Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 117

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 117
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 | Single, 10 minutes surgical procedure; |

| ● | Implantable via open or minimally-invasive surgical techniques; |

| ● | Manufacturing process allows for low cost of goods and scalability; and |

| ● | Intended for the repair of focal defects in cartilage and/or osteochondral defects. |

All of these advantages were
demonstrated in the Pilot Study where the recovery of the patient took approximately two weeks of non-weight bearing activity, and led
to a full recovery within three to six months. Additionally, 100% of the participants who were followed up with in the Pilot study reported
no pain in their recovery through at least four years thereafter.

Future Products; Additional Applications

Based on similarity of mechanism
of action for cartilage and based on animal studies performed by the Company for osteoarthritis, we believe that in the future, our Gelrin
technology platform may also provide a solution to osteoarthritis and other cartilage injuries related to the ankle, wrist, and elbow.

| ● | GelrinP – a paste form of GelrinC, which is cured with UV light, developed for treatment of injuries in smaller joints like the ankle, wrist, and elbow. |

| ● | GelrinV – Novel intra-articular injectable gel, long-lasting with pro-healing capabilities. It is a thermo-responsive, hydrophobic polymer, which is injected as a thin liquid, and turns into a thick gel at body temperature. Targeted for treatment of moderate osteoarthritis. |

Clinical Development of GelrinC

Completed Pilot Study

In medical devices, the
efficacy trial first tested on larger groups of patients is called a pilot study. We carried out the Pilot Study on 56 patients that
were treated with GelrinC and followed up for up to four years in multiple sites in Northern Europe and Israel. The primary efficacy
endpoints were changes from baseline for overall KOOS scores and KOOS pain subscale at 18 months and the primary efficacy end points
were met. No serious adverse events were observed in the completed Pilot Study. In addition to pre-clinical studies we conducted for
GelrinC, the Pilot Study we carried out was the sole study we used in order to obtain approval of GelrinC as a medical device in
Europe in 2017. The near and long-term improvements in KOOS and VAS scores which are the commonly used scales with which pain is
measured and the imaging diagnostic measurements of MRI