Spectral Medical Inc. Message Board

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Spectral Medical Inc.

EDTXF 0.596

-4.0%

2:41 PM EDT

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next

From: Sultan	5/13/2025 11:00:16 AM
	of 504

Spectral Medical Update as posted on Linkedin Today We’re pleased to share important progress as we continue advancing PMX through its final clinical and regulatory stages: Tigris Trial Milestone • Enrollment complete: 157 patients enrolled; 151 evaluable; 100 treated with PMX • Topline results expected in Q3 2025, approximately two weeks after data lock • Finalizing enrollment marks a key step forward on the regulatory path FDA PMA Submission • Non-clinical components submitted under a modular approach • On track to submit clinical data by end of October 2025 EDEN Study Results • Presented at SCCM 2025 by Dr. Mark Tidswell • Data from 84 evaluable patients show significantly higher mortality in those with endotoxic septic shock (60% vs 14.1%, p < 0.001) • Findings support both regulatory discussions and define the U.S. addressable patient population Focused on Commercialization & Funding • Post-approval planning underway • ICU system integration in focus “Finalizing enrollment represents another key milestone and brings us a step closer on our regulatory path to potential approval of PMX,” said Chris Seto, CEO. “We’re now heavily focused on regulatory progress and commercialization planning. The recent financing agreement provides a clear, non-dilutive path to advance PMX toward market.” buff.ly

Report TOU Violation

Share This Post

Public Reply Prvt Reply Mark as Last Read File

Previous 10 Next 10 Previous Next