Cytosorbents Corporation

Good afternoon, ladies and gentlemen, and welcome to the Cytosorbent's first quarter 2025 earnings conference call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, May 8th, front bearing five. I would now like to turn the conference over to Mr. Dan Alexander. Please go ahead.

Thank you, Constantine, and good afternoon, everyone. Welcome to SIDUS Auburn's first quarter 2025 financial results and recent business highlights conference call. Joining me today from the company for prepared remarks are Dr. Philip Chan, Chief Executive Officer, Dr. Micah Delia-Garris, Chief Medical Officer, and Pete Mariani, Chief Financial Officer. 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 the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today. The forward-looking statements we make reflect our views and estimates as of today, May 14, 2025, 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 first quarter 2025. Following the presentation, we will open the line to analysts for their questions. And now, it is my pleasure to turn the call over to Dr. Philip Chan. Phil?

Thank you very much, Adana. Good afternoon, and welcome, everyone, to our first quarter 2025 earnings call. As a quick summary for those who are new to the company, Citus Servants is a leader in the treatment of life-threatening conditions in the intensive care unit in cardiac surgery through blood purification and the removal of harmful substances from blood with our proprietary Sorbent bead technology. Cartridges filled with these beads are high-margin, single-use disposables that are plug-and-play compatible with existing blood pump machines in a hospital, such as dialysis, ECMO, and heart-lung machines. Our technologies are used in a broad number of blood purification applications, specifically Cytosorb, our flagship product, which is approved in the European Union, is used primarily to treat life-threatening conditions in the ICU and cardiac surgery, such as sepsis, acute respiratory distress syndrome, liver failure, blood thinner removal, and infective endocarditis. Cladisorb is the anchor of our core international business, with over 270,000 devices utilized to date in more than 70 countries worldwide, and drove 35.6 million in core product sales in 2024. Our second product, DrugSorb ATR, is an investigational FDA breakthrough designated medical device intended to reduce the severity of perioperative bleeding in patients undergoing cardiac surgery due to blood thinning drugs. We are focused initially on the blood thinner Berlinta in patients undergoing coronary artery bypass grafting or CABG surgery. And in September and November of 2024, we submitted marketing applications to both FDA and Health Canada, respectively. Micas will have some updates on the status of these applications later. Given that we just had a broader update on the company in our end of year earnings call a month and a half ago, today's agenda will just focus on the three main areas where we are concentrating our efforts. I will discuss our core Cytosorb business and highlight key catalysts for growth. Micas and I will then cover the regulatory status and activity of DrugSorb ATR in the US and Canada to outline our plans going forward And then Pete will go over our progress in our goal to have our core business near break even by the end of this year with sufficient cash to fund our company initiatives.