PolarityTE® Announces Presentation of SkinTE™ Clinical Outcomes at Symposium on Advanced Wound Care
SALT LAKE CITY, Nov. 1, 2018
SALT LAKE CITY, Nov. 1, 2018 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE), 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, announced today that SkinTE clinical outcomes will be presented at the Symposium on Advanced Wound Care fall meeting held November 2-4, 2018 in Las Vegas.
The Symposium on Advanced Wound Care, which occurs each fall and spring, is a forum to connect the entire wound care team – physicians, nurses, physical therapists, researchers, scientists, podiatrists and dietitians – with the foremost experts in wound care to improve patient outcomes through education. There are expected to be more than 1,300 participants in attendance at the conference.
During the session entitled, What's New in Wound Care Technology, Mark Granick, MD, Professor of Surgery, Chief of Plastic Surgery, Rutgers New Jersey Medical School, an early adopter of SkinTE and Clinical Advisor for PolarityTE, will discuss clinical outcomes from his use of SkinTE.
PolarityTE will also be hosting an exhibit during the three-day conference.
"We appreciate each time that SkinTE clinical results are able to be shared with the medical community. Case studies help demonstrate the capabilities of the technology and how the product can be used successfully to regenerate full-thickness, functional skin for patients. The Symposium on Advanced Wound Care was a productive experience for us when we attended in the spring, and we look forward to again connecting with the wound care community," said Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE.
PolarityTE is a commercial-stage biotechnology and regenerative biomaterials 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. The PolarityTE platform technology begins with a small piece of the patient's own, or autologous, healthy tissue, rather than artificially manipulated individual cells. From this small piece of healthy autologous tissue, the company creates an easily deployable, dynamic and self-propagating product designed to enhance and stimulate the patient's own cells to regenerate the target tissues. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures with the patient's own tissue and uses the patient's own body to support the regenerative process to create the same tissue from which it was derived. PolarityTE's innovative method is intended to promote and accelerate growth of the patient's tissues to undergo a form of effective regenerative healing.
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. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.
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, and SKINTE are trademarks or registered trademarks of PolarityTE, Inc.
VP, Investor Relations
LifeSci Advisors, LLC
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SOURCE PolarityTE, Inc.