JERUSALEM – May 8, 2026
Alpha Tau Medical Ltd. announced the completion of patient enrollment in its pivotal U.S. ReSTART clinical trial evaluating the company’s innovative Alpha DaRT® (Diffusing Alpha-emitters Radiation Therapy) technology for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). The milestone represents a major step toward potential FDA pre-market approval (PMA) of Alpha DaRT and marks the first U.S. pivotal clinical study completed by the company.
The ReSTART trial enrolled all 88 patients targeted for the multicenter study, which is evaluating the efficacy and safety of Alpha DaRT in patients with recurrent cSCC who have exhausted standard treatment options and are no longer suitable for surgery or conventional therapies. The technology has already received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), further strengthening Alpha Tau’s regulatory pathway in the rapidly growing oncology device market.
Alpha DaRT Targets Hard-to-Treat Skin Cancer Tumors
Alpha DaRT is an innovative intratumoral alpha-radiation therapy designed to deliver potent and localized radiation directly into solid tumors while minimizing damage to surrounding healthy tissue. The technology uses radioactive sources implanted into tumors that release short-lived alpha particles capable of destroying cancer cells within a confined treatment area.
The company stated that skin cancer was the first clinical application explored for Alpha DaRT and has become the foundation of its broader oncology development strategy. According to Alpha Tau Chief Executive Officer Uzi Sofer, years of clinical research conducted across multiple countries have consistently demonstrated encouraging efficacy and safety results for the technology. He emphasized that completion of enrollment in the company’s first U.S. pivotal study brings Alpha Tau significantly closer to potential commercialization and FDA approval.
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The ReSTART study is a prospective, multicenter, single-arm, open-label pivotal trial involving patients with biopsy-confirmed recurrent cSCC who previously failed at least first-line standard-of-care therapy. Researchers will evaluate co-primary endpoints including objective response rate (ORR) and duration of response (DOR) at six months, alongside secondary endpoints such as progression-free survival, overall survival, local tumor control and quality of life outcomes.
Growing Demand for New cSCC Treatment Options
Cutaneous squamous cell carcinoma is the second most common form of skin cancer globally, with incidence rates continuing to rise worldwide. While surgery remains effective for many patients, a significant number eventually develop recurrent disease that becomes resistant to conventional treatment approaches. For these patients, therapeutic options remain limited, creating a growing unmet clinical need for targeted and well-tolerated cancer therapies.
Alpha Tau believes Alpha DaRT may provide an alternative treatment strategy for patients who are no longer eligible for curative surgery or standard radiation therapies. Clinical studies conducted previously in Israel, Italy, France and the United States have treated hundreds of tumors and generated encouraging evidence supporting the therapy’s safety and antitumor activity.
Chief Medical Officer Dr. Robert B. Den stated that the ReSTART trial represents the most rigorous evaluation of Alpha DaRT to date and credited participating investigators and clinical teams for advancing the study. He noted that the technology’s development journey has expanded internationally over several years, steadily building clinical evidence supporting its potential in recurrent skin cancer treatment.
FDA PMA Submission Process Continues
Alpha Tau previously submitted the first module of its modular PMA application to the FDA in January 2026 and will now continue patient follow-up and data collection necessary for regulatory review. The company indicated that completion of enrollment marks a critical transition from recruitment to data maturation and endpoint assessment.
Industry observers continue monitoring Alpha DaRT as a potentially important advancement in localized radiotherapeutic oncology treatments. If approved, the technology could open new opportunities for minimally invasive treatment of difficult-to-treat solid tumors while expanding innovation in targeted cancer radiation delivery systems.
Source: Alpha Tau press release
