Robocath launches First-In-Human (FIH) clinical study of second-generation robot with unique capabilities in coronary artery disease

Rouen, France, January 27, 2026 – Robocath, a global leader in robotic solutions dedicated to interventional cardiology, today announces the launch of the world’s first FIH (First-In-Human) clinical study evaluating its new robotic system in coronary artery disease.

This second-generation robot, developed thanks to the clinical and technological experience Robocath gained with its first robotic platform – which is already deployed in numerous centers worldwide – integrates unprecedented and unrivaled capabilities designed to meet the increasing demands of complex coronary procedures. 
 
The study will recruit 20 patients with coronary artery disease, primarily complex cases representative of the routine activity of a catheterization laboratory. It will be conducted at the Centre Cardiologique du Nord (CCN) in Saint-Denis, France, under the leadership of Dr. Mohammed Nejjari, principal investigator, and Dr. Franck Digne, co-investigator.
 
The study will also benefit from the involvement of distinguished members of Robocath’s Medical Advisory Board (MAB), including Dr. Michael Haude and Dr. Jean Fajadet, who will provide their clinical and scientific expertise throughout the program.
 
“The launch of this First-In-Human study represents a major milestone for Robocath. With our second-generation robot we are leveraging the strong clinical and industrial experience acquired with our first platform, now in use internationally. This world first illustrates our leadership position and our commitment to continuing to push the boundaries of interventional robotic technology,” said Philippe Bencteux, president of Robocath.
 
The global vascular interventional robot market was valued at $61.1 million in 2024. The market is projected to grow from $78.3 million in 2025 to $297 million by 2031, exhibiting a CAGR of 26% during the forecast period. The market growth is driven by increasing demand for minimally invasive surgeries, technological advancements in robotic systems and the rising prevalence of cardiovascular diseases. Furthermore, growing healthcare expenditure and adoption of AI-powered surgical solutions are accelerating market expansion.
 
This clinical launch confirms Robocath’s ambition to further strengthen its global leadership in this market and to contribute sustainably to the evolution of standards of care for patients with coronary artery disease.
 
About Robocath
Founded in 2009 by Philippe Bencteux, MD, Robocath designs, develops and markets smart robotic solutions to treat cardiovascular and neurovascular diseases. As an active player in the digital evolution of the medical industry, its smart connected solutions aim to enhance hand gestures and make medical procedures safer.
Robocath develops robotic solutions which integrate a unique bionic technology that optimizes the safety of robotic-assisted coronary angioplasty. This medical procedure consists of revascularizing the cardiac muscle by inserting one or more implants (stents) into the arteries that supply it with blood. Every 30 seconds, somewhere in the world, this type of procedure is performed. Robocath’s robotic solutions are designed to operate with precision and perform accurate movements, creating better interventional conditions. Thanks to their open architecture, they are all compatible with market-leading devices and cathlabs.
Robocath has obtained CE and NMPA certifications for its first robotic solution. Several multicenter clinical studies have been conducted and a meta-analysis has demonstrated R-One’s safety and efficacy as it achieved more than 98% technical procedure success with no MACE (major adverse cardiovascular events). Currently R-One is used in Europe, Africa and China.
Robocath, based in Rouen (France), a world leader in vascular robotics, continues to push the boundaries of interventional cardiology technology by developing smart digital solutions.
www.robocath.com