Paris Medtech HighLife Raises More Than $90 Million to Take Its Transcatheter Mitral Valve Into Europe and a US Pivotal Study

HighLife, a Paris-based medical-device company developing a transcatheter mitral valve replacement (TMVR) system, has completed a financing of more than $90 million (€80 million), one of the larger European medtech rounds of the year.

The round, announced on 22 September 2026, was co-led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners. New investors include the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, SPRIM Global Investments and an unnamed strategic investor. Existing investors USVP, Sectoral and VI Partners also participated.

The capital will fund the commercial expansion of HighLife's system in Europe and the start of a pivotal clinical study in the United States.

Treating patients with few options

HighLife's technology is designed for patients with severe mitral regurgitation, a condition in which the heart's mitral valve does not close properly, allowing blood to flow backwards into the left atrium. Over time, the condition can lead to heart failure, reduced quality of life and increased mortality.

Conventional treatment often involves open-heart surgery to repair or replace the valve. However, many patients, particularly elderly people and those with other serious illnesses, are considered too high-risk for surgery. For some of these patients, less invasive repair techniques that clip the valve leaflets together via a catheter can help, but they are not suitable for everyone.

HighLife targets patients who are not suitable for either conventional surgery or transcatheter repair. Its system replaces the diseased valve using a catheter-based approach, avoiding the need to open the chest and stop the heart.

Regulatory milestones in Europe

The company has reached important regulatory milestones in recent months. Its TMVR system received CE Mark approval in January, allowing a limited market release in Europe. Its newer Clarity valve received its own CE Mark in July.

HighLife says the Clarity valve is specifically designed to reduce the risk of left ventricular outflow tract (LVOT) obstruction, one of the most significant technical barriers to wider adoption of TMVR. When a replacement valve is placed in the mitral position, it can push the native valve tissue into the path through which blood leaves the heart, obstructing flow. This complication has limited the number of patients who are anatomically suitable for many TMVR devices.

If Clarity can meaningfully reduce that risk, it could expand the pool of eligible patients, a key factor in the commercial potential of any structural-heart device.

A costly transition from development to commercialisation

The financing arrives at a pivotal point. HighLife is moving from development and regulatory validation into commercialisation in Europe, while simultaneously preparing to run a pivotal study in the United States, the largest single market for medical devices.

That combination is expensive. Medical-device companies at this stage must fund engineering, clinical trials, regulatory submissions, physician training, manufacturing scale-up and a commercial organisation, often years before revenue can support the business. A US pivotal study alone typically involves enrolling patients across multiple centres, following them for extended periods and collecting rigorous data for review by the Food and Drug Administration.

The size and composition of the investor syndicate suggest confidence that HighLife can navigate this phase. The participation of the European Investment Bank, which has supported a range of European health-technology companies, and of a strategic investor, points to institutional and industry interest in the company's approach.

A competitive and promising market

Structural heart disease has become one of the most dynamic segments of the medical-device industry. The success of transcatheter aortic valve replacement, which transformed treatment for aortic stenosis over the past two decades, has encouraged companies to pursue similar catheter-based solutions for the mitral and tricuspid valves.

The mitral valve, however, has proved more challenging. Its anatomy is more complex, it lacks the firm, circular structure that helps anchor aortic devices, and patients' disease patterns vary widely. As a result, TMVR has developed more slowly than its aortic counterpart. Large device makers, including Abbott and Edwards Lifesciences, have invested heavily in transcatheter mitral therapies, alongside a number of specialised startups.

For HighLife, the competitive landscape means it must demonstrate not only that its device works, but that it offers advantages in safety, ease of implantation, durability or patient eligibility that justify adoption by cardiologists and hospitals.

What investors are underwriting

Investors in HighLife are effectively betting that mitral valve replacement can become a large structural-heart category alongside established catheter-based procedures. The addressable population is substantial: mitral regurgitation is one of the most common valve diseases, and its prevalence increases with age, making it more significant as populations in Europe, North America and Asia grow older.

Unlike software markets, where scale and network effects can drive rapid growth, competitive advantage in medtech depends on clinical outcomes, physician adoption and reimbursement. No amount of capital can substitute for positive trial data. The next several years of clinical and commercial results will therefore determine whether HighLife's financing translates into lasting value.

Europe's medtech ecosystem

The round is also a signal of the strength of Europe's medical-device ecosystem. France, in particular, has produced several notable cardiovascular device companies, supported by specialised healthcare investors such as Sofinnova and Andera. Supernova Invest and Mérieux Equity Partners bring further depth in deep-tech and healthcare investing.

European medtech companies have often faced a funding gap compared with their US peers, particularly at late stages when large sums are needed for pivotal trials. Rounds of this size help close that gap and allow European innovators to pursue global markets without relocating or selling early.

The physician adoption challenge

Even with regulatory approval, structural-heart devices depend on the confidence of interventional cardiologists and cardiac surgeons, who work together in heart teams to decide on treatment. Physicians must be trained in implantation techniques, imaging specialists must learn to assess patient anatomy for suitability, and hospitals must invest in procedural capacity. Early commercial experience in Europe will therefore be as much about building clinical expertise and referral pathways as about selling devices.

What comes next

With fresh capital in hand, HighLife's priorities are clear: expand its European commercial footprint following the CE Mark approvals, train physicians and build hospital adoption, and launch the US pivotal study that could eventually support FDA approval.

For patients with severe mitral regurgitation who have run out of options, the stakes are high. If HighLife's devices can be implanted safely and deliver durable results, they could offer a meaningful treatment to people for whom surgery is too risky. For investors and the wider medtech industry, the company's progress will be an important test of whether transcatheter mitral replacement can finally fulfil its long-promised potential.