SALT LAKE CITY, Sept. 11, 2018 /PRNewswire/ -- PolarityTE, Inc. (COOL), 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 for the fields of medicine, biomedical engineering and material sciences, today announced that it was awarded best podium presentation at the 2018 American Professional Wound Care Association (APWCA) 17th Annual National Clinical Conference for the Company's work entitled, "Regeneration of Full Thickness Hair-Bearing Skin in Chronic Refractory Wounds with an Autologous Homologous Skin Construct: Preclinical and Clinical Experience."
Following the talk, President of the APWCA, Dr. Steven Kavros, stated, "Great presentation of very interesting research and promising clinical results."
The presentation detailed preclinical data, as well as clinical data from the use of SkinTE in the treatment of a large, non-healing lower extremity wound that failed two prior split thickness skin grafts, the current standard of care. The clinical data demonstrated regeneration of full-thickness hair-bearing skin with pigment regeneration, decreased pain, increased sensation, and improved functional outcomes.
Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE, said, "The APWCA conference was a great forum and opportunity to connect with the wound care community, and we are encouraged by the interest from clinicians to use SkinTE after learning more about its potential, and the new relationships developed at the meeting."
Denver Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE commented, "The insights learned at the APWCA conference will help us better meet the needs of both wound care patients and providers. We sincerely look forward to returning next year to share more of our clinical outcomes and work toward a common goal of improving patient care worldwide."
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 regulated by the FDA as an HCT/P 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.
LifeSci Advisors, LLC
Russo Partners LLC
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