Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 70

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 70
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, which could negatively impact our business.

The ability of the FDA to
review and clear or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory,
regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other
events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated
in recent years as a result. In addition, government funding of other government agencies that fund research and development activities
is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and
other agencies may also slow the time necessary for new medical devices or modifications to cleared or approved medical devices to be
reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several
years, including for 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies,
such as the FDA, have had to furlough critical FDA employees and stop critical activities. On December 21, 2024, President Biden signed
legislation that funds the federal government through March 14, 2025.

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Separately, in response to
the COVID-19 pandemic, on March 10, 2020 the FDA announced its intention to postpone most inspections of foreign manufacturing facilities,
and on March 18, 2020, the FDA temporarily postponed routine surveillance inspections of domestic manufacturing facilities. Subsequently,
on July 10, 2020 the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to
a risk-based prioritization system. The FDA intends to use this risk-based assessment system to identify the categories of regulatory
activity that can occur within a given geographic area, ranging from mission critical inspections to resumption of all regulatory activities.
Regulatory authorities outside the United States may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic.
If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from
conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or
other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our
business.

Risks Related to this Offering and Investment in Our Ordinary