Spectral Medical Inc.

Greetings. Welcome to Spectral Medical year-end 2025 corporate update and year-end review call. At this time, all participants are in a listen-only mode. A 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. Please note this conference is being recorded. I will now turn the conference over to Ali Mondavi, Capital Markets and Investor Relations. Thank you. You may begin.

Thank you, Sherry. Good morning, everyone, and thanks for joining us for today's year-end corporate update call. Joining me this morning are Chris Seto, Chief Executive Officer of Spectral Medical, and Dr. John Kellen, Spectral's Chief Medical Officer. Following remarks from Chris and John, we will open the call for a Q&A session. Before we begin, we are required to provide the following statements regarding forward-looking information, which is made on behalf of Spectral Medical and all of its representatives on this call. The remarks and answers to your questions today may contain forward-looking information about future events or the company's future performance. This information is subject to risks and uncertainties that may cause actual events or results to differ materially. Any information regarding forward-looking statements is made as of today's date, and the company does not undertake to provide any forward-looking statements. I'll now turn the call over to Chris.

Thank you, Ali, and good morning, everyone. This morning, Dr. Kellam and I are here to provide our year-end corporate update. Our intention is to give you a clear, structured view of where we stand today, the milestones immediately ahead of us, and how we are positioning Spectral for a successful 2026. Specifically, we will speak to the upcoming FDA filing and our PMA submission timeline, our progress on the Tigris manuscript and expectations for publication, our commercialization readiness activities with Vantiv, and finally, our funding position. After our prepared remarks, we'll open up the floor to a Q&A session. As many of you know, this has been a truly pivotal year for Spectral. Earlier in the year, we achieved full enrollment in the TIGRIS confirmatory trial with 157 patients in total, yielding 100 treated PMX patients. In the world of sepsis research, that is no small feat. It reflects the sustained commitment of our clinical site staff, the dedication of our internal team, and the willingness of patients and families to participate in a study aimed at addressing one of the most challenging conditions in critical care. We're deeply grateful to all of them. And of course, in August, we released the positive top line results from Tigris. These results demonstrated clinically meaningful benefit at both 28 and 90 days, consistent with the precision medicine approach that underpins PMX and the treatable cohort defined in Euphrates. The data reinforced our confidence in the therapy and have been very well received by many of our key stakeholders, including clinicians globally, our distribution partner, our manufacturing partner, as well as the capital markets. The top line results not only validated years of scientific work, but they also provided the momentum needed to progress fully into the regulatory phase with clarity and conviction. But as we said at the time, completing enrollment and releasing the top line results were not the end points. They were the beginning of the next phase. With the strength of the TIGRIS data now well established, our focus shifted immediately toward regulatory execution. From day one, our priority has been to ensure that our PMA is not only complete, but that it is constructed to the highest possible standard, one that anticipates FDA expectations, incorporates the most current requirements, and fully reflects the quality and significance of the TIGRIS results. And as our work has progressed, we have continued to receive constructive feedback from the FDA. Much of that feedback has already been incorporated, and the remainder is being integrated now as we finalize the submission package. These updates are strengthening the filing and ensuring that we deliver a PMA that is both comprehensive and durable. With that overview, I will now turn the call over to Dr. Kellam, who will walk you through the PMA submission timeline and regulatory pathway in more detail. John?