PTE: Interim Data Diabetic Foot Ulcer PR 7/24, Web 7/27/20

SALT LAKE CITY

PolarityTE, Inc. (Nasdaq: PTE) announced that data from a protocol-specified interim analysis of the first 50 patients enrolled in a multi-center randomized controlled trial (RCT) entitled “SkinTE™ in the Treatment of Diabetic Foot Wounds” will be featured in a poster presentation at the Symposium on Advanced Wound Care (SAWC) Spring Virtual Conference to be held July 24-26, 2020. This study is a prospective, multi-center RCT designed to collect patient outcome data on SkinTE plus standard of care (SOC) versus SOC alone for the treatment of diabetic foot ulcers (DFUs). The primary endpoint is a comparison of the percent of index ulcers closed at 12 weeks. These data will be presented by the Study Chair, David Armstrong, DPM, MD, PhD, Professor of Surgery at the Keck School of Medicine of University of Southern California, and will be available to registrants of the SAWC Spring 2020 Virtual Conference to be held July 24-26, 2020. Details for the SAWC 2020 Virtual Conference can be found at www.sawcspring.com/.

PolarityTE will issue a press release announcing top-line data on Friday, July 24th at 8:00 am ET, and will also host a conference call and webcast to discuss the results with Dr. Armstrong at 4:30 pm ET on Monday, July 27th. The conference call can be accessed by calling 1-888-599-8688 (U.S. and Canada), with confirmation code 552780 and referencing “PolarityTE DFU Interim Data Conference Call.” A webcast of the conference call can be accessed by using the link below.

Link to Webcast

SkinTE is a human cellular and tissue-based product derived from a patient’s own skin (autologous) intended for the repair, reconstruction, replacement, or supplementation of skin tissue. Aseptic surgical procedures and handling during skin harvest, wound preparation, and SkinTE deployment are mandatory.

SkinTE is currently marketed as a human cell, tissue, and cellular and tissue-based product regulated solely under Section 361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271 (i.e., as a 361 HCT/P). PolarityTE plans to file an investigational new drug application (IND) with FDA followed by a biologics license application (BLA) to have SkinTE regulated as a biologic under the federal Food Drug & Cosmetic Act and Section 351 of the PHS Act (i.e., as a 351 HCT/P), and will propose to FDA a plan for transitioning SkinTE from a 361 HCT/P to a 351 HCT/P.

SkinTE is donated human tissue for autologous, single application use only. SkinTE has not been evaluated for infectious substances. SkinTE may contain trace amounts of antibiotics (e.g., gentamicin), which may potentially cause an adverse effect in patients who are hypersensitive or allergic to antibiotics. For patients sensitive to or allergic to gentamicin, alternative processing is available with prior notice. Patients with multiple comorbidities, or who have any condition that could compromise recipient site vascularity and wound healing, should be carefully evaluated prior to using SkinTE. Such conditions may prevent successful outcomes or lead to suboptimal results. Failure to ensure proper aseptic technique may result in contamination of the harvested skin, donor site, tissue product and/or wound bed, and could result in potential adverse events including local, regional, or systemic infection, failure of the graft to take upon deployment, failure of skin to heal and/or regenerate, deleterious effects on potential surrounding or adjacent reconstructions including infection, failure of adjacent grafted material to take and heal, the need for further surgical operations(s), and/or debridement or other serious injuries or death. Failure to follow instructions may lead to suboptimal outcomes, product failure and/or patient harm. Outcomes may vary. Risks also include those associated with skin grafting such as graft failure, infection, and/or effects on adjacent tissue or reconstructions.