Mr. Chris Seto reports
SPECTRAL MEDICAL ANNOUNCES MAJOR MILESTONE BY REACHING ITS INTERIM ENROLLMENT TARGET OF 90 PATIENTS
Spectral Medical Inc. has achieved a major milestone by reaching its interim enrolment target of patient 90 in its Tigris trial.
Under the terms of the company's exclusive distribution agreement with Baxter International, at interim enrolment, Baxter has the option to make a second milestone payment to Spectral to maintain its PMX exclusive distribution rights. As such, Spectral has formally notified Baxter of reaching its interim enrolment target of 90 patients.
"Enrolling patient 90 represents a major milestone in many ways for Spectral as we continue to see acceleration across our Tigris trial sites and building confidence and momentum towards completing the trial," said Chris Seto, chief executive officer of Spectral Medical. "We remain confident in the outcome of Tigris and our potential for FDA approval, and look forward to our continued partnership with Baxter to commercialize PMX and bring a new standard of care across ICUs in the United States."
About Spectral Medical Inc.
Spectral is a phase 3 company seeking U.S. Food and Drug Administration 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.
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