Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 56

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 56
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 approved by the
FDA or approved by any foreign regulatory body may not effectively treat such conditions, which could harm our reputation in the marketplace
among healthcare providers and patients.

If the FDA or any state or
foreign regulatory body determines that our promotional materials or training constitute promotion of an off-label use, it could request
that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance or imposition
of an untitled letter, which is used for violators that do not necessitate a warning letter, injunction, seizure, civil fine or criminal
penalties. It 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