Company: DRTSW
Filing Date: 2025-06-23
Form Type: F-3
Source: 0001213900-25-056744
Chunk: 8

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-06-23
Form: F-3
Chunk 8
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 systemic therapies such as checkpoint inhibitors.

In
our initial proof of concept of the Alpha DaRT technology, we have evaluated, and continue to evaluate, the feasibility, safety and efficacy
of the Alpha DaRT technology for the treatment of superficial lesions, i.e., tumors of the skin, head or neck, in multiple clinical trials
conducted in clinical sites around the world. In a first-in-human study of locally advanced and recurrent squamous cell carcinoma, or
SCC, cancers of the skin and head and neck, efficacy was evaluated in 28 tumors, and results showed that Alpha DaRT achieved 100% objective
response rate and over 78% complete response rate. The Alpha DaRT was 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 shonin pre-market approval of Alpha DaRT for use in patients with recurrent head & neck
cancer. To support our U.S