Healiva announced today that it acquired critical manufacturing assets from B. Braun’s B. Braun Medical AG Switzerland affiliate.
The companies declined to disclose financial details for the acquisition.
Lugano, Switzerland-based Healiva develops precision medicine for patients with chronic and acute wounds. It acquired a qualified cell bank for the manufacturing of its first cell therapy product.
The company said in a news release that the cell bank is “essential” for the GMP-compliant manufacturing of EpiDex. It designed EpiDex as an autologous epidermis derived from the patients own hair cells.
“This transaction will enable Healiva to accelerate the launch of EpiDex, which is projected for Q4 2023,” said Priyanka Dutta-Passecker, 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.”
EpiDex offers a means to treat chronic venous leg ulcers and other chronic wounds, according to Healiva. The company says it is “as effective as surgery” for severe chronic wounds. However, it provides improved const-effectiveness and patients prefer it, the company noted.
The platform holds approval for the Swiss market. Healiva plans to initially launch it in Switzerland, pending Swissmedic approval. Following that, it plans to launch in Germany and other EMEA countries.
“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,” said Dr. Andreas Emmendoerffer clinical advisor at Healiva.
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