JERUSALEM, May 8, 2026
Alpha Tau Medical Ltd. announced the completion of patient enrollment in its ReSTART pivotal clinical trial, a major milestone supporting the company’s effort to secure potential U.S. FDA pre-market approval for its investigational Alpha DaRT® technology in the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). The multicenter U.S. pivotal study successfully enrolled all 88 patients evaluating the safety and efficacy of Alpha DaRT in patients with recurrent cSCC who previously failed standard therapies and are no longer candidates for surgery or conventional treatment options. The completion of enrollment marks Alpha Tau’s first fully enrolled U.S. pivotal study and represents a significant advancement toward commercialization of the company’s proprietary alpha-radiation cancer therapy platform. Alpha Tau also confirmed that it has already initiated the FDA’s modular pre-market approval (PMA) submission process after previously receiving Breakthrough Device Designation for Alpha DaRT in recurrent cSCC. The company believes the technology could provide an important treatment alternative for patients with limited remaining therapeutic options in one of the world’s most common skin cancers.
ReSTART Trial Advances Alpha DaRT Toward Potential FDA Approval
The ReSTART trial is a prospective, multicenter, single-arm, open-label pivotal clinical study evaluating intratumoral Alpha DaRT therapy in patients with biopsy-confirmed recurrent cSCC who have exhausted first-line standard-of-care treatment options. Patients enrolled in the study were considered unsuitable for surgery or conventional therapies and lacked available curative systemic treatment alternatives. The study’s co-primary endpoints include objective response rate (ORR) and duration of response (DOR) measured six months after initial response observation.
Secondary endpoints include progression-free survival, overall survival, local tumor control, and patient quality of life assessments. With enrollment now completed, the study enters the follow-up and data maturation phase, where investigators will continue evaluating efficacy and long-term safety outcomes. Company leadership described the transition as a critical step toward potential commercialization of Alpha DaRT in the United States. Alpha Tau executives emphasized that the ReSTART study represents the most rigorous clinical evaluation of Alpha DaRT conducted to date and builds upon years of prior clinical experience from studies conducted across Israel, Italy, France, and the United States involving hundreds of treated tumors.
Alpha DaRT Technology Targets Tumors with Localized Alpha Radiation
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Alpha DaRT® (Diffusing Alpha-emitters Radiation Therapy) is designed as a highly targeted intratumoral radiation therapy intended to destroy solid tumors while minimizing damage to surrounding healthy tissue. The treatment involves inserting Alpha DaRT sources directly into tumors, where short-lived alpha particles disperse locally within cancer tissue to deliver potent therapeutic radiation. Because alpha particles travel only short distances, the technology aims to provide highly localized tumor destruction with reduced exposure to nearby healthy structures.
The company believes this localized radiotherapeutic strategy may offer advantages for difficult-to-treat recurrent skin cancers where surgery, external beam radiation, or systemic therapies are no longer appropriate. Clinical studies conducted internationally have reportedly demonstrated encouraging efficacy and favorable safety findings in recurrent skin cancer patients. Alpha Tau stated that Alpha DaRT’s skin cancer development program served as the foundational clinical application for the company’s broader oncology strategy and continues supporting expansion into additional solid tumor indications.
Rising cSCC Burden Highlights Unmet Clinical Need
Cutaneous squamous cell carcinoma is currently the second most common form of skin cancer globally, with incidence rates continuing to rise. Although most cSCC cases are successfully managed through surgical excision, a subset of patients develop recurrent or advanced disease that becomes increasingly difficult to treat with existing therapies. These patients often face limited treatment options, particularly after failing surgery, radiation, or systemic approaches. Alpha Tau believes Alpha DaRT may address this unmet need by offering a minimally invasive intratumoral treatment designed specifically for localized tumor control in recurrent disease settings.
Company executives highlighted that years of international clinical development have consistently reinforced confidence in the technology’s therapeutic potential. The FDA’s Breakthrough Device Designation and the company’s active PMA modular submission process further position Alpha Tau for a potentially important regulatory pathway in oncology radiotherapeutics. If approved, Alpha DaRT could become a novel treatment option for recurrent cSCC patients who currently have few remaining curative alternatives.
Source: Alpha Tau press release
