Hy2Care and the EIC Accelerator: Cartilage Gel at the Threshold

Hy2Care, a University of Twente spin-off founded in 2014, makes CartRevive, a hydrogel that fills cartilage defects in the knee. Injected during keyhole surgery, it is meant to stop scar tissue forming and let the body regenerate "true hyaline cartilage", according to its EIC project. Its chief executive, Leo Smit, has said the gel "conforms to the exact shape of the cartilage defect, eliminating the need for drilling or cutting".

The European Innovation Council granted €2,500,000 towards ACTIVE, a €3.7 million project from October 2022 to September 2024 to evaluate the gel's safety and performance, and the EIC Fund invested in 2022. The final report lists 10 first-in-human patients and 36 in a pivotal study with 12-month follow-up in the Netherlands, and FDA Breakthrough Device designation. In April 2025 the FDA approved a US trial, and in May 2025 the company raised €4.5 million, half from the EIC Fund, according to Brightlands. It said CE marking and the first US patient would follow in early 2026; neither has been announced.

Where Hy2Care Stands Now

When the FDA approved its Investigational Device Exemption on 22 April 2025, Hy2Care said the first US patient would be treated in early 2026 and that CE marking was "targeted for 2026", according to Novel-T. In 2025 it told Med-Tech World it had closed a convertible debt round and was raising a Series B of about €35 million, with a first tranche expected in late 2025. We found no announcement of the CE Mark, the Series B close or a first US patient, and no US study is registered on ClinicalTrials.gov.

The Technology: A Gel That Takes the Shape of the Hole

CartRevive is made from natural polysaccharides and carries no cells, unlike the cell-based therapies it competes with. The report says patient comfort, measured with the KOOS knee score, rose significantly after surgery, "with results on par with the expensive cel-based therapies", and that MRI scoring was used to assess the repair tissue. It does not publish the scores. The Dutch trial is registered as NCT05186935, with no update posted since February 2022.

What the EIC Project Promised, and What CORDIS Shows

ACTIVE set out to evaluate the gel's safety and performance, and the report says it moved the product from technology readiness level 6 to 8 through the Dutch trials. It planned market authorisation in the Netherlands, Germany, Austria and Switzerland and a distribution deal with an established medtech company "around 2026/2027".

1. First-in-human studyDelivered10 patients.
2. Pivotal studyDelivered36 patients, 12 months.
3. Published outcome dataNot publishedNo scores released.
4. CE markingNot announcedDue early 2026.

The Money

Hy2Care raised €3.7 million in a 2019 Series A, received EIC Fund equity in 2022 and raised €4.5 million in May 2025, half from the EIC Fund and half from shareholders led by Brightlands Venture Partners with LIOF, the Limburg development agency. It does not publish revenue, and without a CE Mark it cannot sell CartRevive in Europe.

What Cannot Be Checked

Why Europe Should Care

The EIC is both a grant-giver and a shareholder here, and put up half of Hy2Care's 2025 round. The clinical work it funded was done in Dutch hospitals. Whether that becomes a product European surgeons can use depends on a CE decision the company has not yet announced.

The Verdict

Hy2Care and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.