HighLife SAS Announces FDA Breakthrough Device Designation for HighLife TSMVR System

Apr 10, 2025 18:09 CST Updated 18:09

HighLife

Companies Focusing on Transcatheter Mitral Valve Replacement (TMVR)

Peijia Medical

Developer of Cardiac and Cerebrovascular Interventional Medical Devices

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April 7, 2025HighLife SASAnnounces itsTransseptal Mitral Valve Replacement System——HighLife TSMVRAwarded the "Breakthrough Device" designation by the FDA.

HighLifeSASChief Executive OfficerStefan Pilz Indicates:"ObtainFDA'Breakthrough Device'"It is our honor."HighLifeSignificant clinical progress has been made, addressing a huge unmet clinical need. This designation recognizesHighLifeIn obtainingFDA"After approval and market launch, it has the potential to become the gold standard for mitral regurgitation treatment."

HighLife TSMVR The system isChina's first mitral valve replacement system accessed via femoral vein atrial septal puncture to enter clinical trials, in2022Year9Passed in the monthNMPASpecial Approval Application for Innovative Medical Devices ("Green Channel"), and on2024Year6Month obtained in the United StatesFDAInvestigational Device Exemption (IDE) license, while inTCT、PCRThe interim data of the feasibility clinical trial disclosed at international conferences such as... confirmed that, compared with existing treatment methods, this technology may achieve mitral valve replacement with less trauma.

In addition,2020Year12Month,Peijia MedicalAnnounce that it will cooperate withHighLife Sign a licensing agreement. According to this agreement,Highlife Will grant Peijia Medical access to its under-developmentTSMVR Exclusive license for patented products, Peijia Medical has the right inGreater ChinaProduction, development, and sales of these products, whileHighLife Entitled to receive upfront licensing fees and subsequent milestone payments.

# Research Background

Mitral Regurgitation (MR）One of the most common heart valve diseases globally, its incidence significantly increases with age. In the general population, the prevalence of mitral regurgitation is approximately10%。

In recent years, the treatment strategies for mitral regurgitation have been continuously optimized, including traditional valve repair and replacement surgeries, as well as emerging transcatheter interventional treatment technologies.

Compared with transcatheter mitral valve repair,Transcatheter Mitral Valve ReplacementHas unique先天 advantages:

Can cover more mitral regurgitation anatomical types
Can reduce reflux to a greater extent or even completely eliminate it.
The durability of treatment effects can be reliably predicted.
Compared with traditional open-chest surgery, it has less trauma and is suitable for more elderly or high-risk populations.

However, transcatheter mitral valve replacement faces many technical challenges, such as access difficulties caused by the complexity and heterogeneity of mitral valve anatomy, issues with artificial valve anchoring and sealing, and the risk of left ventricular outflow tract obstruction.

Most of the existing transcatheter mitral valve replacement systems are designed based on the transapical approach./Or mainly rely on radial support force to anchor or seal the artificial valve, butThe transapical approach, due to its relatively greater degree of traumaMay reduce patient benefit. The radial support force anchoring or sealing mechanism may result in a larger designed size of the artificial valve, leading to difficulties in device delivery and potentially affecting long-term myocardial reverse remodeling.

# AboutHighLife TSMVR

HighLife TSMVR The system uses "Valve-in-Ring"The concept, ingeniouslyA ring structure is pre-placed around the mitral valve chordae tendineae via the aortic route as an anchor., and thenVia the femoral-transseptal approach`, Implantation`Self-expanding Bovine Pericardial Valve。

Through the mutual locking of two implants, an anchoring method based on non-prosthetic radial support force is formed. This anchoring method not only adapts to a wide range of anatomical structures with a single specification size but also avoids damage to the native structure, while effectively forming a seal to prevent paravalvular leakage.

HighLife TSMVR There is no need for rotational positioning or coaxiality consideration during valve deployment.Self-adaptation and self-coaxial alignment can be achieved during the release process.. Its delivery system through the atrial septum only30Fr The outer diameter size effectively reduces the occurrence of corresponding vascular complications. In addition, the surgical process...DSA Imaging as the main, ultrasound as the auxiliary, conducive to the popularization of technology.

▲HighLife TSMVRInstrument Iteration

The valve of this system has two configurations:Standard ValveAndClarity Valve。Clarity The valve is specifically designed for patients withLVOT(Patients at risk of left ventricular outflow tract) obstruction。

Optimization 1“Window Design”：HighLife Clarity The valve adopts an "open window design" at the outflow end, with perforations made in the original outer fabric covering to reduce...LVOT Obstruction, reductionLVOT Risk of obstruction.
Optimization Two“Large Annulus”：HighLife Without changing the main body and conveyor, addedLarge Annulus Valve（LAV) Large-size valve, expanding the range of application for autologous valve rings from the original45mm Upgrade to53mm, significantly reducing the failure rate caused by an excessively large autologous mitral valve annulus diameter (from33%Reduced to6%）。

▲HighLife TSMVRThe Implantation Process

# Clinical Study Results

HighLife TSMVR System Initiated Multi-Center Registration Clinical Trial in China in November 2022, with the First Case Enrolled by Professor Mao Chen's Team from West China Hospital, Sichuan University.All surgeries achieved excellent immediate outcomes, with a 100% success rate and no residual regurgitation.。

HighLife TSMVRCurrently, the US EFS study has been launched globally., EU/AUSTRALIA Expanded Study, HighFLO Study, with over 30 centers actively participating,More Than 110 Patients Benefit Clinically from HighLife Clarity and Large-Size Valves。

Based on the 30 clinical results from the HighLife TSMVR feasibility trial in Europe/Australia,HighLife TSMVR Achieved90% Technical Success Rate，The all-cause mortality rate of patients was only 17% at 1 year post-operation.All patients had mitral regurgitation reduced to mild or below, and no patient required reintervention on the mitral valve.。During the 1-year follow-up period, approximately 80% of patients had mitral regurgitation ranging from none to trace, while 20% of patients experienced mild regurgitation. Over 75% of patients maintained NYHA Class I/II at 1 year, and their quality of life (based on KCCQ) also showed significant improvement at 1 year.

This result indicates that,For high-risk surgical patients with moderate to severe and severe mitral regurgitation，HighLife Achieves Good Technical Success, Reaching Good Primary Safety Endpoint and High Efficacy Endpoint。

# Mitral Regurgitation Market Size

In the field of mitral regurgitation treatment, in the first half of this yearTwo China-Made Transcatheter Mitral Valve Devices Commercially Launched, marking the competition between domestic manufacturers and international giants in the high-end medical device market. However, facing the mature product MitraClip from the multinational company Abbott,Chinese-produced mitral valve products face challenges in market promotion and cultivating doctors' surgical habits.。

In terms of price, domestically produced mitral valve products have obvious advantages.，For example, the price of捍宇医疗's products is about 40% lower than that of MitraClip, and德晋医疗's products are about 20% lower., which may prompt price competition in the market.

In China, the prevalence of moderate to severe mitral regurgitation in the population aged 35 and above increased from 1.31% in 2017 to 1.37% in 2021.It is expected that by 2027, the prevalence will increase to 1.42%.The number of patients with moderate to severe mitral regurgitation in China increased from 10 million in 2017 to 11.1 million in 2021, with a compound annual growth rate of 2.6% from 2017 to 2021. This patient population is expected to continue expanding.It is expected to reach 12.6 million people by 2027.，2The compound annual growth rate from 2021 to 2027 is 2.1%.。

▲Source:Frost & Sullivan

The surgical treatment options for mitral regurgitation mainly include mitral valve repair and mitral valve replacement. In terms of the number of marketed products,Although the treatment pathways are abundant, the overall number of approvals is relatively low, with mitral valve repair being more mature.。

Globally, 9 Mitral Valve Intervention Devices Have Been Approved。

The Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) field includes Abbott's MitraClip, which is the only TMVr product to have received FDA/CE/NMPA triple certification. Edwards' PASCAL obtained CE and FDA certifications in 2019 and 2022, respectively.In September and December 2023, HanYu MedicalValveClamp、Dejin MedicalDragonFlyTwo China-made TEERs Gain NMPA Approval for Market Launch, breaking the situation of China's market being monopolized by foreign capital.

Compared with TEER, the development of related devices for annuloplasty and chordal repair is relatively slow, and there is also less evidence from evidence-based medicine.In the field of mitral valve replacement, currently only Abbott's transapical approach product, Tendyne, has been approved with a CE mark.`, becoming the world's first approved and marketed transcatheter mitral valve replacement device.`

▲Globally Approved Mitral Valve Repair and Replacement Products

Due to the complexity of the mitral valve structure and the high technical barriers,Transcatheter Mitral Valve Replacement (TMVR) Development is Challenging，Currently, the vast majority are in the exploratory or early clinical exploration stage.，Abbott TendyneApproved by CE and launched in early 2020，Medtronic, Edwards, and others followed closely in pursuit of breakthroughs.

Domestic MarketTMVRAmong the challengers, the TAVR Trio启Ming Medical, Xintong Medical, Peijia MedicalMainly rely on strategic cooperation to layoutBy introducing foreign technologies through purchasing, agency, and other methods, a rapid track layout can be achieved in a short period of time. However, it is difficult to fully master the core key technologies, and subsequent re-innovation capabilities may be insufficient.

Currently in ChinaMitral Valve Replacement FieldForming a tripartite balance isNuPulse Medical, Yixin Medical, and Zhenyi Medical, the three companies correspond to three TMVR products respectively:Mi-thos, MitraFix, and TruDelta。All three products have entered the registration clinical stage, with promising prospects.。

# AboutHighLife

HighLife Founded in2010Year, headquartered in Paris, France。The company isGeorg BörtleinFounded, he wasCoreValve Inc.The co-founder and chief operating officer has extensive experience in the research and development of medical devices.

HighLifeThe representative product is itsTransseptal Mitral Valve Replacement System (TSMVR）, the system adopts a unique“Valve-in-Ring”Design concept: A pre-set annular structure is anchored through the transaortic approach, followed by valve implantation via the transseptal route, effectively avoiding postoperative adverse events caused by individual patient differences. This design simplifies the surgical procedure, enhances safety, and is suitable for use in most patients.2019Since the year, the system has been successfully implanted in clinical trials in multiple countries exceeding100Example, showing a good technical success rate and postoperative outcomes.

2017Year,HighLifeObtained bySofinnova PartnersLed the first venture capital financing.Sofinnova Partnersis a European life sciences venture capital firm, and alsoHighLifeEarly major supporters. Since then, blue-chip investorsUSVP、Andera Partners、SectoralAndVI PartnersAlso joined the investment.

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