Indicate by check mark whether the registrant
files or will file annual reports under cover of Form 20-F or Form 40-F.
Attached hereto and incorporated
herein is the registrant’s press release issued on January 29, 2026, titled “Regentis Expanding Pivotal Phase III GelrinC
Clinical Site Network: Adding Several Leading Orthopedic Centers Across the U.S.”
A copy of the press release
is furnished herewith as Exhibit 99.1 and incorporated herein by reference.
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
Exhibit 99.1
Regentis Expanding Pivotal Phase
III GelrinC Clinical Site Network: Adding Several Leading Orthopedic Centers Across the U.S.
New sites expected to further accelerate patient
enrollment, which surpassed 50% in Phase III study, as well as support future clinical programs
GelrinC is set to transform cartilage repair
market with off-the-shelf regenerative products
Herzliya, Israel, January 29, 2026— Regentis
Biomaterials Ltd., (“Regentis” or the “Company”) (NYSE American: RGNT), a regenerative medicine company focused
on innovative tissue repair solutions, today announced the expansion of its U.S. clinical site network, further strengthening its infrastructure
to support its ongoing pivotal Phase III study of GelrinC® for knee cartilage repair as well as future clinical programs.
“Building on our existing clinical collaborations, we are adding
several new, highly regarded academic and clinical orthopedic centers to our network,” stated Dr. Ehud Geller, Executive Chairman
of Regentis. “This expansion is designed to further accelerate patient enrollment, increase the efficiency of our clinical strategy,
leverage leading orthopedic expertise, and generate robust clinical data to support product development and future commercialization efforts
following our company’s recent IPO.”
GelrinC® is approved for knee
cartilage repair in the European Union and is currently at midpoint in a pivotal FDA trial for the same indication to address a U.S.
market of more than 470,000 potential cases annually.
The expanded clinical site network brings together leading orthopedic
surgeons and institutions with strong experience in cartilage repair, joint preservation, and sports medicine, ensuring high-quality clinical
execution and data generation.
Among the Participating Clinical Sites being added are:
| ● | NYU Langone Orthopedic & Sports Medicine, New York, NY |
A world-class academic orthopedic center consistently ranked among
the top programs in the United States, known for surgical excellence and innovation. Dr. Laith Jazrawi is a leading authority in cartilage
repair and joint preservation, bringing extensive academic leadership and clinical trial experience.
| ● | The Ohio State University Wexner Medical Center, Columbus, OH |
A premier academic health system with a high-volume orthopedic department
and strong translational research capabilities. Dr. David Flanigan is an internationally recognized surgeon-scientist specializing in
knee reconstruction and cartilage restoration.
| ● | University of Cincinnati Medical Center, Cincinnati, OH |
A respected academic medical center integrating advanced orthopedic
care with outcomes-driven research. Dr. Brian Grawe is known for his expertise in cartilage preservation and rigorous clinical research
methodology.
| ● | Loyola Medicine Orthopedic, Maywood, IL |
An academic clinical program emphasizing innovation in joint preservation
and participation in multicenter clinical studies. Dr. John Miller contributes deep clinical insight in cartilage and meniscal pathology.
| ● | Tulane University School of Medicine – Orthopedics, New Orleans, LA |
A distinguished academic institution with a long history of impactful
musculoskeletal research and interdisciplinary collaboration, providing strong academic depth and research infrastructure.
| ● | UNC Orthopedics, University of North Carolina, Chapel Hill, NC |
A nationally recognized academic orthopedic department with a strong
focus on clinical research and outcomes science. Prof. Joe Hart brings leadership in musculoskeletal research and experience in joint
preservation studies.
| ● | Rush University Medical Center, Chicago, IL |
A top-tier academic medical center widely recognized for orthopedic
innovation and evidence-based care. Dr. Adam Yanke is a leading expert in cartilage regeneration and knee preservation, contributing both
surgical and research excellence.
About GelrinC
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
is available.
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
the expansion of the Company’s clinical site network. 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 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.
Contact:
acarlquist@medicavp.com
