PolarityTE Announces Findings of Study Using SkinTE on Venous Leg Ulcers

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Salt Lake City, UT– October 31, 2019 – PolarityTE, Inc., a biotechnology company developing and commercializing regenerative tissue products and biomaterials, announced findings from an open-label, single-arm pilot study, which examined the impact of SkinTE™, a novel human cellular and tissue-based product derived from a patient's own skin, in closing venous stasis leg ulcers (VLUs) following failure of conventional treatments. The clinical outcomes were reported in a poster presentation, entitled Pilot Study Assessing Novel Autologous Homologous Skin Construct Treatment of Venous Stasis Leg Ulcers, at the Symposium on Advanced Wound Care (SAWC) Fall Meeting, held in Las Vegas, October 12-14, 2019. In addition, the study poster abstract received the highest scores from reviewers in the Case Series/Study Category, the largest category at the conference.

"The completion of this pilot study is a pivotal step in further establishing SkinTE as a treatment for VLUs," said study first author David Armstrong, DPM, MD, PhD, Keck School of Medicine, University of Southern California, and Study Chair. "As a clinician and researcher, study findings provide valuable learnings into real-world outcomes and offer the opportunity to broaden treatment options for health care providers and patients. We look forward to further data that build upon these initial results."

The pilot study included 10 patients with VLUs that remained open after at least one month of conventional treatments. The patients were treated with SkinTE, 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.

The study found an 80 percent closure rate of the VLUs within 12 weeks after treatment with SkinTE. In addition, all of the patients' wounds demonstrated graft take and initial signs of closure, including granulation and progressive epithelialization, shortly after a single treatment with SkinTE. One treated VLU, which had previously been deemed closed, had reopened prior to the two-week durability visit as a result of external factors unrelated to the SkinTE procedure. Further, another VLU did not close within 12 weeks, which was the largest in the study (12.2cm2) and had remained open for several months prior to treatment with SkinTE after previously failed treatment with a split-thickness skin graft; this VLU closed within 13.5 weeks post application of SkinTE.

"We are pleased with the results of our VLU pilot study and today's announcement further signifies the strides we are making to build a comprehensive clinical body of evidence to validate the utility of SkinTE," said Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. "As we look ahead, we remain committed to investing in clinical initiatives that meet the needs of patients, health care providers, and payors. Importantly, the goal of our VLU pilot study was to gain critical insights to design our multi-center, randomized controlled trial, which is currently enrolling patients and will rigorously evaluate the ability of SkinTE to treat VLUs in a larger subset of patients"

The open-label, single-arm study was designed to be a pilot study for a larger multi-center, randomized controlled clinical trial evaluating SkinTE for treatment of VLUs, which the Company previously announced first patient enrollment in April 2019. For additional information on the trial, visit: clinicaltrials.gov (identifier: NCT03881267).

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®.

The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies.

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