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Clinical Outcomes Data on SkinTE(TM) from Lower Extremity Chronic Wounds to be Presented at Diabetic Limb Salvage (DLS) Conference
SALT LAKE CITY, March 27, 2019 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, announced today that two clinical outcomes abstracts on SkinTE™ for the treatment of diabetic foot ulcers (DFUs) will be presented at the Diabetic Limb Salvage (DLS) Conference in Washington, DC being held on April 4-6, 2019. 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 patient's own skin.
One of the abstracts, which includes data from the pilot study for a randomized controlled trial evaluating SkinTE for DFUs, has been recognized with a Top Abstract Special Designation. The abstracts are being presented by investigators, independent providers and users of the Company's SkinTE product.
Charles M. Zelen, DPM, Foot and Ankle Associates of Southwest Virginia and Director of Professional Education and Research Institute, will present an abstract on the use of SkinTE for treatment of DFUs. This abstract was selected as one of only three abstracts for a Top Abstract Special Designation. The abstract presentation will detail the status of healing of eleven patients treated with SkinTE as part of the pilot study for a randomized controlled trial evaluating SkinTE for treatment of DFUs.
Additionally, Stephen J. Frania, DPM, Foot and Ankle Specialists of Ohio and Director Fellowship, FASO Reconstructive Foot & Ankle Surgery and Deformity Correction, will present an abstract that details the use of SkinTE for treatment of two complex DFU patients that were refractory to conventional therapy efforts.
"The presentation of the data from the pilot study for the chronic wound DFU clinical trial is a significant milestone, and we are honored it will be featured with special recognition at the Diabetic Limb Salvage Conference, a well-attended forum for leaders in the field," commented Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. "We believe this data will help build momentum for SkinTE as a treatment for chronic wounds."
Both abstracts will be presented on April 5, 2019.
The Diabetic Limb Salvage Conference, hosted by Medstar Georgetown University Hospital, is held from April 4-6, 2019. The yearly conference hosts more than 800 healthcare professionals from various fields of medicine who specialize in diabetic foot and limb salvage. PolarityTE will also be exhibiting at the conference. Learn more about the conference at dlsconference.com.
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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