Carvolix Completes Clinical Program for TAVIPILOT AI in Aortic Valve Procedures
Carvolix has successfully completed the SAITO clinical program for TAVIPILOT, an AI software designed to assist in aortic valve positioning during TAVI. This program aimed to support commercial acceptance in the U.S. and CE marking in Europe, involving 30 patients across France and Australia.
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The SAITO clinical program has demonstrated a procedural success rate of 100% for TAVIPILOT, with no device-related complications. The studies were conducted at the Clinique Pasteur in France and Macquarie University Hospital in Australia, focusing on patients with severe symptomatic aortic stenosis.
Carvolix has secured financial backing from Truffle Capital, extending its visibility until June 2026 and supporting ongoing product development. The results contribute to the standardization and improvement of TAVI procedures, addressing a significant need in a complex clinical area. Future growth potential remains tied to the completion of a €30 million funding round aimed at advancing their clinical and technological portfolio.
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