{"id":50739,"date":"2025-12-14T22:23:54","date_gmt":"2025-12-14T14:23:54","guid":{"rendered":"https:\/\/flcube.com\/?p=50739"},"modified":"2025-12-14T22:23:56","modified_gmt":"2025-12-14T14:23:56","slug":"peijia-medical-wins-nmpa-approval-for-taurustrio-tav-first-transfemoral-system-for-aortic-regurgitation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50739","title":{"rendered":"Peijia Medical Wins NMPA Approval for TaurusTrio TAV, First Transfemoral System for Aortic Regurgitation"},"content":{"rendered":"\n

Peijia Medical Limited<\/strong> (HKG: 9996<\/a>) announced that China\u2019s National Medical Products Administration (NMPA) approved the registration application for its TaurusTrio Transcatheter Aortic Valve (TAV) system<\/strong>, the first domestic device designed to treat native symptomatic severe aortic regurgitation (AR)<\/strong> via transfemoral access.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Approval Date<\/strong><\/td>12\u202fDec\u202f2025<\/td><\/tr>
Agency<\/strong><\/td>NMPA (China)<\/td><\/tr>
Product<\/strong><\/td>TaurusTrio TAV system<\/td><\/tr>
Indication<\/strong><\/td>Native symptomatic severe aortic regurgitation (AR)<\/td><\/tr>
Innovation<\/strong><\/td>First TAV system for AR<\/strong> via transfemoral approach<\/td><\/tr>
Launch Timeline<\/strong><\/td>Q2\u202f2026 (hospital channel rollout)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Technology Profile<\/h2>\n\n\n\n
Feature<\/th>TaurusTrio TAV System<\/th>Competitive Context<\/th><\/tr><\/thead>
Origin<\/strong><\/td>Developed under exclusive license from JenaValve Technology, Inc.<\/td>Leverages proven Trilogy THV platform<\/td><\/tr>
Access<\/strong><\/td>Transfemoral (minimally invasive)<\/td>Avoids open\u2011heart surgery<\/td><\/tr>
Anchoring<\/strong><\/td>Proprietary locator technology<\/strong> attaches to native leaflets<\/td>No calcification required, solving key AR treatment barrier<\/td><\/tr>
Alignment<\/strong><\/td>Ensures commissural alignment<\/td>Reduces paravalvular leak risk<\/td><\/tr>
Differentiation<\/strong><\/td>Addresses unmet need<\/strong> in AR patients lacking calcified anchor points<\/td>Existing TAVs approved only for aortic stenosis<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Opportunity<\/h2>\n\n\n\n
Metric<\/th>Value<\/th>Implication<\/th><\/tr><\/thead>
China AR Prevalence<\/strong><\/td>~400,000\u2011500,000 severe AR patients (2024)<\/td><15% receive surgical intervention<\/td><\/tr>
China TAV Market<\/strong><\/td>\u00a52.5\u202fbillion (\u2248\u202fUS$350\u202fM)<\/td>Currently 100% aortic stenosis\u2011focused<\/td><\/tr>
AR\u2011Specific Market<\/strong><\/td>\u00a5800\u202fmillion\u20111.2\u202fbillion<\/strong> potential by 2030<\/td>Untapped segment with no approved TAVs<\/td><\/tr>
Peak Sales Forecast<\/strong><\/td>\u00a5600\u2011900\u202fmillion<\/strong> (\u2248\u202fUS$85\u2011125\u202fM) by 2029<\/td>25\u201130% share of eligible AR patients<\/td><\/tr>
Competitive Moat<\/strong><\/td>First\u2011mover<\/strong> in China AR market; 3\u2011year regulatory exclusivity<\/td>Protected by Class\u202fIII medical device innovation pathway<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Strategic Implications<\/h2>\n\n\n\n