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Recently, Shanghai MicroPort EP MedTech Co., Ltd. (referred to as "MicroPort EP") and Stereotaxis (NYSE: STXS) announced regulatory approval of the Genesis RMN® System by China's National Medical Products Administration (NMPA).
This approval is a significant milestone, making available the latest advances in minimally-invasive robotic surgery technology to physicians and patients in China. MicroPort EP is initiating full commercial launch of Genesis through its existing sales teams focused on the electrophysiology community. Approval of Genesis is a key element in a broader collaboration between Stereotaxis and MicroPort EP which entails the development, integration and commercialization of Stereotaxis’ robotic system, robotically-navigated catheters, and MicroPort EP’s mapping system. MicroPort EP is one of China’s leading medical device companies with a portfolio of cardiovascular medical devices designed to diagnose and treat arrythmias. Stereotaxis and MicroPort EP previously announced their collaboration in August 2021.
“We are proud to partner with Stereotaxis to bring the benefits of the Genesis system to China,” said Dr. Sun Yiyong, President of MicroPort EP. “We look forward to launching this significant technology and continuing our partnership to provide China’s electrophysiology community with the most advanced innovations.”
"We are delighted to receive NMPA clearance for the Genesis System in China," said David Fischel, Stereotaxis Chairman and CEO. "This approval represents another key milestone as we establish the foundations for significant growth across key focus geographies. Our investment to advance the substantial innovations underscores our commitment to pioneering the frontiers of medical technology to improve the lives of patients with cardiovascular disease around the world.”
Genesis is the latest innovation in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to minimally-invasive endovascular procedure. The Genesis RMN System has FDA clearance and is CE marked, with systems across the United States and Europe having been used to treat thousands of patients.
