Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 137

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 137
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same time also saw a reduction of over 25% in dimension of an untreated lesion elsewhere in the liver. The patient was discharged as planned
and had an uneventful recovery. Histopathological analysis suggested a pronounced adaptive immune response in the treated lesion.

Lung Cancer

According to the World Health
Organization’s International Agency for Research on Cancer, lung cancer is the leading cause of cancer death, with an estimated
1.8 million deaths in 2022. The term lung cancer, or bronchogenic carcinoma, refers to malignancies that originate in the airways or
pulmonary parenchyma. Approximately 95% of all lung cancers are classified as either small cell lung cancer (SCLC) or non-small cell
lung cancer (NSCLC) based upon histologic examination. A mediastinal tumor is a tumor in the mediastinum, the cavity that separates the
lungs from the rest of the chest. It contains the heart, esophagus, trachea, thymus, and aorta. Lung cancer typically spreads to the
lymph nodes in the mediastinum.

In preclinical experiments, clinicians have successfully demonstrated the ability to deliver Alpha DaRT
sources into the lung and mediastinum using an endobronchial ultrasound procedure. A total of 158 Alpha DaRT sources were inserted successfully
in the lung parenchyma and mediastinum of five swine. No adverse event or change in the health and general condition of
animals was observed. Hematologic evaluation did not show any clinically significant abnormality related to the Alpha DaRT sources. Histopathology
demonstrated local mild inflammatory changes, minimal fibrosis, and dystrophic mineralization with giant cells. Minimal movement and
no migration of Alpha DaRT sources were observed.

Recurrent lung cancer
- Hadassah Medical Center, Israel (recruiting)

We have initiated a clinical
study at Hadassah Medical Center in Jerusalem, Israel, for the treatment of mediastinal tumors from recurrent lung cancer. Recruitment
is open for up to 10 patients with recurrent tumors of the mediastinum of up to 3cm in the longest dimension. The primary endpoints of
the study are feasibility, as measured by the successful placement of the Alpha DaRT sources, and safety, by assessing the frequency,
severity and causality of acute SAEs related to Alpha DaRT source insertion, according to CTCAE version 5