Spectral Medical Achieves Enrollment for Tigris Trial
TORONTO, April 16, 2025 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), dedicated to advancing treatment options for sepsis and septic shock, is thrilled to announce that it has successfully completed the enrollment phase of its Tigris trial. This Phase 3 clinical study focuses on assessing the efficacy of Polymyxin B Hemoperfusion (“PMX”) for adult patients suffering from endotoxic septic shock, and it marks a pivotal step forward in the Company’s research endeavors.
Key Highlights of Tigris Trial Enrollment
As of now, 157 patients have been enrolled in this substantial clinical trial, with 151 being assessed for efficacy. This remarkable participation showcases robust interest from both researchers and clinicians in the clinical utility of PMX.
Enrollment Details
The completion of enrollment signifies a milestone for the Company, with significant metrics outlining the outcomes:
- Total Enrolled Patients: 157 total participants have been involved; among them, 151 patients will be evaluated, and 100 have received treatment with PMX.
- Follow-Up Procedures: A 28-day follow-up for the final enrolled patient will be conducted, with completion anticipated by May 8, 2025.
Expected Outcomes from the Trial
Data analysis is structured to occur approximately 90 days post the last patient’s follow-up, with results expected to be released about two weeks after this data lock. The anticipation surrounding the topline results is high, as it could provide important insights into the efficacy of PMX.
Regulatory Advancements and PMA Submission
Following the completion of the Tigris trial enrollment, Spectral is intensifying its focus on regulatory processes related to PMX's Premarket Approval submission. This submission will utilize a modular approach, whereby non-clinical information has been submitted separately from clinical findings, enabling efficient review by the US Food and Drug Administration (FDA).
As of now, all necessary non-clinical studies and reports have been forwarded to the FDA for their consideration, with plans in place to submit clinical data by the close of October 2025.
Company Leadership Highlights
Dr. John Kellum, Chief Medical Officer, expressed appreciation for the involvement of patients and clinical sites that facilitated the rapid enrollment of participants. He emphasized the significance of the trial outcomes, noting that the results could potentially revolutionize treatment protocols for septic shock.
“Finalizing enrollment represents another major milestone for the Company and puts us on track towards our regulatory goal for PMX. We have a clear path ahead, and we remain committed to advancing our commercialization efforts in collaboration with our partners,” stated Chris Seto, CEO of Spectral.
Looking Ahead – Upcoming Corporate Update Call
In light of the Tigris trial’s success, the Company will host a corporate update call, scheduled for May 15, 2025, at 11:00 a.m. ET. During this call, leaders from Spectral will discuss the regulatory trajectory and provide insights into corporate funding.
All interested parties are encouraged to participate.
About Spectral Medical
Spectral is at the forefront of a major advancement within the medical field, actively seeking U.S. FDA approval for its innovative PMX product designed for the management of septic shock. PMX serves as a therapeutic hemoperfusion system that effectively removes endotoxins from the bloodstream, guided by the Company’s FDA-cleared Endotoxin Activity Assay (EAA™). This product holds significant promise, having been utilized successfully over 360,000 times across Japan and Europe.
With recent recognition from the FDA as a Breakthrough Device, PMX is positioned uniquely to address the urgent medical need; approximately 330,000 patients are diagnosed with septic shock in North America annually.
Frequently Asked Questions
What is the Tigris trial about?
The Tigris trial evaluates the effectiveness of Polymyxin B Hemoperfusion (PMX) in treating adults with endotoxic septic shock.
How many patients were enrolled in the Tigris trial?
A total of 157 patients have been enrolled in the Tigris trial.
When will the topline results be announced?
The topline results are expected to be released around two weeks after the data lock, which occurs approximately 90 days after the last patient's follow-up.
How is Spectral Medical addressing regulatory submissions?
Spectral is employing a modular approach for its Premarket Approval submission to facilitate efficient review by the FDA.
Where can I learn more about Spectral Medical?
For further information about Spectral Medical and its products, visit www.spectraldx.com.
