Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 61

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 61
---
 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 is not
reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If
we fail to comply with our reporting obligations, the FDA or other regulatory bodies could take action, including warning letters, untitled
letters, administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance or approval,
seizure of our products or delay in clearance or approval of future products.

<div align='center'>38</div>

The FDA and foreign regulatory
bodies have