The clinical trial process is an important step in bringing new therapies to patients. These are designed to test whether the new therapy is safe for patients and if it works in the intended population. Each trial is designed to answer different questions and to generate information that can help inform future trials.
SkinTE®, our lead investigational product candidate for chronic cutaneous ulcers, is advancing in clinical development. Prior to PolarityTE receiving approval for its investigational new drug application (IND), the Company conducted an initial clinical trial on a specific class of diabetic foot ulcers (Wagner 1).
We are currently conducting a clinical trial under IND in patients with more complex diabetic foot ulcers (Wagner 2), and plan to pursue additional trials in chronic and acute wounds, based on ongoing regulatory discussions with the FDA.
For more information about PolarityTE clinical trials, please contract Clinical Research at 800-653-8031 or clinicalresearch@PolarityTE.com.