Robocath has launched the world’s first clinical study that evaluates its new robotic system in coronary artery disease.

The second-generation robot, developed with the help of the clinical and technological experience Robocath gained with its first robotic platform (now deployed in numerous centers worldwide) integrates unprecedented and unrivaled capabilities to meet the increasing demands of complex coronary procedures, according to the company. 
 
The FIH (first-in-human) 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 principal investigator Dr. Mohammed Nejjari and co-investigator Dr. Franck Digne.
 
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,” Robocath President Philippe Bencteux, M.D., said.
 
The global vascular interventional robot market was valued at $61.1 million in 2024 and is projected to expand from $78.3 million in 2025 to $297 million by 2031 (a 26% annual growth rate). That growth will likely be driven by increasing demand for minimally invasive surgeries, technological advancements in robotic systems, and the rising prevalence of cardiovascular diseases. Rising healthcare expenditures and the adoption of artificial intellligence (AI)-powered surgical solutions also are expected to accelerate market expansion.
  
Founded in 2009 by Dr. Bencteux, Robocath designs, develops, and markets smart robotic solutions to treat cardiovascular and neurovascular diseases. Its smart connected solutions aim to enhance hand gestures and make medical procedures safer. Robocath develops robotic solutions that 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.

Robocath’s robotic solutions are designed to operate with precision and perform accurate movements, creating better interventional conditions. Their open architecture makes them compatible with most 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 major adverse cardiovascular events. Currently, R-One is used in Europe, Africa, and China.