Cardiawave is a late-stage French medtech company transforming care for patients with Severe Symptomatic Calcific Aortic Stenosis. Aortic Stenosis is a life-threatening disease caused by progressive valve calcification that stiffens the aortic valve. The Valvosoft® device, the first non-invasive, image-guided ultrasound therapy, restores leaflet mobility without surgery or implants, offering hope to patients with no or limited therapeutic alternatives. Clinically validated in 100 patients and CE-marked, Cardiawave is raising €3–5 million to accelerate European launch and FDA development in a €10 billion market.
Premarket/clinical phase
20.000.000€
2027-2030
Medical devices
12%
1.000€
Share this project on your website.
Copy and paste the following code into your content.
Cardiawave is a late-stage French medtech company transforming the treatment of Aortic Stenosis, a life-threatening heart valve disease worldwide. Headquartered in Levallois-Perret, France, the company is a spin-off from leading academic laboratories and clinical institutions, including Langevin Institute, Physics for medicine Institute, and HEGP AP-HP, and is built on over a decade of cutting-edge research in therapeutic ultrasound.
Aortic Stenosis affects more than 10 million patients in Europe and the US, primarily aged 65 or older. Aortic Stenosis is caused by progressive calcification of the aortic valve, which stiffens the valve leaflets and obstructs blood flow from the heart. Left untreated, the disease leads to severe fatigue, shortness of breath, heart failure, and drastically reduced quality of life.
Current standards of care leave most patients behind Despite available Surgical and Transcatheter Aortic Valve Replacement procedures (SAVR and TAVR), around 300,000 patients at the severe stage remain untreated mostly due to age, comorbidities, or refusal of invasive procedures. Until the disease reaches the severe stage, patient management is generally limited to monitoring disease progression. Treatment is only offered when the Aortic Valve Area (AVA) falls below 1 cm² (vs. 2–2.5 cm² for a normal valve), at which point life expectancy drops to 2–5 years, leaving a large, underserved patient population with urgent medical need.
Cardiawave has developed Valvosoft®, a proprietary robotic, image-guided ultrasound device designed to treat severe calcific Aortic Stenosis without surgery or implants. Focused ultrasound pulses generate controlled cavitation within calcified valve leaflets, creating micro-fractures of the calcifications included in the leaflets, softening tissue, restoring mobility and improving blood flow – all while preserving the native valve.
The procedure is simple, fast and patient-friendly:
100 patients treated successfully Cardiawave has executed a robust clinical program, including pre-clinical studies, First-in-Human trials, and a European pivotal study. 100 patients have been treated in 12 leading European centers using five Valvosoft® devices. Results show:
The First-in-Human results were published in The Lancet.
Valvosoft® is CE-marked and ready for European commercialization from 2026. Letters of intent have been signed with hospitals in France (CH Rouen, HEGP), The Netherlands and Germany, with distribution agreements pending across Spain, Italy, UK, Norway, Austria, UAE and Saudi Arabia.
The flexible, scalable business model includes system sales, leasing, per-procedure fees, and bundled packages, facilitating adoption while generating recurring revenue. Cardiawave is led by an experienced management team and supported by a world-class scientific and medical advisory board. The company holds a strong IP portfolio, with 10 patent families.
The global addressable market for Aortic Stenosis exceeds €10 billion, with Cardiawave initially targeting 300,000 patients in Europe and the US who are not recommended for immediate AVR or refuse such a therapy. There is significant potential to expand into moderate forms of the disease, representing millions more.
Cardiawave is executing a dual-track strategy. In Europe, following CE-mark approval, Valvosoft® is rolling out in hospitals, with two new devices ready by September 2026. Simultaneously, the company is laying the groundwork for the US. Valvosoft® is not yet approved by the FDA and is not commercially available, but the company has initiated FDA discussions and is preparing for an Investigational Device Exemption (IDE). This approach ensures rapid European adoption while positioning Cardiawave for a strong US market entry.
Cardiawave is targeting €3–5 million in this equity crowdfunding, of which €2.2 million has already been secured from existing shareholders to start production and begin FDA processes. By supporting Cardiawave, you help bring life-changing therapy to a large, underserved population while investing in the growth of a cutting-edge medtech company.
The global heart valve market faces a critical gap: over 40% of patients with severe valve narrowing are too frail or high-risk for standard replacement surgery or catheter-based implants. For these “no-option” patients, the current alternative is an invasive balloon procedure that carries high risks and offers only short-lived relief.
Cardiawave addresses this with Valvosoft, a breakthrough non-invasive ultrasound therapy. The investment case is anchored in three key differentiators:
1. Superior safety profile: Valvosoft is the only therapy that works from outside the body. It uses image-guided ultrasound to soften calcified valves without catheters, incisions, or permanent implants. Pivotal data confirmed a 0% stroke risk, a major safety advantage over traditional invasive methods.
2. Regulatory de-risking: The device is already CE-marked in Europe (granted late 2025). This milestone validates the technology’s safety and clinical effectiveness, enabling immediate commercial rollout and significantly reducing the risks typical of early-stage medical technology.
3. Strategic exit potential: Cardiawave is a category-defining asset. Recent multibillion-dollar acquisitions in the sector—such as the $13.1B deal for Shockwave Medical—demonstrate a massive appetite from medical giants for non-implant cardiac technologies that expand the treatable patient population.
Led by a team of veterans from industry leaders like Edwards Lifesciences, Cardiawave represents a high-conviction opportunity to back a first-in-class solution for a massive, underserved medical market.
Investment in Cardiawave involves critical clinical and regulatory risks. While CE marked in Europe, long-term durability remains unproven as current data is limited to short-term studies. The US regulatory pathway is the primary uncertainty and requires substantial capital for future trials. Commercially, the lack of dedicated reimbursement and the expansion of invasive alternatives like TAVR into more patient groups could pose long-term hurdles.
Already have an account? Please login here .
You can now make your investment without any commitment, and without making any payment.
Simply indicate the amount you want to invest, click "Continue" and complete the booking confirmation process. At this stage we will not ask you for any bank details or credit card number.
As soon as the campaign gains momentum and more investors show interest, we will contact you to formalize the payment, and you will have up to 5 days to confirm your investment and make the payment. Until then, you can cancel this reservation without any commitment.
If you choose to continue to make this pledged investment when the campaign opens, you should be aware that your capital would be at risk. Please read our Risk Warningfor further details of the risks involved with early stage investing.
