Vanarix, a Biopôle-based start-up specializing in cartilage regeneration, has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its bioengineered cartilage mini-implants, Cartibeads.
Founded in 2018, Vanarix is making significant strides in regenerative medicine with its innovative Cartibeads technology. These bioengineered cartilage mini-implants use donor cartilage cells to repair articular cartilage damage, addressing a critical unmet medical need. Cartibeads are available in two forms: autologous, derived from a patient’s own cells, and allogeneic, using donor cells. The latter eliminates compatibility concerns between donor and recipient while minimizing rejection risks.
The implants deliver high-quality hyaline cartilage, a marked improvement over existing solutions that typically produce fibrocartilage. While the current focus is on knee treatments, Vanarix envisions broader applications for other joints, offering hope to millions affected by cartilage damage and osteoarthritis worldwide.
Promising clinical results and future plans
The FDA’s Orphan Drug Designation for Cartibeads in the treatment of osteochondritis dissecans represents a major step forward for Vanarix. This designation provides several benefits, including tax credits for clinical trial expenses, market exclusivity upon approval, waived application fees, and access to grant funding. These incentives reduce the financial and regulatory burden, accelerating the development of treatments for rare diseases.
Vanarix has already demonstrated the potential of its allogeneic Cartibeads in Phase I/IIa clinical trials, with patients resuming intensive activity within a month of treatment. The company now aims to scale production to treat 200 patients during Phase 2 and Phase 3 trials, targeting completion by 2026/2027.
