Healiva®, a patient-centric company delivering life-enhancing precision medicine for chronic wounds, announced today a strategic collaboration with Lausanne University Hospital (CHUV, ?Centre Hospitalier Universitaire Vaudois') for the manufacturing and approval of its autologous epidermal equivalent, Epidex®. Originating from the patient's own hair follicles, EpiDex® enables non-invasive treatment of severe chronic venous leg ulcers (VLUs).
"We are very pleased to partner with CHUV on EpiDex® production", said Dr. Priyanka Dutta-Passecker, Co-founder and CEO of Healiva. "Joining forces with a recognised centre of excellence in skin cell therapy marks a major milestone for the market launch plan for EpiDex®."
The partnership enables Healiva to access the GMP compliant manufacturing site of the CHUV Cell Production Centre (CHUV-CPC), its unique expertise in the development of Advanced Therapy Medicinal Products, and to combine the complementary competences of the partners for the treatment of chronic and acute wounds with cell therapy products.
To produce EpiDex®, cells originating from patient hair follicles will be cultured at the CHUV-CPC to generate small discs of autologous epidermis. Once delivered to the patient's treatment centre, these discs can be applied to the wound during a simple, non-surgical procedure, where they promote the growth and healing of the skin. The manufacturing of EpiDex® at CHUV-CPC will facilitate Healiva's plans to make EpiDex® available to patients in Switzerland.
"Healiva's technology represents a significant opportunity to change the way we treat people with chronic wounds," said Dr Jean-François Brunet (PhD), Director of CHUV-CPC. "We are fully committed to leveraging our experience in manufacturing technologies to support Healiva's manufacture of EpiDex®."
EpiDex® solves an urgent need for VLUs and other chronic wounds affecting 60 million patients worldwide. EpiDex® had been approved for the Swiss market until 2013 and will be relaunched initially in Switzerland, followed by EMEA countries.
Founded in 2020 by Bioseutica and Dr. Dutta-Passecker, Healiva creates tailored solutions across the wound care spectrum through a multi-pronged approach combining enzyme technology, medical devices, and cell therapy.
CHUV-CPC produces cells and tissues to provide doctors and patients with cell and tissue therapy treatments. CHUV-CPC is a reference centre in the production of autologous skin for the treatment of burn patients.
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