Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 56

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 56
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 is also possible that other federal, state or foreign enforcement authorities might take action under other regulatory
authority, such as false claims laws, if they consider our business activities to constitute promotion of an off-label use, which could
result in significant penalties, including, but not limited to, criminal, civil and administrative penalties, damages, fines, disgorgement,
exclusion from participation in government healthcare programs and the curtailment of our operations. We may become subject to such actions
and, if we are not successful in defending against such actions, those actions may have a material adverse effect on our business, financial
condition and results of operations. Equivalent laws and potential consequences exist in foreign jurisdictions.

In addition, if our products
are cleared or approved, healthcare providers may misuse our products or use improper techniques if they are not adequately trained,
potentially leading to injury and an increased risk of product liability. If our devices are misused or used with improper technique,
we may become subject to costly litigation by our customers or their patients. As described above, product liability claims could divert
management’s attention from our core business, be expensive to defend and result in sizeable damage awards against us that may
not be covered by insurance.

Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.

If GelrinC or our other future
products receive clearance or approval, we will be subject to the FDA’s medical device reporting regulations and similar foreign
regulations, which require us to report to the FDA when we receive or become aware of information that reasonably suggests that one or
more of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were
to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report is triggered by the date
we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become aware
within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if
it