Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 126

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 126
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 or superficial soft tissue tumor 1-5 cm in size that is suitable for percutaneous interstitial
brachytherapy, a form of radiotherapy, with a minimum longest dimension for the tumor of 1 cm and a minimum tumor thickness of 4 mm.

After enrolling in the trial,
eligible subjects underwent a volumetric assessment of the tumor by a CT planning scan. Volumetric images were used to generate the plan
for delivering Alpha DaRT by defining the optimal number, size and location for Alpha DaRT source placement. After radiation planning
is completed, the Alpha DaRT sources were inserted using pre-planned radiotherapy parameters (with a specified number and size of Alpha
DaRT sources). Immediately after placement of the Alpha DaRT sources, a standard planning CT was performed to assess source positions
within the tumor. A physical dose of 10 Gy was prescribed, which is equivalent to a weighted radiation dose of 200 CGyE.

Approximately two to three
weeks after placement of the Alpha DaRT sources, the placement of the sources was reassessed by volumetric imaging, and then they were
removed. Tumor response was assessed periodically three months after removal of the Alpha DaRT source.

Feasibility and safety evaluation

The study met its primary
feasibility endpoint, as all patients had successful delivery of radiation by Alpha DaRT. 22 AEs were reported across seven patients,
and 13 of the AEs were considered unrelated to the Alpha DaRT. There were only 2 reported SAEs, both in a single patient, but both events
were deemed unrelated to the Alpha DaRT. The most common AEs were dermatitis and pruritus over the implanted area, which subsequently
resolved when treated with conservative measures. No Alpha DaRT-related SAEs were reported, and no long-term toxic effects were observed.

Efficacy results

At approximately 12 weeks,
all ten lesions treated demonstrated a complete response to treatment. Computerized tomography scans, or CT, obtained at 24 weeks posttreatment
showed no evidence of recurrent disease in any of the ten patients. An example of a CR observed in a patient with a recurrent nose tumor
is shown in the figure below.

  Pre-Treatment      12 weeks after Alpha DaRT Removal  

ReSTART - U. S. multi-center pivotal
study in recurrent cutaneous SCC (ongoing)

Following receipt of a conditional
IDE from the FDA, whose conditions were subsequently satisfied, we initiated a trial