Robocath receives NMPA approval for R-One robotic platform in China

Rouen, France, January 9, 2024 – Robocath, a company that designs, develops and markets innovative robotic solutions to treat cardiovascular diseases, today announces the granting of a marketing authorization to distribute its R-One^TM robotic platform in China. This was issued on December 8, by the Chinese National Medical Products Administration (NMPA); making it the first vascular robotic platform to be granted approval in China.

This approval is based in part on the outstanding results achieved in Cathbot’s multicenter clinical trial involving 145 patients in China. Cathbot is the joint venture between Robocath and MedBot, the robotic subsidiary of the MicroPort Scientific Corporation. The full trial data will be published in the coming weeks via a special statement.

“I’m delighted that R-One is coming to the Chinese market. This approval will boost our commercial growth, allowing more people to take advantage of more precise endovascular procedures under improved working conditions. The interventional cardiologists who use R-One will benefit from complete protection from X-rays and increased precision during the procedure. Our next step is to develop a solution that can perform angioplasty remotely, to provide better and efficient medical care for vascular diseases patients all over the country,” said Chao He, president of Medbot.

“This approval to start the commercialization of our technology in China symbolizes the success of our joint venture (Cathbot), which we established together with our partner MicroPort-MedBot in 2020. I would like to thank all the collaborators from the different entities involved in this process who contributed their expertise, know-how and high energy to make this major project a reality. China today has a large number of patients experiencing coronary heart disease. By 2030, the number of coronary angioplasties in China is set to triple, to 3.2 million, driven by population growth, an aging population and the increased prevalence of certain risk factors. This all makes China the world’s largest and most dynamic vascular market. The NMPA approval is therefore outstanding news for Robocath. We are delighted to have taken this key step in our international growth strategy,” said Lucien Goffart, CEO of Robocath.

“We are extremely proud to have received approval for our platform in this highly strategic market. R-One is currently the only vascular robotic platform available in China. We share our partner’s deeply held conviction that the future of interventional medicine lies in robotics and artificial intelligence. Given this major achievement and the operational effectiveness of the partnership, we are now confident that we have everything we need to build a world-leading presence in vascular robotics. Other projects are already underway, including the development of remote treatment. The first human trials took place a few months ago and were very promising,” said Philippe Bencteux, president and founder of Robocath.

About Medbot

Founded in 2014, MedBot develops intelligent surgical robotic systems and solutions. It is committed to meeting the most cutting-edge development needs of minimally invasive surgery and innovatively providing integrated intelligent surgical solutions that can save patients’ lives or improve their quality of life. Following years of research and development, innovation and industrial accumulation, MedBot has grown to become a medical robot company that masters the underlying technology in the entire chain. With its three flagship products in the three major segments, namely the Toumai™ laparoscopic surgical robot, Skywalker™ joint replacement surgical robot and DFVision™ three-dimensional electronic laparoscope, and having entered the special approval procedure (Green Path) for innovative medical devices at the National Medical Products Administration (NMPA), Medbot is the only surgical robot company with three ‘Green Path’ grants in the People’s Republic of China (PRC). Its current business covers five areas, including endoscopy, orthopedics, vascular intervention, natural orifice and percutaneous puncture.

www.medbotsurgical.com

About Microport

MicroPort® was founded in 1998 at ZJ Hi-Tech Park in Shanghai China, where a group of dedicated individuals joined together in the common belief that advancements in medical technology could transform patients’ lives in China and around the globe. Over the last two decades, MicroPort has taken important steps towards fulfilling its mission of providing access to the best means of prolonging and reshaping lives. Today, MicroPort is focused on covering ten major areas, including cardiovascular intervention & structural heart diseases, electrophysiology & cardiac rhythm management, orthopedics & soft tissue repair, endovascular & peripheral vascular diseases, neurovascular intervention & neurosciences, life sciences (endocrine management), surgical devices & medical robotics, urology & gynecology & respiratory & gastroenterology, aesthetics & rehabilitation, and in vitro diagnostics & medical imaging. Thanks to over 300 MicroPort devices currently approved for use in nearly 10,000 hospitals worldwide, one of our devices is used every six seconds. With a vast global footprint of R&D and manufacturing sites (Shanghai; Memphis, TN in the US; Clamart in France; Saluggia in Italy; Santo Domingo in the Dominican Republic), a strong focus on technology innovation with over 4,700 patent applications and a global workforce of over 7,000 employees, MicroPort is committed to its vision of building a people centric consortium of companies focused on emerging medical technologies.

www.microport.com

About Robocath

Founded in 2009 by Philippe Bencteux, MD, Robocath designs, develops and commercializes smart robotic solutions to treat cardiovascular 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.

In 2019 the company received the CE marking for R-OneTM, its first robotic solution. In a prospective, multicenter, non-randomized, single-arm clinical trial, R-One demonstrated safety and efficacy as it achieved more than 95% technical procedure success with no MACE (major adverse cardiovascular events). Currently R-One is used in Europe, Africa and China.

By pursuing the development of smart digital solutions, Robocath aims to become a world leader in vascular robotics. Based in Rouen, France, Robocath has more than 70 employees.

www.robocath.com