Peijia Medical Ltd (HKG: 9996) announced it has submitted CE mark registration under the European Union Medical Device Regulation (EU MDR) for its GeminiOne transcatheter edge-to-edge repair (TEER) system, targeting the mitral regurgitation (MR) market in Europe. The filing advances Peijia’s global commercialization strategy alongside ongoing NMPA review in China and US early feasibility study approval.
Regulatory Milestone
Item
Detail
Company
Peijia Medical Ltd (HKG: 9996)
Asset
GeminiOne – Transcatheter edge-to-edge repair (TEER) system
Access to ~450 million population; premium pricing vs. China
China
NMPA registration under review
World’s largest MR patient population; domestic manufacturing advantage
United States
Early feasibility study approved
Pathway to pivotal trial and PMA submission; validation for global credibility
Strategic Positioning & Competitive Landscape
Competitor
Product
Market Position
GeminiOne Advantage
Abbott
MitraClip
Global TEER leader (>150,000 implants)
Smaller profile for complex anatomies
Edwards Lifesciences
Pascal
Second-generation TEER with independent grasping
Simpler delivery system, reduced procedure time
Valcare Medical
AMEND
Early-stage European player
Patent-protected design differentiation
HighLife Partnership: Collaboration with HighLife SAS leverages established European structural heart commercial infrastructure, accelerating hospital onboarding and reimbursement negotiations without building de novo EU sales force.
China-to-Global Expansion: Peijia’s dual-track regulatory approach (China NMPA + EU MDR + US EFS) mirrors successful medtech globalization strategies employed by MicroPort and Mindray, positioning GeminiOne as first Chinese TEER device with credible US/EU pathway.
Mitral Regurgitation Market: Global TEER market projected to exceed $5 billion by 2030, driven by aging populations and expanding indications to functional MR; smaller-profile devices address unmet need in patients with challenging anatomy.
Development Roadmap
Phase
Activity
Timeline
Current
EU MDR CE mark submission; NMPA review ongoing
Q1 2026
Near-term
CE mark approval (anticipated)
2026-2027
Parallel
US early feasibility study enrollment
2026
Expansion
European commercial launch with HighLife
Post-CE mark
Future
US pivotal trial initiation; China NMPA approval
2027-2028
Forward‑Looking Statements This brief contains forward‑looking statements regarding GeminiOne CE mark approval timelines, European commercial launch with HighLife, and Peijia Medical’s global TEER market penetration. Actual results may differ due to EU MDR review delays, competitive responses from Abbott and Edwards, and US pivotal trial enrollment challenges.-Fineline Info & Tech
By Fineline Cube