Preclinical data show successful regeneration of the skin by pairing Spray-On Skin Cells with Houston Methodist Research Institute's patented RNA technologies to reverse cellular aging. 

Preclinical data successfully established proof of concept for Avita Medical’s Spray-On Skin Cells in skin rejuvenation and epidermolysis bullosa (EB), the company reports.

AVITA Medical’s first US product, the RECELL System, was approved by FDA in September 2018. The RECELL System is indicated for use in the treatment of acute thermal burns at the point of care alone or in combination with autografts depending on the depth of the burn injury. 

“We are very pleased to partner with leading scientists to explore opportunities for utilizing Spray-On Skin Cells in new and broad applications such as skin rejuvenation and genetic skin defects,” says Dr. Mike Perry, Chief Executive Officer of AVITA Medical, in a news release. “These data, while early, demonstrate promise for skin regeneration from modified Spray-On Skin Cells, for treatment of aging skin with reverse-aged skin cells and for treatment of epidermolysis bullosa with gene-corrected skin cells.”

In partnership with researchers at the Houston Methodist Research Institute (HMRI), preclinical data show successful regeneration of the skin by pairing AVITA Medical’s proprietary Spray-On Skin Cells with HMRI’s patented RNA technologies to reverse cellular aging. 

“We are encouraged by these early results and look forward to continuing to work with AVITA Medical to explore technologies for reversing aging of skin cells,” says Dr. John Cooke, Chair of the Department of Cardiovascular Sciences, and Medical Director of the RNA Therapeutics department at Houston Methodist Research Institute. “Skin is the body’s largest organ, and molecular signaling from aged cells can have a significant impact on the rest of the body. Therefore, reversing aging of skin could have significant implications for other systems in the body.”

Epidermolysis Bullosa

In partnership with scientists at the Gates Center for Regenerative Medicine at the University of Colorado School of Medicine, preclinical data show successful regeneration of skin from gene-modified skin cells to correct the mutation associated with recessive dystrophic epidermolysis bullosa, a rare and incurable skin disorder caused by mutations in the gene encoding structural proteins, resulting in skin fragility, and blistering.

“These initial results are a meaningful step forward in the advancement of our epidermolysis bullosa program,” says director of the Gates Center for Regenerative Medicine Dr. Dennis Roop. “We’re looking forward to continuing to work with AVITA Medical on this novel approach to delivering gene-edited skin cells to patients.”

In related news, Avita announced that it has completed enrollment in a pivotal trial evaluating the Recell System for soft-tissue reconstruction. Topline data is expected to be shared later this year.

“Completing enrollment of the pivotal trial assessing use of the RECELL System for treatment of soft-tissue reconstruction is an important milestone for AVITA Medical and moreover, is synergistic with our current commercial focus in burns. Ultimately, with FDA approval of this indication, we expect to expand the use of RECELL to include all acute wounds,” says Dr. Perry. “Early completion of enrollment in our soft tissue reconstruction trial underscores the need and physician desire for new treatment options.”

“I’m very pleased to have participated in this clinical trial, which we expect will confirm that less donor skin is needed for soft-tissue injuries while not compromising healing outcomes relative to conventional autografting,” adds Dr. Steven E. Mapula, Assistant Professor of Surgery TCU and Division Chief of Plastic Surgery at John Peter Smith Hospital. “We believe the RECELL System has the potential to become an important new treatment option for those in need of soft-tissue reconstruction.”