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

Executive Summary

• Inretio completed the first cohort of its First‑in‑Human (FIH) study for the PREVA™ Neuro‑Thrombectomy System, receiving positive feedback from the Data Safety Monitoring Board (DSMB).
• The DSMB approval enables continued patient enrollment and supports Inretio’s planned U.S. Investigational Device Exemption (IDE) filing and multi‑center pivotal trial later this year.
• Therma Bright is advancing a capital raise to fund FDA submission, clinical operations, and manufacturing scale‑up for the PREVA™ system.

Key Details

• Clinical Progress: First cohort of FIH study completed; DSMB review was positive, allowing continued enrollment.
• Regulatory Pathway: Inretio aims to secure an IDE from the U.S. FDA and launch a multi‑center pivotal trial within 24 months.
• Manufacturing Scale‑Up: Company is expanding facilities and integrating manufacturing enhancements to meet anticipated trial demand.
• Capital Raise: Ongoing financing round intended to fund regulatory submissions, clinical execution, and production capacity expansion (specific amount not disclosed).
• Market Context: Stroke accounts for ~87 % of all strokes globally (~8 million cases/year), underscoring significant market opportunity for the PREVA™ system.

Notable Quotes

“We are executing with precision across all critical fronts,” – Raviv Vine, CEO, Inretio
“We are thrilled by Inretio's rapid progress and the definitive steps taken toward commercialization,” – Rob Fia, CEO, Therma Bright