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Regenerative Medicine FDA

 News Release - December 28, 2018

PolarityTE Registers OsteoTE(TM) with U.S. Food and Drug Administration

SALT LAKE CITY, Dec. 28, 2018 -- (Healthcare Sales & Marketing Network) -- 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 and biomaterials for the fields of medicine, biomedical engineering and material sciences, today announced that it registered OsteoTE™ with the U.S. Food and Drug Administration (FDA) pursuant to applicable regulations governing human cells, tissues and cellular and tissue-based products (HCT/Ps).

OsteoTE is a first-of-its-kind autologous (from the patient, for the patient) and homologous (bone for bone) product intended to repair, reconstruct, replace and supplement many types of bones using a small sample from the patient. In pre-clinical studies, OsteoTE demonstrated the capacity to regenerate bone with function and composition similar to natural bone. Pre-clinical animal studies suggest the product is a viable alternative to bone grafts and bone substitutes in treating long bone, craniomaxillofacial, spine, dental, hand and foot/ankle defects.

"With the registration of OsteoTE with the FDA, we remain on track to meet our goal of commercialization through a phased release starting in early 2019," said Denver M. Lough, M.D., Ph.D., Chairman and Chief Executive Officer of PolarityTE. "OsteoTE is the second product from our platform technology which is based on understanding how cells across the body work and how they can be deployed to regrow where needed. Through OsteoTE, we are giving providers an advanced regenerative solution that challenges current standards of care and improves patient outcomes."

About OsteoTE™

OsteoTE is a human cellular and tissue-based product derived from a patient's own bone intended for the repair, reconstruction, and replacement of bone tissue. OsteoTE preclinical results have shown the regeneration of full-thickness corticocancellous, functionally-polarized bone.

OsteoTE is intended to be used by physicians or other appropriate healthcare providers for the homologous use of bone. OsteoTE is for autologous use only. Aseptic technique during harvest and deployment of OsteoTE is mandatory. OsteoTE is a human cells, tissues, and cellular and tissue-based product (HCT/P) registered with the FDA under Section 361 of the Public Health Service Act and 21 CFR 1271.

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®.

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.


Source: PolarityTE

Issuer of this News Release is solely responsible for its content.
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