PolarityTE, which seeks to change the way we think about regenerative medicine, announced preclinical results showing its SkinTE platform regenerated full-thickness skin in swine models of third-degree burns.
The study demonstrates the first successful regeneration of full-thickness skin in swine models, the standard animal model for human skin, the company said in a statement. The SkinTE platform showed scarless healing, hair follicle growth and immediate complete wound coverage. The team plans to launch a human trial in the third quarter of this year.
"These findings using SkinTE demonstrate an entirely new and pragmatic system whereby Polarity has used autologous tissue to regenerate full-thickness skin, hair follicles and appendages for the treatment of burns and wounds,” said said Denver Lough, M.D., Ph.D., Polarity CEO, chief scientific officer and cofounder, in the statement. “This is a first for regenerative medicine and validation of the Polarity regenerative tissue platforms in pre-clinical studies across a variety of species.”
Skin grafts are the standard treatment for burn patients, but they can be challenging for large burns that require extensive skin coverage, Lough said. SkinTE uses the subject’s own skin, which is expanded in a lab, used to regenerate all layers of skin and then applied to the wound in less than 24 hours, the company said.
"Our revolutionary approach to a new form of regenerative healing offers hope to both burn and wound patients, as well as medical providers who have not seen a significant advance in skin regeneration since the 1980s," said Stephen Milner, M.D., who left his post as director of the Johns Hopkins Burn Centers to become chief clinical officer of PolarityTE. "The efficacy and utility of current approaches to burn and wound care are currently severely limited, and leave a lasting effect on patients who suffer with scarring, disfigurement or even death.”
What differentiates PolarityTE’s platform from other regenerative medicine approaches is that its platform does not focus on a stem cell, growth factor or scaffold, Lough said. The autologous and homologous platform instead uses the idea that a patient’s own skin can be used to regenerate itself. It has products in the pipeline, dubbed OsteoTE and CartTE, which aim to regenerate bone and cartilage.
PolarityTE was born when Lough and Ned Swanson left the plastic surgery residency program at Johns Hopkins. When he first joined the program, Lough thought he might, later on, be able to open his own lab to regenerate skin for burn patients.
“But I began to realize you can’t do that type of stuff in academia,” he said. “There are a lot of factors that slow down efficiency, the professionalization of research and product development.”
The Salt Lake City-based company went public via a reverse merger with Majesco Entertainment, a gaming company that looked en route to bankruptcy. Majesco reported operating losses of $13.3 million in FY 2014 and $12.2 million in FY 2013 and slashed its employees about 40%. Bloomberg puts PolarityTE's market cap at $94.9 million.