According to the Complaint, 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. The Company operates through two segments, Regenerative Medicine Products and Contract Services. It offers SkinTE, a tissue product used for the repair, reconstruction, replacement, and supplementation of skin in patients for the treatment of acute or chronic wounds, burns, surgical reconstruction events, scar revision, or removal of dysfunctional skin grafts, as well as contract research services.

On April 30, 2020, PolarityTE issued a press release announcing that the Company had decided to pursue a plan to submit an IND and thereafter a BLA to the FDA for SkinTE. On July 23, 2021, PolarityTE submitted the SkinTE IND to the FDA seeking authorization to commence a clinical trial to evaluate SkinTE for the proposed indication of treatment of chronic cutaneous ulcers.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) the SkinTE IND was deficient with respect to certain Chemistry, Manufacturing, and Control items; (ii) as a result, it was unlikely that the FDA would approve the SkinTE IND in its current form; (iii) accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.

On December 20, 2021. the Court issued an Order appointing Lead Plaintiff and Counsel. Lead Plaintiff filed an amended Complaint on February 21, 2022. Defendants filed a Motion to Dismiss the amended Complaint on April 22. On September 13, the Court issued an Order granting Defendants' Motion to Dismiss. Plaintiffs were given leave to amend the Complaint.

On October 3, 2022, Lead Plaintiff filed a second amended Complaint. Defendants filed a Motion to Dismiss the second amended Complaint on November 2. On April 19, 2023, the Court issued an Order granting Defendants' Motion to Dismiss. The case was dismisssed with prejudice.