Ra Medical Systems, Inc.

Good afternoon, and welcome to the raw medical conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. Please note, this event is being recorded. I would now like to turn the conference over to Jody Kane. Please go ahead.

This is Jody Kane with LHA. Thank you for participating in today's call. Joining me from Raw Medical are Will McGuire, Chief Executive Officer, and Andrew Jackson, Chief Financial Officer. Earlier today, Raw Medical issued a news release announcing financial results for the 2021 fourth quarter and full year. 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 Daniel Shurtalk. You can also sign up for email alerts and access the news releases in the investor relations section of the raw medical website at ir.rawmed.com. During this call or in response to listener questions, management will be making a number of forward linking statements within the meaning of the Private Securities Litigation Reform Act of 1995. to the extent that 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 March 23, 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 impacts of the COVID-19 pandemic and the military actions launched by Russian forces in Ukraine on the business and results of operations, including our supply chains. This means that results could change at any time, and the impact of COVID-19 and or the military action in Ukraine on raw medicals operations, financial results, and outlook is the best estimate based on the information for today's discussion. For details about these risks, please see the company's SEC filings, including raw medicals annual report on Form 10-K for the year ended December 31, 2021. which will be filed with the SEC shortly, and any other period filings done by the company, including quarterly reports on Form 10Q. 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 and operating the business. Non-GAAP financial measures are presented solely for information and comparative purposes and should not be regarded as a replacement for corresponding GAAP measures. Reconciliation between GAAP and non-GAAP financial measures can be found at the end of the financial results news release that was issued earlier today. With that, I'd like to turn the call over to Will McGuire. Will?

Thanks, Jody. Good afternoon, everyone, and thank you for joining us. Today, I am pleased to outline key objectives for 2022 and highlight the significant progress we've made on our engineering programs and the clinical study for an atherectomy label. This progress was made during an especially challenging period as the pandemic continues to impact our industry's ability to conduct clinical studies and persistent supply chain challenges are affecting engineering project schedules. Starting with our engineering initiatives, last month our team met a key milestone by filing a 510 application with the FDA for our next generation Dabra catheter with a braided overjacket design and a six-month shelf life. Internally, we refer to this catheter as the Dabra 2.0. We believe the Dabra 2.0's more robust design improves deliverability and kink resistance for the physician when navigating tortuous anatomy. The design overhaul was technically demanding and required building and testing hundreds of catheters during the engineering verification and validation testing phase. We look forward to receiving feedback from the FDA on our 510 application later this year, and I want to thank the team at Raw Medical for driving this project to this point while facing the aforementioned supply chain challenges. Although the DABRA 2.0 510 filing represents a major engineering and regulatory milestone, our flagship commercial catheter will be a guidewire compatible version of the DABRA 2.0, which we refer to as the DABRA-RX. The DABRA-RX will incorporate many of the DABRA 2.0's design improvements intended to create a more robust catheter, along with the added feature of guidewire compatibility. We believe that we have made great progress toward a design freeze for the Dabra Rx following our preclinical study conducted in the fourth quarter of last year with interventionalists evaluating its use, handling, and overall performance. We anticipate finalizing the design for the Dabra Rx and completing engineering verification and validation testing later this year. We are also planning to submit a 510 application to the FDA seeking regulatory clearance at the end of the year. And lastly, under engineering accomplishments, I want to update you on two additional initiatives. First, we continue to make progress on the laser development front with various upgrades to the DABRA system, and we anticipate completing design work for a new CPU over the next few months. Second, we continue to build upon our work that we believe will show that 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. Fracturing calcium in coronary or peripheral arteries can make them less rigid, thus facilitating the ease and safety of subsequent procedures. We are currently fabricating various prototype systems and intend to conduct further preclinical studies in the next few months to advance our initial bench-top and preclinical findings. We anticipate completing design concept selection and initiating a development project in the second half of this year. Although we're still in the early phases of this project, I continue to be quite excited about this application given the potential to create significant shareholder value if we are able to develop a competitive product in the emerging intravascular lithotripsy market. One final note before turning to the clinical study. We announced the granting of a US patent last month for a support catheter for use with a small flexible liquid core catheter for laser ablation of arterial plaque blockages to restore blood flow. This new patent is the 10th US patent issued to Raw Medical under an intellectual property strategy that we believe to be important for maintaining our competitive position both now and in the future. Moving to our pivotal clinical study to obtain an FDA atherotomy indication for the DABRA eczema laser system. This continues to be a top priority for all medical and we believe that securing clearance for this indication will significantly expand our addressable market beyond our existing clearance for crossing chronic total occlusions or CTOs. As I have referenced before, A third-party research group estimates the value of the combined CTO and atherectomy markets in the U.S. at approximately $900 million for 2022. We are pleased that the FDA agreed to a protocol amendment to increase trial enrollment from 100 to 125 subjects. Our primary reason for this request was subject fallout, for follow-up visits that we believe was due to the COVID-19 pandemic. We have enrolled an additional 13 subjects in this study since mid-November, bringing total enrollment to date to 98 subjects. This trial is approved for up to 10 clinical sites, and we currently have seven sites cleared for enrollment. Two of these sites have reached their quota for the maximum number of subjects, and the remaining five sites are actively screening subjects. Due to the unpredictable impact the COVID-19 pandemic has had and will continue to have on enrollment in this study, we cannot accurately estimate when enrollment will be complete. With that being said, our goal is to complete study enrollment in Q3 2022 and finish six-month follow-up in early 2023. Now, I will turn the call over to Andrew Jackson to review our financial results. Andrew?