Spectral Medical Announces Fourth Quarter and Fiscal 2024 Results and Provides Corporate Update
Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2024
Tigris:
- Total of 154 patients randomized to date in the Tigris trial.
- Despite enrollment headwinds experienced in the fourth quarter of 2024, due to the impact of Hurricane Helene on the medical supply chain, Tigris 2024 enrollment was incredibly robust
- 59 patients enrolled in 2024 vs. 31 patients enrolled in 2023
- Strong start to 2025 enrollment
- 14 patients enrolled 2025 year-to-date
- Timing
- Closing in on the full enrollment of 150 evaluable patients:
- Estimate a further two to four patients (given the randomization scheme) to reach 150 evaluable patients
- Addresses the six patients randomized into the PMX arm who did not receive the treatment
- Enrollment of 100 patients in the PMX arm and 50 patients in the standard-of-care arm who received the assigned treatment is important for PMX regulatory review with respect to safety analysis and secondary analyses
- Based on current rate of enrollment, management believes full Tigris enrollment is impending – and should be completed in the next few weeks.
- EDEN Abstract Presentation
- On February 23, 2025, an abstract of the EDEN study was presented by Dr. Mark Tidswell at the 2025 Society of Critical Care Medicine Annual Congress (see abstract: Critical Care Medicine)
- The Company completed its EDEN study in Q4 2023 with 92 patients enrolled. The ancillary observational study collected data on patients with sepsis even if ineligible for Tigris, and captured much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity.
- Based on the results of 84 evaluable patients, compared to other patients with septic shock, those with endotoxic septic shock (EAA = 0.6 and SOFA >11) had significantly higher mortality (60% vs 14.1%, p < 0.001).
- These data will inform subsequent discussions with the FDA on labelling for PMX, as well as to provide the medical community and the Company a better picture of the addressable population in the U.S. for PMX.
- A manuscript describing the full results of the EDEN study is in preparation and will be submitted to a medical journal in the next few weeks.
PMX Commercialization:
- On January 31, 2025, Baxter International Inc. (“Baxter”) completed the sale of its Kidney Care business, including Vantive and its affiliated entities throughout the world, to funds affiliated with The Carlyle Group, pursuant to which Spectral Medical’s PMX distribution agreement was assigned to Vantive.
- Commercialization Activities
- In anticipation of a positive Tigris trial outcome, the Company has been working closely with Vantive on post-approval marketing plans for PMX commercialization.
- In February 2025, the Vantive PrisMax sub-study was completed
- Vantive intends to submit a 510(k) application and obtain clearance for its PrisMax System
- The PrisMax System, with its leading installed base in ICUs throughout the U.S., is anticipated to be the primary ICU device utilized for PMX treatments on commercial launch
“We are on the cusp of full Tigris enrollment, which marks a major clinical milestone for Spectral. Completion of the Tigris study represents a big step forward in the potential of bringing the PMX therapy to market, and we look forward to our continued partnership with Vantive, and the development of a robust commercialization strategy,” said Chris Seto, CEO of Spectral. “Spectral is now entering a heavily-focused regulatory phase for PMX. The Company will be providing a more comprehensive view on Spectral’s regulatory pathway in the coming weeks.”
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