Spectral Medical Provides January Tigris Trial Update

85 patients enrolled

TORONTO, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Enrollment:

• Robust enrollment activity continued throughout January 2024:
  • 85 patients enrolled to-date
  • Four patients enrolled in the month of January
• Closing in on the interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment, Baxter has the option to make the second milestone payment to Spectral to maintain its PMX exclusive distribution rights.

Trial Sites:

• Continue to make progress opening an additional six new, high quality clinical sites.
  • University of Texas Health Sciences Center at Houston finalized and executed the Tigris clinical trial agreement; the Company anticipates another Texas-based site to execute its clinical trial agreement in the coming days.
  • Expect significant site onboarding activity in Q1/24, with final training scheduled at four sites in February so far.
    

“We are very excited about our prospects for 2024. The robust enrollment activity throughout January puts Spectral within striking distance of our interim enrollment milestone of 90 patients, which is expected to play as a major catalyst for the Company,” said Chris Seto, Chief Executive Officer of Spectral Medical. “Additionally, with 65 patients to go, we are entering the final push to fully enroll and finish the Tigris trial.”

About Spectral 

Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA), the only FDA cleared diagnostic for the risk of developing sepsis.

PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.