VCEL News & Events

MediWound (MDWD) announced that Vericel (VCEL), its exclusive distributor of NexoBrid in North America, has been awarded a ten-year contract valued at up to $197M by the U.S. Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Vericel reported that the contract is for the procurement of NexoBrid, establishment and maintenance of a Vendor Managed Inventory system, design and validation of a U.S.-based manufacturing facility, and the development of a next generation formulation and additional indication for NexoBrid. Vericel further reported that the base period contract of $35M includes approximately $10M over the next 12 months for the initial procurement of NexoBrid for the U.S. Strategic National Stockpile and VMI establishment, funding for VMI-related services and initial development activities for a potential expanded NexoBrid indication for the treatment of blast trauma injuries. According to Vericel, the ten-year contract, effective as of April 1, also includes optional awards for additional NexoBrid procurement to expand the Strategic National Stockpile, further clinical development for a potential blast trauma indication, design and validation of a potential U.S.-based manufacturing facility and the development and procurement of a room temperature stable formulation of NexoBrid.

Vericel has been awarded a contract by Health and Human Services with a total contract value of $196.87M. This acquisition will allow BARDA to support procurement of an FDA-approved enzymatic debridement product and support development of a next generation product for increased preparedness value, the government said in a statement.

Vericel Corporation announced that the U.S. Food and Drug Administration, FDA, has granted approval for MACI commercial manufacturing at its state-of-the-art cell therapy manufacturing facility in Burlington, Massachusetts. The approval enables Vericel to begin commercial production of MACI at its new facility in the second quarter of 2026, positioning the Company to expand capacity to meet increasing demand for its restorative cartilage repair product and potentially commercialize MACI outside of the United States. "This FDA approval reflects a major achievement for Vericel and underscores the Company's operational and scientific expertise in complex cell therapy manufacturing," said Nick Colangelo, President and Chief Executive Officer of Vericel. "Bringing our Burlington facility online for commercial MACI production strengthens our supply chain and supports our mission to deliver innovative, high-quality therapies to patients. We look forward to building on this foundation as we continue to scale our business and create long-term value for patients and shareholders."