HighLife SAS has announced the successful completion of a financing round worth in excess of US$90 million, with funding to be used to accelerate its commercial expansion across Europe and advance its US clinical development programme.
The fundraise was co-led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners. Other new investors also joined the round, including the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, SPRIM Global Investments and a global strategic alongside existing investors USVP, Sectoral and VI Partners, who participated in the round.
The news comes following several significant regulatory and clinical milestones for the company, including the receipt of CE marking for its transcatheter mitral valve replacement (TMVR) system in January, enabling the start of a limited market release in Europe while also initiating its US pivotal clinical study.
In July, HighLife received CE marking for the Clarity Valve, its next-generation valve, purpose-built to further mitigate left ventricular outflow tract (LVOT) obstruction risk.
“This financing represents an important milestone as HighLife continues to build momentum toward establishing its technology as a new treatment option for patients suffering from mitral regurgitation who have limited therapeutic alternatives. It will support HighLife’s strategic roadmap, by accelerating commercial expansion across Europe, advancing its pivotal clinical study and strengthening the organisation to support long-term growth”, said Stefan Pilz, CEO of HighLife.
“We believe transcatheter mitral valve replacement is reaching a critical inflection point. With differentiated technology, a highly experienced team and a strong financial foundation, we believe HighLife is particularly well positioned to establish itself as a global leader in this new therapeutic approach,” said Rémi Spagnol, partner, Supernova Invest, co-lead investor in the round.
“The strength of this financing reflects strong investor confidence in the leadership of the company, its strategy and winning technology. HighLife has built a strong foundation, and we believe the company is well positioned to execute its next phase of growth to treat patients who have no other option today,” said Jose (Pepe) Calle Gordo, chairman of the Board.
The HighLife TMVR system consists of a valve-in-ring concept, both ring and valve being implanted percutaneously. This mimics the surgical gold standard (annuloplasty ring + valve), and is intended for the treatment of adult patients suffering from symptomatic moderate-severe or severe mitral valve regurgitation (MR), who are deemed unsuitable for surgical repair/replacement and transcatheter edge-to-edge repair by a multi-disciplinary heart team.
