Robocath has announced the granting of a marketing authorisation to distribute its R-One robotic platform in China.
The authorisation was issued on 8 December 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 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 commercialisation of our technology in China symbolises 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.
