Ra Medical Systems, Inc.

Hello, and welcome to the Raw Medical Systems Third Quarter 2021 Financial Results Conference Call. All participants are now in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. Please note, today's event is being recorded. I now would like to send the conference over to Jody Cain. Please go ahead.

This is Jody Cain 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 third quarter of 2021. 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 release in the investor relations section of the raw medical website at ir.rawmed.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 these 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 November 15, 2021. You should not place undue reliance on 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. This means results could change at any time, and the impact of COVID-19 on raw medical operations, financial results, and outlook is the best estimate based on information for today's discussion. For details about these risks, please see the news release that accompanies this call and the company's SEC filings, including raw medical's annual report on Form 10-K for the year ended December 31, 2020, and form 10Q for the period ended September 30th, 2021, which was filed with the SEC earlier today. 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 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. 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. I'm pleased to have this opportunity to update you on our progress in developing a competitive vascular product portfolio targeting the large and growing market for medical devices to treat peripheral artery disease, or PAD. I'll start with our pivotal clinical study that's underway and is designed to obtain an FDA atherectomy indication. As a reminder, this study is approved for up to 10 clinical sites and 100 subjects. Seven sites are currently cleared to enroll subjects. This is an increase of three sites since our last quarterly conference call in mid-August. These seven sites include the reactivation of one site following relocation and the opening of two new clinical sites in Michigan and Florida, both of which are led by highly regarded interventional cardiologists. One of the seven sites has reached the maximum number of patients allowed for enrollment in our study, and the remaining six sites are actively screening subjects. We have enrolled an additional 15 subjects in the study since mid-August, bringing total enrollment to date to 85 subjects. I continue to be pleased with the pace of enrollment and appreciate the work of our clinical team to navigate continued challenges due to COVID-19. Next, I would like to provide an update on our engineering initiatives for next generation Dabra catheters. We have generated accelerated aging and real-time aging data for various catheter configurations that we believe support the achievement of a six-month shelf life for our next-gen catheters and are planning to generate additional data to support a shelf life of at least 12 months. Our team made good progress on our catheter development projects last quarter. As you will recall, in Q2 we achieved design trees on our next-gen catheter that incorporates a braided overjacket. to facilitate deliverability and make the catheter more robust when navigating tortuous anatomy. I continue to expect we will complete all engineering work and file for regulatory clearance with the FDA for this next-gen Dabra catheter in the first quarter of 2022. The engineering team is also proceeding with the development of an improved Dabra catheter that is compatible with standard 014 interventional guide wires. This project leverages the work of the previously described NextGen Dabra catheter with the added guidewire compatibility design goal. In response to physician feedback from the workshop we held with interventional physicians in June, our engineering team is making a few design changes to further increase robustness and deliverability. We intend to conduct another hands-on workshop with interventional physicians later this year to confirm our design changes have achieved the desired performance improvements. The timing of this project, as well as other projects to a lesser extent, has been impacted by supply chain delays and the availability of key resources due to a tight labor market. We now believe that the overall design work for the guidewire compatible catheter will be completed in the first quarter of 2022 rather than by the end of 2021. Before leaving R&D, I want to update you on two additional initiatives we discussed on our last quarterly call. First, we continue to execute 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 showing the DABRA laser system can be utilized to create shock waves of sufficient magnitude to fracture calcium in arteries. This type of procedure is commonly referred to as intravascular lithotripsy. Fracturing calcium in coronary or peripheral arteries can make the arteries less rigid, thus making subsequent procedures easier and or safer to perform. We have fabricated a prototype system and intend to conduct a preclinical study in the next few months to confirm our initial benchtop results. Although it's still very early, I continue to be quite excited about this application, given the potential to create significant shareholder value. Next, as announced in August, we completed the divestiture of our dermatology business during the third quarter. That transaction provided immediate cash proceeds to further our initiatives in the large and growing vascular market. Andrew will provide further details on the divestiture in a moment. Lastly, I would like to thank everyone at Raw Medical for their hard work and dedication. In addition to making real progress on our engineering projects and supporting enrollment in our pivotal clinical study, the team also executed the divestiture of our dermatology business and continued building more robust quality and compliance systems to support our future growth plans. Now, I will turn the call over to Andrew to discuss our financial results.