PolarityTE Announces Conclusion of SEC Investigation

SALT LAKE CITY--(BUSINESS WIRE)-- PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing and commercializing regenerative tissue products and biomaterials, today announced that it has received correspondence from the United States Securities and Exchange Commission (“SEC”) advising PolarityTE that the SEC’s investigation relating to a range of securities, financial, personnel, and other matters has concluded. The correspondence states that, based on the information the SEC has received to date, the SEC Staff does not intend to recommend an enforcement action by the SEC against PolarityTE.

The substance of the investigation was previously disclosed in PolarityTE’s reports filed with the SEC; most recently under the section “Risks Related to Our Common Stock” under Item 1A—Risk Factors of PolarityTE’s annual report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 12, 2020.

David Seaburg, PolarityTE’s Chief Executive Officer, stated, “We have worked hard over the past year and a half to cooperate fully with the SEC and to produce materials responsive to their requests. We have the utmost respect for the SEC and its investigative process, and we are of course pleased with the closure of this investigation. Now we look forward to continuing to focus on the growth of our business, and to address the challenges posed by the COVID-19 pandemic.”

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®.

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 the impact of the COVID-19 pandemic, which cannot be predicted, and the 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.

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