Q3 2024 Stereotaxis Inc Earnings Call
Speaker Change: Good afternoon. Thank you for joining us for Stereo Taxi's 3rd Quarter 2024 Earnest Conference Call.
Speaker Change: Certain statements during the conference call and question and answer session period to follow may relate to future events, expectations, and as such constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Speaker Change: Such statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the company in the future to be materially different from the statements that the company executives may make today.
Speaker Change: This was described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q.
Speaker Change: We assume no duty to update these statements. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions and comments following the presentation. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to your host, David Fischel, Chairman and CEO of Stereotaxis. David.
David Fischel: Thank you operator and good afternoon everyone. I'm pleased with our performance this quarter. We demonstrated solid commercial execution, successfully closed and integrated the ACT acquisition, and are advancing in parallel a broad range of innovation and regulatory efforts that are strategically transformational.
David Fischel: On our last call, I provided significant commentary on our innovation strategy and APT. I'll keep today's remarks relatively brief, with just a focus on the key updates.
David Fischel: Kim will then share financial results and we will open the call to Q&A.
David Fischel: Our revenue growth in the third quarter was predominantly driven by partial revenue recognition of three Genesis systems that were delivered to customers late in the quarter.
David Fischel: All three were delivered to European hospitals, two of which are upgrading their existing robotic labs to Genesis, and one of which is establishing an entirely new robotic program.
David Fischel: As has been our custom, we'll announce Genesis launches in coordination with each hospital as they treat their first patients.
David Fischel: Our pipeline of Genesys customers remains robust, and we received orders for two additional Genesys systems in the third quarter.
David Fischel: The combination of these incremental orders and system revenue left us with a capital backlog of $15.5 million at the end of the third quarter.
David Fischel: We continue to see an active pipeline of interested customers in Genesys, and expect to continue to receive orders in this and coming quarters.
David Fischel: The recent CE mark for Genesys X has allowed us to start to build a pipeline of Genesys X customers that incrementally adds to our robotic opportunity.
This GenesysX pipeline will ultimately dwarf our Genesys pipeline.
David Fischel: While we have not yet received CE Mark approval for the MAGIC catheter, which is key to the launch of Genesis X, we expect it in the near term. At around a similar time as that milestone, we expect to receive our first Genesis X system order.
David Fischel: We are very excited to start to see the impact Genesys X will have on patients, physicians, hospitals and on our overall growth trajectory.
David Fischel: Our capital results have been predominantly driven by Europe, where we have the most advanced product ecosystem coming into fruition.
David Fischel: With regulatory approvals in the United States and China, slightly behind Europe, we look forward to those geographies increasingly contributing to our capital orders and revenue.
David Fischel: Our robotic system orders have also historically remained fully driven by the electrophysiology specialty.
David Fischel: In the coming year, as we introduce the first vascular catheters and guide wires, we look forward to starting to receive orders driven by a broader array of specialties.
David Fischel: Recurring revenue in the third quarter benefited from the partial quarter contribution of capital revenue from the acquisition of APT.
David Fischel: This contribution was approximately half a million dollars in the third quarter and will be larger in the fourth quarter.
David Fischel: We are excited by the positive reception to APT's catheters from our customers in the community of robotic electrophysiologists.
David Fischel: We expect meaningful, sequential revenue growth from these catheters in the fourth and subsequent quarters.
David Fischel: I described on our last call the clinical and commercial synergy as well as the commercial strategy with these differentiated catheters.
David Fischel: I'm pleased that the early months following the acquisition continue to validate synergy and strategy.
David Fischel: While the addition of APT is supporting a return to growth in recurring revenue,
That segues well into updates on our innovation strategy.
David Fischel: We are aggressively driving broad-based progress across the late stages of a comprehensive innovation strategy.
David Fischel: The MAGIC catheter, our proprietary, robotically navigated cardiac ablation catheter, is close to receiving European CE mark approval.
David Fischel: During the third quarter, following our earnings call, we received questions on the last outstanding area of review, Microbiology.
David Fischel: We responded to those questions, received a second round of brief clarification questions, and are awaiting final confirmation that our microbiology review has been completed.
We should receive CE Mark from MAGVIC shortly afterwards.
David Fischel: We are very much looking forward to approval and expect significant commercial adoption of MAGIC given our clinical experience in the ongoing European study and the positive feedback we received from our community of robotic customers.
David Fischel: In the U.S., FDA is continuing its review of the MAGIC PMA submission, and we continue to have collaborative and thoughtful dialogue.
David Fischel: We have aligned an unexpected indication for magic and the data that support that indication.
David Fischel: The ongoing dialogue supports our expectation of achieving an initial regulatory approval leveraging the data being generated in the ongoing European MAGIC study, with a clear plan for subsequent post-approval studies in the U.S.
David Fischel: We appreciate the collaborative nature of these discussions and believe they are reflective of a shared appreciation for the importance of ensuring magic becomes available for patients and physicians who depend on it.
David Fischel: Beyond MAGIC, we made significant progress with what will be the first ever robotic high-density mapping catheter and vascular guidance catheter.
David Fischel: Both of these catheters were being advanced with APT over the last couple of years and completed development around the time of acquisition.
David Fischel: During the third quarter, we manufactured the hundreds of catheters needed for formal regulatory testing and expect to complete all testing within a couple months, setting us up for regulatory submissions next quarter in early 2025.
Both catheters provide significant value clinically, commercially, and strategically.
David Fischel: Some very recent anecdotal color on the interest in these two catheters may be helpful.
David Fischel: I had the opportunity to meet with dozens of our customers at the Society for Cardiac Robotic Navigation's annual conference two weeks ago in Portugal.
David Fischel: Immediately after that, I visited physicians at one of the most prestigious and globally well-respected EP centers in France.
David Fischel: At both the conference and at this prestigious hospital there was significant focus on the importance of mapping and how our robotic mapping catheter addresses a primary barrier to physician interest and use of robotics.
David Fischel: The French hospital viewed our emerging comprehensive product ecosystem and the mapping catheter in particular as highlights warranting reassessing the impact robotics can have on the field.
David Fischel: Following the meeting in France, I visited London, where I had the opportunity to meet amongst other activities with non-electrophysiologists to explore initial uses of our robotic guide catheter and guide wire.
David Fischel: We identified several new indications with unmet medical need where our overall approach and a guide catheter specifically can improve care and add value.
David Fischel: We are excited by how the mapping and guide catheter can boost adoption of robotics in EP and initiate adoption in the broader endovascular field.
David Fischel: I want to highlight the contributions of our new teammates from APT who work diligently and efficiently on the development and manufacturing of these catheters.
The unique expertise of APT.
David Fischel: is highly complementary and additive to Stereo Texas' strategy as we increasingly focus on a broad family of robotically-steered endovascular devices.
David Fischel: Beyond catheters, we have several other significant regulatory and development efforts ongoing.
David Fischel: The primary milestone in the last quarter was attaining CE mark for Genesys X in Europe and submitting Genesys X to the FDA for US 510k clearance.
David Fischel: FDA reviewed our submission and sent us a first round of questions in October. We have begun preparing our answers and expect to respond in the coming weeks.
David Fischel: In China, we have been working with our partner, Microport, to gain regulatory approval for the Genesis robot, mapping integration, and a novel ablation catheter.
David Fischel: The Chinese NMPA regulatory body recently completed an on-site audit of our quality systems and the Genesys system in St. Louis.
David Fischel: The success of that audit, with very positive feedback shared by the reviewers, is a testament to our team and the high-quality operations they established. The successful audit portends wealth for near-term approvals in China.
David Fischel: There is much more going on, but we are keeping today's call focused on the primary milestones and will provide a more comprehensive review on our next call. Our broad-based progress on a new foundational product ecosystem across three key geographies is transformational. We are in a particularly exciting period.
David Fischel: I'll hand the call over to Kim to discuss our financial results, and then I'll make a few financial comments as well before we open the line to Q&A.
Kim, thank you, David and good afternoon. Everyone.
Kim: Revenue for the third quarter of 2024 totaled $9.2 million, an 18% year-over-year increase compared to $7.8 million in the prior year third quarter.
Kim: System revenue for the third quarter was 4.4 million driven by partial revenue recognition on delivery of three Genesis systems.
Kim: This compares to system revenue of $3.5 million in the prior year third quarter.
Kim: Recurring revenue of 4.8 million compares to 4.3 million in the prior year third quarter and reflects the two-month contribution of our previously announced acquisition of APT.
Kim: We received two orders in the quarter, and we maintained system backlog of $15.5 million as of the end of the third quarter.
Kim: Gross Margin for the third quarter of 2024 was 45% of revenue. Recurring Revenue Gross Margin was 70% and System Gross Margin was 16%.
Kim: Recurrent and revenue gross margin was impacted by accounting related to the acquisition of APT. As part of GAAP acquisition accounting, we are required to value finished goods inventory at market, giving us minimal accounting gross margin on the subsequent sales of that inventory.
This is a temporary marketing reduction with no economic impact.
Kim: Once this inventory is sold in the next few months, we expect recurring revenue gross margin, including the APP products, to return to historical levels.
Kim: System gross margin continues to reflect the allocation of significant overhead expenses on low production volume.
Kim: Operating expenses in the quarter of $10.4 million included $2.5 million in non-cash stock compensation expense and a $0.7 million non-cash mark-to-market adjustment for acquisition related contingent earn out consideration.
Kim: Excluding these non-cash charges, adjusted operating expenses were $7.2 million, comparable to prior year adjusted operating expenses of $7.1 million.
Kim: Operating expenses in the current year third quarter include two months of APT operating expenses following closing of the acquisition.
Kim: Operating loss and net loss in the third quarter were $6.3 million and $6.2 million compared with $5.6 million and $5.4 million in the prior year third quarter.
Kim: Negative free cash flow for the third quarter was $4.2 million.
Kim: At September 30th, stereo taxes had cash and cash equivalents, including restricted cash of $11 million and no debt.
Speaker Change: Significant cash receipts in October increased Stereo Taxes' balance of cash and cash equivalents, including restricted cash, to $13.3 million at the end of October. I will now hand the call back to David.
Thank you, Kim.
David Fischel: We are maintaining the revenue guidance provided on our last call and are glad that our third quarter performance exceeded expectations.
David Fischel: This year's revenue is expected to be approximately equal to 2023 without incorporating potential revenue from the launch of Genesis X and Magic.
David Fischel: We expect year-over-year growth in both system revenue and recurring revenue in the upcoming quarters.
David Fischel: We are cognizant of the importance of protecting our balance sheet, protecting shareholders from unnecessary dilution, and managing stereo taxes in a financially prudent fashion.
David Fischel: Maintenance of operating expenses at essentially a flat level as last year.
David Fischel: Despite the acquisition and inclusion of APT is reflective of our focus on prudent financial management
David Fischel: This posture is balanced with continued investment in the technologies, team, and infrastructure that supports growth and success, with investments still being made from which we will only reap the fruits of in several years.
David Fischel: We expect to end this year with approximately 12 million dollars cash and no debt. Review our existing balance sheet as allowing us to reach key milestones, commercialize our new innovations and profitably grow our business.
David Fischel: We have no intention of diluting shareholders at current valuation levels and will be thoughtful in how we manage our financial position and protect shareholder value.
Operator, can you please open the line to Q&A?
Speaker Change: We will now begin the question and answer session. If you'd like to ask a question, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again.
Speaker Change: And your first question comes from the line of Frank Pakinen, with Lake Street Capital Markets. Frank, please go ahead.
Speaker Change: CE mark still seems pretty reasonable given where you're at with that process. One, can you confirm that? And two, the US timeline, how does the interaction influence that timeline? Is it feeling like it's a first half 2025 event or is it maybe a little bit too early to call?
Sure. Hi, Frank. Thanks for the good questions.
Speaker Change: our responses to the original microbiology questions, and then the, as I mentioned, a couple of clarification questions that came after that. Those were very benign, and so I think that we are in an overall very good fundamental place, and we are
Speaker Change: sitting patiently on our hands awaiting a certificate. So yeah I think that that is in the very short term but again there's no statutory requirement for the regulator so we will sit here patiently until we receive it.
Speaker Change: When it comes to the U.S., I think it's still a little bit early to know, and FDA is definitely reviewing the spectrum of the submission, the various components of it, the various aspects of it.
Speaker Change: There is, there are some activities like manufacturing facility audit, which will probably be a part of the review process and that has not taken place yet. So I think there's still several things there, but I would think that kind of over the next.
Speaker Change: a couple quarters or so that would be a reasonable time frame but again that is that is something that we're working very collaboratively with FDA we appreciate the way that they've been working with us
Speaker Change: and we'll see how that review goes in terms of the exact timeline. I think what has been very nice is how we've reached alignment on indication, the type of data that should be supportive of that indication, and how also we can expand our indications after the original approval with post-approval studies in the U.S.
Speaker Change: I wanted to understand how the U.S. market is feeling today. It sounds like Europe is strong. I don't know if that's just a current quarter dynamic.
Speaker Change: or if there's more to understand there between Europe and the U.S. market. And then is there any waiting in the U.S. market for maybe the mobile robot and the magic catheter to come down the pike, or is it still, they're still full speed ahead on Genesis, but it's maybe just a little bit of a softer macro?
Yep.
Speaker Change: Sure, it's a great question. I've spoken obviously for many, many, not just quarters, but even a few years, about this whole concept of product ecosystems.
and how you can't really think about a specific product.
Speaker Change: on its own. You have to think about the ecosystem that it works within, and that's why we've been advancing this comprehensive innovation strategy which really addressed...
Speaker Change: that addresses the ecosystem and creates an attractive ecosystem that can scale significantly.
Speaker Change: the commercial impact that we that we start to see in the marketplace and this is obviously without yet magic on the market without the vascular devices on the market and without actually Genesis X truly on the market because
Speaker Change: viewed in the marketplace as very near-term and with kind of the mapping integration of Abbott, kind of the the way that that starts to create a positive dynamic for our sales team, kind of with our customers.
Speaker Change: And so I think that's what you're seeing in Europe. In the US and in China, we're a little bit kind of further behind in terms of bringing that ecosystem together. And so it's just kind of been more challenging.
Speaker Change: and I kind of spoke in the call about kind of how China, I think,
Speaker Change: very close also to a couple regulatory approvals that will be very helpful for that ecosystem.
Speaker Change: The results in Europe are really a reflection of how the ecosystem effect ultimately drives commercialization and why having a good ecosystem is so valuable.
Got it. Okay, that's helpful. I'll stop there. Thank you.
Thank you.
Speaker Change: Your next question comes from the line of Josh Jennings with TD Co and Josh, please go ahead.
Hi, good afternoon. Thanks for the questions.
Speaker Change: Can you divulge what the initial indication is that's been agreed upon and what the requirements are to have the FDA look positively around the trial design and ultimately the results and make an approval decision?
Speaker Change: Hi Josh, good afternoon. Sure, let me try to touch upon your question. Generally, I think it's best to, you know, kind of on regulatory matters, it's best not to be too specific. I think that's kind of both the norm and what's expected by the regulator, but let me provide some color.
and in the, we can use.
the totality of that data to some extent to address
overall safety, overall performance of the catheter.
Speaker Change: David Fischel, M.D.: Gain an indication in the US, because that is really an area where there is unmet clinical need and with patients and with physicians were magic provides kind of it's a it's most dramatic benefits.
Speaker Change: And so I think that's kind of where you should expect our focus to be on.
Speaker Change: and kind of the initial effort and then there will be again opportunities to expand indications over time, but obviously we're most focused on making sure that magic is available for the patients and physicians that benefit from it the most.
Speaker Change: Understood, understood. I wanted to ask about the the ATP catheter portfolio.
Speaker Change: and then how you see this ramp. Is it really just a matter of getting the catheter out into more accounts in the United States and internationally to secure that sequential revenue to just maybe help us make it through the drivers of and what meaningful growth means.
Sure, so maybe stepping back again...
APT developed and it commercialized a family of specialty diagnostic
and their catheters are very synergistic with us.
Speaker Change: because we have a sales force that is in cardiac ablation procedures on a daily basis, on a regular basis, supporting those cases, and so these types of catheters can be used in those procedures. They're also synergistic from a messaging perspective, and if you look at some of the main catheters that drive the revenue of APP, there are catheters that are used in more complex ventricular tachycardia procedures.
or in pediatric and congenital patients.
Speaker Change: That's in terms of kind of the products themselves and how they align with with our focus
Speaker Change: We have been, over the last few months now, educating our entire commercial team on the portfolio of APT, in turn educating our physician customers on the portfolio of APT. The vast, vast majority of them had never heard of, 90 plus percent, 95 percent of our physician customers had never heard of APT, never heard of the catheters, so really while these are attractive products with some KOLs in the field who really love to use these catheters, the vast majority of the field didn't know they existed. And then we've been working in the U.S., if I focus predominantly on the U.S. for now, we've been focusing on the U.S.
Speaker Change: to see the benefit of that in the third quarter and as you kind of work more hospitals through that process you get more of a benefit in the fourth quarter and I think that's going to continue for several quarters. This should be something that has a fairly significant tailwind to it as we work through that process.
Speaker Change: Generally, I would view these catheters as having opportunities in the, you know, high single-digit millions or double-digit millions. These aren't catheters that we're trying to create into, you know, 100 million plus portfolios with, but you've seen how some companies, I'm kind of thinking, let's say, of a company like Bayless that was acquired by Boston a year or something ago, right? They had
oftentimes devices that also work and
Speaker Change: or kind of replacements for other products. And ultimately, you can build fairly substantial businesses off of catheters that are, you know, a little bit better and slightly differentiated and provide value. And so I think kind of this will definitely help our team. And again, strategically, I mentioned this on the call three months ago, there's a great benefit to being able to sell these synergistic catheters in the primary goal of expanding robotic adoption, because it does increase our touch points with more physicians in EP. It allows us to afford a larger sales team, and it allows us to then gradually drip.
Speaker Change: relationship with various physicians that have never used robotics in the past and we're going to have a much more capable sales team to do that launch.
Speaker Change: Sounds exciting, and maybe just lastly on the robotic HD mapping catheter, just I mean did I hear that you could get approval potentially as early as the beginning of 2025?
Speaker Change: And we've always just, I know you've done this before, in the recurring remedy per case.
Speaker Change: will be exponentially higher as you build up this ecosystem of catheters.
Speaker Change: but maybe just help us, remind us current competitors, HD mapping catheters, what their ASPs are, maybe the guide catheters, sheets are running and just remind us of the current
Speaker Change: recurring revenue per case since stair taxes is ringing the registrar on today versus once the full portfolio is built out you know how big that should be per case. Thanks a lot.
Speaker Change: Sure. So, I mentioned that in early 2025, in the first quarter, we'd expect to submit regulatory, to do the regulatory submissions for the high-density mapping catheter, the robotic-reared high-density mapping catheter, and the robotic vascular guidance catheter. So, those would be the regulatory submissions.
and much simpler than what we've experienced, obviously, with magic.
Speaker Change: I think kind of on the last call I provided some more color on that, where generally if you think about our disposable revenue per procedure that we currently get for every robotic procedure, an ablation catheter would, you know, again it depends a lot on the geography and...
but generally should.
Speaker Change: Let's say triple the revenue, the introduction of the ablation catheter to probably triple our disposable revenue per procedure, adding a high-density mapping catheter on top of that probably again doubles again the revenue there. So you're talking about something in the five times.
Speaker Change: or so, what our current disposable revenue per procedure is as you introduce these two.
Speaker Change: Probably in the beginning, in the non-EP space, as we start to enter into the vascular field, I'd expect generally the revenue per procedure to be lower, but there's also a multi-year strategy there for how that can increase over time that I wouldn't expect in the beginning that we're pursuing it.
Speaker Change: you know, the same level of disposable revenue per procedure. Our goal, really, in the beginning, is to demonstrate the value of the robot across multiple clinical specialties, and then we'll build out the vascular portfolio over a few years after that.
Speaker Change: Excellent. Thanks for clarifying that timeline and for all those details. Appreciate it.
Thank you, Josh.
Speaker Change: And your next question comes from the line of Adam Mayter with Piper Sandler. Adam, please go ahead.
Adam Mayter: Hi, David. Thank you for taking the questions and congrats on the progress in the next quarter. Maybe to start from me, I wanted to ask about your magic catheter. You know, it sounds like CE mark approval is, you know,
Adam Mayter: approaching pretty quickly here. Just remind us kind of how you're feeling about the ability to kind of, you know, supply the market, you know, from an inventory standpoint. And then also just give us a refresher on the Salesforce.
Adam Mayter: and how many folks are in the European commercial organization, how many folks are in the U.S., as well. And then I had a follow-up. Thanks.
Sure. Hi Adam. Good afternoon. Thanks
Speaker Change: When we look at MAGIC in Europe, we are confident that MAGIC is a good catheter and that it can benefit our physician customers and will be a nice improvement to their clinical experience. Given all of our human experience over the last year in the clinical trial, we feel confident with it as a good clinical solution.
Speaker Change: and we're working a lot with OSIPCA on ensuring that the manufacturing ramp-up goes well. And so they've been putting a lot of effort into building inventory, into making sure they're more efficient in the manufacturing process.
Speaker Change: And so that kind of overall has been a lot of engagement to make sure that we are prepared for the launch in a nice way and that that won't be a big barrier. And then from a sales perspective, we have about 30, 35 hospital customers in Europe.
Speaker Change: We have a sales force right now, if you include trainers and kind of the full team, it's kind of about a dozen or so sales team in Europe.
Speaker Change: and so that team kind of overall works well with all the customers. In Europe you don't have the same dynamic of requiring a rep in every single procedure but we do have a plan for how we can, as we start to introduce the magic catheter and gain adoption at individual accounts, how we will start to hire dedicated reps who will be focused on a specific hospital and that will allow us to grow our sales team over the next over the coming quarters as we launch magic in a nice sustainable fashion and really providing that added level of service then for each individual hospital.
Speaker Change: That's helpful, Culler. Thanks for that, David. And for the follow-up, just wanted...
Speaker Change: Just to ask briefly about the the PFA program You know, I think you gave an update on last quarter earnings call. It sounds like you have a couple PFA initiatives in development, but just wanted to ask for the latest and greatest there and thanks again for taking the questions
Sure, thanks a lot.
So we have had quite a lot of
both actually.
of the robotic
Speaker Change: PFA programs that we that we mentioned on the last call and we had one actually this past weekend So and so we we kind of have it had quite a lot I think that there is like I mentioned on the last call. I think that with one of those programs
Speaker Change: With both of those programs we probably can be in first in human studies and next year with one of those even probably having regulatory clearance in in the European geography next year.
Speaker Change: And so that's kind of, those I'd say are the two main things that we're advancing. There are other PFA companies that we are collaborating with that are not as advanced as those two primary robotic efforts.
Speaker Change: But those two, we've had quite a busy few months with pre-clinical studies, including high-quality survival studies where you assess performance over a longer time period post-procedure.
Thanks for the color.
Thank you.
Speaker Change: Again, if you'd like to ask a question, simply press star followed by the number 1 on your telephone keypad.
And your next question comes from...
Okay, so there's no further question at this time.
Speaker Change: I will now turn the call back over to Mr. Fischel for closing remarks.
Speaker Change: I see one more, Mark, if you want to open it up to the last question, it seems like. Sure, no problem. Our next question comes from the line of Guy Joukowski with Barberfish Capital. Guy, please go ahead. Hey David, how are you? Hi, good afternoon.
Guy Joukowski: Thanks. I wanted to see if you could just touch base, I guess, a little bit of a color on the guidewire on synchrony and syncs. In particular, the last two I've seen on the website, but I've seen no product announcement.
Sure.
Speaker Change: So the guide wire and the guide catheter have been our two initial products.
Speaker Change: that would allow us to expand the value of our robotic system beyond electrophysiology into the broader vascular navigation field. And so those are kind of two products that we've worked on for some time. The GuideWire with a contract manufacturer that we've had a relationship with, and the GuideCatheter was with APT even prior to the acquisition, and the GuideCatheter has now advanced very smoothly, very nicely, and so that's where we plan to do a submission in the first quarter, and that would allow us, not too long after that, to
Speaker Change: to actually commercialize and start to use our robot in non-EP procedures and kind of start to expand the use case and the value proposition. And on the Guidewire side, the ramp-up of manufacturing has been
fairly slow and with all sorts of starts and stops.
Speaker Change: We are making progress there. I still don't know what the right timeline for that is, given all the start and stops that we've had historically, and so I haven't commented because I'd rather kind of comment when I know with confidence that we're going to meet a timeline.
And so I think kind of there's a
Speaker Change: decent chance that we get that also kind of in a good place in the coming months, but that's not certain. And so again, right now, kind of our most focus on the guide paths that are given the high level of confidence we have there.
Speaker Change: with that coming out. And again, when we visit customers like the ones that I mentioned in London, or not customers, but potential customers who are non-electrophysiologists, like in London, there are definitely also a range of applications where the guide catheter by itself can be very beneficial.
Speaker Change: If I shift over to SYNCHRONY-SYNC, again, there wasn't kind of any reason not to talk about that other than the desire to focus more on the things where there have been kind of significant milestones near term.
Speaker Change: SYNX has been available on the App Store and we are using it internally with physicians whenever we do preclinical studies and we've kind of used it in this kind of limited release setting. Synchrony is entering formal regulatory verification validation testing very very shortly and that's a class one device that will be a relatively
Speaker Change: Benign regulatory process to it and so overall kind of we feel good about how that's coming together when we have physicians and hospital administrators visit it is and it is very nice to see how excited they are by that technology given that it is really ancillary to what we've been our core robotic offering but we get very good feedback on it so I think that there is going to be a good opportunity with those products outside of just improving the robotic ecosystem and then and when we when we start to launch the product I think it'll be great to do kind of a real tech demo for interested physicians and investor community
Perfect. Thanks, David.
Thank you.
Speaker Change: All right, so there's no further question at this time, and I will now turn the call back over to Mr. Fischel for closing remarks.
David Fischel: Okay, thank you very much. Thank you all for all your questions. We look forward to working hard on your behalf to close out the year strong, and I look forward to speaking again next year.
Speaker Change: And that concludes today's call. Thank you all for joining. You may now disconnect.