Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 59

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 59
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, which may prevent or delay clearance or approval of our future products under development on a timely basis. Such
policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new clearances or approvals,
increase the costs of compliance or restrict our ability to maintain any approvals we are able to obtain. Legislative or regulatory reforms
in the United States or the EU may make it more difficult and costly for us to obtain regulatory clearances or approvals for our products
or to manufacture, market or distribute our products after clearance or approval is obtained.

Our products must be manufactured in accordance with federal, state and foreign regulations, and we could be forced to recall our devices or terminate production if we fail to comply with these regulations.

The methods used in, and the
facilities used for, the manufacture of our products must comply with the Quality System Regulation, or QSR, which is a complex regulatory
scheme that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling,
packaging, handling, storage, distribution, installation, servicing and shipping of medical devices.

Furthermore, we are required
to verify that our suppliers maintain facilities, procedures and operations that comply with our quality standards and applicable regulatory
requirements. The FDA enforces the QSR through periodic announced or unannounced inspections of medical device manufacturing facilities,
which may include the facilities of subcontractors. Our products are also subject to similar state regulations and various laws and regulations
of foreign countries governing manufacturing.

Our third-party manufacturers
may not take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of our products. In addition,
failure to comply with applicable FDA or state or foreign requirements or later discovery of previously unknown problems with our products
or manufacturing processes could result in, among other things: warning letters or untitled letters; fines, injunctions or civil penalties;
suspension or withdrawal of approvals; seizures or recalls of our products; total or partial suspension of production or distribution;
administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals for our products;
clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us, our suppliers or our employees.

Any of these actions could
significantly and negatively affect supply of our products. If any of these events occurs, our reputation could be harmed, we could be
exposed to product liability claims and we could lose customers and experience reduced sales and increased costs.

The