HighLife Raises $90 Million to Fund US Heart Valve Trial and European Expansion

HighLife, a Paris-based medical technology company developing a transcatheter mitral valve replacement device, has closed a financing round of more than $90 million, roughly 80 million euro, co-led by Andera Partners, Sofinnova Partners, Supernova Invest, and Merieux Equity Partners. New investors in the round include the European Investment Bank, BNP Paribas Developpement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, and SPRIM Global Investments, alongside continued participation from existing investors USVP, Sectoral, and VI Partners.

The company's technology targets mitral regurgitation, a structural heart condition where the heart's mitral valve fails to close properly, through a minimally invasive transcatheter replacement rather than open-heart surgery. The fresh capital will fund a pivotal clinical study in the United States, a required step toward regulatory approval and commercial launch in the American market, alongside continued commercial expansion of the device across Europe, where HighLife has already been building its market presence.

HighLife's funding history stretches back nearly a decade, including a 12.3 million euro round led by Sofinnova Partners in 2017 and a 32 million euro Series B co-led by USVP and Andera Partners in 2019, with Sofinnova, which led the original Series A, returning again for this latest and by far largest round. That progression, a medtech company steadily scaling its raise size as its device advances through clinical and commercial milestones, reflects the long, capital-intensive development timeline typical of implantable cardiac devices, where a company can spend a decade or more validating a single device category before reaching a pivotal US trial.

The structural heart device market has drawn sustained investor interest over the past several years as an aging population in developed markets increases demand for less invasive alternatives to open surgery, and mitral valve disease specifically remains a large, underserved condition relative to the more heavily treated aortic valve category. A successful US pivotal trial would position HighLife to compete for a meaningful share of that market alongside a small number of other companies pursuing transcatheter mitral solutions.

For a medtech company at this stage, the participation of a development bank like the European Investment Bank alongside a roster of established European life sciences investors signals a level of institutional confidence in both the device's clinical progress and its path to a US regulatory filing, a combination that is not always present at this stage of a cardiac device company's development.

The size of the round also stands out against the broader European medtech funding environment, where rounds of this scale remain relatively uncommon outside of a small handful of late-stage device companies each year. Reaching a US pivotal trial is typically the single largest capital-intensive milestone in a cardiac device company's lifecycle, both because trial enrollment and monitoring costs scale with the number of implant sites required for statistical significance, and because a company must usually build out US-facing regulatory, clinical, and eventually commercial infrastructure well before generating any US revenue.

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