HONG KONG, – Peijia Medical Limited (HKEX: 9996) announced today the formal submission of its application for the European Union Medical Device Regulation (EU MDR) CE Mark for its GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System. The device is designed for the treatment of mitral regurgitation, a condition where the mitral valve doesn’t close properly, allowing blood to leak backward in the heart. HighLife SAS is serving as Peijia Medical’s European partner for this endeavor.
The submission marks a key step in Peijia Medical’s international expansion strategy, signaling its commitment to bringing its technology to major global markets. Mitral regurgitation affects millions worldwide and can lead to heart failure, significantly impacting quality of life and increasing mortality risk. Current treatment options range from medication to open-heart surgery, but TEER offers a less invasive alternative for select patients.
GeminiOne distinguishes itself through several design features, according to the company. It incorporates a sliding groove mechanism intended to allow for a longer coaptation length – the area where the valve leaflets meet – while maintaining a relatively small implant size and delivery system. Here’s crucial for navigating the complex anatomy of the heart. The system also features an independent leaflet grasping design aimed at simplifying the procedure, an auto-locking mechanism to prevent slippage during implantation and multi-angular detachment capability to accommodate variations in patient anatomy. Peijia Medical states that the system’s design is globally patented and has undergone freedom-to-operate (FTO) analyses.
The TEER market is currently dominated by Abbott’s MitraClip device, which is approved for both secondary and primary mitral regurgitation. However, the emergence of new players like Peijia Medical, with innovative designs, is expected to increase competition and potentially drive down costs, ultimately benefiting patients. Secondary mitral regurgitation, often caused by enlargement of the heart due to conditions like heart failure, is a particularly challenging area, as highlighted in a recent review published in Eurointervention.
Beyond the EU submission, Peijia Medical is simultaneously pursuing regulatory approvals in other key markets. The company reports that its application for GeminiOne has been accepted by the National Medical Products Administration (NMPA) in China and is currently under review. The U.S. Food and Drug Administration (U.S. FDA) has granted Investigational Device Exemption (IDE) approval for an Early Feasibility Study (EFS) in the United States, allowing the company to begin initial clinical trials to assess the safety and performance of GeminiOne in a limited number of patients.
The progression of GeminiOne through these regulatory pathways demonstrates Peijia Medical’s ambition to establish itself as a significant player in the structural heart intervention market. The company, founded in and headquartered in Suzhou, China, has been rapidly expanding its portfolio of cardiovascular devices, including four Transcatheter Aortic Valve Replacement (TAVR) systems and nearly twenty neurointerventional devices already registered in China. Peijia Medical’s focus on both structural heart and neurovascular diseases positions it within a high-growth segment of the medical device industry.
The company’s financial performance will be closely watched as it navigates the complexities of global regulatory approvals and commercialization. While the EU MDR submission is a positive step, obtaining the CE Mark is not guaranteed and can be a lengthy process. Successful completion of the EFS in the U.S. And subsequent clinical trials will be critical for gaining FDA approval and accessing the lucrative American market. Peijia Medical’s ability to effectively compete with established players like Abbott will depend on demonstrating the clinical superiority and cost-effectiveness of GeminiOne.
Peijia Medical’s forward-looking statements acknowledge that actual results may vary due to regulatory, clinical, and market factors. The company emphasizes that the GeminiOne TEER System is currently under clinical and regulatory evaluation and is not yet approved for commercial sale in any country or region. Investors and healthcare professionals will be monitoring the company’s progress closely as it seeks to bring this novel technology to patients worldwide.
The development of less invasive treatments for mitral regurgitation represents a significant advancement in cardiovascular care. As the global population ages and the prevalence of heart failure continues to rise, the demand for effective and accessible TEER solutions is expected to grow substantially.
