Regentis' GelrinC Establishes Long-Term Durability of Cartilage Repair Through Quantitative MOCART Evaluation Marks a world-first as Regentis uses MOCART, a quantitative standard to measure regeneration of cartilage in a

Regentis' GelrinC Establishes

Long-Term Durability of Cartilage Repair Through Quantitative MOCART Evaluation

Marks a world-first as Regentis uses

MOCART, a quantitative standard to measure regeneration of cartilage in a clinical trial, as a predefined endpoint

New peer-reviewed data published in the scientific

journal Cartilage uses the complete set of follow-up data from GelrinC's Phase II study, which establishes GelrinC as a leader in

long-term durable cartilage repair, using objective, quantitative MOCART assessment to demonstrate morphologic outcomes that consistently

outperform other treatment modalities

The data presented by Regentis show that two

years after treatment, the repaired cartilage appears very close to normal healthy cartilage, highlighting the long-term durability of

GelrinC and reinforcing its competitive superiority in the cartilage repair landscape

approved in Europe and currently in a pivotal Phase III U.S. FDA study

Herzliya, Israel, January 6, 2025- Regentis

Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American: RGNT), a regenerative medicine company focused

on innovative tissue repair solutions, today announced publication of long-term follow-up results from its successfully concluded Phase

II clinical trial of GelrinC in the peer-reviewed journal Cartilage. The study, led by Prof. Siegfried Trattnig

of Vienna University and colleagues, reports strong radiologic evidence of durable cartilage regeneration at 24 months.

Regentis is the first company to extensively

use MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue), a validated MRI-based quantitative measure of cartilage

quantity and quality as a secondary endpoint in a clinical study, and to have the U.S. Food and Drug Administration's (FDA)

acceptance of this approach. In contrast to the predominantly subjective clinical endpoints commonly used in cartilage repair

studies, Regentis deliberately selected objective, imaging-based endpoints as a rigorous measure of structural repair from the

outset. Regentis is unique in having predefined MOCART as a prospective imaging and primary endpoint built into the protocol from

day one, and in having the MOCART assessments conducted by the Vienna University-based team that developed the method which is

widely regarded as the gold standard.

As such, Regentis is advancing what it believes is a more rigorous

standard for assessing cartilage regeneration by emphasizing objective, quantitative structural outcomes alongside the current standard

of care KOOS (Knee Injury and Osteoarthritis Outcome Score) which is a questionnaire-based patient-reported measure of pain.

Key highlights from the Cartilage publication:

In practice, these results mean that two years after treatment, the

repaired cartilage appears very close to normal, healthy cartilage based on objective MRI assessment. Importantly, the imaging shows ongoing

tissue maturation over time, supporting the durability of the repair.

"We believe, these outcomes position GelrinC among the most advanced

cartilage repair solutions, demonstrating near-complete long-term morphologic restoration," said Dr. Ehud Geller, Executive Chairman

of Regentis. "We are grateful to Prof. Siegfried Trattnig and Dr. Markus Schreiner for their leadership and rigorous analysis reflected

in this peer-reviewed publication. When we benchmark the few competitor MOCART results, GelrinC far outperforms them."

GelrinC is currently being evaluated in a pivotal Phase III U.S. Food

and Drug Administration investigational device exemption (IDE) study designed to support a future premarket approval (PMA) submission,

with 80 patients and two-year follow-up as part of the core study design. Regentis has achieved over 50% enrollment.

Regentis' lead product, GelrinC ,

is a cell-free, off-the-shelf hydrogel synchronized erosion and resorbable implant for the treatment of painful injuries to focal articular

knee cartilage. As an innovative regenerative medical product, GelrinC offers an unprecedented solution that gives surgeons and payers

an off-the-shelf, ready to use, simple to perform, reliable, and cost-effective procedure that provides patients with a single, 10-minute

procedure, faster recovery, sustained pain relief, and functional improvement for more than 4 years, based on clinical study results

to date. No effective off-the-shelf, ready to use treatment for focal knee cartilage defects is currently available on the market. GelrinC

has CE Mark approval in the European Union and is now being evaluated in a pivotal U.S. Food and Drug Administration (FDA) study, which

has completed over 50% enrollment.

About Regentis Biomaterials

Regentis Biomaterials Ltd is a regenerative medicine company dedicated

to developing innovative tissue repair solutions that restore health and enhance quality of life. With an initial focus on orthopedic

treatments, Regentis' Gelrin platform technology, based on synchronized, degradable hydrogel implants, regenerates damaged or diseased

tissue including inflamed cartilage and bone. Regentis' lead product GelrinC, is a cell-free, off-the-shelf hydrogel that is eroded

and resorbed in the knee, allowing the surrounding cells to regenerate the cartilage in a controlled and synchronous process. GelrinC

aims to address a market of approximately 470,000 cases for cartilage knee repair annually in the U.S. where no off-the-shelf treatment

Forward Looking Statements

This press release contains "forward-looking statements"

that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press

release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words

such as "anticipate," "believe," "contemplate," "could," "estimate," "expect,"

"intend," "seek," "may," "might," "plan," "potential," "predict,"

"project," "target," "aim," "should," "will" "would," or the negative

of these words or other similar expressions, although not all forward-looking statements contain these words, and include beliefs regarding

Regentis' market positioning. Forward-looking statements are based on Regentis' current expectations and are subject to inherent

uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions

as to future events that may not prove to be accurate. Factors that may affect future results and may cause these forward-looking statements

to be inaccurate include, without limitation: the ability of our clinical trials to demonstrate safety and efficacy of GelrinC or any

future product candidate, and other positive results; the timing and focus of our preclinical studies and clinical trials, and the reporting

of data from those studies and trials; the size of the market opportunity for of GelrinC or any future product candidate, including our

estimates of the number of patients who suffer from the diseases we are targeting; our ability to accurately identify demand for product

candidates; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and

therapeutic effects of our product candidates; our ability to obtain FDA approval for of GelrinC or any future product candidate and obtain

and maintain regulatory approval; our ability to obtain market acceptance of GelrinC or any future product candidate from the medical

community and third-party payors; our plans relating to the further development of GelrinC or any future product candidate, including

additional disease states or indications we may pursue; existing regulations and regulatory developments in the United States and other

jurisdictions; our plans and ability to obtain or protect intellectual property rights, including extensions of patent terms where available

and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability

to attract and retain such personnel; our estimates regarding expenses, future revenue, capital requirements and needs for additional

financing; our dependence on third parties; our financial performance and our ability to repay our loans and debts; and our ability to

negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter and perform our obligations under

such collaborations. For a more detailed description of the risks and uncertainties affecting Regentis, reference is made to the Company's

reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not limited to, the risks

detailed in the section titled "Risk Factors" in the final prospectus related to the public offering filed with the SEC. Forward-looking

statements contained in this announcement are made as of this date, and Regentis undertakes no duty to update such information except

as required under applicable law.