HighLife Raises $90 Million To Start US Heart Valve Study and Grow in Europe

There are four valves in the heart that ensure blood flows correctly. The mitral valve is between the left chambers of the heart. When it is not properly closed up, blood leaks backward. Doctors describe this as mitral regurgitation. 

To solve this problem, HighFife raises $90 million to build a simpler way to replace a leaking valve without opening the chest

HighLife Raises $90M

HighLifeannouncedit has closed a financing round of more than $90 million. The company said it’ll use the money to speed up expansion across Europe. The startup also plans to push its clinical program in the US

The fundraising was also led by Andera Partners, Sofinnova Partners, Supernova Invest and Mérieux Equity Partners. Other new investors also joined, including the European Investment Bank, BNP Paribas Développement, Capricorn Partners, Critical Path Ventures, Pro Benefis Familiae, SPRIM Global Investments Ltd. and a global strategic investor. 

Existing investors USVP, Sectoral and VI Partners also took part in the round. For HighLife, this is the biggest financing step since it started developing its transcatheter solution for structural heart disease. It comes right after two major approvals in Europe

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What HighLife Actually Does

TSMVR System Overview

HighLife focuses on structural heart disease. Its main product is a Transcatheter Mitral Valve Replacement, or TMVR system. The market for this has been hard to crack. 

Many earlier TMVR devices ran into a problem called LVOT obstruction. That means the new valve blocks the path where blood leaves the heart, which is dangerous. HighLife has tried to solve that specific problem

In January, the company received CE Mark approval for its first TMVR system. CE Mark means it is cleared to be sold in Europe. In July, it received a second CE Mark for its next-generation valve called the Clarity Valve. 

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Why The Funding Matters Now

In Europe, HighLife is moving from clinical development into early commercial sales. Having the CE Mark is one thing. In the US, the story is different. 

To sell a heart valve in the US, a company needs to run a large, formal study called a pivotal study that proves safety and effectiveness. That study is expensive and takes years. 

Chief Executive Officer Stefan Pilz said this financing is 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 alternatives. 

What The Money Will Be Used For

The company laid out a clear plan for the latest capital injection. The first priority is Europe. The funds will be used to expand the limited market release of the TMVR system that already has a CE Mark. 

The second priority is the Clarity Valve. With the CE Mark now in place for this next-generation valve, HighLife wants to bring this improved version to more sites. 

The third priority is the US pivotal study. The capital will be used to open more US trial sites, enroll patients, and build the data needed for a future US approval. 

Lastly, part of the capital will go into strengthening the organization itself. That includes manufacturing scale-up, quality and regulatory work, and hiring to support long-term growth on both sides of the Atlantic

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Source: ventureburn.com