Dutch-based Hy2Care raises €4.5M from EIC, others for US clinical trial and commecial expansion

Hy2Care, a spin-off company of the MIRA Institute of the University of Twente, has successfully raised €4.5M in new funding to complete critical preparations for its upcoming clinical trial in the United States.

Half of the funding comes from the European Innovation Council (EIC) Fund investment awarded to Hy2Care in 2022 as part of the EIC Accelerator.

The European Innovation Council Fund from the European Commission is agnostic; it invests across all technologies and verticals, and all EU countries and countries associated with Horizon Europe.

The remaining amount was raised from existing shareholders, led by Brightlands Venture Partners, with participation from new investors including LIOF, the regional development agency for Limburg.

Fund utliistion

The funding announcement comes as the company recently received FDA Investigational Device Exemption (IDE) approval, allowing it to start clinical evaluation of its CartRevive hydrogel implant for cartilage repair.

The capital will also support strategic steps toward commercial rollout in Europe and other key global markets.

“This round gives us the momentum we need to take the next big step.” says Leo Smit, CEO of Hy2Care. “We’re entering a transformative phase — launching a U.S. clinical trial while laying the foundation for commercialization in EMEA. We are incredibly proud of the support from our investors, both existing and new.”

Hy2Care: Advancing CartRevive hydrogel platform

Led by Leo Smit, Hy2Care has developed a patented hydrogel technology platform to revolutionise cartilage repair.

The company’s flagship product — the CartRevive hydrogel implant– is specifically engineered for knee cartilage repair and is currently being evaluated in clinical trials through the “ACTIVE” study.

The company has completed patient enrolment for its EU trial in 2024, and CE marking / European market approval is anticipated by early 2026.

CartRevive was granted FDA Breakthrough Device Designation in 202,3 and in April 2025, Hy2Care received FDA IDE approval to start its first clinical trial in the United States.