PolarityTE and University Hospitals Cleveland Medical Center Announce System-Wide Approval of SkinTEtm

SALT LAKE CITY and CLEVELAND, Dec. 19, 2018 /PRNewswire/ -- PolarityTE, Inc. (Nasdaq: PTE), a commercial-stage biotechnology company focused on transforming the lives of patients by discovering, designing and developing a range of regenerative tissue products using a patient's own tissue, and the University Hospitals Cleveland Medical Center jointly announced today that SkinTEtm is now available for use throughout the UH network of healthcare facilities. SkinTE is the first commercially-available autologous, homologous product that regenerates full-thickness skin that is fully-functional, and is an alternative to skin grafts and skin substitutes. UH is the first healthcare provider in the state of Ohio to offer SkinTE to its patients.

Denver M. Lough, MD, PhD, Chairman and Chief Executive Officer of PolarityTE said, "Our goal is to bring to market innovative, regenerative therapies that provide significant benefits to both patients and providers, and set new standards of care in wound and burn treatment. The agreement with University Hospitals is another example of our continued success in building strong relationships with national healthcare providers. We are thrilled to partner with UH in delivering a solution that is both clinically-beneficial and cost-effective and one that can improve the lives of their patients."

"SkinTE has made an immense impact on our pediatric patients at UH by minimizing donor skin site pain, discomfort and unsightly scarring. Patients and their parents have noticed that the regenerated skin is soft, pliable and non-adherent to the underlying wound. SkinTE is a complete paradigm shift from adherent split graft treatment of the last century," said Anand Kumar, MD, FACS, FAAP, Division Chief of Pediatric Plastic Surgery, Rainbow Babies Children's Hospital of Case Western Reserve University.

SkinTE is intended for the repair, reconstruction and replacement of lost or damaged skin due to burns, wounds, injuries, surgical reconstruction, scars and failed skin grafts. The UH network joins the growing list of healthcare facilities where SkinTE is approved for commercial use.

About University Hospitals / Cleveland, Ohio
Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 40 outpatient health centers and 200 physician offices in 15 counties throughout northern Ohio. The system's flagship academic medical center, University Hospitals Cleveland Medical Center, located on a 35-acre campus in Cleveland's University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including "America's Best Hospitals" from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals ? part of The Harrington Project for Discovery & Development. UH is one of the largest employers in Northeast Ohio with 27,000 employees. For more information, go to www.UUhospitals.org. Follow UH on Facebook @UniversityHospitals and Twitter @UHhospitals.

About PolarityTE®
PolarityTE is a commercial-stage biotechnology and regenerative biomaterials 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. Learn more at www.PolarityTE.com ? Welcome to the Shift®.

About SkinTEtm 
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 and WELCOME TO THE SHIFT are trademarks or registered trademarks of PolarityTE, Inc.

CONTACTS

Investors:
Rich Haerle
VP, Investor Relations
PolarityTE, Inc.
[email protected] 
(385) 831-5284

Hans Vitzthum
LifeSci Advisors, LLC
[email protected] 
(617) 535-7743

Media:
Jenna Mathis
PolarityTE, Inc.
[email protected] 
(610) 751-3985

SOURCE PolarityTE, Inc.