speaker
Josh
Conference Operator

Good day and thank you for standing by. Welcome to the C-STAR Medical Report Second Quarter 2026 Financial Results. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. I would now like to hand the conference over to your speaker today, Jackie Kosman.

speaker
Jackie Kosman
Investor Relations, Wheelhouse Life Science Advisors

Thank you, Josh. Good afternoon, and thank you for joining the Seastar Medical Second Quarter 2026 Financial Results Conference Call. I'm Jackie Kosman with Wheelhouse Life Science Advisors. Joining me from Seastar Medical today are Eric Schlorff, Chief Executive Officer, Tim Varacek, Senior Vice President of Commercial and Business Operations, Dr. Kevin Chung, Chief Medical Officer, and Mike Messinger, Chief Financial Officer. 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 differ materially from any anticipated results. For our list and description of these risks and uncertainties, please review Seastar Medical's filings with the Securities and Exchange Commission. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, August 12, 2026. The Star Medical undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law. And now I'd like to turn the call over to Eric. Eric?

speaker
Eric Schlorff
Chief Executive Officer

Thank you, Jackie. And thank you all for joining us today. We are very pleased with our progress this quarter. Our pediatric AKI market penetration and continued strong Quell Immune revenue growth bodes well for our future potential opportunity in the adult AKI market that is 50 times larger than the pediatric market in the United States. Successful treatment of pediatric AKI with Quell Immune therapy by patient care teams is driving greater clinical confidence from the tight-knit from the Critical Care Pediatric Community, which we believe will only strengthen the future potential launch of this therapy in the adult AKI market. Tim will speak further on our plans for our continued adoption of Quell Immune in the pediatric AKI market, and also discuss how we are strategically planning for a potential launch of this therapy in the adult AKI market. And Kevin will describe our progress in our neutralized AKI pivotal clinical trial. and our regulatory strategy for the adult AKI indication. Before I turn the call over to Tim, if you are new to Seastar Medical Story, I'd like to clarify that the same foundational therapy in Quell Immune known as the selective cytophernic device or SCD is the same therapeutic device that we are evaluating in our pivotal study for the adult AKI indication. The adult version is simply a larger device to accommodate larger blood volumes. Also, I'd like to emphasize that our SCD therapy is first in class. It is the only immunomodulatory therapy that targets and neutralizes hyperactive leukocytes and monocytes and immune cells, the immune cells primarily responsible for causing the cytokine storm that shuts down organs and takes the lives of far too many patients with AKI requiring renal replacement therapy. Given the unique mechanism of our STD therapy and the significant value of finding a potential solution to this continuing unmet need, I would note that we anticipate our current pharmacological or pharmaceutical-like gross margins to continue for Quell Immune and to extend to our adult therapies if approved. Furthermore, we believe that the FDA understands the importance of bringing innovative treatments advancements to critically ill patients with AKI. The FDA approved Quell Immune for Pediatric AKI under humanitarian device exemption and also awarded us breakthrough device designation for the SCD therapy for adult patients with AKI on continuous renal replacement therapy, which should support a more collaborative and rapid approval process. We also have received breakthrough device designations for our other pipeline indications, including systemic inflammation from cardiac surgery and chronic inflammation in end-stage renal disease among others. I provide this context today to reiterate our strong belief that our opportunity is significant. We remain keenly focused on achieving our near-term goals and understand the importance of driving new customer adoption for Quell Immune and enrolling patients in our neutralized AKI trial. By the same token, we are not losing sight of our long-term opportunities in what Seastar Medical can achieve for all our stakeholders. With that, I'll turn it over to Tim. Tim?

Disclaimer

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