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SkinTE Data to be Presented at the 19th Annual Diabetic Foot Global Conference

October 3, 2019 Off By BusinessWire

SALT LAKE CITY–(BUSINESS WIRE)–PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, today announced that two abstracts demonstrating the impact of the Company’s SkinTE™ product in treating diabetes-related wounds were accepted for poster presentations at the 2019 Diabetic Foot Global Conference (DFCon), an international, interdisciplinary diabetic foot conference hosted by the Keck School of Medicine of University of Southern California in collaboration with Baylor College of Medicine and University of California San Francisco from October 17-19, 2019 in Los Angeles. Today’s announcement further signifies the Company’s momentum with its clinical research program, bringing the total SkinTE data presentations at medical conference in 2019 to 36, of which 14 were podium presentations.

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. SkinTE has regrown skin over exposed bone, muscle, joint, and tendon and has been used to treat a variety of skin defects, including wounds, traumatic injuries, burns, surgical reconstruction, scars, and failed skin grafts or conventional treatments for wounds and burns.

The abstract titled Veterans Affairs Hospitals Case Series: Chronic Diabetes-related Wounds Treated with Autologous Homologous Skin Construct details a retrospective cohort analysis of five patients with diabetes who were treated with SkinTE for chronic lower extremity wounds that had failed other available treatments in the Veterans Affairs hospital setting. This case series is particularly relevant for the veteran community as nearly 25% of Veterans Affairs patients have diabetes and over two thirds of amputations in VA patients are due to complications from diabetic foot ulcers.

The abstract titled Autologous Homologous Skin Construct for the Healing of a Chronic Stump Wound and Repair of Sinus Tract in Diabetic Patient is a single case study involving a patient with a below-the-knee amputation who developed a chronic stump wound due to prosthetic use that was treated with SkinTE. The chronic wound was treated with multiple conventional therapies including a split-thickness skin graft, all of which were unsuccessful, prior to treatment with SkinTE.

The poster presentations will occur during the poster reception on Thursday, October 17 at 6:00pm in the Poster Hall, Hilton Los Angeles/Universal City.

Abstract Title	First Author, Poster Number
Veterans Affairs Hospitals Case Series: Chronic Diabetes-related Wounds Treated with Autologous Homologous Skin Construct	Frank Padberg, MD Veterans Affairs New Jersey Health Care System #41
Autologous Homologous Skin Construct for the Healing of a Chronic Stump Wound and Repair of Sinus Tract in Diabetic Patient	Diane Duncan, MD Plastic Surgical Associates of Fort Collins #54

To learn more about DFCon, please visit: dfcon.com.

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.