Ra Medical Systems, Inc.

Good day and welcome to the RA Medical Systems first quarter 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. 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 Bruce Voss. Please go ahead.

Thank you. This is Bruce Voss with LHA. Thank you all for participating in today's call. Joining me from Raw Medical are Will McGuire, Chief Executive Officer, and Andrew Jackson, Chief Financial Officer. Earlier this afternoon, Raw Medical issued a news release announcing financial results for the first quarter of 2022. If you've not received this news release or if you'd like to be added to the company's email distribution list, please contact LHA at 310-691-7100 and speak with Danny Chertok. You can also sign up for email alerts and access the news releases in the investor relations section of the company's website at ir.rahmed.com. During this call, management will be making a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent the statements made by management are not descriptions of historical facts regarding raw medical, they are forward-looking statements reflecting the beliefs and expectations of management as of May 16, 2022, including financial regulatory product development and clinical trial expectations. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors that are, in some cases, beyond the company's control and could materially affect actual results. In particular, there is significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic and the military action by Russia and Ukraine. as well as the impact other global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn, and changes to inflation or interest rates may have on raw medical's business and results of operations, including its supply chain. This means that results could change at any time, and the impact of any of these events on raw medical's operations, financial results, and outlook is the best estimate based on information for today's discussion. For details about these risks, please see the company's SEC filings, including Raw Medical's report on Form 10-Q for the quarter ended March 31, 2022, which will be filed with the SEC later this afternoon, and other filings by the company, including its annual report on Form 10-K for the year ended December 31, 2021, which was filed with the SEC on March 24th. 2022. Raw Medical expressly disclaims any intent or obligation to update forward-looking statements except as required by law. Today's conference call remarks will include both GAAP and non-GAAP financial results. Raw Medical believes the non-GAAP financial results provide investors with useful supplemental information about the financial performance of the business, enable the comparison of financial results between periods for certain items that may vary independently of business performance, and allow for greater transparency with respect to key metrics used by management in operating the business. These non-GAAP financial measures are presented solely for informational and comparative purposes and should not be regarded as a replacement for corresponding GAAP measures. A reconciliation between GAAP and non-GAAP financial measures can be found at the end of the financial news release that was issued earlier today. With that, I'd now like to turn the call over to Will McGuire. Will?

Thanks, Bruce. Good afternoon, everyone, and thank you for joining us. We are reporting good progress in developing a competitive and differentiated vascular product portfolio targeting the large and growing market for treating peripheral artery disease, or PAD. Our team's performance has been exceptional in the face of multiple challenges as COVID-19 continues to impact our industry's ability to conduct clinical studies and persistent supply chain issues affect our engineering project schedules. This is in addition to other economic uncertainty resulting from rising inflation and interest rates and the ongoing conflict in Ukraine. Today, I'll provide updates on the key objectives for 2022 we outlined during our conference call in late March, beginning with our pivotal clinical study to obtain an FDA atherectomy indication for the Dabra Eximer Laser System. Enrollment continues to proceed at a steady pace. I am pleased to report that as of today, 107 of the planned 125 subjects have been enrolled. That's nine additional subjects joining our trial since our last update in late March and 18 additional subjects being enrolled since the beginning of this year. I'm also pleased to announce the qualification last week of a new trial site with a highly regarded interventional cardiologist serving as principal investigator. As a reminder, our trial is approved for up to 10 sites, and as of today, we have eight sites cleared for enrollment. Three of these sites have reached their quota, while active subject screening is underway at the other five, including our newest site. We are still unable to predict the exact date for enrollment completion due to the impact of COVID-19. However, given the pace of enrollment over recent months and the addition of the new site, We continue to target full enrollment by the end of Q3 2022. As I've said before, obtaining FDA clearance for an atherotomy indication continues to be a top priority for raw medical and a critical part of our business strategy. The atherotomy clearance will significantly expand our addressable market beyond our existing clearance for crossing chronic total occlusions, or CTOs. A third-party research group estimates the value of the combined CTO and atherotomy markets in the U.S. at approximately $900 million for the current year. Turning to our engineering initiatives, we are actively working with the FDA to support the review of the 510K application we submitted in February for our next-generation DAPRA 2.0 catheter. This catheter features a braided overjacket design and a six-month shelf life. We believe the more robust design of the Dabra 2.0 improves deliverability and kink resistance when navigating tortuous anatomy. We continue to expect 510 clearance for the Dabra 2.0 in Q3 2022. The Dabra 2.0 510 filing represents a major engineering and regulatory milestone in our endeavor to commercialize our flagship Dabra RX catheter. The Dabra RX will incorporate many of the Dabra 2.0 features for robustness and improved deliverability in a guidewire compatible version of the Dabra catheter. We selected the Dabra RX design following our preclinical study last December with interventionalists evaluating its use, handling, and overall performance. We anticipate finalizing the engineering work for the Dabra RX later this year and are targeting a 510 applications seeking regulatory clearance at the end of this year. I would also like to update you on a few other important engineering initiatives underway. First, we continue to make very good progress on the DABRA laser development front in our own track to submit a 510 to the FDA in Q3 2022 that incorporates various upgrades to the laser system, including a new CPU. We are building upon preliminary work that we believe shows our laser system can be utilized to create shock waves of sufficient magnitude to fracture calcium in arteries in a procedure known as intravascular lithotripsy. We have fabricated several new prototype systems, putting us on track to conduct further preclinical studies in the next few months to verify our initial bench stop and preclinical findings. We anticipate completing the design concept work and initiating a development project in the second half of this year. This is an exciting application for our technology given the potential to create significant shareholder value with a competitive product in the emerging intravascular lithotripsy market. Before opening the call to questions, I want to announce that Andrew Jackson has tendered his resignation as CFO at Raw Medical. Andrew has accepted a position as CFO of another company and will be leaving Raw Medical later this quarter. Andrew has been a valued member of the Raw Medical management team, including seeing the company through the IPO and multiple financings and seamlessly stepping in as interim CEO prior to my appointment. I'm currently in discussion with potential interim CFO candidates and Andrew has committed to assist us through the transition. We wish Andrew well in his future endeavors. And lastly, given the challenges faced by micro companies when raising capital in the current economic environment, management and our board of directors are currently reviewing strategic alternatives to our current path with the goal of maximizing shareholder value. That review is being conducted along with an investment bank and could result in changes to our business strategy and future operations. At this time, I cannot commit as to the timing of our determination or the strategy we may adopt, if different from the current path. Certain alternatives may require us to refocus our efforts or rebuild raw medical around a new strategic initiative and may require us to raise additional capital. Again, I'm unable to provide further detail at this time because the review is still ongoing. In the meantime, the team and I continue to be committed to advancing our business and under the current strategy and against the current timetables. Now, I will turn the call over to Andrew Jackson to review our financial results. Andrew?