19-10-2023
Hy2Care® receives FDA Breakthrough Device Designation for its CartRevive™ hydrogel implant
Geleen, October 19, 2023
Hy2Care® proudly announces FDA Breakthrough Device Designation for its revolutionary CartRevive™ hydrogel implant. This milestone underlines the FDA's acknowledgment of the CartRevive™ hydrogel implant’s potential in the field of cartilage repair.
Leo Smit, CEO Hy2Care, notes: "With many patients facing limited solutions for effective cartilage repair, Hy2Care’s CartRevive™ hydrogel implant is the game-changer in a long-standing clinical challenge. The FDA's Breakthrough Device Designation not only recognizes the potential of our implant but underscores the pressing need for advanced treatments with improved surgical outcomes in the area of cartilage repair."
Recognition FDA Breakthrough Device Designation
The Breakthrough Device Designation supports a more efficient development and review process, accelerating access for patients to this transformative therapy. With its current ACTIVE study in the Netherlands and US clinical trial in preparation, Hy2Care ® is committed to delivering the promise of the CartRevive™ hydrogel implant to patients worldwide.
Hydrogel technology for cartilage regeneration
Employing state-of-the-art hydrogel technology, the CartRevive™ hydrogel implant offers a unique approach to cartilage regeneration. The hydrogel is based on joint-tissue-matching natural polymers and acts as a scaffold. This facilitates patients' own cells to naturally restore optimal cartilage tissue, striving to reduce repeat surgeries.
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