Healiva, a patient-centric company delivering life-enhancing precision medicine for patients with chronic and acute wounds, announced today the acquisition of critical manufacturing assets from B. Braun Medical AG Switzerland, an affiliate of German medical and pharmaceutical device company, B. Braun SE. The acquisition includes a qualified cell bank, which is essential for the GMP-compliant manufacturing of Healiva’s first cell therapy product, EpiDex: an autologous epidermis derived from the patient’s own hair cells. Financial details have not been disclosed.
“This transaction will enable Healiva to accelerate the launch of EpiDex, which is projected for Q4 2023,” said Priyanka Dutta-Passecker (MBA, PhD), Co-founder and CEO of Healiva. “This will allow us to deliver our clinically proven, surgery-free solution to patients with severe chronic wounds more promptly, shortening the path to market for EpiDex by approximately one year.”
“To produce EpiDex, progenitor keratinocyte cells obtained from a patient’s hair are cultured in the presence of fibroblast feeder cells, generating small discs of autologous epidermis,” explained Eric Rolland (PhD), Scientific Lead and Advisor at Healiva. “These discs are then applied onto the wound, where they promote the growth and healing of the skin.”
“The acquisition of a qualified fibroblast cell bank that meets the regulatory requirements for Advanced Therapy Medicinal Products (ATMPs) and has previously been approved for the commercial production of EpiDex is a key step in Healiva’s product development,” added Andreas Emmendoerffer (MD, PhD), Clinical Advisor at Healiva.
EpiDex forms part of Healiva’s broad wound care portfolio, which combines cell therapy, medical devices, and enzyme technology to cover the whole wound healing process. EpiDex solves an urgent need for new solutions to treat chronic venous leg ulcers and other chronic wounds, which affect 60 million patients worldwide. With an aging population, combined with the growing incidence of metabolic diseases, this burden is growing. Today, the standard treatment for chronic wounds requires multiple procedures, with surgery required in the most severe cases. EpiDex is as effective as surgery for severe chronic wounds, while being more cost-effective and significantly preferred by patients.
EpiDex had previously been approved for the Swiss market. EpiDex will be launched initially in Switzerland, pending approval by Swissmedic, followed by Germany and other EMEA countries. Healiva intends to first seek reimbursement in Switzerland for EpiDex, followed by other European countries.