Spectral Medical Announces Amendment and Extension of Exclusive Supply and Distribution Agreement With Baxter Healthcare Corporation - Seite 2

Baxter Milestone Payment to Spectral

Under the terms of the Amended Agreement, once 90 patients were enrolled in Spectral’s PMX-focused Tigris Trial, Baxter had the option to make a milestone payment to Spectral to maintain its exclusive distribution rights for PMX products in the United States and Canada.

On February 15, 2024, Spectral announced that it had reached the 90-patient enrollment threshold and provided written notification to Baxter of this achievement. Subsequently, Baxter exercised its option to maintain exclusive distribution rights.

Spectral Medical Tigris Trial and Corporate Update Call

Chris Seto, Chief Executive Officer, will host the call followed by a question-and-answer session. All interested parties are invited to participate.

CONFERENCE CALL DETAILS:

Date: Thursday, February 22, 2024

Time: 10:00 a.m. (ET)

Dial in Numbers: 1-877-407-0792 or 1-201-689-8263

Replay Dial-In: 1-844-512-2921 or 1-412-317-6671 (available after 3:00 p.m. ET, February 22, 2024)

Replay Expiration: Thursday, March 7, 2024 at 11:59 p.m. ET

Access ID: 13744665

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 U.S. 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.

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 severe form of sepsis with significant impact on patient outcomes and healthcare costs. https://www.youtube.com/watch?v=6RANrHHi9L8.