Clinical TrialMay 8, 2026, 09:02 AM
Alpha Tau completes enrollment in pivotal U.S. ReSTART trial for cSCC
AI Summary
Alpha Tau Medical Ltd. announced the completion of enrollment for its ReSTART pivotal trial, a U.S. multicenter study evaluating Alpha DaRT for recurrent cutaneous squamous cell carcinoma (cSCC). This marks the first U.S. pivotal study for Alpha Tau to complete enrollment, representing a critical milestone towards potential FDA pre-market approval (PMA). The company has already initiated the modular PMA application process for Alpha DaRT, which holds Breakthrough Device Designation for this indication. The trial enrolled 88 patients and builds on prior clinical data from multiple countries.
Key Highlights
- Alpha Tau completed enrollment of all 88 patients in its ReSTART pivotal trial.
- This marks the first U.S. pivotal study for Alpha Tau to complete enrollment.
- The trial evaluates Alpha DaRT for recurrent cutaneous squamous cell carcinoma (cSCC).
- Alpha DaRT has received Breakthrough Device Designation from the FDA for this indication.
- The company initiated its modular PMA application process in January 2026.
- Co-primary endpoints are objective response rate and duration of response at six months.