By Fineline Cube 
Peijia Medical Limited (HKG: 9996) announced today that the National Medical Products Administration (NMPA) of China has confirmed acceptance of its registration application for the GeminiOne transcatheter edge‑to‑edge repair (TEER) System. The approval marks a significant regulatory milestone for the company’s first‑in‑class TEER device, positioning Peijia Medical for accelerated commercialization in the Chinese market.
Company Announcement
- Regulatory Status – NMPA’s acceptance signals that the GeminiOne system has met the stringent safety, efficacy, and quality thresholds required for market entry.
- Next Steps – Peijia Medical will proceed with clinical data submission, post‑marketing surveillance planning, and manufacturing ramp‑up in accordance with NMPA guidelines.
Device Overview
- GeminiOne TEER System – An internally developed, minimally invasive device designed for percutaneous repair of mitral regurgitation.
- Key Features
- Sliding Groove Mechanism – Enables longer coaptation length while maintaining a smaller implant footprint.
- Independent Leaflet Grasp – Simplifies procedural workflow by allowing discrete grasping of each valve leaflet.
- Auto‑Locking Mechanism – Prevents inadvertent unlocking during deployment, enhancing procedural safety.
- Multi‑Angular Detachment – Accommodates a wide range of mitral valve anatomies, expanding the device’s clinical applicability.
Innovation Highlights
- Reduced Implant Size – The compact delivery system facilitates easier vascular access and reduces the risk of vascular complications.
- Enhanced Procedural Efficiency – The auto‑lock feature and independent grasp reduce the number of device manipulations, potentially shortening procedure time and radiation exposure.
- Broad Anatomical Coverage – Multi‑angular detachment allows the device to be used in diverse patient anatomies, addressing a current gap in the TEER market.
Commercial Outlook
- Market Potential – China’s growing burden of valvular heart disease and increasing adoption of transcatheter therapies creates a sizable opportunity for the GeminiOne system.
- Strategic Partnerships – Peijia Medical is exploring collaborations with local hospitals and device distributors to accelerate market penetration.
- Global Expansion – Successful approval in China will serve as a launchpad for subsequent regulatory submissions in other major markets, including the United States and Europe.-Fineline Info & Tech