Cardiawave is a French medtech scale-up addressing aortic valve disease, a condition that affects more than 12 million people worldwide. Since its founding in 2014, Cardiawave has developed its Valvosoft technology from concept to clinical use, treating the first 100 patients and recently receiving the CE Certificate. 

We spoke to the company’s CEO Carine Schorochoff, about Cardiawave’s path to recognition and success – and the challenges that had to be overcome to get this far.

Transforming care for patients beyond valve replacement 

Cardiawave’s CEO Carine explains that the current standards of treating aortic valve disease rely on valve replacement – surgical for younger, fitter patients and transcatheter procedures for older or more fragile individuals. 

Cardiawave’s first target population consists of patients who are too frail for any type of valve replacement. For this group, the company developed Valvosoft, a fully non-invasive therapy that has already been used in Europe under three clinical studies, two first-in-human trials and a pivotal study. On 27 November 2025, Valvosoft was granted CE Marking under the EU Medical Device Regulation (MDR 2017/745), thereby establishing the credibility of this technology and the robustness of the clinical data.

The company is now preparing to address an earlier-stage population: patients at the onset of the disease who are not yet sick enough to justify the risks associated with surgical or transcatheter valve replacement. Cardiawave plans to initiate clinical studies for this group in 2026, positioning Valvosoft as a non-invasive first-line option. 

Carine explains that the current Valvosoft device is a fully developed second-generation system, ready for commercial use. Its key advantage is the simplicity of deployment – Valvosoft can be used in a standard echocardiography room. The procedure requires only light sedation, and not for all patients, lasts about 70 minutes, and allows same-day discharge.

Harnessing ultrasound to rethink aortic valve treatment

Cardiawave’s technology was developed at the Hôpital Européen Georges-Pompidou in Paris, part of Europe’s largest public hospital network. The invention originated with Professor Emmanuel Messas, a cardiologist who recognised a critical gap in care: patients too fragile for valve replacement procedures and those in early stages of aortic valve disease who are not yet eligible for intervention.

Working with three leading physicists from the Physics for Medicine Paris Institute, he explored the therapeutic potential of ultrasound – already central to diagnosis and widely used in non-invasive treatments such as kidney stone fragmentation. This collaboration led to Cardiawave’s non-invasive ultrasound therapy for aortic valve disease, built on a simple idea: if high-intensity ultrasound can break kidney stones, could it also fragment the calcium deposits that stiffen the aortic valve?

Aortic stenosis develops when calcification accumulates within the valve’s leaflets, restricting their ability to open and close and ultimately reducing blood flow from the heart. Cardiawave’s solution uses high-intensity focused ultrasound (HIFU) delivered non-invasively to target these calcified areas. The result is not a removal of calcium but a change in its structure: from a rigid block that restricts valve motion to smaller, more flexible fragments that allow the leaflets to move more freely. 

Cardiawave has built a strong intellectual property portfolio across major markets in Europe, the United States and Asia. The company is now preparing its next phase of clinical and industrial development. It has initiated discussions with the FDA to set up a U.S. study and will also run a study in France on moderate aortic stenosis patients, supported by public funding.

Building trust through rigorous data and long-term investor support

Cardiawave’s primary challenge was to prove that its non-invasive approach was truly safe. After extensive in-vitro and preclinical work to de-risk the technology, the company still needed to convince clinicians – many of whom were initially sceptical given how unconventional the concept was.

To build confidence, Cardiawave conducted its pivotal study in France, Germany and the Netherlands – countries known for strict regulatory oversight. The rigorous monitoring and review structure, combined with partnerships with top centres and leading physicians, produced a data set that the company considers robust and non-questionable. Clinicians who were hesitant five years ago now actively request the technology, as Carine explains:

“We had to face the big challenge of being breakthrough innovators and being faced with a lot of skepticism. But fortunately, we found groups of physicians, prominent, key opinion leaders, who were willing to believe in it. [..] I would say to a lot of inventors, I think it’s a good thing to focus on high-profile centers, because it's allowing you to then defend your study.”

Another major challenge for Cardiawave has been fundraising in today’s tougher investment climate. Carine tells us that the fundraising process now takes significantly longer than it did a few years ago, with deeper due diligence and investors demanding clarity not only on clinical plans but also on reimbursement strategy – often earlier than is typical for a company at this stage.

Despite this, Cardiawave is supported by a solid base of long-standing investors who have backed the company throughout its 11-year journey and continue to provide stability while the next financing round is completed. Carine says:

“It's very important to be supported by investors that are trustworthy and understand the nature of what you do, and that understand that it takes time to go from a breakthrough  idea on a piece of paper to its commercialisation. This is what we have at Cardiawave and it's highly appreciated.”

To scale manufacturing for European commercialisation and to launch the U.S. clinical programme from 2026 to 2029, Cardiawave is raising a €50 million ($55 million) Series C round, which the company aims to close in the second half of 2026.

A leadership team built for breakthrough innovation

CEO Carine Schorochoff, although officially only 6 months with the company, brings more than 30 years of experience in the medtech industry, with a career focused on cardiovascular diseases and, specifically, structural heart diseases. She shares:

“I had been following Cardiawave for some years, and it has been fascinating for me  that Cardiawave is developing the next frontier for the treatment of aortic valve disease – a fully non-invasive therapeutic approach [..] which was very attractive to me, as I love great innovation [..] I’ve always been looking for the opportunity to contribute to the development of solutions for large unmet needs.”

Carine highlights the strength of the whole leadership team. Maurice Delplanque, COO, oversees R&D, production and industrialisation, and brings deep expertise in ultrasound, having spent five years with the company. Luc Morisset, Director of Quality and Regulatory Affairs and a biomedical engineer, has been with Cardiawave for eight years and has led preclinical, early clinical work and the CE Marking submission. Dirk Pauwels, Director of Clinical Affairs, joined four  years ago and managed the pivotal 60-patient study.

Cardiawave operates with a lean organisation and a highly committed team, with several employees having stayed for nearly a decade, including engineers who began during their PhD work and chose to remain with the company.

Finding deep value in the EIC Scaling Club

As to being a part of the EIC Scaling Club, Carine shares that it offers three key benefits for Cardiawave. First, it provides visibility to its member companies. Second is the high-quality coaching support, particularly for pitch preparation, which the team considers extremely valuable. Third are the events organised by the Club – including the Growth Forum on 18th of March in Paris, which Cardiawave plans to attend.

Note for transparency: Valvosoft® is a CE Marked medical device in the EU and is an investigational medical device, not yet approved for commercial use in other countries or areas, including the United States.

About the EIC Scaling Club

The EIC Scaling Club is a curated community where 120+ European deep tech scale-ups with the potential to build world-class businesses and solve major global challenges come together with investors, corporate innovators and other industry stakeholders to spur growth.

The top 120+ European deep tech companies will be carefully selected from a pool of high-growth scale-ups that have benefitted from EIC financial schemes, other European and national innovation programmes, and beyond.

The EIC Scaling Club is an EIC-funded initiative run in partnership by Tech Tour, Bpifrance (EuroQuity), Hello Tomorrow, Tech.eu (Webrazzi), EurA and IESE Business School.

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