– Final Data Readout of Pilot Trial Evaluating SkinTE for Treatment of Venous Stasis Leg Ulcers Designated Highest Scoring Poster Abstract in the Conference’s Case Series/Study Category
– Four Poster Abstracts Will Be Presented Demonstrating Positive Clinical Outcomes of SkinTE in Wound and Trauma Patients
SALT LAKE CITY–(BUSINESS WIRE)–PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, today announced that four abstracts regarding the Company’s SkinTE™ product were accepted for poster presentations at the Symposium on Advanced Wound Care (SAWC) Fall Meeting in Las Vegas, which will be held from October 12-14, 2019. Notably, the final data readout from the Company’s pilot trial evaluating SkinTE for the treatment of venous stasis leg ulcers will be presented at the conference and was named the highest scoring poster abstract in the Case Series/Study Category. The pilot trial poster abstract entitled, “Pilot Study Assessing Novel Autologous Homologous Skin Construct Treatment of Venous Stasis Leg Ulcers,” was first authored by David Armstrong, MD, Keck School of Medicine, University of Southern California.
SkinTE is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for the repair, reconstruction, and replacement of a patient’s own skin. The poster presentations will highlight clinical outcomes supporting SkinTE’s impact on skin regeneration across the wound and trauma markets. Today’s announcement further emphasizes the significant momentum in building SkinTE clinical data, with these SAWC poster presentations bringing the total number of presented abstracts in 2019 to 34, 14 of which are podium presentations.
“The data being presented at SAWC underscores the clinical impact providers are experiencing with SkinTE. We are especially honored that the abstract reporting the final results of the venous leg ulcer pilot study received the highest scores in the Case Series/Study category, the largest category at the conference,” said Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE. “The success in treating a variety of wound types reported by these abstracts reinforces our commitment to provide this novel autologous solution to advance the available treatments for wound and trauma patients.”
Authors will be presenting the following during the poster reception on Sunday, October 13, 5:15-6:15pm in the Poster Hall, Caesars Palace Las Vegas. Posters will also be available for general viewing on Sunday, October 13, 8:00am-4:00pm.
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Abstract Title |
First Author, Poster Number |
|
Pilot Study Assessing Novel Autologous Homologous Skin Construct Treatment of Venous Stasis Leg Ulcers*
*The abstract announcing the results of this pilot study was recognized by SAWC with a designation for the highest scores from SAWC reviewers in the Case Series/Study Category, the largest research portion of the conference. |
David Armstrong, MD Keck School of Medicine, University of Southern California CS-001 |
|
Pilot Study Assessing Novel Autologous Homologous Skin Construct Treatment of Non-Healing Diabetic Foot Wounds |
David Armstrong, MD Keck School of Medicine, University of Southern California CS-006 |
|
Durable Closure of a Large Traumatic Wound with a Single Application of an Autologous Homologous Skin Construct |
Kevin Hopkins, MD Craniofacial and Cleft Center, Driscoll Children’s Hospital GR-06 |
|
Use of New Novel Autologous Homologous Skin Construct in Complicated Diabetic Foot Wounds |
Eric Lullove, DPM South Florida Podiatry Specialists PI-012 |
To learn more about SAWC Fall, visit sawcfall.com.
About PolarityTE®
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®.
About SkinTE™
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.
Contacts
Investors:
Rich Haerle
VP, Investor Relations
PolarityTE, Inc.
ir@PolarityTE.com
(385) 831-5284
Hans Vitzthum
LifeSci Advisors, LLC
Hans@LifeSciAdvisors.com
(617) 535-7743
Media:
Jenna Mathis
PolarityTE, Inc.
JennaMathis@polarityTE.com
(610) 751-3985