PolarityTE wants to eliminate skin grafts with its platform of regenerative technology. The Utah-based biotech is still new to the industry, but co-founders Denver Lough and Ned Swanson are betting that their company can take on the clinical standard of care for wound management.
“No other product, whether it be a drug, a biologic device, or a cell therapy type of product has been able to regenerate full thickness hair-bearing skin,” Lough, who serves as the company’s chairman, CEO, president & chief scientific officer, told Drug Delivery Business News.
The two former Johns Hopkins residents have grown their company to include more than 80 employees in the last year. PolarityTE is in the middle of a limited market roll-out for SkinTE – doctors are using the product for burn reconstruction and to address acute and chronic wounds.
The company, which Lough said is “waging war on skin grafts”, wants to create technologies that can tackle the array of problems that crop up when doctors use skin grafts.
“Split-thickness skin grafts don’t regenerate hair follicles. They don’t generate sebaceous glands or sweat glands and therefore have an intrinsic defect. While there are a variety of skin substitute technologies or skin substitute engineered products that are out there, all of them have fallen short of the skin graft and the skin graft continues to be the clinical standard of care,” he said.
To apply PolarityTE’s SkinTE product, doctors use the company’s kit to harvest a full-thickness hair sample from the patient, which is then packed into a cooling system and sent off to the company’s headquarters.
There, PolarityTE will process the tissue and send it back to the provider. The product arrives at the doctor’s office, where the provider can then deliver the autologous skin tissue product directly to the patient’s wounds and apply dressings – just as they would for any other skin graft.
Unlike traditional skin regenerative technologies, PolarityTE’s product produces full-thickness skin that has sweat glands and can grow hair, Lough said.
In parallel with its limited roll-out, the company is running a head-to-head trial comparing skin grafts to its SkinTE product in multiple centers.
“We plan to release SkinTE nationally within the next year after we’ve shown everyone that it has been able to essentially beat skin grafts and replace skin grafts across all of these different types of conditions,” Lough said.
Investors are excited at the potential for PolarityTE’s platform. Since the company went public in 2017, their stock has climbed from $3 apiece to more than $28 per share.
And last month, PolarityTE announced that they raised $34.2 million in a public offering.
“This raise was what we needed to essentially get SkinTE fully commercialized over the next 18-24 months and also bring our OsteoTE bone-regeneration product to market toward the end of this year and essentially start repeating the blueprint we laid out with our SkinTE product,” COO Swanson told us.
“We think that really brings the company into a new phase and a new stage of life and into the realm of fully commercializing two products,” Swanson added.
As the company gears up for commercialization of both the SkinTE and OsteoTE products, Lough and Swanson know they have a challenging road ahead; Convincing doctors to reach for new solutions is no easy task.
“We want to be able to provide the best technology that’s out there, one that’s truly superior to the clinical standard of care. But that’s still not enough to displace the current clinical standard of care. You need to make it easier than the current clinical standard of care,” Lough said.
He noted that the product also needs to be cost-efficient. While most skin substitutes are priced between $100 and $250 per square centimeter, PolarityTE sells its system for close to $50 per square centimeter, according to Lough.
“You can have the greatest technology in the world. It can be easy to use. But if it’s very expensive, that’s still a barrier and people will utilize the clinical standard of care because it’s cheaper,” he explained.”We don’t want people going bankrupt because of technologies like this.”
The company is also in talks with major biopharma companies, Lough said, to set up potential distribution deals nationally and internationally.
Doctors were skeptical of the company’s technology at first, the CEO noted.
“A lot of clinicians, as well as the market, have been skeptical of SkinTE and one of the reasons is that the field of regenerative medicine is littered with the bodies of failed regenerative medicine companies,” Lough said. “There have been a lot of empty promises.”
Lough believes that his company’s approach stands out from previous attempts made by other industry players because PolarityTE doesn’t try to stick to the traditional line of thinking that a regenerative technology should be composed of a single stem cell, a single growth factor or a single scaffold.
These technologies don’t work, according to Lough, “because they’re all missing incredibly important components. SkinTE is dramatically different in that it simply obeys elements of biology that we know actually work.”
Over the next year, PolarityTE plans to continue its limited release of SkinTE, as well as disclose data from its clinical work. Early data show great promise for the company’s first commercial product, according to Lough, who described a case in which doctors used SkinTE to treat a 45-year-old patient who had burns permeating 75% of their body.
“The patient was coding the night before the SkinTE product was put onto them,” he said. “Typically these patients, if they do live, they’re in the burn center for over a year. And the average cost for that type of burn care is usually $1.3 to $1.5 million, per the National Burn Repository data that’s out there. Following application of the SkinTE product, the patient was ambulating, grew full-thickness skin and was discharged six weeks later.”