SALT LAKE CITY, Sept. 4, 2018 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: COOL) today announced that it will present an abstract entitled, "Regeneration of Full Thickness Hair-Bearing Skin in Chronic Refractory Wounds with an Autologous Homologous Skin Construct: Preclinical and Clinical Experience," at the 17th Annual National Clinical Conference of the American Professional Wound Care Association Conference (APWCA), which will be held on September 6-8, 2018 in Baltimore, MD. In addition, PolarityTE is pleased to announce that its abstract was selected as one of the four top abstracts submitted and will be presented orally by the Company's Chief Scientific Officer, Nikolai Sopko, MD, PhD.
Dr. Sopko remarked, "We are excited to present these preclinical and clinical data regarding SkinTE to the hundreds of providers expected to attend the prestigious 17th Annual APWCA National Clinical Conference. The APWCA brings together multidisciplinary practitioners across the continuum of health care who manage wound care patients. We are thrilled to be a part of the conference, and we share in APWCA's mission to promote excellence in wound healing for the innumerable patients suffering from non-healing wounds."
"PolarityTE is dedicated to delivering solutions for patients who suffer from non-healing wounds of all types. The APWCA and its membership have been a leading light of advocacy in this area for nearly 20 years, and we are honored by their selection of our abstract highlighting the healing observed in a chronic, non-healing refractory wound with SkinTE," said Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE.
About 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.
About SkinTE™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 StatementsCertain 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.
CONTACTS:Investors:Rich HaerlePolarityTE, Inc. [email protected](385) 831-5284
Hans Vitzthum LifeSci Advisors, [email protected](617) 535-7743
Media:David SchullRusso Partners [email protected] (858) 717-2310
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Dr. Sopko remarked, "We are excited to present these preclinical and clinical data regarding SkinTE to the hundreds of providers expected to attend the prestigious 17th Annual APWCA National Clinical Conference. The APWCA brings together multidisciplinary practitioners across the continuum of health care who manage wound care patients. We are thrilled to be a part of the conference, and we share in APWCA's mission to promote excellence in wound healing for the innumerable patients suffering from non-healing wounds."
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"PolarityTE is dedicated to delivering solutions for patients who suffer from non-healing wounds of all types. The APWCA and its membership have been a leading light of advocacy in this area for nearly 20 years, and we are honored by their selection of our abstract highlighting the healing observed in a chronic, non-healing refractory wound with SkinTE," said Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE.
About 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.
About SkinTE™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 StatementsCertain 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.
CONTACTS:Investors:Rich HaerlePolarityTE, Inc. [email protected](385) 831-5284
Hans Vitzthum LifeSci Advisors, [email protected](617) 535-7743
Media:David SchullRusso Partners [email protected] (858) 717-2310
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