San Diego, CA -- (SBWIRE) -- 10/11/2021 -- An investor, who purchased shares of PolarityTE, Inc. (NASDAQ: PTE), filed a lawsuit over alleged violations of Federal Securities Laws by PolarityTE, Inc.

Investors who purchased shares of PolarityTE, Inc. (NASDAQ: PTE) have certain options and for certain investors are short and strict deadlines running. Deadline: November 23, 2021. NASDAQ: PTE investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Salt Lake City, UT based PolarityTE, Inc., a biotechnology company, develops and commercializes a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering, and material sciences in the United States.

On August 24, 2021, PolarityTE, Inc. issued a press release "provid[ing] an update regarding correspondence from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) for SkinTE® with a proposed indication for chronic cutaneous ulcers, which was filed on July 23, 2021. The FDA provided feedback that certain Chemistry, Manufacturing, and Control (CMC) items need to be addressed prior to proceeding with a pivotal study. As a result, the study proposed in the IND has been placed on clinical hold. In accordance with standard practice and regulations, the FDA has advised that it will issue a clinical hold letter providing details on the basis for the hold to the Company by September 21, 2021."

Shares of PolarityTE, Inc. (NASDAQ: PTE) declined to $0.64 per share on August 24, 2021.

The plaintiff claims that between April 30, 2020 and August 23, 2021, the Defendants made false and/or misleading statements and/or failed to disclose that the SkinTE IND was deficient with respect to certain Chemistry, Manufacturing, and Control items, that as a result, it was unlikely that the FDA would approve the SkinTE IND in its current form, that accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval, and that as a result, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of PolarityTE, Inc. (NASDAQ: PTE) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.