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.”
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