"I Would Choose SkinTE Every Time," says Patient Treated with PolarityTE's New Skin Regeneration Product

SALT LAKE CITY, April 18, 2018 (GLOBE NEWSWIRE) -- PolarityTE, Inc. COOL today announced continued success with SkinTE during its limited-market release across a variety of conditions, including burns, wounds, surgical reconstruction and the replacement of skin grafts.

"We at PolarityTE are incredibly excited to see the success of SkinTE throughout such a wide spectrum of patients in such a short period of time. We expect to receive additional clinical results through multiple channels, such as case studies, peer-reviewed publications and a PolarityTE hosted Key Opinion Leader (KOL) Summit to learn more about SkinTE in clinical practice from early adopters. In the end, however, the most important outcome is the impact on the patient's life," said Dr. Denver Lough, CEO of PolarityTE.

Among the outcomes observed are a SkinTE case involving a patient who suffered from a large chronic leg wound for multiple years. Prior failed treatment attempts included not only other wound care products, but also two failed skin grafts. Skin grafts have traditionally been considered the clinical standard of care in covering both small and large wounds.

Devon, who was treated with SkinTE, commented: "After a motorcycle accident a few years ago, I was treated for several injuries; however, wounds on my leg were persistent and after trying a few different options for treatment, nothing was working. We eventually tried two skin grafts, which took many months for any healing, and each time we removed those bandages, about 75 percent of the graft came off with the bandage. These non-healing wounds were limiting my ability to do physical therapy and fully recover because the wounds would bleed through the bandages. Then, a few weeks ago, I was treated with a new product – SkinTE – and it has already provided nearly full coverage of the wounds and healing is a lot better than it was with the other stuff we tried. My leg feels as close to normal skin as I can imagine, and there is even some hair growth. If I had to choose between SkinTE and another skin graft, I would choose SkinTE every time because it is actually working, and you don't have a huge area of healthy skin removed that also then needs to heal, like with traditional skin grafts."

Dr. Mark S. Granick, MD, Professor and Chief of Plastic Surgery at Rutgers New Jersey Medical School and an early adopter of SkinTE commented on his experience with the product: "I recently used SkinTE on a patient with a significantly sized leg wound which was the result of a traumatic skin avulsion. A hyper-granulating wound had persisted for more than two years despite treatments with currently available options, including split thickness skin grafts. The wound was painful, and long-term dressing care was insufficient for returning this otherwise healthy 39-year-old to his pre-injury function level."

Dr. Granick continued, "Ultimately, the best thing for this patient, and generally any patient who is suffering with wounds, is to replace his own skin. SkinTE seems to be providing that. Thus far in the healing process, SkinTE has resulted in what appears to be full-thickness, pigmented skin regeneration. Certainly, in this case, SkinTE provided superior results with a quicker and less invasive procedure. I look forward to continuing to evaluate the potential and capabilities of this exciting and ground-breaking product." 

"Nothing speaks more highly of the product's success than a patient testimonial," said Dr. Ned Swanson, Chief Operating Officer of PolarityTE. Dr. Swanson continued, "The remainder of 2018 will be dedicated to building robust clinical packages across all wound types in concert with this first phase rollout, and we look forward to sharing additional information about these exciting outcomes."

About PolarityTE™
PolarityTE is a commercial-stage biotechnology and regenerative medicine 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. The PolarityTE platform technology begins with a small piece of the patient's own, or autologous, healthy tissue, rather than artificially manipulated individual cells. From this small piece of healthy autologous tissue, the company creates an easily deployable, dynamic and self-propagating product designed to enhance and stimulate the patient's own cells to regenerate the target tissues. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures with the patient's own tissue and uses the patient's own body to support the regenerative process to create the same tissue from which it was derived. PolarityTE's innovative method is intended to promote and accelerate growth of the patient's tissues to undergo a form of effective regenerative healing.

About SkinTE™
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 use is contraindicated in patients who have suffered autoimmune responses to the auto-transplantation of their own tissues.

SkinTE is regulated by the FDA as an HCT/P solely under Section 361 of the Public Health Service Act and 21 CFR 1271. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.

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. Forward looking statements contained in this release relate to, among other things, the Company's ongoing compliance with the requirements of The NASDAQ Stock Market and the Company's ability to maintain the closing bid price requirements of The NASDAQ Stock Market on a post reverse split basis. 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).

CONTACT

Investors:
John Stetson
InvestorRelations@PolarityTE.com 
(385) 237-2365

Hans Vitzthum
LifeSci Advisors, LLC
(617) 535-7743
Hans@LifeSciAdvisors.com

Media:
David Schull
Russo Partners LLC
(858) 717-2310
David.Schull@RussoPartnersLLC.com  

Jenna Mathis
jennamathis@polarityte.com
(610) 751-3985