Miromatrix Medical Inc.

Greetings and welcome to the MiroMatrix Medical, Inc. fourth quarter and full year 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Hannah Jeffrey, with Investor Relations. Thank you, Ms. Jeffrey. You may begin.

Good afternoon, and thank you for joining us. Earlier today, Miro Matrix released financial results for the fourth quarter and full year ended December 31, 2022. The release is currently available on the company's website at www.miromatrix.com. Jeff Ross, Chief Executive Officer, and Jim Douglas, Chief Financial Officer, will host this afternoon's call. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact including statements regarding the potential timing of pre-IND and IND filings and the initiation of related clinical trials, future expenses and revenue, capital requirements, cash runway, and needs for additional financing should be deemed to be forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and descriptions of the materials, risks, and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, March 31st, 2023. Mirror Matrix disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements, whether because of new information, future events, or otherwise. I'll now turn the call over to Jeff.

Thanks, Hannah. Good afternoon, and thank you to everyone who has joined us today for our fourth quarter and full year 2022 earnings call. The past year was very rewarding and challenging at the same time. one of the most rewarding accomplishments was the submission of our IND application for mural liver ELAP in November. We believe this was the first IND submission for a bioengineered organ therapy, putting us on the forefront of pioneering a new class of therapies to treat patients suffering from organ failure. The FDA then notified us in December that our IND application was placed on clinical hold, and in January, we received the formal clinical hold letter from the FDA detailing the specific deficiencies and the information needed to resolve the clinical hold. After evaluating the clinical hold letter internally and with our outside advisors, we remain optimistic about the ultimate success of Mural Liver eLab. We are focused on providing patients with acute liver failure access to Mural Liver eLab as soon as possible. And over the coming months, we will focus our efforts on resubmitting the IND in the second half of 2023 with the goal of gaining IND clearance from the FDA shortly thereafter. We believe gaining IND clearance from Mural Liver eLab is a significant value creation event for Mural Matrix. because it will be the first time one of our bioengineered organs is authorized for human use in human clinical trials. Following IND clearance for Mural Liver eLab, our attention will immediately turn to enrolling patients in a phase one clinical trial, which our clinical team is preparing for in parallel to our IND resubmission. As a reminder, Mural Liver ELAP is designed to provide liver dialysis by connecting a Mural Matrix single-use bioengineered liver with a software-modified Baxter Prismac system outside of the body to treat patients suffering from acute liver failure. The potential addressable market for Mural Liver ELAP includes the approximately 80,000 patients who are hospitalized each year due to various types of acute liver failure. Our initial clinical trial will be targeting patients who represent approximately 5,000 of the 80,000 hospitalizations, and an expansion study would likely be required to address the remaining ALS segments. The prioritization of mural liver ELAP enables MuralMatrix to sharpen our focus on gaining IND clearance and initiating a Phase I clinical trial, while maintaining a disciplined operational approach with our strong cash position. As a result of our prioritization of mural liver ELAP, investment in our fully implantable kidney and liver programs will be reduced during this time of mural liver ELAP focus, which will push out our targeted pre-IND submission dates. That said, we remain very enthusiastic about our fully implantable bioengineered organ programs. Of course, we could potentially reinvigorate any of our fully implantable bioengineered organ programs if the appropriate partnership arises or circumstances change. I'd like to remind everyone on today's call that we have already achieved essential proof of concept milestones for both fully implantable organ programs and look to maintain that momentum. For mural kidney, we previously announced that we demonstrated urine production and protein retention in a preclinical testing model. We believe this is the first time a bioengineered kidney has produced urine in any model. We were also selected as one of four finalists by KidneyX to participate in the Innovate KidneyX Winner Showcase at ASN Kidney Week, which was the second time Mural Matrix has been a KidneyX Award recipient. For mural liver, we previously published the results of a study done in collaboration with the Mayo Clinic announcing the successful implantation of our bioengineered livers into large animals. This study showed proof-of-concept data for mural liver and our decelerization-recelerization technology. In closing, I am proud to announce that we recently had three presentations selected for the upcoming American Transplant Congress in June 2023, two relating to mural kidney and one relating to mural liver elab. We look forward to continuing to share our progress with the transplant community. With that update, I will now turn the call over to Jim Douglas, our Chief Financial Officer, to discuss our financial results.