Healiva® has acquired significant cell therapy manufacturing assets from B. Braun. | So Good News

Lugano Switzerland–(Business Wire)—Healiva®, a provider of life-enhancing precision medicine for patients with chronic and acute injuries, today announced the acquisition of key manufacturing assets from German medical and medical device company B. Braun Medical AG Switzerland. , B. Braun SE. The acquisition includes a qualified cell bank essential to the GMP compliant manufacturing of Healiva’s first cell therapy product, EpiDex®. 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), Healiva’s co-founder and CEO said. “This will shorten the path to market for EpiDex by a year, immediately proving it to patients with severe chronic wounds without surgery.”

“To produce EpiDex, progenitor keratinocyte cells derived from the patient’s hair are cultured in the presence of fibroblast feeder cells, generating small discs of autologous epidermis,” said Eric Rolland (PhD), Scientific leader and advisor at Healiva explains. “These patches are applied to the wound to promote skin growth and healing.”

“The acquisition of a qualified fibroblast cell bank that meets the regulatory requirements for Advanced Therapeutic Medical Products (ATMPs) and prior approval for the commercialization of EpiDex is a key step in Healiva’s product development,” said Andreas Emmendoerffer (MD, PhD, ) Clinical Advisor at Healiva.

EpiDex is part of Healiva’s broad wound care portfolio; cell therapy; Encompasses the entire wound healing process, combining medical devices and enzyme technology. EpiDex addresses the need for new ways to treat chronic leg ulcers and chronic wounds that affect 60 million patients worldwide. the elderly population; Combined with the rise of metabolic diseases, this burden is increasing. Today, Standard treatment for chronic ulcers requires multiple surgeries and procedures in severe cases. EpiDex is as effective and less expensive as surgery for severe chronic wounds, and is significantly preferred by patients.

EpiDex was previously approved for the Swiss market. EpiDex will initially be launched in Switzerland; Approval is pending from Swissmedic, followed by Germany and other EMEA countries. Healiva is seeking reimbursement for EpiDex in Switzerland and intends to do so in other European countries after that.

About Healiva

Healiva is a patient-centered biotechnology company providing life-enhancing precision medicine for patients with chronic and acute wounds. The company was founded in 2020 by Bioseutica BV and Priyanka Dutta-Passecker (PhD, MBA).

To learn more Visit www.healiva.com