Spectral Medical Provides August Tigris Trial Update

Management provides view on recently announced Vantive-Carlyle Group transaction

TORONTO, Sept. 03, 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, today provided an update on 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 endotoxemia and septic shock.

Tigris Enrollment:

• Robust enrollment into the second half of 2024, which continues the pace experienced since January 2024:

  • 129 patients enrolled at end of August 2024

    • Four patients enrolled in August, which is a typically slow period for clinical trial activity

    • 48 patients enrolled in 2024 so far – represents the most robust enrollment rates since the start of the Tigris study

• With 21 patients to full enrollment, the Company has entered the final push to fully enroll and finish the Tigris trial

  • Based on current rate of enrollment, Tigris could be completed as early as December 2024

Dr. John Kellum, Chief Medical Officer of Spectral, noted, “It's gratifying to see that despite August vacation schedules, enrollment continues to be strong. We continue to enjoy very strong activity at our sites. As such, we remain confident in finalizing full Tigris enrollment around year end 2024.”

Vantive-Carlyle Group Transaction:

On August 13, 2024, Baxter International (NYSE:BAX) announced that it had reached a definitive agreement with The Carlyle Group (NASDAQ:CG) to divest its Vantive business (“Vantive-Carlyle transaction”) (Baxter Announces Definitive Agreement to Divest Its Vantive Kidney Care Segment to Carlyle for $3.8 Billion | Baxter). Spectral Medical’s PMX distribution agreement with Baxter will be assigned to Vantive upon closing of the Vantive-Carlyle transaction, which is expected to close in late 2024 or early 2025.

Chris Seto, Chief Executive Officer of Spectral, commented, “We believe the Vantive-Carlyle transaction is an overwhelmingly positive event for Spectral. The Carlyle Group has been a leading private equity investor in the medical technology sector, with investments totaling over $40 billion in enterprise value. While the announcement means that Vantive will have a change of ownership, it does not mean it will have a change in strategy. EAA and PMX is a unique product offering that has the potential to be a high margin, high growth offering for Vantive. Ultimately, with the change in ownership to The Carlyle Group, Vantive should be in a strong financial position to support and drive the commercialization effort of EAA and PMX.”

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 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 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 company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, 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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