Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 125

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 125
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 as each time a lesion was treated, a second, non-target lesion responded as well, manifesting
as CR to the treatment. The details of this patient’s unique response were published in a 2019 case report in the Journal of
Contemporary Brachytherapy. The publication concluded that Alpha DaRT treatment may play a very important role because it could stimulate
an anti-tumor immune reactivity with more ease than low-LET radiation that is used with conventional EBRT.

Furthermore, the destruction
of the tumor by Alpha DaRT maintains an intact vasculature around the tumor, enabling an influx of immune cells to recognize and destroy
tumor cells.

Following these initial positive
results, we expanded our clinical evaluations to a wider patient population and initiated follow-on trials at multiple clinical sites
in Israel and around the world. These trials are designed to evaluate Alpha DaRT in cancers of the skin, superficial soft tissue, or oral
cavity, regardless of cell type, which includes SCC as well as basal cell carcinoma, melanoma, skin metastases, and others. We also initiated
a trial to evaluate the retreatment of patients who previously were treated with the Alpha DaRT. The data from these first trials led
to the FDA granting Breakthrough Device Designation to the Alpha DaRT for the treatment of patients with SCC of the skin or oral cavity
without curative standard of care.

Memorial Sloan Kettering Cancer
Center, NY / Multi-Center (completed; 2021)

Following receipt of an investigational
device exemption, or IDE, from the FDA, we conducted a U. S. pilot clinical study to evaluate the feasibility of Alpha DaRT in treating
malignant skin and superficial soft tissue tumors, at Memorial Sloan Kettering Cancer Center, New York and four other clinical sites around
the U. S. All ten patients in this trial were treated in the second half of 2021.

Study design

The initial IDE study was
a pilot feasibility trial in which 10 subjects were enrolled. The primary objectives were to explore the feasibility of delivering radiotherapy
for malignant skin and superficial soft tissue tumors using Alpha DaRT, with a goal of achieving successful delivery in at least 7 of
the 10 patients, as well as to determine the frequency and severity of acute adverse events. Secondary objectives included assessments
of radiotherapy-related adverse events, tumor response, radiation safety, stability of device placement, and quality of life measures.
Eligible patients had a malignant skin