Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 55

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 55
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-approved indications
for use, known as “off-label uses.” We cannot, however, prevent a physician from using our devices off-label, when in the
physician’s independent professional medical judgment he or she deems it appropriate. There may be increased risk of injury to
patients if physicians attempt to use our devices off-label. Furthermore, the use of our devices for indications other than those 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