SALT LAKE CITY — Among the most devastating medical injuries imaginable is suffering serious, debilitating burns to the skin. Those inflicted with such wounds often undergo long, painful treatments, along with the lasting impacts of scars that can be permanently disfiguring.
But a Utah-based biotechnology company is creating a treatment option that could regenerate a patient's own human skin.
Launched earlier this year, the platform developed at PolarityTE allows the company's products to regenerate a patient’s tissues using their own cells, explained Dr. Denver Lough, president and CEO of PolarityTE.
"It is regenerating full thickness, fully functioning (skin) tissue of the patient," Lough said.
The company's first product is being optimized for clinical use in skin regeneration, with all layers, hair and appendages, he noted.
Skin regeneration will propel PolarityTE into numerous other arenas, including bone, muscle, fascia, cartilage and nerve, said Chief Operating Officer Dr. Ned Swanson.
"We see the potential in where things are today with the development of these technologies," Swanson said. "It could be totally revolutionary across a wide spectrum (of patients) throughout the world."
Lough and Swanson both were in medical residency at the Johns Hopkins Hospital in Baltimore as plastic reconstructive surgeons until December, when they decided to make the move to business and start PolarityTE. They did so with the help of a few high-net-worth pharma investors, and quickly went public in April through a reverse merger.
Many fellow Johns Hopkins colleagues followed them to Utah, including the former head of the burn unit there. In just a few short months, they have gone from three employees to more than 20, with expansion plans already in the works.
Speaking from PolarityTE's headquarters on the University of Utah campus, Lough said the company is preparing to announce data that shows for the first time the ability to produce fully functioning, full-thickness skin with hair follicles in a swine model.
The animal model, he noted, is currently the standard for skin research because it represents the closest comparison to actual human skin. In the next few months, scientists will conduct the first human study at burn centers nationwide.
"Coming from plastic surgery, skin was one of the main focuses," Swanson said. "Just providing skin, not only to burn patients, but also a whole host of other patients would change their lives in a very significant way."
Lough is credited with inventing the initial skin product at Johns Hopkins, which involves the combination of stem cells and biological growth factors. Currently, manufacturing is taking place at the company's U. facility.
Lough said the company is developing a streamlined process for how a plastic surgeon in a burn unit can have everything needed in a single box to take a patient’s skin sample and send it to the lab for use in the process. Then within 48 hours, they can have the regenerative cells necessary to begin the treatment process.
With this skin product, PolarityTE is looking to give burn victims back what they need most to live — fully functioning skin, Lough said.
"(We try) to get the product back (to) the patient when they really need it — before real scar tissue begins to develop," he explained.
Lough said he and Swanson started the company to change the way the medical community cares for burn patients, as well as those who have other severe conditions that require major treatment.
"We want to change the paradigm of the way medicine works," Lough said. "Things are becoming too costly, and (patients) are not getting the treatment and the care they want or they deserve and they need."
One of the goals of the company's product development is to create treatments that are affordable and readily available, he said. Because the treatments use naturally occurring organic materials, no time-consuming regulatory approvals are required — just a registration with the U.S. Food and Drug Administration. However, the company will do its own human testing to ensure safety and reliability, Lough said.
"Polarity is really set out on providing this platform … to help physicians find ways to get that product onto patients quickly at a lower cost with better outcomes," he said. "We're here to help (doctors) get the best products to patients as cheaply and as quickly as possible.
"It's not all about profits," Lough said. "It's about getting the best products out there and really help humanity."
Swanson said making big profits are not the company's main objective, but rather to bring new science and new ideas to patient treatment in a way that has not been done before.
"We left our careers in plastic and reconstructive surgery not to go into business; it was to impact the same patients we always wanted to help on a much broader scale," he said. "Instead of one patient at a time, maybe 10 a day, it's hopefully going to be thousands of patients that can be helped much more rapidly when these products are brought to market."
The company is currently in the animal testing phase and will move to human testing in the coming months, with commercial production planned for early next year. Swanson noted that because the product uses patients' own skin, the results can be virtually seamless, making scarring a thing of the past.
"It's almost scarless healing," Lough said, estimating that the healing process would take about two to three months.
The company chose to locate in Utah because of its burgeoning tech environment and the availability of qualified, well-educated talent, Lough said. He believes companies like PolarityTE will become more prevalent as the state's biotech ecosystem begins to flourish in the years to come.
"Utah and the Salt Lake Valley area is on the cusp of something great," Lough said.