.
Yes came in a little bit softer so just any additional color on on those would be helpful. Thanks for taking the questions Im sure Youre right. We did have a really strong us business in this quarter and we continue to see a lot of strength in the us going forward.
That market is one that we're incredibly strong I have great coverage, we saw a little bit of weakness in parts of Europe , we had a little bit the currency exchange impact that many people add but a little bit of it was also in Germany, and the Netherlands, where we felt a little bit of pressure what were strong in many other countries around Europe . Those two countries in particular were little bit softer.
There's nothing in particular, you can look and say this is what caused that we were just a little bit softer in those countries and so the percentage.
Had an impact on us.
But nothing really specific we think that that will come back over time and overall the rest of international is actually very strong.
That's helpful. Thanks.
Your next question comes from the line of Jason Mills from Canaccord. Your line is open.
Hi, This is actually stay on for Jason.
Just wanted to ask about your open business again.
Typically cabbage penetration with the new clam.
How you see this going forward in 2020 and other drivers.
You see that can help drive penetration higher.
Yes, another another really good question relative to the new innovations, we're coming out with I'm really excited about the new innovation.
Plant that we just talked about because if you actually kind of go back in our history, we really havent had a new innovation on the opens on of our business for eight plus years.
Even with a more since the PMAG that the PM and 2011 focus then was on training and education teaching people to do the procedure correctly.
Working with a different societies, helping get the guidelines kind of where they are all that work has been done we've created a lot awareness and we've moved the needle a lot, but a lot of did we have to make a procedure even easier to use for a broader base.
And that's really what the reason that we're doing this this new plant, we think it's going to be really well received its easier and simpler to use and so we're pretty excited about that it will likely come out.
Sometime next year, I don't anticipate and look at it being a catalyst to open revenue in 2020, but it really should help us sustain the kinds of open growth into 2021 and beyond it can have it's entirely complimentary to the work we've done in the training that we've done in the past.
Relative to that.
Great. Thank you and I guess, if I could just ask for your Chris their business as well.
What you've seen recently in terms of just areas of strength in adoption.
Any sales team dynamics and how you see this business are you see building this business going forward.
Sure I mean, we've we've hired or up to eight therapy aware option to clinicals and that team. So about 10 people and then a leader or manner for the front in that group right. Now then just on a phenomenal job combined in working with our existing salesforce that understand the hospitals that are selling into one of the things that have been most impressed with his how well they partner.
At the hospital level in the markets that we're in a lot of what we're seeing is in the long resection I'd say that the vast majority of the cases.
And that but also thats because thats the vast majority of cases that drastic surgeons are doing and.
And so we see a lot of those cases some replacing.
Some others and select areas in some smaller markets, but overall, that's really where we're seeing the vast majority of the cases today. We anticipate next year can stabbing considerably to that team as we expand to other in new geographies around the country, adding a combination of both sales team members and also Clint.
Holes that can support the cases, so we do believe in that space. We think that we can impacted and more and more data is coming out to support the therapy.
Great. Thank you and congrats on a good quarter.
Thanks.
Your next question comes from the line of frequency from Stifel. Your line is open.
Hi, Mike and Andy It's drew on for rig Tonight.
Just wanted to go back to converge for second.
At the time of your final patient hitting when your follow up it looks like there's probably about 100 patients that might have two years a follow up.
Just when it comes time to see the data at the panel and when you submit that.
Well you just summit 12 month follow up for the entire patient pool.
Well, we also be able to see a longer term durability data.
From the broader patient population and just how do you think that might factor into the FDA approval and labeling decision then translate into the also your ultimate market opportunity.
It's a great question will likely all the data that we basically have access to some of the durability data, we we might be presenting some of the panels I think you're asking a really good question.
Hi, Andrew on top of that as I've said before I mean, when we look at kind of all of the single center data. That's out there we were very confident and feel very good about kind of where we are as a business with this we've got over 10000 procedures that have been out there. We know how durable has long term and we think that that's also going to play a big role. We know the safety profile is both low not only in that.
Trial, but also incredibly low in the use in the market and we're going to use all that data is available to us as we move forward that to get the approval next year.
And then just hopping over to the Larry.
I think I heard you write saying that you are now at.
579 patients enrolled I know the amaze trial is a big focus for you.
You are up close to 40 patients since I think you announced the center hard transact deal.
But why is first quarter 2020 of the right target and not sooner is there anything that you're seeing in terms of enrollment slowdown or is it just kind of the holiday season that might kind of.
Delay that a little bit into next year.
You are asking that great question, and we could absolutely called it out and get it done by the end of this year, we're on a great pace I'm only being a little bit cautious just because we just acquired them, we're getting a sense, where the patterns look like but right now patient flow looks fantastic.
And it can be very early in 2020 or late this year. The guidance, we want to give to stick to as early part of mention the first quarter Justice.
No what happens in the end of the year with holidays and things like that and against the first time that we've only owned this and I'm getting a sense for and so quite frankly the difference between whether its gets done on December 30, Onest for February 15th really doesn't make it a large difference that's on the long term market. What we're going after here, we're already doing the work on the back end up getting doing.
May readiness, we're getting other modules behind so we're doing all that work behind the scenes so I.
I'm not the difference in day says it really matter, yes, you're right we've had great enrollment and it's very possible, we called it out by the end of year.
Great and then just one last one if you wanted to provide an update on some of your other clinical trials like I said.
I'd say CCF deep and then separately on Frost that I think you've mentioned before that you expected in 2020 can you maybe put a little finer point on when you might expect data either at a conference or publication. Thank you.
All good questions.
So clinical trial data, that's kind of walking through the clinical trials, you're right. We really want to focus this call on kind of explaining and remaining of brand. The process for conversion that also kind of talking a little bit about our new acquisition with amazing kind of making sure everybody was up to speed on that.
But you're right on Icesave, that's our open trial as reminder to everybody.
860 patient on 60 patient enrollment we've enrolled over 20 patients today, it's actually ahead of what our planet schedule was we've got 11 sites up and running we may add a couple more sites over the course of the next.
Several months to the early part of next year, but our focus now is to get the sites that we have up and running going.
Feel really bullish about that trial, it's created a lot of excitement again, another way to kind of gather more clinical evidence within that open space, which is a big part of our business as everybody knows.
On top of that we've got the you mentioned frost and the data coming off a process. When you. Many submissions have been had with various different journals. So we do anticipate in one of the major shows next year that it will be accepted as an abstract.
And as a paper and be presented at one of those shows it could be STS depends on whether or not these are accepted or several others. That's kind of occur in the first half of the year.
When it comes through CCF Thats, our trial, that's kind of the deep trial over in Europe .
And we are at 147 patients.
And so we're near statistical significance on the overall trial in terms of the enrollment we'll know more by the end of year and our hope is that that will kind of conclude enrollment sometime in the early part of next year and then obviously have to wait for one year follow up and everything after that point in time.
Then I think the.
And then deep is deal and obviously, which is deep in the us.
Deep AF trial 62 patients enrolled total we're back on track. We've got we had we've got about 12 sites or so enrolling now we've got a pipeline of six or seven sites that we anticipate over the next six months will kind of get up and running into that trial and feeling very good about the excitement for that and the cases that have happened so far.
Today, so lots of good activity thanks for asking the question.
Within our other clinical pillars as well great. Thanks, Mike I appreciate the color.
There are no further questions at this time please continue.
Great well again, everyone. Thank you for joining US today, we look forward to a another strong quarter in the fourth quarter and finishing out 2019, as we continue our commitment to treating people what they said around the globe. Thank you and had a wonderful that.
Ladies and gentlemen. This concludes today's conference. Thank you for participation and have a wonderful day you may all disconnect.