- 157 patients enrolled
- Topline results expected to be released in August 2025
- Company to host Corporate Update Call on May 15, 2025
TORONTO, April 16, 2025 (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 announced the completion of full enrollment in 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 endotoxic septic shock.
Key Post-Tigris Enrollment Milestones
- Total enrolled patients:
- 157 total patients enrolled
- 151 evaluable patients, 100 treated with PMX
- 28-day follow-up for last patient enrolled to be completed on May 8, 2025
- 157 total patients enrolled
- Release of topline results:
- Data lock to be completed approximately 90 days after final patient 28-day follow-up
- Expected release of topline results approximately 2 weeks post-data lock
- Data lock to be completed approximately 90 days after final patient 28-day follow-up
- PMA submission:
- The Company's Premarket Approval submission ("PMA") is a modular approach, whereby non-clinical aspects are submitted separately from the clinical data
- To-date the Company has submitted all non-clinical studies and reports to the US Food & Drug Administration ("FDA") for evaluation
- On track to submit the clinical results and reports by end of October 2025
Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, "We are grateful for the strong interest in the clinical development of PMX among researchers and clinicians that has helped drive us towards completing full enrollment in the Tigris trial with a total of 157 patients. On behalf of Spectral Medical, I would like to express gratitude to the patients and their families in addition to the dedicated teams at the clinical sites, as well as our clinical and regulatory staff. We remain confident in the potential of PMX, and if ultimately approved, to play a major role in reducing the tragic rates of mortality caused by endotoxic septic shock."
"Finalizing enrollment represents another key milestone for the Company and brings us a step closer on our regulatory path to potential approval of PMX. Spectral is now heavily focused on the regulatory phase for PMX, in addition to our continued commercialization activities with our distribution partner Vantive," said Chris Seto, CEO of Spectral. "With enrollment now complete, we expect to be in a position to share topline results in the third quarter of this year. Additionally, the Company will be hosting a corporate update call to provide a comprehensive view on Spectral's regulatory pathway as well as a corporate funding update."
Balance Sheet and Financing Update
The Company is in the late stages of finalizing a non-dilutive financing with a view to be fully funded to PMX commercialization.
Spectral Medical Tigris Trial and Corporate Update Call
Chris Seto, Chief Executive Officer, and Dr. John Kellum, Chief Medical Officer, will host the call followed by a question-and-answer session. All interested parties are invited to participate.
CONFERENCE CALL DETAILS:
Date: Thursday May 15, 2025
Time: 11:00 a.m. ET
Dial-in: 1-877-407-0792 or 1-201-689-8263
Call me: https://callme.viavid.com/viavid/?callme=true&passcode=13744665&h=true&info=company&r=true&B=6
Participants can use Guest dial-in s above and be answered by an operator OR click the Call me link for instant telephone access to the event. *Available 15 minutes prior to scheduled start time.
Replay Dial-in: 1-844-512-2921 or 1-412-317-6671
Available May 15, 2025, 3:00 p.m. ET, until May 29, 2025, 11:59 p.m. ET
Conference ID: 13753414
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 FDA cleared Endotoxin Activity Assay (EAA), the clinically available test for endotoxin in blood.
PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively over 360,000 times 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.
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in "Bayesian methods: a potential path forward for sepsis trials".
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
| Ali Mahdavi | Chris Seto | |
| Capital Markets & Investor Relations | CEO | |
| Spinnaker Capital Markets Inc. | Spectral Medical Inc. | |
| 416-962-3300 | ||
| am@spinnakercmi.com | cseto@spectraldx.com |
