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

Rhea-AI Summary

Therma Bright (OTCQB: TBRIF) announced that portfolio company Inretio completed the first cohort of its First-in-Human study for the PREVA™ Neuro-Thrombectomy System and received positive DSMB review to continue enrollment.

Inretio is pursuing a U.S. IDE and a multi-center pivotal trial planned to conclude within 24 months while scaling manufacturing and advancing a capital raise.

Positive

• Completed FIH first cohort for the PREVA™ system
• Positive DSMB review approved continued patient enrollment
• Targeting a U.S. IDE and multi-center pivotal trial to finish within 24 months
• Upgrading manufacturing capacity to support pivotal-trial demand
• Advancing a capital raise to fund FDA pathway and clinical operations

Negative

• None.

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 transformative 2026." https://www.cdc.gov/stroke/data-research/facts-stats/index.html

About Inretio

Inretio is a privately held medical device company based in the Sha'ar HaNegev Industrial Park, Israel. The company is dedicated to transforming acute ischemic stroke care through its PREVA™ platform, a unique neuro-thrombectomy solution designed to improve the efficacy, speed, and accessibility of clot removal procedures.

About Therma Bright Inc.

Therma Bright is a developer and investment partner specializing in advanced diagnostic and medical device technologies. The Company's portfolio includes innovative solutions for vascular health, respiratory diagnostics, and topical treatments. Therma Bright is listed on the TSX Venture Exchange (THRM), the OTCQB (TBRIF), and the Frankfurt Stock Exchange (JNX0).

For further information, please contact:

Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com

Follow us on X:

https://x.com/Bright_Therma

FORWARD-LOOKING STATEMENTS

Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the advancement of the PREVA™ Neuro-Thrombectomy System and related technology as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether such results will be achieved. Actual results could differ materially from those anticipated due to several factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information, future events or otherwise, except as required under applicable securities regulations.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/283378

FAQ

What milestone did Inretio achieve for PREVA™ as announced on February 10, 2026 (TBRIF)?

Inretio completed the first cohort of its First-in-Human PREVA™ study, achieving a key clinical milestone. According to Inretio, a positive DSMB review cleared continued enrollment, which supports progression toward a U.S. pivotal trial and regulatory filings.

When does Inretio plan to start a U.S. pivotal trial for PREVA™ (TBRIF)?

Inretio aims to secure a U.S. IDE and launch a multi-center pivotal study later in 2026. According to Inretio, the planned trial is designed to conclude within 24 months from initiation, subject to regulatory clearance and enrollment pace.

How does the DSMB decision affect PREVA™ development and TBRIF shareholders?

The positive DSMB review permits continued patient enrollment, reducing an early clinical hurdle. According to Inretio, this safety validation strengthens the dataset for an FDA submission and helps justify planned manufacturing and funding efforts.

What operational steps is Inretio taking to support the pivotal trial for PREVA™ (TBRIF)?

Inretio is expanding and upgrading manufacturing capabilities to meet pivotal-trial demand and clinical needs. According to Inretio, these enhancements aim to ensure supply readiness and incorporate physician feedback into the PREVA™ system design.

Why is Inretio pursuing a capital raise and how will funds be used (TBRIF)?

Inretio is advancing a capital raise to support the U.S. regulatory process, clinical operations, and manufacturing scale-up. According to Inretio, proceeds are intended to fund the IDE submission, trial execution, and facility upgrades tied to commercialization preparation.