PolarityTE
Discover, Design, Develop

“The field of regenerative medicine is littered with the bodies of failed companies.” The CEO, President, Co-founder, and Chairman of the Boardat PolarityTE, Inc., Denver Lough begins with a veracious statement. Although the regenerative medicine market is growing with a CAGR of 22.3 percent and is projected to hit a worldwide market size of around $60 billion by 2020, the fact is that no company has yet figured out how to regenerate full functioning tissue. PolarityTE’s first product, SkinTE, is able to regenerate a patient’s own functioning skin for the repair, reconstruction, and replacement of full-thickness skin. “There are a lot of companies that create skin substitutes, but the problem remains as they are not creating actual skin but only a sheet of fibroblasts,” explains Lough.

The company’s PolarityTE platform harnesses natural regeneration and allows cells to function as they normally do in the body. Through its revolutionary platform, PolarityTE seeks to induce cell and tissue polarity and ultimately create functional tissue. PolarityTE uses its proprietary technology to create the first-of-its-kind skin regeneration product, SkinTE. With SkinTE, all layers of the skin regenerate including epidermis, dermis, and hypodermis, as well as appendages like hair follicles and sweat glands. These layers and appendages are critical to the function of skin, which is much more than a barrier. Current treatment options for burns, wounds, and other skin defects cannot deliver to a patient what they lost – their own skin. Without full functioning skin, burns, wounds, and defects can become chronic (non-healing) and scarred closures can contract overtime, which can lead to limits in mobility for a patient. SkinTE is positioned to significantly change treatment and outcome options for patients.

We want to change standards of care and introduce genuine solutions to patients and providers, and believe the regeneration of full thickness, functional tissue can do just that

SkinTE is made using a patient’s own skin, so the patient’s body won’t reject it. First, a provider takes a small skin sample from the patient and sends it to PolarityTE in a PolarityTE-provided parcel. Then PolarityTE manufactures the patient-specific SkinTE product and returns the paste-like substance in a syringe to the provider for application on the patient, typically within 48-72 hours. The skin then regenerates on the patient overtime. Using the patient as a bioreactor allows the skin tobe regenerated. What is truly remarkable is that the technology can be carried over to other tissues in the body.

Founded by plastic and reconstructive surgeons who saw the significant limitations of so-called regenerative medicine to date, PolarityTE technology drives components in the body to work with human biology instead of working against it, so that the tissues can be used to regenerate themselves. Beyond SkinTE, PolarityTE has a robust pipeline with additional products expected to launch in the future. “The main goal that PolarityTE pursues is to come out with different applications of the platform across all cells, tissues, and composite structures, that can eventually transform tissue engineering and take it to the next level,” states Lough.

Being in the late-stage development of OsteoTE, a regenerative bone product, with an anticipated limited market release in 2019, the company strives to design, develop, and build technologies to create pragmatic products that deliver superior technology, simplicity, and cost effectiveness. “We want to change standards of care and introduce genuine solutions to patients and providers, and believe the regeneration of full thickness, functional tissue can do just that,” informs Lough. PolarityTE is also developing related technology derivatives as well as other platform technologies to cater to applications in complex fields related to antimicrobial peptide therapies, transplant immune tolerance, oncology, composite tissue neo-generation, and gene therapy.