Healiva, a company developing precision medicine for chronic and acute wounds, has acquired B. Braun manufacturing assets including a qualified cell bank to make its EpiDex cell therapy product, an autologous epidermis derived from the patient’s own cells.
 
“This transaction will enable Healiva to accelerate the launch of EpiDex, which is projected for Q4 2023,” Priyanka Dutta-Passecker MBA, Ph.D., co-founder and CEO of Healiva told the press. “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,” added Eric Rolland Ph.D., scientific lead and advisor at Healiva. “These discs are then applied onto the wound, where they promote the growth and healing of the skin.”
 
Healiva’s portfolio combines cell therapy, medical devices, and enzyme technology to cover the wound healing process. According to the company, EpiDex is an equally effective alternative to surgery to treat chronic venous leg ulcers and other chronic wounds.
 
“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, Ph.D., clinical advisor at Healiva.
 
EpiDex will initially be launched in Switzerland, followed by Germany and other EMEA countries.