Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 184

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4A
Chunk 184
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 generally well-tolerated, with limited local toxicity and no systemic
toxicity. On the basis of this clinical trial as well as some of our further clinical trials, we received marketing approval in Israel
in August 2020 for the treatment of SCC of the skin or oral cavity using the Alpha DaRT. In June 2021, the U. S. Food and Drug Administration,
or FDA, granted the Alpha DaRT Breakthrough Device Designation for the treatment of patients with SCC of the skin or oral cavity without
curative standard of care. In October 2021, the FDA granted the Alpha DaRT a second Breakthrough Device Designation, in treating recurrent
Glioblastoma Multiforme, or GBM, as an adjunct to standard medical therapies or as a standalone therapy after standard medical therapies
have been exhausted. In the second half of 2021, we treated ten patients in the U. S. in a multi-center pilot feasibility trial conducted
at Memorial Sloan Kettering Cancer Center and four other U. S. clinical sites, to explore the feasibility of delivering radiotherapy for
malignant skin and superficial soft tissue tumors using Alpha DaRT. The study met its primary feasibility endpoint, as all patients had
successful delivery of radiation by Alpha DaRT. At approximately 12 weeks and 24 weeks after treatment, all ten lesions treated demonstrated
a complete response to treatment, with no product-related serious adverse events observed. In November 2023, on the basis of a clinical
trial completed in Japan as well as data collected elsewhere in the world, we submitted to Japan’s Pharmaceuticals and Medical Devices
Agency, or PMDA, an application for shoninpre-market approval of Alpha DaRT for use in patients with recurrent head & neck
cancer. To support our U. S. strategy, we are conducting a multi-center pivotal trial, which we refer to as the ReSTART trial, to explore
the delivery of radiotherapy for up to 86 patients with recurrent cutaneous squamous cell carcinoma tumors using Alpha DaRT at clinical
sites around the United States and selected other clinical sites outside the U. S. We anticipate completing recruitment of this trial around
Q3 2025 and receiving results of the trial in early 2026 for potential submission to the FDA.

We have also evaluated and
continue to evaluate the feasibility, safety and efficacy of the Alpha DaRT technology for the treatment of solid tumors in internal organs,
including the pancreas, lung, prostate