Healiva acquires manufacturing facility for cell therapy product

Healiva has announced that it has agreed a deal to acquire cell therapy production facilities from B. Braun Medical AG Switzerland. This acquisition from the subsidiary of the German medical and pharmaceutical device company B. Braun SE includes a cell bank that is essential for the production of Healiva’s first cell therapy product known as EpiDex.

Healiva is an innovative Swiss start-up headquartered in Lugano in the canton of Ticino that is supported by Bioseutica, a Dutch manufacturer of natural proteins and enzymes. The company combines digital health, enzyme technology and cell therapy, with the aim of offering personalized solutions in the area of regeneration biology.

To produce EpiDex, discs of epidermis are generated from the hair of a person suffering from a chronic leg ulcer or other chronic wound, further details of which can be found in a press release. “These discs are then applied onto the wound, where they promote the growth and healing of the skin”, explains Eric Rolland, Scientific Lead and Advisor at Healiva.

“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”, comments Andreas Emmendoerffer, Clinical Advisor at Healiva.

EpiDex had previously been approved for the Swiss market. Pending additional authorization from the Swiss Agency for Therapeutic Products (Swissmedic), EpiDex will initially be launched in Switzerland, before being rolled out in Germany and other EMEA (Europe, Middle East, Africa) countries.