Therma Bright Portfolio Update: Inretio Successfully Completes First-in-Human Cohort for PREVA(TM) Stroke Platform; Targets 2026 U.S. FDA Trial

About this update from Therma Bright Inc.

Toronto, Ontario--(Newsfile Corp. - February 10, 2026) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX0) ("Therma" or the "Company"), a developer and investment partner specializing in advanced diagnostic and medical device technologies, is pleased to announce a major clinical milestone for its portfolio company, Inretio. The medical device innovator has successfully completed the first cohort of the First-in-Human (FIH) study for the PREVA™ Neuro-Thrombectomy System, moving the company rapidly toward a planned U.S. pivotal trial. Clinical & Regulatory Acceleration: Following the positive review from the Data Safety Monitoring Board (DSMB), Inretio has received approval to continue patient enrollment. This clinical data is vital for the company's upcoming submission to the U.S. Food and Drug Administration (FDA). Inretio aims to secure an Investigational Device Exemption (IDE) to launch a multi-center U.S. study later this year, designed to conclude within 24 months. "We are executing with precision across all critical fronts," said Raviv Vine, CEO of Inretio. "The positive DSMB feedback validates our safety profile and provides a strong foundation for our U.S. strategy. As we prepare for our FDA submission, we are simultaneously refining the PREVA™ system based on direct physician feedback to ensure superior clinical utility." Operational Scaling & R&D: Inretio is actively upgrading its manufacturing capabilities to meet pivotal trial demand. This includes expanding facilities and integrating manufacturing enhancements. Strategic Outlook To fuel these milestones, Inretio is currently advancing a capital raise. These funds will support the U.S. regulatory process, clinical operations, and the scaling of manufacturing. The company continues to strengthen relationships with global Key Opinion Leaders (KOLs) and major hospital networks. "We are thrilled by Inretio's rapid progress and the definitive steps taken toward commercialization," stated Rob Fia, CEO of Therma Bright. "According to the CDC, Ischemic stroke accounts for approximately 87% of all strokes, affecting nearly 8 million people globally every year. With the aging population driving incidence rates higher, the market demand for Inretio's intuitive, effective solution is undeniable. We look forward to a tra...

View stock analysis, news, and events for Therma Bright Inc.