SkinTE Clinical Data to be Presented by PolarityTE
Salt Lake City—PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, announced that new clinical data on the use of its SkinTE™ product will be presented at the Symposium on Advanced Wound Care (SAWC) Spring, Wound Healing Society meeting in San Antonio, TX from May 7 – 11, 2019. In addition, PolarityTE will host a booth and an interactive event featuring patients treated with SkinTE and a presentation from Dr. Gerhard S. Mundinger, MD, Division of Plastic Surgery, Louisiana State University Health Sciences Center, an early adopter of SkinTE, on his clinical experience with the product.
The data presented at the SAWC Spring, Wound Healing Society meeting will include:
- results from four patients who had contracted split-thickness skin grafts removed and replaced with SkinTE
- results from a series of patients with diabetic foot ulcers and venous stasis ulcers treated with SkinTE
- bench-to-bedside overview of the use of SkinTE in pre-clinical and clinical applications, highlighting the SkinTE technology
The three accepted abstracts will be available to view in the Poster Hall on Thursday, May 9 and Friday, May 10 from 7:30 a.m. to 6 p.m. Posters will be presented on Thursday, May 9, from 6-7 p.m.
A complete listing of the abstracts to be presented includes:
|Poster Title||Author, Poster Number|
|Closure of Refractory Complex Lower Extremity Wounds Using a Single Application of a Novel Autologous Homologous Skin Construct in the Clinical Setting; A Clinical Case Series||David Armstrong, DPM, MD, PhD, Southwestern Academic Limb Salvage Alliance (SALSA) and Keck School of Medicine, University of Southern CaliforniaCS-003|
|Novel Therapy for Complete Regeneration of Functional Skin in Burn Reconstruction: Observations of the Efficacy and Clinical Utility of Autologous Homologous Skin Construct||Michael A. Marano, MD, Saint Barnabas Medical Center Burn Center, Department of SurgeryCS-050|
|Neogenesis of Full-thickness Skin and Concomitant Dermal Appendages in Acute Wounds Using Novel Autologous Homologous Skin Construct Therapy in Preclinical and Clinical Settings||Nikolai Sopko, MD, PhD, PolarityTE, Inc.CR-052|
Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE, said “We are honored to present additional pre-clinical and clinical data on the use of SkinTE at this important conference. The clinical data presented from the early adopters of SkinTE is vital to expand available information about SkinTE and to allow providers to understand its efficacy for patients in need of a full-thickness, functional skin replacement. With patients at the heart of everything we do, we are eager for patients to speak directly to clinicians during the SkinTE symposium on May 8.”
On May 8, PolarityTE will host an evening symposium on SkinTE, featuring a burn survivor treated with SkinTE who will present her experiences, as well as presentations from Dr. Gerhard S. Mundinger, MD, Division of Plastic Surgery, Louisiana State University Health Sciences Center, an early adopter of SkinTE and a PolarityTE clinical advisor, and Dr. Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. Additional patients treated with SkinTE will be in attendance as well.
The SkinTE Symposium is Wednesday, May 8 at 7 p.m. at Biga on the Banks, 203 South St. Mary’s Street, San Antonio, TX. Please visit https://rsvp.polarityte.com to RSVP.
PolarityTE will be exhibiting during the conference at booth #643. For more information on the SAWC Spring, Wound Healing Society conference please visit www.sawcspring.com.
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 method is 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®.
SkinTE is a human cellular and tissue-based product derived from a patient’s own skin intended for the repair, reconstruction, and replacement of skin tissue.
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 marketed as an HCT/P regulated by the FDA solely under Section 361 of the Public Health Service Act and 21 CFR 1271.
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 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, WHERE SELF REGENERATES SELF, WELCOME TO THE SHIFT, and SKINTE are trademarks or registered trademarks of PolarityTE, Inc.