HighLife raises $90M+ to start US pivotal study for its mitral valve
Paris medtech HighLife has landed more than $90 million from four French co-leads to fund a US pivotal study, months after CE marking its transcatheter mitral valve system.
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Founded 2010 · Paris, France
HighLife has raised more than $90 million (about €80 million) in a growth round co-led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners, to start the US pivotal study of its transcatheter mitral valve replacement system and accelerate its commercial rollout across Europe.
The Paris-based medtech announced the round on 22 September 2026. No series letter was attached – after sixteen years and a CE mark, the labels stop mattering – but the shape is unmistakably growth capital: four institutional co-leads, the European Investment Bank and BNP Paribas Développement among the new backers, and a use of funds that reads like a scale-up plan rather than a research budget.
Four co-leads and a fourteen-strong syndicate
Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners co-led the financing. The new investors joining them: the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, SPRIM Global Investments and a global strategic investor the company has not named. Existing backers USVP, Sectoral and VI Partners all returned.
The money goes three ways, per the company’s announcement: accelerating commercial expansion across Europe, advancing the pivotal clinical study in the United States, and strengthening the organisation to support long-term growth. CEO Stefan Pilz, who joined HighLife in 2024 from heart-pump maker Abiomed, now has the balance sheet to run both a European commercial ramp and an American trial at once.
Sixteen years to build a valve that goes in through a vein
Founded in 2010 and working out of Paris with a second site in Irvine, California, HighLife builds a transcatheter mitral valve replacement (TMVR) system for patients with symptomatic moderate-severe or severe mitral regurgitation – a leaking valve between the heart’s left chambers – who are not candidates for open surgery or repair.
The system is a two-part, valve-in-ring design: a ring is placed around the native valve, then the replacement valve anchors inside it, with both components delivered percutaneously through the femoral vein. No opened chest, no heart-lung machine. The system received its CE mark in January 2026, and the second-generation Clarity valve – designed to reduce the risk of left ventricular outflow tract obstruction, one of TMVR’s known complications – followed with its own CE mark in July 2026.
Sofinnova Partners led a €12.3 million round in HighLife back in October 2017, per its own announcement at the time. Nearly a decade later it is co-leading again, at several times the size. Patient capital, in the most literal sense.
Replacement is the fastest lane of a $2.5bn market
The global market for transcatheter mitral and tricuspid valve repair and replacement stood at $2.5 billion in 2025 and is projected to reach $6.8 billion by 2035, a 10.7% CAGR over 2026-2035 (Global Market Insights, July 2026). The detail that matters for HighLife: repair devices hold 83% of that value today, while replacement valves account for just 17% – but replacement is the fastest-growing segment at 12% a year, and Europe already generates 27.2% of global revenue (same source).
For scale against recent European health rounds: Penelope Health’s $100 million round last week and Biolevate’s €30 million Series A were both software plays. HighLife’s $90 million+ is hardware that goes inside a beating heart, with the regulatory bill to match.
A French syndicate playing the long game
So what does a nine-figure medtech round with an all-French co-lead line actually tell us? Look at that line again: Andera, Sofinnova, Supernova Invest, Mérieux Equity – four Paris institutional investors, with the European Investment Bank and BNP Paribas Développement behind them. We keep hearing that Europe cannot finance deeptech patience. Here is a French cap table doing exactly that, sixteen years in, in the same week Tekever closed a $580 million Series D and Verda a $189 million Series B.
The catch is equally visible: the pivotal study, the reimbursement dossiers and much of the commercial prize all sit across the Atlantic. Even a CE-marked, Paris-built valve has to prove itself in US cath labs before it becomes a global standard of care. What to watch is whether the European commercial ramp – the part this round explicitly accelerates – builds enough momentum to keep the company anchored here while the US data matures. The sector’s full flow is on our fundraising data hub.
Sixteen years from founding to CE mark, and the biggest cheques arriving only now. That is what building in medtech looks like – and Europe just showed it can still write those cheques. Let’s keep them coming!
