Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 122

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 122
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 of the 5mm range surrounding the source. This result is also seen
clearly under histological stain, where the corresponding section of the tumor was destroyed while the surrounding environs continued
to be unaffected by radiation.

The radioisotopes are designed
to disperse in the cancerous medium by diffusion and convection due to the tumor chaotic vascularity, as well as from ongoing recoil during
the repeated alpha decays. Moreover, the blood vessels formed in tumors tend to have leaky walls, which we believe increases the chance
of the radioactive isotopes staying in the tumor and potentially prolonging killing activity. The net result is that the potential range
of cell killing in the tumor is up to five millimeters, which is up to 100 times the range of the alpha particles themselves. By contrast,
healthy tissue has a highly organized vascular structure, with numerous, well-ordered blood vessels through which a radioisotope can be
easily washed out.

In our animal studies, the
range of the Alpha DaRT was meaningfully more extensive in tumor tissue than it was in healthy tissue, as shown in the two images below
comparing radioactivity visible on a radiograph when inserting the Alpha DaRT into SCC tissue and healthy tissue.

  Diffusion in SCC      Diffusion in Healthy Tissue  

Our Programs

Clinical Development Plan

Our development strategy
is focused on evaluating the safety and efficacy of the Alpha DaRT technology across multiple solid tumor types through
broad-ranging pre-clinical studies and into clinical trials. We have successfully completed a first-in-human trial in patients with
superficial and skin tumors, as well as a U. S. multi-center pilot feasibility trial in patients with malignant skin and superficial
soft tissue tumors, and are focused on continued clinical development as we seek FDA marketing authorization and other foreign
regulatory approvals for use of the Alpha DaRT in these tumors, beginning with recurrent cutaneous squamous cell carcinoma. We are
also generating additional clinical evidence regarding the Alpha DaRT technology in superficial and skin tumors from clinical sites
around the world, to provide further support for a potential FDA marketing authorization and third-party payor coverage and
reimbursement in the United States and around the world. In parallel, we are pursuing a similar approach towards developing the
Alpha DaRT technology for other uses by conducting feasibility studies and then generating potentially registrational data in other
indications, such as pancreas, brain, lung, and prostate cancers, or applications such as