HighLife TMVR Secures CE Mark Approval as Third Transcatheter Mitral Valve Replacement System to Launch in Europe

HighLifeAnnounce itsTranscatheter Mitral Valve Replacement System---HighLife TMVRReceived CE approval for marketing, applicable to adult patients with symptomatic moderate-to-severe or severe mitral regurgitation who are assessed by a multidisciplinary heart team as unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair.

PI Evaluation

"Long-term durability data in the TMVR field is extremely limited, making HighLife's clinical experience particularly valuable. The system has demonstrated stable performance over years of validation, combined with a transfemoral approach and predictable valve function, offering an important new option for patients with severe mitral regurgitation who are unsuitable for surgery or repair."

---Wolfgang Rottbauer Universitätsklinikum Ulm

"The surgical solution provided by HighLife feels familiar to the interventional team. The two-step process of first implanting the fixed ring and then deploying the valve is intuitive and easy to repeat, perfectly suited for the cath lab environment, with procedure times comparable to transcatheter edge-to-edge repair."

---Michael Joner  Deutsches Herzzentrum München

Executive Evaluation

"CE Approval Marks a New Journey for HighLife — Providing European Patients, Especially Those with Limited Current Treatment Options, a New Transcatheter Mitral Valve Replacement Choice. Approximately 300,000 mitral regurgitation patients in Europe each year do not receive surgical or transcatheter repair treatment, and we are honored to bring a new option to this group. We will advance commercialization with prudence, collaborating with top cardiac centers to ensure high-quality clinical outcomes."

---Stefan Pilz  HighLife SASChief Executive Officer (CEO)

WithHighLife TMVRThe listing will provide patients withVeinApproach to Mitral Valve Replacement.HighLife TMVRAdopting a unique dual-component valve-in-ring design, it covers among the currently CE-approved TMVR products.The widest range of native mitral valve annulus sizes（30-53mm）。

HighLife TMVRThe commercial rollout will be launched in phases across Europe, in close collaboration with experienced structural heart disease centers, supporting the initial cases, physician training, and post-market clinical follow-up.

Currently Edward'sSAPIEN M3 and Abbott'sTendyne has already received CE and FDA approval,HighLife TMVRBecoming theThree Overseas-Launched ProductsThe transcatheter mitral valve replacement system is also the second TMVR with a transfemoral venous approach. As more and more TMVR products come to market (in the future, TMVR from Qiming Medical, Medtronic, and others will also gradually become available), mitral regurgitation is about to enter a new era — an era of flourishing diversity, unlike the duopoly seen in TAVI."A hundred flowers blooming means faster technological iteration, more intense market competition, and patients will have access to better TMVR."

According toHighLifeIntroduction,HighLife TMVRClinical data show its lasting efficacy.

• Continuously reduce mitral regurgitation to mild or lower

• Achieved durable annular sealing through the design of a sub-annular fixation ring, with no reported cases of perioperative or postoperative paravalvular leak closure.

• No cases of clinically significant hemolysis or valve thrombosis were reported.

• No reported cases of left ventricular outflow tract obstruction

• Evidence of Left Ventricular Reverse Remodeling

• Improvement in New York Heart Association (NYHA) Functional Classification and Quality of Life, including clinically significant changes in the Kansas City Cardiomyopathy Questionnaire and 6-minute walk test.

HighLife TMVR

• Conforms to Physiological Anatomy
  

HighLife TMVRThe design is in line with physiological anatomy. Its outer surface features non-traumatic rounded edges and a smooth, symmetrical structure, as the anchoring method solely relies on the equilibrium position between the valve prosthesis and the annular valve ring (SAI). The implantationValveFalseThe force is evenly distributedAnnular Valve Ring（SAI）Up.

• Excellent sealing effect

TMVR has been plagued by poor sealing.HighLife TMVRThe design is expected to address this pain point.HighLife TMVRHave usedAnnular Valve Ring（SAI）StirrupValveFalseBody, avoiding because the patientConforms to Physiological AnatomyAbnormalities leading to paravalvular leakage.

• Adapt to every patient

The mitral valve coverage area is generally uniform in size for most patients with mitral regurgitation.HighLife TMVRImplantableAnnular Valve Ring（SAI）, with a maximum diameter ranging from 35 millimeters to 50 millimeters, and adaptable to anatomical structures in any situation.

HighLife SAS