SALT LAKE CITY, May 21, 2019 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, announced today that final data from a pilot study on the use of its SkinTE™ product for hard-to-treat diabetic foot ulcers (DFUs), will be presented at the American Diabetes Association's 79th Scientific Sessions conference at the Moscone Center in San Francisco, California. 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.
The poster, Results of a Pilot Evaluation of a Novel Autologous Homologous Skin Construct Treatment of Diabetic Foot Wounds Refractory to Conventional Treatments (#45-LB), will be presented on Sunday, June 9, 2019 from 12:00 PM – 1:00 PM 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. The clinical outcomes data, which was accepted as a late-breaking abstract, will be available for general viewing in Hall F (North, Exhibition Level) from June 8 – 9.
The study evaluated the efficacy, safety and durability of a single application of SkinTE to close DFUs that had not healed with conventional treatment strategies, and it served as a feasibility study for a randomized controlled trial comparing treatment of DFUs with SkinTE to the standard of care that began enrolling earlier this year (NCT03881254).
"We are pleased that this abstract was one of only a few accepted as a late breaking abstract to this important conference. Chronic wounds like DFUs impact a critical number of diabetes patients every year, and the struggle to heal from them can be extremely taxing and life-limiting," said Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. He continued, "We hope that this data, along with the data that will come from our randomized controlled clinical trials, encourages more providers to seek better outcomes for their patients suffering from chronic wounds like DFUs over the current standards of care, which can lead to lower extremity amputation. Through this pilot study, SkinTE has shown it is a viable solution for some of the most difficult and challenging chronic wounds, including DFUs."
For more information on the American Diabetes Association's 79th Scientific Sessions, please visit: professional.diabetes.org/scientific-sessions.
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®.
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.
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