October 3, 2017
By Alex Keown, BioSpace.com Breaking News Staff
SALT LAKE CITY – PolarityTE is making some big moves. Not only has the company registered its lead product with the U.S. Food and Drug Administration, but PolarityTE has acquired a 60-acre facility in Utah to facilitate a massive expansion that could see the company grow to 1,000 employees over five years.
PolarityTE announced it will purchase the former headquarters of Fairchild Semiconductor for approximately $21 million, The Desert News of Utah reported Sunday. The purchase is expected to close quickly and PolarityTE will begin renovating “much of the existing 300,000-square-foot building” before it takes over the space. The company will update the facility to provide space for PolarityTE’s research and development, laboratory testing and administrative staff. Polarity TE President and Chief Executive Officer Denver Lough told The Desert News that the massive space already had many of the amenities the company needed due to similar safety and cleanliness standards called for in the microchip manufacturing industry.
Renovations, which will be handled in stages, are expected to cost PolarityTE about $70 million. As the renovations are conducted, the company will look to rapidly expand. PolarityTE currently has about 60 employees, Lough said.
The new facility will be the home of PolarityTE’s SkinTE, an autologous, minimally manipulated construct intended for homologous uses of skin tissues. This morning, the company announced that it had registered SkinTE with the U.S. Food and Drug Administration. PolarityTE has released the product in a limited manner already, but with the new registration the company intends to accelerate commercialization in 2018 as the company scales up manufacturing efforts.
In a statement, Lough called the FDA registration “an important regulatory step that sets the stage for commercialization and a staged market entry of this revolutionary technology into clinical application.
SkinTE, the company’s lead product, was designed to regenerate “full-thickness and fully-functional” skin in patients. The company said skin is regenerated from a small biopsy. The regenerated skin includes all layers, epidermis and dermis, as well as hair and appendages. The company’s initial aim is to help burn victims and later provide skin regeneration for patients who have suffered from acute and chronic wounds, as well as cosmetic scarring.
“This achievement enables us to deliver an entirely new and pragmatic solution for skin regeneration as well as the ability to change the face and practice of regenerative medicine toward patient-tailored tissue constructs,” Lough added.
PolarityTE intends a “progressively-staged market release” of SkinTE in order to allow time to scale the manufacturing process, Edward Swanson, PolarityTE’s chief operating officer said in a statement.
Shares of PolarityTE are trading at $27.95 as of 10:57 a.m.
