Purchased in June from Smith+Nephew, EpiDex is an autologous epidermal equivalent that provides a surgery-free approach to healing chronic venous leg ulcers (VLUs) and disabling diabetic foot ulcers (DFUs).

Healiva, founded in November 2020 by Priyanka Dutta-Passecker and Dutch ingredients company Bioseutica, said the cell bank, which passes the regulatory requirements for Advanced Therapy Medicinal Products, is essential for the GMP-compliant manufacturing of EpiDex, which has previously been approved for the Swiss market.

“This transaction will enable Healiva to accelerate the launch of EpiDex, which is projected for Q4 2023,” said Dutta-Passecker, the company’s co-founder and CEO. “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.”

The existing standard treatment for VLUs and DFUs requires multiple procedures with lengthy recovery times. In severe chronic cases, surgery is required. According to Healiva, less than 50% of these wounds will heal after surgery and those that do not heal will continue to worsen, potentially leading to amputation or, in severe cases, death.

Eric Rolland, Healiva’s scientific lead and advisor, explains that to produce EpiDex, progenitor keratinocyte cells from a patient’s hair are cultured in the presence of fibroblast feeder cells, generating small discs of autologous epidermis. These discs are then applied to the wound, where they promote the skin’s growth and healing, an approach that the Lugano-based biotech said is more cost-effective than surgery and significantly preferred by patients.

Once launched in Switzerland, Healiva will then introduce the skin-healing product in Germany and other countries across Europe, the Middle East and Africa.

Author: Elaine Burridge, Freelance Journalist