Cytosorbents Corporation

Good day and welcome to the Cytosorbents Corporation third quarter 2022 earnings conference call. Today's call is being recorded at the request of the company. At this time, all participants will be in a listen-only mode. At this time, I'd like to turn the conference over to Michelle Almonte. Please go ahead.

Thank you and good afternoon. Following the formal remarks today, we will open the call for your questions. Please be advised that the call will be recorded at the company's request. Joining me today from the company are Dr. Philip Chan, Chief Executive Officer, Vincent Caponi, Chief Operating Officer and President, Kathleen Block, Chief Financial Officer, Dr. Estimio Celio-Guerres, Chief Medical Officer, Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of Cytosorbents Europe, GMBH, and Christopher Kramer, VP of Business Development. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the company claims protection under safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today and therefore, We refer you to a more detailed discussion of these risks and uncertainties in the company's filings with the SEC. Any projections as to the company's future performance represented by management include estimates today as of November 3rd, 2022, and we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the operating and financial highlights for the third quarter by management. Following that presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. At this time, it's now my pleasure to turn the call over to Dr. Philip Chan.

Thank you very much, Michelle, and good afternoon, everyone. From an operational standpoint, we've been making good progress. As we continue to celebrate our 10th year of commercialization of Cytosorb, we've had 186,000 cumulative Cytosorb devices utilized as of the end of the third quarter, up from around 152,000 last year. As Micah will discuss in his comments in greater detail, the START-T trial is enrolling well, and we expect to achieve the first milestone of 40 patients this month. This puts us on track to potentially complete the study by summer of next year. Yesterday, we announced final key data from the USCTC registry on 100 critically ill COVID-19 patients with refractory respiratory failure from five US ECMO centers, where enhanced lung rest with Cytosorb and ECMO, led to a 90-day survival of 74%, and where early intervention yielded better clinical outcomes. During the third quarter, we achieved ISO 13485 certification of our Princeton, New Jersey manufacturing facility. We also had some excellent news on the reimbursement front, with reimbursement of Cytosorb by the Israeli Ministry of Health for cardiothoracic surgeries, which will go into effect in 2023, and reimbursement from the Turkish Ministry of Health for critical care and cardiothoracic surgery application. We recently announced two major awards for our HumanFM BGA product that enables universal plasma that could be given to any patient. The Department of Defense has awarded us a $2 million two-year award to develop commercial-ready devices for preclinical porcine studies and a $4.3 million three-year award to customize a device to enable freeze-dried universal plasma that could be used off the shelf for patients in trauma and in military service. Finally, we announced the release of new cardiac surgery data at EAX 2022, highlighting new positive data using Cytosurf intraoperatively during cardiothoracic surgery to improve outcomes in staph aureus, endocarditis, heart transplantation, and antithrombotic drug removal, and also received a $282,000 award from NIH to test new and existing polymers for cytokine and LPS endotoxin removal to advance new treatments for deadly gram-negative sepsis. With that, I will now turn it over to Kathy Block to cover our financial performance for the quarter. Kathy?