SALT LAKE CITY, Oct. 19, 2017 (GLOBE NEWSWIRE) -- PolarityTE, Inc. (NASDAQ:COOL) today announced that multiple value analysis committees have approved SkinTE™ for use at their respective medical institutions as the Company continues its commercialization efforts and manufacturing scale-up. Clinical application is expected in the fourth quarter of 2017, and data is planned to be released through multiple channels in the first half of 2018.
“The approval of SkinTE™ by multiple medical institutions’ value analysis committees validates our belief that the medical community is eager to employ our technology and the SkinTE™ product,” said Denver M. Lough, M.D., Ph.D., Chief Executive Officer of PolarityTE™.
Dr. Lough continued, “we have received tremendous interest from surgeons and other medical providers, and we are committed to executing on our manufacturing and commercialization strategy leading into 2018 to meet the significant demand we are seeing and anticipating, and to address the unmet needs of patients suffering from burns, wounds, and other defects of skin tissues.”
About SkinTE™ and FDA Tissue Establishment Registration
SkinTE™ is marketed and regulated by the U.S. Food and Drug Administration (FDA) as a human cell, tissue, and cellular and tissue-based product (HCT/P) solely under Section 361 of the Public Health Service Act and 21 CFR 1271. HCT/Ps that meet the criteria for regulation solely under these legal authorities are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.
SkinTE™ is processed and will be marketed in accordance with the FDA’s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured for PolarityTE by American Association of Tissue Banks (AATB) and Foundation for the Accreditation of Cellular Therapy (FACT)-accredited facilities.
Important Safety Information
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for SkinTE™, as such conditions may compromise successful outcomes or lead to sub-optimal results.
Whenever clinical circumstances require use in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. Unused or expired tissue product should be discarded according to local, state, federal and institutional requirements. Utilization of the SkinTE™ construct, process and/or technology is limited to healthcare professionals and facilities that are capable of handling such tissue products.
Proper aseptic procedural and/or surgical handling is mandatory when using SkinTE™. Failure to ensure proper aseptic technique may result in contamination of the tissue product and wound bed. Contamination of the tissue product and/or wound bed due to failure to ensure aseptic technique could result in local, regional, or systemic infection, partial or complete failure of graft take, healing, and/or regeneration, serious injury, and/or death. Failure to follow instructions may lead to sub-optimal outcomes and/or product failure.
Potential adverse effects may include but are not limited to the following: local tissue, wound bed, regional tissue, or systemic infection, hypersensitive, allergic, or other immune response to the product or trace amounts of antibiotic retained from primary harvest, deleterious effects on potential surrounding or adjacent autologous, allogeneic, or xenogenic grafts, skin substitutes, or other reconstructions including infection and/or failure of adjacent grafted material to take and heal, requirement for further surgical operation(s) and/or debridement, or death.
PolarityTE, Inc. is a regenerative medicine company, and the first to successfully regenerate full-thickness tissue. The Company's novel regenerative medicine platform and proprietary technology employs a patient's own cells for the healing of full-thickness, functionally-polarized tissues. If clinically successful, the PolarityTE™ platform will provide medical professionals with a truly new paradigm in wound healing and reconstructive surgery by utilizing a patient's own tissue substrates for the potential regeneration of skin, bone, muscle, cartilage, fat, blood vessels and nerves. The PolarityTE™ platform leverages natural and biologically-sound principles which are readily adaptable to a wide spectrum of organ and tissue systems. This revolutionary technology, paired with the Company's world-renowned clinical advisory board, position PolarityTE™ to drastically change the field and future of translational regenerative medicine. More information can be found online at www.PolarityTE.com.
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. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. They are generally identified by words such as "believes," "may," "expects," "anticipates," "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.
Russo Partners LLC
Released October 19, 2017