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8/13/2025
Thank you for standing by. My name is Tina, and I will be your conference operator today. At this time, I would like to welcome everyone to the C-STAR Medical Second Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. To the speaker's remarks, there will be a question and answer session. To ask a question, simply press star followed by the number one on your telephone keypad. To withdraw your question, press star one again. It is now my pleasure to turn the call over to Jackie Cosman, You may begin.
Thank you, Tina. Good afternoon, and thank you for joining the Seastar Medical Second Quarter 2025 Financial Results Conference Call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from Seastar Medical today are Eric Schlarf, Chief Executive Officer, David Green, Chief Financial Officer, Dr. Kevin Chung, Chief Medical Officer, and Tim Barachek, Senior Vice President of Commercial and Business Operations. I would like to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. These forward-looking statements involve risks and uncertainties that could cause actual results to materially differ from any anticipated results. For a list and description of these risks and uncertainties, please review Seastar Medical's filings with the Securities and Exchange Commission. Furthermore, the comments of this conference call contain information that is accurate only as of the date of the live broadcast, August 13, 2025. T-Star Medical undertakes no obligation to revise or update any statements to reflect events or circumstances as required by law. And now, I'll turn the call over to Eric. Eric?
Thank you, Jackie. Thank you, Jackie. And thank you for joining us today. Since the beginning of the second quarter, we've made great progress on several fronts. We enrolled 125 patients in total, 12 in the month of July into the neutralized AKI trial, reported three new Quell Immune customers from top-rated U.S.-based children's hospitals, announced positive survival results from the first 20 pediatric patients treated in a commercial setting with Quell Immune from the SAVE surveillance registry, and raised additional capital to shore up our balance sheet. With respect to our Quell Immune product launch, we predicted that sales would be lumpy in the first year, and that rings true of the first half of the year. The first quarter net revenue jumped up fourfold from the fourth quarter, and we saw a 15% increase in net revenue in the second quarter. So overall, we saw nearly a 370% increase in revenue in the first six months of 2025 compared to the first six months of launch. As such, we are pleased with our progress on the Quell Immune launch, and plan to continue to focus our efforts on new customer adoptions, which should translate to an upward trend in sequential quarter sales. Now, let me say a few words about the SAVE surveillance registry. We are especially pleased with the early data from the registry that continues to show life-saving benefits from the Quell Immune Therapy. Confirming the 75% survival data is decisive in our view and clearly demonstrates that the Quell Immune Therapy is benefiting patients in the real-world setting. As Tim will explain, we are already sharing these early results with existing and potential customers in hopes of expanding the use of Quell Immune in these critically ill pediatric patients with acute kidney injury or AKI. Before I turn the call over to Tim, I'd like to emphasize one last point. That is, we experience great reward when we hear that Quell Immune has helped another critically ill pediatric patient who in many cases have little hope of survival. With each of these cases, we realize that we may be able to do this again and again with adult patients who suffer the same destructive hyper-inflammation that shuts down organs and takes lives. The numerous stories that we have heard about the use of Quell Immune is why we at Seastar Medical are so eager to bring the SCD therapy to a much broader market than we serve today. And we believe we are well on our way. We look forward to reporting our upcoming milestone in progress in our neutralized AKI pivotal trial. And with that as an overview, I will turn the call over to Tim to discuss our commercial achievements and market opportunities.
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