Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 27

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 27
---
 historically been slow to change their medical diagnostic and treatment practices
because of perceived liability risks arising from the use of new products. Delayed adoption of GelrinC by healthcare professionals could
lead to a delayed adoption by patients, as well as government and private third-party payors. Healthcare professionals may not recommend
GelrinC until certain conditions have been satisfied including, among others:

| ● | there is sufficient long-term clinical and health-economic evidence to convince them to alter their existing tissue repair methods and recommendations; |

| ● | there are recommendations from prominent physicians, educators and/or associations indicating that GelrinC is safe and effective; |

| ● | we obtain favorable data from clinical and health-economic studies for GelrinC; |

| ● | reimbursement or insurance coverage from government and private third-party payors is available; |

| ● | healthcare professionals obtain required approvals and licensures for the handling, storage, dispensing and disposal of GelrinC; and |

| ● | healthcare professionals become familiar with the complexities of GelrinC. |

We cannot predict when, if
ever, healthcare professionals and patients may adopt the use of GelrinC. Even if favorable data is obtained from clinical and health-economic
studies for the regulatory approval of GelrinC, there can be no assurance that prominent physicians would endorse it or that future clinical
studies will continue to produce favorable data regarding GelrinC. In addition, prolonged market exposure may also be a pre-requisite
to reimbursement or insurance coverage from government and private third-party payors. If GelrinC does not achieve an adequate level of
acceptance by patients, healthcare professionals, and government and private third-party payors, we may not generate significant product
revenues and we may not become profitable.

<div align='center'>20</div>

We are dependent upon contract manufacturing organizations and raw material suppliers making us vulnerable to supply shortages and problems, increased costs and quality or compliance issues, any of which could harm our business.

Some of the critical materials
and components used in manufacturing GelrinC are sourced from single suppliers. Our suppliers may encounter problems during manufacturing
for a variety of reasons, including, for example, failure to follow specific protocols and procedures, failure to comply with applicable
legal and regulatory requirements, equipment malfunction and environmental factors, failure to properly conduct their own business affairs,
and infringement of third-party intellectual property rights, any of which could delay or impede their ability to meet our requirements.
An interruption in the supply of a key material could significantly delay