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

Baxter to act as exclusive partner to Spectral for 10 years following PMX approval by U.S. FDA

TORONTO, Feb. 21, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, is pleased to announce an extension to its supply and distribution agreement (the “Amended Agreement”) with Baxter Healthcare Corporation, a subsidiary of Baxter International Inc. (“Baxter”) (NYSE: BAX), originally entered into in February 2020.

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 Spectral’s Endotoxin Activity Assay (EAA™), 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 ten (10) years following the date that the U.S. FDA marketing authorization for PMX products in the United States is obtained. Upon Baxter International Inc.’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 ten-year period upon U.S. FDA approval provides us with great confidence in our commercialization path,” said Chris Seto, CEO of Spectral Medical. “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 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.

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

Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-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 managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingthe company’s ability to raise capital and the availabilityoffundsandresourcestopursueR&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies (and the receipt of any required regulatory approvals or clearances), the success of Baxter’s commercialization efforts, 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.

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