News Releases

PolarityTE Hosts Symposium Featuring SkinTE-Treated Burn Survivor, New Clinical Data at American Burn Association Annual Meeting

SALT LAKE CITY, March 21, 2019 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, announced today it will host a symposium at the American Burn Association (ABA) 51st Annual Meeting featuring a burn survivor who will share her story after being treated with the Company's SkinTE™ product. Additionally, two abstracts on the clinical use of SkinTE will be presented during the conference.

PolarityTE (PRNewsfoto/PolarityTE, Inc.)

The ABA Annual Meeting will be held at the Rio All-Suites Hotel and Casino in Las Vegas from April 2-5, 2019. The Company's symposium is Wednesday, April 3, from 7-8:30 p.m.

SkinTE is a first-of-its-kind autologous, homologous human cellular and tissue-based product designed to regenerate full-thickness, functional skin for skin repair, reconstruction and replacement.

The Company's symposium will highlight the use of SkinTE and its potential to help advance treatments for burn patients. During the symposium, a burn survivor and SkinTE patient will share her journey to recovery and perspective on the many challenges that she faced as a burn patient. Following a house fire in January 2018 that resulted in burns covering approximately 85 percent of her body, she was initially treated with conventional split-thickness skin grafts. After many surgeries and with no more healthy skin to harvest for skin grafts, her doctor applied SkinTE to her lower limbs, which significantly aided in her recovery. The patient will discuss her experiences with conventional treatment options and SkinTE during the Wednesday evening symposium.

"Patients motivate the PolarityTE team to work harder each day, and we are honored to give this patient a forum to share her experiences with others in the field," said Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE. "We have learned a great deal from listening to our patients' stories, including gaining a greater understanding of vital importance that our platform technology has on their lives after treatment. This patient's story is validation of the transformative results of SkinTE compared to the current standard of care – split-thickness skin grafts. We hope her inspiring story will be as impactful to the American Burn Association as it is to all of us here at PolarityTE. We look forward to continuing to tell our patients' stories in the hopes of forcing a positive change in how providers care for patients and in understanding how different treatments impact patients long after they leave their provider's care."

Other presenters during the symposium include Dr. Stephen Milner, Chief Clinical Officer at PolarityTE, who will discuss his experiences as one of the nation's leading burn surgeons and how the industry treats burn cases. Dr. Milner served for more than 20 years as Professor of Plastic and Reconstructive Surgery at the Johns Hopkins University School of Medicine and was the former Director of Johns Hopkins Burn Center. Dr. Nikolai Sopko, MD, PhD, Chief Scientific Officer of PolarityTE, will detail the clinical history of SkinTE for use in burns over the last year. Retired United States Army Major General Jay W. Hood will discuss the impact that advanced technologies, such as SkinTE, could have beyond treating civilian burn patients. General Hood is a consultant for PolarityTE.

Two Poster Presentation Demonstrate SkinTE Effectiveness

Providers who have used SkinTE will present two abstracts during the ABA Annual Meeting highlighting further clinical data on the effectiveness of the product.

The first poster presentation, "Coverage of Bilateral Lower Extremity Burns with Autologous Homologous Skin Construct," will be presented by Dr. David Smith from Tampa General Hospital, USF Plastic Surgery Division, on Wednesday, April 3 from 12:30-1:45 p.m. in the Exhibit Hall – Rio Pavilion. This case study details the use of SkinTE in acute lower extremity burn wounds. SkinTE resulted in full-thickness skin with re-pigmentation and function, facilitating patient discharge from the hospital within two-months post application.

The second poster presentation, "Regeneration of Full-Thickness Skin Using a Novel Autologous Homologous Skin Construct (AHSC) for Acute Burn Injury," will be presented by Dr. Michael Marano from Saint Barnabas Medical Center Burn Center, on Thursday, April 4 from 12:30-1:45 p.m. in the Exhibit Hall – Rio Pavilion. This case study details the use of SkinTE in a lower extremity burn wound that resulted in the regeneration of full-thickness skin.

PolarityTE will also be exhibiting during the conference at booth #506.

About PolarityTE®
PolarityTE is a commercial-stage biotechnology company 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 results have shown the regeneration of full-thickness (epidermis, dermis and hypodermis), functionally-polarized skin with all the appendages including hair and glands.

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 
(800) 656-6194

 

SOURCE PolarityTE, Inc.