SALT LAKE CITY, Sept. 24, 2018 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE) today announced that SkinTE™ clinical results will be presented at the American Society of Plastic Surgeons (ASPS) Plastic Surgery The Meeting and the International Society of Plastic Regenerative Surgeons (ISPRES) Congress, both held in Chicago the weekend of September 28, 2018. Presenters will be discussing patient outcomes with SkinTE, as well as data points about the regenerated skin.
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.
Dr. Gerhard S. Mundinger, MD, FAAP, Director of Plastic Surgery at Children's Hospital in New Orleans, Assistant Clinical Professor of Plastic Surgery and Assistant Professor of Cell Biology and Anatomy at LSU Health New Orleans, and PolarityTE Clinical Advisor, will present at the ASPS conference a patient case involving the replacement of a contracted split-thickness skin graft and keloid scar with SkinTE. The discussion will include data from a biopsy taken of SkinTE, which shows regeneration of full-thickness skin.
Dr. Stephen Milner, MD, DDS, DSc, FRCSE, FACS, PolarityTE Chief Clinical Officer, will present at the ISPRES conference a patient case involving a chronic non-healing wound resulting from a traumatic injury that healed with SkinTE. The presentation will include tissue, sensory, and bioimpedance analysis of SkinTE.
"It is important for early adopters to share their experiences with SkinTE at conferences like ASPS and ISPRES, especially because the field of plastic surgery has a history of pioneering new technologies and medical innovations. We look forward to these presentations, as well as our presence on the exhibit floor at ASPS where we will have the opportunity to connect with others in the field about our work," said Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE.
Plastic Surgery The Meeting is the premier scientific conference for plastic surgeons. Held annually by ASPS, the conference brings together surgeons in the specialty to share experiences and learn about the latest research, technology, and educational offerings in plastic and reconstructive surgery.
The ISPRES Congress is held in conjunction with Plastic Surgery The Meeting to highlight the latest research and innovations in plastic and regenerative surgery. ISPRES is dedicated to promoting the art and science of regenerative plastic surgery, to evaluate medical techniques related to regenerative plastic surgery, and to promote and encourage the highest ethical standards of personal and professional conduct among plastic surgeons and other scientists with an interest in this field.
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 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.