Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 15

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 15
---
 to marketing is able to request down-classification of the device to Class I or Class II on the basis that the device presents
a low or moderate risk. If the FDA grants the de novoclassification request, the applicant will receive authorization to market
the device. This device type may be used subsequently as a predicate device for future 510(k) submissions.

The PMA approval, 510(k) clearance
and de novoclassification processes can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process usually
takes from three to 12 months, but can take longer. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance
process and generally takes from one to three years, or even longer, from the time the application is submitted to the FDA. In addition,
a PMA generally requires the performance of one or more clinical trials. Clinical data may also be required in connection with an application
for 510(k) clearance or a de novorequest. Despite the time, effort and cost, a device may not obtain marketing authorization by
the FDA. Any delay or failure to obtain necessary regulatory marketing authorizations could harm our business. Furthermore, even if we
are granted such marketing authorizations, they may include significant limitations on the indicated uses for the device, which may limit
the potential commercial market for the device.

To date, we have not obtained
authorization from the FDA to market any product candidate in the United States, and we expect to pursue PMA approval for our Alpha DaRT
technology, which may limit our ability to implement product changes following any potential approval. For example, any modifications
to a PMA-approved device that could affect its safety or effectiveness, including design and manufacturing changes, or that would constitute
a change in its intended use, manufacture, design, components, or technology, requires approval of a new PMA or PMA supplement. However,
certain changes to a PMA-approved device would not require submission and approval of a new PMA or PMA supplement and may only require
notice to FDA in a PMA 30-Day Notice, Special PMA Supplement - Changes Being Effected or PMA Annual Report. The FDA requires every
manufacturer to make such determinations in the first instance, but the FDA may review any manufacturer’s decision. The FDA may
not agree with any decisions regarding whether new approvals are necessary. If the FDA disagrees with our determination and requires us
to seek PMA