SALT LAKE CITY, April 1, 2019 /PRNewswire/ -- PolarityTE, Inc. (PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, announced today that patient enrollment has begun for two new randomized controlled trials evaluating SkinTE™ for the treatment of chronic wounds, specifically diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). SkinTE is commercially available through a regional market release and is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for skin repair, reconstruction and replacement.
The Company's two randomized controlled trials will be led by the principal investigator David G. Armstrong, DPM, MD, PhD, Professor of Surgery at the University of Southern California, founder of the Southwestern Academic Limb Salvage Alliance, and a world expert in wound healing and limb preservation. The concurrent trials will evaluate patient outcomes following treatment with SkinTE in DFUs and VLUs compared to the standard of care.
"We are pleased to announce enrollment of the first patients in our chronic wound trials. Patients and providers both struggle to find adequate solutions for chronic wounds with DFUs and VLUs being painful, prone to infection and challenging to treat using current standards of care," said Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. "We are encouraged by our chronic wound pilot evaluation studies initiated last year, and we look forward to further evaluating the efficacy of SkinTE in treating chronic wounds through randomized controlled trials."
PolarityTE is a commercial-stage biotechnology company 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®.
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 results have shown the regeneration of full-thickness (epidermis, dermis and hypodermis), functionally-polarized skin with all the appendages including hair and glands.
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.
VP, Investor Relations
LifeSci Advisors, LLC
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