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PolarityTE Announces Positive Pilot Study Data of SkinTE as a Treatment for Venous Stasis Leg Ulcers

SALT LAKE CITY--(BUSINESS WIRE)--

  • Open-label, single-arm pilot study concluded SkinTE demonstrated an 80 percent overall wound closure rate within 12 weeks
  • Median time to closure for cohort was 21 days
  • Prospective multi-center, randomized controlled trial (NCT03881267), designed from this pilot, will further assess the ability of SkinTE to treat Venous Stasis Leg Ulcers

 

PolarityTE, Inc. (PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, today 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.

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“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 healthcare 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 2-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, healthcare 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). A copy of the poster that was presented at SAWC is included with this press release.

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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.

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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