-- PolarityTE today announced that the Company’s lead product, SkinTE™, has been registered with the U.S. Food and Drug Administration (FDA) pursuant to applicable regulations governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). SkinTE™ is an autologous, minimally manipulated construct intended for homologous uses of skin tissues. As an FDA-registered HCT/P, SkinTE™ may now be made available for appropriate human use in the United States. PolarityTE™ has initiated a controlled, limited-market release of the product to select medical institutions, and expects to accelerate commercialization in 2018 as the company scales up manufacturing efforts.
“The FDA registration of SkinTE™ is an important regulatory step that sets the stage for commercialization and a staged market entry of this revolutionary technology into clinical application,” said Denver M. Lough, M.D., Ph.D., Chief Executive Officer of PolarityTE™. “This achievement enables us to deliver an entirely new and pragmatic solution for skin regeneration as well as the ability to change the face and practice of regenerative medicine toward patient-tailored tissue constructs.”
In pre-clinical studies, SkinTE™ demonstrated full-thickness regenerative healing, nascent hair follicle formation, cutaneous appendage development, immediate and complete wound coverage, and the progressive regeneration of all skin layers including epidermis, dermis and hypodermal layers. (www.PolarityTE.com/products/SkinTE).
“This progressively-staged market release of SkinTE™ to select institutions will give the Polarity team time to scale manufacturing processes and facilities to meet future demands of SkinTE™ as well as other tissue substrate technologies we have in our translational development pipeline,” said Edward W. Swanson, M.D., Chief Operating Officer of PolarityTE™.
About SkinTE™ and FDA Tissue Establishment Registration
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.
SkinTE™ is processed and marketed in accordance with the FDA’s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured 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 implantation 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
“The FDA registration of SkinTE™ is an important regulatory step that sets the stage for commercialization and a staged market entry of this revolutionary technology into clinical application,” said Denver M. Lough, M.D., Ph.D., Chief Executive Officer of PolarityTE™. “This achievement enables us to deliver an entirely new and pragmatic solution for skin regeneration as well as the ability to change the face and practice of regenerative medicine toward patient-tailored tissue constructs.”
In pre-clinical studies, SkinTE™ demonstrated full-thickness regenerative healing, nascent hair follicle formation, cutaneous appendage development, immediate and complete wound coverage, and the progressive regeneration of all skin layers including epidermis, dermis and hypodermal layers. (www.PolarityTE.com/products/SkinTE).
“This progressively-staged market release of SkinTE™ to select institutions will give the Polarity team time to scale manufacturing processes and facilities to meet future demands of SkinTE™ as well as other tissue substrate technologies we have in our translational development pipeline,” said Edward W. Swanson, M.D., Chief Operating Officer of PolarityTE™.
About SkinTE™ and FDA Tissue Establishment Registration
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.
SkinTE™ is processed and marketed in accordance with the FDA’s requirements for human tissue and current good tissue practices (21 CFR 1271) and is manufactured 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 implantation 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
