At this time, PolarityTE does not have an expanded access program that allows patients to have access to the Company’s investigational products outside of clinical trials or prior to FDA approval. PolarityTE believes clinical trials are the most appropriate way for patients to access investigational products developed by PolarityTE. In these trials, the safety and efficacy of investigational products are rigorously assessed by PolarityTE and the relevant regulatory agencies in order to understand the product’s benefits, risks, and appropriate use, including whether or not it should be approved as a therapy for its intended use. Obtaining regulatory approval is the best way to bring safe and effective medicines to the greatest number of patients who may benefit from treatment. PolarityTE may update this policy as its product development programs are progressing and reassess its approach to expanded access programs.
Should patients, families, or physicians have any questions, please contact our Clinical Information department by email at clinicalresearch@PolarityTE.com.