Mr. Chris Seto reports

SPECTRAL MEDICAL ANNOUNCES AMENDMENT AND EXTENSION OF EXCLUSIVE SUPPLY AND DISTRIBUTION AGREEMENT WITH BAXTER HEALTHCARE CORPORATION

Spectral Medical Inc. has extended its supply and distribution agreement with Baxter Healthcare Corp., a subsidiary of Baxter International Inc., originally entered into in February, 2020.

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 Spectral's endotoxin activity assay, the only diagnostic currently cleared by U.S. FDA for the risk of developing sepsis.

Under the terms of the amended agreement, Baxter's exclusive rights to supply and distribute PMX products will be in effect for 10 years following the date that the U.S. FDA marketing authorization for PMX products in the United States is obtained. Upon Baxter International's previously announced planned separation of its kidney care business (or any other separation of all or part of such kidney care business) into an independent company, the rights and obligations under the amended agreement will be assigned or otherwise transferred by Baxter to the new kidney care company.

"Baxter's continued commitment to Spectral as our exclusive supply and distribution partner being extended for a 10-year period upon U.S. FDA approval provides us with great confidence in our commercialization path," said Chris Seto, chief executive officer of Spectral. "We are grateful and appreciative to the Baxter acute therapies team for the partnership through their investments in Spectral and their continued level of enthusiasm and hands-on involvement in planning for a successful launch of our PMX products into ICUs across the United States."

"We are encouraged by Spectral's evidence generation strategy for PMX, and our teams are fully engaged in support of our shared goal: reaching more critically ill patients with clinically effective and differentiated therapies," said Gavin Campbell, president, acute therapies, Baxter.

He added, "The commercialization of advanced blood filtration therapies like PMX is a strategic priority for Baxter acute therapies."

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

Spectral's Tigris trial and corporate update call

Mr. Seto will host the call followed by a question-and-answer session. All interested parties are invited to participate.

Conference call details

Date:  Thursday, Feb. 22, 2024

Time:  10 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 p.m. ET on Feb. 22, 2024)

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

Access ID:  13744665

About Spectral Medical Inc.

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 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, 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 United States 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 versus standard care alone and is designed as a two-to-one randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a severe form of sepsis with significant impact on patient outcomes and health care costs.

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.

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