FORT LAUDERDALE, FL / ACCESS Newswire / April 18, 2025 / EndoUVtech, a pioneering medical device company dedicated to transforming surgical stroke patient outcomes, today announced a crucial step in its FDA submission preparations with the appointment of Dr. Ken Warrington as its Regulatory Manager. His arrival marks a key inflection point as the company prepares its final FDA submission for the Smart UV™ system by year-end.
"Dr. Warrington's deep regulatory expertise and track record of FDA approvals are instrumental as we fast-track our Smart UV system through the final stages of submission," said Chip Van Vurst, CEO of EndoUVtech. "Ken's knowledge of regulatory frameworks, CMC strategy, and project lifecycle management will be critical as we finalize our submission and prepare for market entry."
Dr. Warrington brings over two decades of regulatory leadership, including oversight of complex FDA pathways and technical dossier development for medical devices. His appointment underscores EndoUVtech's commitment to regulatory excellence and its strategic plan to bring breakthrough technology to market swiftly and safely.
With the Smart UV system, EndoUVtech aims to significantly improve outcomes in ischemic stroke by reducing procedural damage and dissolving downstream clots left behind by existing mechanical thrombectomy tools. The system is designed to integrate seamlessly into current endovascular stroke interventions, adding only 10 seconds to the procedure.
As the company accelerates toward FDA clearance, it continues executing a robust regulatory and commercialization strategy designed to support rapid adoption by top-tier healthcare providers.
Learn more about the EndoUVtech team and technology at https://endouvtech.com/about/
About EndoUVtech
EndoUVtech is a medical device company headquartered in Oakland Park, Florida, dedicated to developing advanced technologies that improve outcomes for patients suffering from ischemic stroke and other cardiovascular conditions. Founded by a team of medical industry experts and scientists, the company focuses on UV-based devices that aim to reduce side effects and enhance recovery for ischemic stroke patients.
The company's flagship product, the Smart UV Laser system, is designed to minimize tissue damage, improve clot removal during endovascular procedures, and dissolve downstream platelet clots that cause stroke side effects.
For more information, visit: www.endouvtech.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding potential product performance, anticipated regulatory approvals, and future market opportunities for EndoUVtech and its manufacturing partner. These statements are based on current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially from those projected.
Such risks and uncertainties include, but are not limited to, the timing and success of regulatory submissions and approvals, market acceptance of new products, manufacturing readiness, competition, intellectual property protection, and other factors. EndoUVtech undertakes no obligation to update forward-looking statements as a result of new information, future events, or otherwise, except as required by law.
Contact
Chip Van Vurst, CEO
Phone: (954) 410-9883
Email: chip@EndoUVtech.com
Riley Gibson, Project Manager
Phone: (757) 752-6999
Email: riley@EndoUVtech.com
Vincent Iantomasi, Investor Relations
Phone: (514) 947-4966
Email: vincent@EndoUVtech.com
Lisa Goddard, Media Relations
Phone: (514) 817 5884
Email: lisa@EndoUVtech.com
SOURCE: EndoUVtech
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