PolarityTE Announces Positive Data Showing SkinTE Regenerated Full-Thickness Skin in Difficult-to-Treat Wounds

• SkinTE, a novel human cellular and tissue-based product derived from a patient's own skin, was used to treat a variety of skin defects that failed conventional treatments
• Limitations of current treatment options create need for new therapies to treat increasing incidence of full-thickness chronic and acute wounds

PolarityTE, Inc. PTE, a biotechnology company developing and commercializing regenerative tissue products and biomaterials, today announced findings from a study showing positive impact of the Company's SkinTE™ skin regeneration product on a broad range of cases, demonstrating progressive wound closure including coverage of exposed underlying structures such as bone and tendon. Highlights of these findings were reported in a podium presentation at the American Society of Plastic Surgeons' (ASPS) 2019 scientific meeting, Plastic Surgery The Meeting, held in San Diego, September 20-23, 2019. In addition, the study received the Top 200 designation at the conference and will be published in PRS Global Open.

In this retrospective multicenter cohort study, all patients treated with a single application of SkinTE regenerated full-thickness skin in wounds and achieved complete wound closure. All of the study patients had failed previous clinical standard of care or presented with complex wounds where treatments beyond skin grafting, such as a lengthy surgical procedure, would have been required. The study highlighted early clinical examples of successful treatment with SkinTE of difficult-to-treat wounds that had exposed underlying structures like tendons and bones. It also showed minimal donor site morbidity for the skin sample needed to create SkinTE and safety in a broad range of cases.

In the study, 15 patients ranging from seven to 72 years of age were treated with SkinTE after a small full-thickness skin sample was taken to create the patient-specific SkinTE product. The patients were followed for an average of four months (±2.9 months). The range of cases was broad and included four late burn reconstructions, one acute flame burn, three acute traumas, one anterolateral thigh donor site, and six chronic wounds stemming from diabetic foot and venous leg ulcers, a trauma, and a spider bite that resulted in a chronic wound. All patients had complete wound coverage, the standard requirement for evaluating treatments in these cases, at the time of follow-up. No complications were observed at the sites from which the skin samples were taken. No repeat treatment with SkinTE or split-thickness skin grafts (STSG) were required in the wounds.

SkinTE is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for the repair, reconstruction, and replacement of a patient's own skin to treat various wound types, like those featured in this case series.

"Our study suggests SkinTE is an efficacious therapeutic option for patients presenting with chronic wounds, traumatic defects, complex wound reconstruction, and burns," said Mark S. Granick, MD, medical director, UH Wound Center, and professor of plastic surgery, Rutgers New Jersey Medical School, Newark, N.J., who presented the findings at ASPS 2019. "These are promising results, given the high prevalence of acute and chronic wounds that cannot be treated with or fail treatment with split-thickness skin grafts or with standard therapy alone."

The study also found at the end of the observation period that there was no difference in skin sensation between SkinTE-regenerated skin and native skin, while skin sensation was significantly lower in STSG-regenerated skin, as measured by the Two-Point Discrimination Test. The Two-Point Discrimination Test assesses if a patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate between the two spots is. Various other analyses also showed skin regenerated with SkinTE was analogous to native skin, and that hair follicles were present in healed SkinTE-treated wounds, which were similar to native skin hair follicles.

"Current approaches to treating complex wounds often lead to sub-optimal outcomes for patients," said Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. "We are excited to continue growing our body of evidence showing how real-world use of SkinTE in clinical practice can be an effective alternative option for patients with wounds, traumatic injuries, and burns."

About PolarityTE®

PolarityTE is focused on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures products from the patient's own tissue and uses the patient's own body to support the regenerative process. From a small piece of healthy autologous tissue, the company creates an easily deployable, dynamic and self-propagating product designed to regenerate the target tissues. PolarityTE's innovative method is intended to promote and accelerate growth of the patient's tissues to undergo a form of effective regenerative healing. Learn more at www.PolarityTE.com – Welcome to the Shift®.

About SkinTE™

SkinTE is a human cellular and tissue-based product derived from a patient's own skin intended for the repair, reconstruction, and replacement of skin tissue. SkinTE has been proven to regrow skin over exposed bone, muscle, joint and tendon and has been used to treat a variety of skin defects, including burns, wounds, traumatic injuries, surgical reconstruction, scars, and failed skin grafts or conventional treatments for wounds and burns.

SkinTE is intended to be used by physicians or other appropriate healthcare providers for homologous uses of skin tissues/integument. Patients who have suffered from an event, disease, process or acquired deficit that results in the functional loss or void of skin/integument systems can receive SkinTE as an adjunct and/or in place of split-thickness skin grafting, full-thickness grafting, temporizing skin coverage and/or skin substitute products. SkinTE is for autologous use only. Aseptic technique during harvest and deployment of SkinTE is mandatory. SkinTE is marketed as an HCT/P regulated by the FDA solely under Section 361 of the Public Health Service Act and 21 CFR 1271.

Forward Looking Statements

Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. They are generally identified by words such as "believes," "may," "expects," "anticipates," "intend," "plan," "will," "would," "should" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

POLARITYTE, the POLARITYTE logo, WHERE SELF REGENERATES SELF, WELCOME TO THE SHIFT, and SKINTE are trademarks or registered trademarks of PolarityTE, Inc.

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