Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 108

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 108
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-stage oncology
therapeutics company focused on harnessing the innate relative biological effectiveness and short range of alpha particles for use as
a localized radiation therapy for solid tumors. Our proprietary Alpha DaRT®technology is designed to utilize the specific
therapeutic properties of alpha particles while aiming to overcome, and even harness for potential benefit, the traditional shortcomings
of alpha radiation’s limited range. We believe that our Alpha DaRT technology has the potential to be broadly applicable across
multiple targets and tumor types. We are currently focused on developing the Alpha DaRT for use in a number of potential applications,
particularly in refractory or unresectable localized tumors which are not being adequately addressed by standard of care, tumor types
with a high unmet need (such as pancreatic adenocarcinoma or glioblastoma multiforme), and metastatic tumors in combination with 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