Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 143

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 143
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 the American Taxpayer Relief Act of 2012, among other things, reduced
Medicare payments to several providers, including hospitals, and increased the statute of limitations period for the government to recover
overpayments to providers from three to five years. The Medicare Access and CHIP Reauthorization Act of 2015, or CHIP, repealed the formula
by which Medicare made annual payment adjustments to physicians and replaced the former formula with fixed annual updates and a new system
of incentive payments that are based on various performance measures and physicians’ participation in alternative payment models,
such as accountable care organizations.

We expect additional state
and federal health care reform measures to be adopted in the future, particularly in light of the new presidential administration, some
of which could limit the amounts that federal and state governments will pay for health care products and services, which could result
in reduced demand for our products or additional pricing pressure.

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European Union Regulation

In
order to sell our products in member states of the EU, our products must comply with the general safety and performance requirements
of the EU Medical Devices Regulation, or Regulation (EU) No 2017/745), which repeals and replaces the EU Medical Devices Directive (Council
Directive 93/42/EEC) and the Active Implantable Medical Devices Directive (Council Directive 90/385/EEC).

Compliance
with these requirements is a prerequisite to be able to affix the European Conformity, or CE, mark to our products, without which they
cannot be sold or marketed in the EU. All medical devices placed on the market in the EU must meet the general safety and performance
requirements laid down in Annex I to the EU Medical Devices Regulation including the requirement that a medical device must be designed
and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose. Medical devices must be
safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and –
where applicable – other persons, provided that any risks which may be associated with their use constitute acceptable risks when
weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account
the generally acknowledged state of the art. The European Commission has adopted various standards applicable to medical devices. These
include standards governing common requirements, such as sterilization and safety of medical electrical equipment and product standards
for certain types of medical