Polarity TE, Inc.
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 to 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.
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