Before the breakthrough: Sofinnova's decade-long bet on HighLife

When Georg Börtlein brought his transcatheter mitral valve replacement concept to Sofinnova Partners in the mid-2010s, the medtech landscape was crowded with solutions addressing peripheral structural heart problems. But mitral regurgitation, affecting millions globally, remained largely underserved. Existing therapies were complex, had high barriers to adoption, and left thousands of patients with few options. Börtlein had a thesis: start from first principles and build a system simpler than what the market offered.

Investor support for his thesis-built HighLife, which announced today, Tuesday September 22nd, a$90+ million fundraise, co-led by Sofinnova Partners, Andera Partners, Supernova Invest, and Mérieux.

Sofinnova was one of the first to back Börtlein's vision. In 2017, Sofinnova led HighLife's €12.3 million Series A, becoming the company’s founding institutional investor, contributing deep structural heart expertise. Sofinnova knew Georg well, having spent years building CoreValve with him and another top rate team. CorValve’s innovative technology fundamentally changed how cardiothoracic surgeons think about aortic valve disease. The company went on to be acquired by Medtronic for close to $1 billion. The CorValve playbook—patient capital, rigorous clinical validation, astute regulatory strategy, and long-term support—became the template for HighLife.

"We saw in Georg and his team the same commitment to solving an unmet clinical need that had driven our success with CoreValve," says Antoine Papiernik, Managing Partner at Sofinnova. "Georg co-founded and was COO of CoreValve, and he brought that same relentless approach to device design and regulatory expertise to HighLife. The structural heart space rewards founders who aren't afraid to iterate and can navigate complexity with discipline."

What followed was nearly a decade of steady, difficult work: testing the device, gathering clinical evidence, working through approvals, and preparing for the market. In June 2024, HighLife received FDA approval to begin its US pivotal study, allowing it to enroll patients across several continents. Ten months later, the U.S. FDA recognized the technology as a Breakthrough Device, a status reserved for technologies that could immediately offer better options for serious conditions. In January 2026, HighLife received CE Mark approval for its TMVR system, opening the way for its commercial launch in Europe.

With the fundraise announced today, the investor roster now includes crossover funds, strategic healthcare investors, the European Investment Bank, and a global strategic partner, reflecting how far the company has progressed since its first financing.

"For a structural heart company, this syndicate composition is a strong signal: the market is convinced the clinical and regulatory heavy lifting is complete," Papiernik said. "The race for adoption has begun."

Sofinnova's place in the syndicate tells its own story. Nearly a decade after leading HighLife's first institutional financing, the firm remains a lead investor alongside some of the sector's most experienced growth-stage backers. Few investors stay with a company from its earliest days through major clinical, regulatory and commercial milestones. Sofinnova's continued participation reflects both long-term conviction and confidence in the team's execution.

The next phase is about scale: enrolling the US study, broadening access, and building the company for growth. For Sofinnova, which recognized the opportunity before the clinical data, regulatory milestones and broad investor interest emerged, this moment represents the culmination of nearly a decade of partnership and conviction and the latest validation of that original thesis.