LUGANO, Switzerland--(BUSINESS WIRE)--Healiva®, a patient-centric company delivering life-enhancing precision medicine for patients with chronic and acute wounds, announced today the acquisition of two innovative cell therapy assets from Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology business. The acquisition enables Healiva® to establish one of the world’s broadest portfolios of affordable, personalized, end-to-end wound care consisting of enzyme technology, autologous & allogenic cell therapies, and medical devices. Financial details have not been disclosed.
The first asset, EpiDex®, is an autologous epidermal equivalent that provides a surgery-free approach to healing chronic venous leg ulcers (VLUs). Having previously been approved for the Swiss market, Healiva’s® acquisition of the complete product dossier should enable the rapid market re-launch of EpiDex®.
The second asset, now named healiva®002, is an off-the-shelf allogeneic cell therapy that has previously demonstrated clinical efficacy in healing VLUs that are resistant to standard treatments.
“We created Healiva® to improve the lives of the millions suffering from chronic wounds by delivering innovative, effective new treatments to patients,” said Healiva’s® Founder and CEO, Priyanka Dutta-Passecker, PhD, MBA. “These remarkable cell therapies will make a pivotal contribution to that mission by addressing crucial needs in early- and late-stage chronic wound care. By adding these pioneering technologies to our growing portfolio of wound treatments, we will be able to continue our rapid growth by progressing to commercialization within four years of founding.”
“With 36 million people worldwide currently suffering from chronic wounds, we urgently need novel solutions for hard-to-treat wounds,” said Valerio Maria Ferrari, Bioseutica Group Chairman and Co-Founder of Healiva®. “Following this acquisition, we are looking forward to bringing two such solutions to market, beginning with EpiDex® in Switzerland, pending approval by Swissmedic, followed by Germany and other EMEA countries. Meanwhile, for healiva®002, we will improve the product, scale up the manufacturing process, and continue its clinical development for future commercial success at scale.”
Among the populations that may particularly benefit from these new treatments are:
- The elderly: 2–3% of whom have venous/arterial leg ulcers.
- People with diabetes: 25% of whom will suffer from potentially disabling diabetic foot ulcers (DFUs) during their lifetime.
With both of these populations continuing to grow, the burden of chronic wounds and, therefore, the need for new treatments will only become more acute. Today, the standard treatment for VLUs and DFUs requires multiple procedures which come with lengthy recovery times. In severe chronic cases, surgery is required. Crucially, less than 50% of such wounds will heal following surgery and those that do not heal will continue to worsen, potentially leading to amputation or, in severe cases, mortality. In the absence of similar market offerings, EpiDex® fills an important niche by promoting healing even in the most severe wounds, with a closure rate equivalent to surgical methods, while being both more cost-effective and significantly preferable for patients.
Founded in 2020 by Bioseutica BV and Dr. Priyanka Dutta-Passecker, Healiva® is a patient-centric biotech company delivering life-enhancing precision medicine for patients with chronic and acute wounds. Healiva® creates tailored wound solutions through a multi-pronged approach that combines enzyme technology, medical devices, and cell therapies. Cell therapy describes a process in which viable cells are introduced into the body to produce medicinal effects; cells may be derived from a cell bank (allogeneic cell therapy) or be patient-derived cells converted into the desired cell type or tissue in a lab (autologous cell therapy). Through the acquisition, development and commercialization of these assets, Healiva® enters the billion-dollar wound-care market. To find out more, visit healiva.com.