On February 24, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that Japan’s Ministry of Health, Labour and Welfare ("MHLW") has granted regulatory (Shonin) marketing approval for Alpha DaRT for the treatment of unresectable locally advanced or locally recurrent head and neck cancer.
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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 (PMDA). 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 (PMS) 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.
"Receiving Shonin approval in Japan is a significant milestone for Alpha Tau and for the Alpha DaRT platform," said Uzi Sofer, Chief Executive Officer of Alpha Tau. "Japan has granted our first marketing approval outside of Israel, and is a country with deep clinical expertise in head and neck oncology. We are grateful to HekaBio for their leadership during this process, and to the six medical societies in Japan who have continually provided their support for the approval and future launch of Alpha DaRT in Japan. Our immediate focus is on working closely with Japanese clinicians to complete the PMS study and to generate high-quality clinical data in patients with unresectable locally advanced or locally recurrent disease. In parallel we anticipate initiating discussions shortly with the MHLW regarding potential reimbursement approaches for Alpha DaRT in Japan. We believe this approval represents an important first step toward broader clinical evaluation of Alpha DaRT, and look forward to discussing with the PMDA further potential clinical studies in Japan evaluating the use of Alpha DaRT in additional tumor types."
Robert E. Claar, CEO of HekaBio K.K., said, "The Alpha DaRT program has been the primary focus for our team for 7 years, and we’re delighted to reach this Shonin milestone with Alpha Tau Medical for the benefit of patients in Japan. Along the way, we got strong and continuous support from medical professionals, regulators and the government of Japan to enable approval for this breakthrough therapy. An approval in Japan in advance of the US and Europe for a foreign-originated new category medical device is an extremely rare event, and we’re grateful to all of our partners who made this possible. Our team is enthusiastically preparing to launch Alpha DaRT to deliver hope and clinical benefit to patients in Japan."
Dr. Jun Itami, Director, High-Precision Radiation Therapy Center, Shin-Matsudo Central General Hospital, said, "Through this domestic clinical trial, Alpha DaRT has demonstrated promise, representing a major advance in the fight against cancer. Demonstrating the efficacy of intratumoral alpha-particle radiation therapy, a modality long considered difficult to implement, for patients who have not responded to conventional therapies is a highly meaningful achievement, offering a new treatment option.
By confirming both safety and efficacy in this study, we have opened the door to delivering this therapy in real-world clinical practice, thereby expanding the range of treatment options available to patients. This outcome also provides important insights for future clinical research aimed at broadening indications.
Bringing hope to patients and their families by offering ‘a new treatment option’ is not only clinically valuable but also provides psychological support in the care setting. Alpha DaRT holds the potential to turn that hope into reality.
Further validation and long-term safety evaluation will be necessary, but we are confident that these results represent a major step forward in advancing discussions toward broader clinical application."
(Press release, Alpha Tau Medical, FEB 24, 2026, View Source [SID1234662897])