Caranx Medical ("Caranx"), a French medical device company specializing in the development of an autonomous robot to democratize access to Transcatheter Aortic Valve Implantation (TAVI), a lifesaving procedure, today announced FDA clearance for US commercialization of the world's first AI Software for real-time intra-operative guidance of transcatheter heart valve implantation.
The FDA clearance marks a significant milestone of Caranx's strategy towards planned market introduction of TAVIPILOT Soft by end of 2025.
"Obtaining FDA clearance for TAVIPILOT Soft is a major achievement for the Caranx team. This clearance confirms the potential of real-time guidance in TAVI/TAVR procedures to enhance precision and improve patient outcomes. We are excited to now move forward with early commercialization by end 2025 and to provide interventional teams with a solution that can support safe and predictable valve deployment," says CEO of Caranx Jorgen Hansen.
The TAVI procedure (minimally invasive transcatheter aortic valve replacement) was introduced app. 20 years ago, and cardiologists still face critical challenges and long learning curves during these procedures to accurately and precisely deploy heart valves. While 300,000 TAVI procedures are performed annually in the US and EU, 1,700,000 patients need a TAVI procedure. According to Frost Sullivan, annual TAVI sales are $8 billion, and the market exhibits double-digit annual growth. Caranx products could significantly increase the number of patients benefiting from TAVI and democratize the procedure to additional interventional cardiology centers.
"At Caranx Medical, our vision extends to developing our proprietary Artificial Intelligence Platform, currently from more than 5000 patients with annotated multimodality images of CT, Fluoroscopy, Echo, data, etc. used to feed our AI algorithms and to revolutionize other cardiovascular indications, such as mitral and tricuspid valve replacements, reshaping the landscape of interventional medicine," adds CEO of Caranx, Jorgen Hansen.
"Allowing a broader number of cardiologists and interventional cardiology centers to perform complex procedures, such as TAVI, with the Caranx AI-driven software and autonomous robot is at the heart of our mission of entrepreneurs and business builders to save lives and revolutionize medicine," says Philippe Pouletty, MD, founder of Caranx and CEO of Truffle Capital. "We are assessing how to make Caranx future even more promising and ambitious, with potential collaborations with other cardiovascular-focused companies, in the context of an ambitious project named CarvOlympics."
TAVIPILOT Soft is an easy-to-use, AI-driven intra-operative software which tracks real-time anatomical and instrument landmarks. It enables precise and accurate heart valve positioning and delivery. TAVIPILOT Soft is expected to be a revolution for the transcatheter replacement of aortic valves, which is currently restricted to the most experienced, TAVI trained, cardiologists. TAVIPILOT Soft is compatible with all cardiac Imaging Systems and will be compatible with all TAVI heart valves on the market.
About Caranx Medical
Backed by a team of top-tier experts, management team and supported by Truffle Capital, a renowned name in European biotech and MedTech investment, Caranx Medical is a French MedTech company, founded by Philippe Pouletty, MD, CEO of Truffle Capital, co-founded by CMO Eric Sejor, MD, and CTO Pierre Berthet-Rayne. Caranx has the ambition to become a global leader in AI and robotic assisted transcatheter heart valve implantation.
Subject to bringing TAVIPILOT Robotic solution, with autonomous control, to First in Human in 2025, Caranx's ambition is to gradually commercialize in all key markets its products and is poised for rapid growth.
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