Alpha Tau Completes Patient Enrollment in its U.S. Pivotal Skin Cancer Study, Advancing Towards Goal of FDA Approval of Alpha DaRT® to Treat Recurrent Cutaneous Squamous Cell Carcinoma
- First U.S. pivotal study for Alpha Tau to have completed enrollment, representing a critical milestone on the path towards potential FDA pre-market approval (PMA); Company has already initiated PMA modular application process - - Enrollment of all 88 patients completed in the ReSTART trial, a U.S. multicenter pivotal study evaluating Alpha DaRT® for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC), for which the Alpha DaRT has received Breakthrough Device Designation from the FDA - - Re ...