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PolarityTE Announces Final Clinical Data from Pilot Study Showing Closure of Diabetic Foot Ulcers Using SkinTE

SALT LAKE CITY, June 10, 2019 /PRNewswire/ -- PolarityTE, Inc. (PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, announced today the final results from a pilot study on the use of its SkinTE™ product for hard-to-treat diabetic foot ulcers (DFUs). The data was presented at the American Diabetes Association's 79th Scientific Sessions conference. 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.

PolarityTE (PRNewsfoto/PolarityTE, Inc.)

The poster, Results of a Pilot Evaluation of a Novel Autologous Homologous Skin Construct Treatment of Diabetic Foot Wounds Refractory to Conventional Treatments, which was authored and presented by David G. Armstrong, MD, PhD, DPM, Professor of Clinical Surgery at the Keck School of Medicine at the University of Southern California and co-Director of the Southwestern Academic Limb Salvage Alliance on June 9, highlighted data from a study evaluating the efficacy, safety and durability of a single application of SkinTE to close DFUs that had not healed with conventional treatment strategies. The pilot study, which included 11 patients with type 2 diabetes and Wagner 1 and 2 DFUs, also served as a feasibility study for a larger randomized controlled trial comparing treatment of DFUs with SkinTE to the standard of care that began enrolling earlier this year (clinicaltrials.gov:NCT03881254).

The results of the study included the healing of all harvest sites and complete SkinTE graft take one week after SkinTE application. Ten of the 11 patients (90.9%) had healed DFUs within eight weeks of SkinTE application and the mean time to heal was 29.7 days. One patient was removed from the study at week three due to adverse events not related to the study or SkinTE procedure. The pilot study results suggest that a single application of SkinTE is capable of closing difficult to treat Wagner 1 and 2 DFUs and that the product can be successfully employed in the clinic setting using normal work flows.

"Diabetic foot ulcers are challenging for patients and the overall health care system, and despite the countless products on the market, many patients struggle to achieve good outcomes. In this study, some of the most challenging wounds in the chronic wound-care market healed after a single application of SkinTE, where other standard treatments had failed," said Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. "We hope this clinical data continues to help build provider confidence in SkinTE as a viable alternative to treating patients with DFUs by demonstrating its ability to achieve better outcomes over current standards."

The abstract will be published in the online supplement to the journal Diabetes later this year. The presented poster is available on the PolarityTE Scientific Communications page at: www.polarityte.com/news-media/scientific-communications.

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 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. Our 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).

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


Rich Haerle
VP, Investor Relations
PolarityTE, Inc.
(385) 831-5284

Hans Vitzthum
LifeSci Advisors, LLC
(617) 535-7743

Jenna Mathis
PolarityTE, Inc.



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