DRTS News & Events

Alpha Tau Medical announced that Japan's Ministry of Health, Labour and Welfare, MHLW, has granted regulator marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer. In Japan, the Shonin approval process is the most rigorous pathway for medical devices, conducted after a review and recommendation by Japan's Pharmaceuticals and Medical Devices Agency. This marks the first regulatory approval of the Alpha DaRT platform outside Israel. As part of the approval, Alpha Tau will need to conduct a post-market surveillance study enrolling 66 patients in total at five selected leading clinical centers in Japan. The PMS study is intended to further evaluate the safety and clinical performance of Alpha DaRT in real-world clinical settings and to generate additional real-world clinical evidence in collaboration with Japanese physicians and treatment centers.

Alpha Tau Medical issued the following letter to shareholders: "Following an incredibly productive 2025, culminating in several significant announcements in recent weeks, I wish to share with you an updated comprehensive picture of Alpha Tau's position and projected upcoming milestones, as we continue to push forward with our clinical, operational and pre-commercial development on a number of different fronts... The Company is currently conducting multiple significant clinical trials around the world, with five concurrently approved trials in the U.S.: Our ReSTART multi-center pivotal trial in patients with recurrent cutaneous squamous cell carcinoma... Our multicenter study in immunocompromised patients with cSCC... Our IMPACT multi-center pilot study in patients with newly-diagnosed pancreatic cancer in combination with chemotherapy... Our feasibility study in patients with recurrent glioblastoma multiforme... Our pilot study in patients with locally recurrent prostate cancer... We are proud of our incredibly comprehensive clinical program, with Alpha DaRT being evaluated simultaneously across a number of indications... In addition, the Company has trials approved in France and Italy and is planning a large potential basket trial in the UK to evaluate our Alpha DaRT across numerous cancer types, alongside a number of ongoing feasibility studies in Israel... As you all know, the Company started its clinical evaluations by treating superficial tumors as a proof of concept, i.e., tumors of the skin or head and neck, and has acquired significant experience in the U.S., Europe, Japan and Israel... Recently we reported the treatment of our first patient in GBM at Ohio State University... To the extent that no safety concerns arise, we would anticipate the removal of enrollment restrictions as well as expansion to New York University as a second site in the trial, in which case we would target the completion of patient accrual for ten patients later in the year, with initial results targeted around year end 2026... 2025 was certainly full of myriad challenges that the Company rose to meet exceedingly well, and we expect 2026 to be a busy and challenging year too."