Motus GI Holdings, Inc.

Good day and welcome to the Motus GI first quarter 2022 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. And to withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Mr. Garth Russell of LifeSci Advisors. Please go ahead.

Thank you, Operator, and thank you, everyone, for joining us for the MODIS GI first quarter 2022 update call. Representing the company are Tim Moran, Chief Executive Officer, Andrew Taylor, Chief Financial Officer, and Mark Pomerantz, President and Chief Operating Officer of MODIS GI. Before turning the call over to management for their opening remarks, I would like to take a minute to remind you that this conference call and webcast will contain certain forward-looking statements about the company. These statements are subject to risks and uncertainties and that could cause actual results to differ. Please note that these forward looking statements reflect our opinions only as of the date of this call. We will not undertake any obligation to revise or publicly release the results of any revisions to these forward looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed or implied by such forward looking statements are discussed in greater detail and our most recent filings on Form 10-K and other periodic filings on Form 10-Q and 8-K filed with the SEC. I would now like to turn the call over to Tim Rand, CEO of Modus GI. Tim, the floor is yours.

Thanks, Garth, and good afternoon, everyone. Thank you for joining our call today. I am pleased to share an update on our business through the first quarter of 2022, as well as provide early insights of what we're seeing in the second quarter. Following my updates, Andrew will provide an overview of our financial performance for the first quarter, and then we will open the call to take your questions. Let's get started. At the end of March, I shared with you on our last conference call my thoughts in terms of Modus GI truly being at an inflection point in our pivot towards growth. While we discussed during the call the very real impact that the pandemic has had on our business for much of the last two years, I also outlined the important milestones we've achieved during that time, including the significant progress we've made in advancing our technology with the FDA clearance of PureView EVS, establishing a clear plan for pursuing outpatient reimbursement with the development of a large multicenter clinical trial, and the expansion of our customer-facing team through increased investment in commercial resources. Our revenue for the first quarter is not reflective of our potential or any of the key advancements I just outlined. As we discussed at the end of March, we were impacted in January and February by the Omicron surge and staffing shortages at hospitals. And March was a transition month as we began to sunset PureView Gen 2 activities and execute initial shipments of our all-new PureView EVS to the first sites. So let's look forward. Approximately six weeks ago, I forecasted that we would have the Peerview EVS placed in approximately 12 sites in the near term. As we sit here at the midpoint of the second quarter, we're well on track with that expectation, having already placed EVS in 11 hospitals. And based on a review of our activity and backlog, I fully expect we will overachieve this initial forecast. Moreover, we continue to receive very positive feedback from all accounts, both from the physicians and their staff. As a reminder, our EVS system provides a much simpler user experience, spanning the staff who sets up and breaks down the product to the physician who navigates through the colon to conduct a high-quality exam. A prominent physician who leads the GI department at a major academic medical center recently commented that PureView EVS is, quote, night and day easier than the last generation system. He said, setup is simple and intuitive, and the slimmer sleeve design allows me to do everything I need to do during the procedure. When you have a great product, you also need a right-sized, talented sales team to gain the critical mass required to close opportunities in the pipeline. As such, we accelerated our commercial expansion in Q1, and now have eight field sales leaders strategically positioned across the US. We have every major region covered and each of the new sales people come with proven track records of selling GI products at many of the world's largest medical device companies. While several of our sales people just recently were brought on board, we believe they will make noticeable positive impact as we penetrate our backlog of qualified accounts. In addition, Now that we've expanded to new geographies, we are already conducting evaluations at hospitals that have not had any previous interactions with our team. When you couple this activity alongside our existing Gen 2 customers and those who have been waiting to evaluate EVS, it gives us the confidence that driving quarter-over-quarter revenue growth is well within our sights. Let's discuss some of the early indicators and metrics that we believe are key to tracking our progress moving forward. Of course, the overall number of sites is the starting point, but that's only part of the equation. The trajectory of our long-term growth will be determined by how many procedures are performed at an individual site on a weekly, monthly, and quarterly basis utilizing our system. This is why we believe it is equally or perhaps even more important that we are also seeing positive initial indicators around utilization, including one, more procedures being performed per month by our customers and evaluation sites than with our previous generation. As a result, we saw very strong procedure volumes in April at both closed and accounts that are under evaluation. Two, the number of procedures being done independently by a physician without a MODIS sales rep on site, which is growing now that the required training has been dramatically reduced. Three, the system being used as an on-demand tool, meaning after a physician starts a case and sees that the patient was not prepped well, they intuitively ask for PureView to salvage the procedure. And four, Continued positive user experience from the entire GI suite on the simplicity of the solution to deploy during their normal procedural workflow. To that point, nothing speaks more about the potential of a product than real-world customer feedback. Let me take just a minute to highlight feedback from a new account who is currently evaluating PureView EVS. Dr. Brian Hansen, Acting Section Chief, of Gastroenterology and Hepatology at the Minneapolis VA Medical Center stated, and I quote, PureView has allowed us to achieve a complete quality colonoscopy in patients that would have otherwise been canceled or aborted. This is an important service to our patients who have complicated medical comorbidities and often travel great distance for procedures. With a growing number of VA hospitals evaluating the PureView EVS, We believe the overall VA system in the U.S., which consists of approximately 170 medical centers across the country, represents a high-yield opportunity for adoption of the PureView EVS system. Now let's discuss our progress on key upcoming catalysts. Let me first review our clinical study activity and outpatient reimbursement strategy. Our European Outpatient Clinical Study is fully enrolled, and we just recently announced that the top line results from this study are expected to be presented during Digestive Disease Week 2022, which will take place in person and virtually May 21st through the 24th. DDW is the world's premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. As a reminder, this study is evaluating the clinical outcomes in patients with a history of poor bowel preparation using a low volume prep with limited diet restrictions and the PureView system. The investigator-initiated study is being conducted at two health centers in the European Union and has enrolled all 44 patients. The primary endpoint for the study is improvement of the bowel preparation from baseline to post-procedure as assessed by the Boston Bowel Preparation Scale. As previously discussed, we have developed a multi-pronged strategy to physician peer review for outpatient reimbursement. There are approximately 18 million outpatient procedures conducted in the U.S. each year, and currently, approximately 4.7 million of these patients struggle to get a high-quality prep prior to their procedure. This can lead to delayed, aborted, and repeat procedures, which puts a burden on the healthcare system and the patient, both from a clinical and economic perspective. A critical step in this process is generating key clinical and economic outcomes via a large multi-center clinical trial. Based on data from the aforementioned EU study and through input from a group of world-class opinion leaders, We've been working diligently in the design and detailed protocol for this study, including recently meeting with CMS to solicit their feedback for incorporation into the design. We expect to initiate this study before the end of 2022 and we'll keep you apprised of our progress. One additional commercial point as it relates to selling Peerview into the outpatient setting. We are making progress in hospital-based outpatient units as well as the previously mentioned Veteran Affairs Medical Centers without having specific reimbursement in place. In terms of ongoing product innovation, as I have discussed on previous calls, we've initiated a project to add upper GI capabilities to the new PureView EVS platform. Some of the key enhancements in the EVS system, such as a much larger suction channel, more efficient irrigation jets, a smaller profile, and improved flexibility will be further optimized to allow the system to provide broad utility in an EGD procedure. As we've discussed previously, this utility is especially important in the 400,000 upper GI bleeding cases where not only stomach content but blood and blood clots can impair the field of view. Finally, turning to potential strategic partnerships and collaborations. As we build momentum and adoption in US hospitals in 2022 and our revenue begins to ramp, we believe that the relationships we've built with potential strategic partners could become actionable. We continue to keep these partners abreast of our progress with the aim of exploring opportunities for potential commercial and or product partnerships that advance our strategy and accelerate value for our shareholders. With that, I will now turn the call over to Andrew to provide detail on our Q1 2022 financials. Andrew?