Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 41

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 3
Chunk 41
---
 as MACRA, may have on our business,
financial condition, results of operations or cash flows.

We expect additional state,
federal and foreign healthcare policies and reform measures to be adopted in the future, any of which could limit reimbursement for healthcare
products and services or otherwise result in reduced demand for our product candidates or additional pricing pressure and have a material
adverse effect on our industry generally and on our customers. We cannot predict what other healthcare programs and regulations will ultimately
be implemented at the federal or state level or the effect of any future legislation or regulation in the United States may negatively
affect our business, financial condition and results of operations. The continuing efforts of the government, insurance companies, managed
care organizations and other payors of healthcare services to contain or reduce costs of healthcare may adversely affect our ability to
set a price that we believe is fair for our product candidates, our ability to generate revenue and achieve or maintain profitability
or the availability of capital.

For instance, on December
13, 2021, the EU Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted. The Regulation
entered into force in January 2022 and has been applicable since January 2025, with phased implementation based on the type of product
i. e., certain high-risk medical devices as of 2026. The Regulation intends to boost cooperation among EU member states in assessing health
technologies, including certain high-risk medical devices, and provides the basis for cooperation at the EU level for joint clinical assessments
in these areas. The regulation will permit EU member states to use common HTA tools, methodologies, and procedures across the EU, working
together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential impact
for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health
technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU member states
will continue to be responsible for assessing non-clinical (e. g., economic, social, ethical) aspects of health technologies, and making
decisions on pricing and reimbursement.

Any changes of, or uncertainty
with respect to, future coverage or reimbursement rates could affect demand for our product candidates, which in turn could impact our
ability to successfully commercialize these devices and could have a material adverse effect on our business, financial condition and
results of operations