Published Data Includes Pilot Study of SkinTE in Diabetic Foot Ulcers and 15-Patient Case Series
PolarityTE, Inc. (Nasdaq: PTE) reports the recent publication of two peer-reviewed manuscripts involving the application of SkinTE in a pilot study of diabetic foot ulcers and a 15-patient case series evaluating multiple wound types.
A publication reporting results from the Company’s diabetic foot ulcer (DFU) pilot study entitled, "Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers" was published in the International Wound Journal. The primary endpoint of the pilot was the rate of closure at 12 weeks following SkinTE treatment. According to the abstract, "All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time-to-complete closure was 25 days." PolarityTE is currently conducting a multi-center randomized controlled trial to further evaluate the use of SkinTE in DFUs (NCT03881254).
Another publication entitled, "Autologous Homologous Skin Constructs Allow Safe Closure of Wounds" was published in Plastic and Reconstructive Surgery – Global Open. The retrospective, noncontrolled, 15-patient case series evaluated various wound etiologies, including 5 acute and chronic, 4 acute traumatic, and 6 chronic wounds. According to the publication, "All wounds were closed with a single application of AHSC manufactured from a single tissue harvest."
Armstrong DG, Orgill DP, Galiano R, et al. Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Int Wound J. 2020; 1–10. https://doi.org/10.1111/iwj.13404 10 ARMSTRONG ET AL.
Mundinger, Gerhard S. MD*,†; Armstrong, David G. DPM, MD, PhD‡; Smith, David J. MD§; Sailon, Alexander M. MD¶; Chatterjee, Abhishek MD, MBA‖; Tamagnini, Greg DPM**; Partridge, Joanna MD††; Baetz, Nicholas PhD‡‡; Labroo, Pratima PhD‡‡; Swanson, Edward W. MD‡‡; Sopko, Nikolai A. MD, PhD‡‡; Granick, Mark S. MD§§ Autologous Homologous Skin Constructs Allow Safe Closure of Wounds, Plastic and Reconstructive Surgery - Global Open: May 18, 2020 - Volume Latest Articles - Issue - doi: 10.1097/GOX.0000000000002840 https://journals.lww.com/prsgo/Abstract/9000/Autologous_Homologous_Skin_Constructs_Allow_Safe.97393.aspx
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 (i.e., homologous use) of skin tissue and the integumentary system. Aseptic surgical procedures and handling during skin harvest, wound preparation and SkinTE deployment are mandatory.
Important Safety Information
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.
PolarityTE is 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. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures products from the patient's own tissue and uses the patient's own body to support the regenerative process. From a small piece of healthy autologous tissue, the company creates an easily deployable, dynamic and self-propagating product designed to regenerate the target tissues. PolarityTE's innovative methods are intended to promote and accelerate growth of the patient's tissues to undergo a form of effective regenerative healing. Learn more at www.PolarityTE.com – Welcome to the Shift®.
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 the impact of the COVID-19 pandemic and FDA regulatory matters, which cannot be predicted, and the 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, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are trademarks or registered trademarks of PolarityTE, Inc.
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