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 February 4, 2026, titled “Regentis Biomaterials Appoints Ori Gon as Chief
Financial Officer and Chief Business Officer as GelrinC Progresses Towards Commercial Launch in Europe and Advances in U.S. Phase III
FDA Trial.”
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 Biomaterials Appoints Ori
Gon as Chief Financial Officer and Chief Business Officer as GelrinC Progresses Towards Commercial Launch in Europe and Advances in U.S.
Phase III FDA Trial
GelrinC, the only restorative product
for knee cartilage repair, has CE Mark approval in Europe and is currently at the midpoint of a pivotal FDA Phase III trial in the U.S.
Ori Gon brings substantial public
company, medtech, and capital markets experience
Herzliya, Israel, February 4, 2026— Regentis Biomaterials Ltd.,
(“Regentis” or the “Company”) (NYSE American: RGNT), a regenerative medicine company focused on innovative tissue
repair solutions, today announced the appointment of Ori Gon as Chief Financial Officer and Chief Business Officer, effective immediately.
Mr. Gon will lead the Company’s commercial and business development activities, as well as its financial strategy, planning, and
reporting.
Mr. Gon joins Regentis at a pivotal time as GelrinC®,
the Company’s proprietary hydrogel implant for knee cartilage repair, advances towards commercial launch in Europe following CE
Mark approval and is being evaluated in a pivotal Phase III FDA clinical trial in the United States.
“Ori’s appointment significantly
strengthens our leadership team as we transition from a development-stage company toward commercialization,” said Dr. Ehud Geller,
Executive Chairman of Regentis. “His deep experience as a public company CFO, combined with his strategic business development
expertise, will be instrumental as we evaluate strategic partnerships to launch GelrinC® in Europe and build the foundation
for sustainable, revenue-generating growth.”
Mr. Gon brings over 15 years of financial leadership experience across
public and private enterprises and medical technology. Most recently, he served as CFO at Tactile Mobility, a sensing and data analytics
company focused on advanced automotive and mobility applications. Prior to that, he held senior financial leadership roles at ReWalk Robotics,
Inc., now Nasdaq-listed Lifeward Ltd., a pioneer in wearable robotic exoskeletons for individuals with lower limb disabilities, where
he served as CFO and Corporate Controller. Earlier in his career, he was Controller at On Track Innovations Ltd., a Nasdaq- and Neuer
Markt-listed fintech company. He began his professional career as an auditor at KPMG Israel.
Mr. Gon has led multiple secondary public offerings and financing transactions
across various structures, raising over $150 million in aggregate capital. He is a Certified Public Accountant (CPA) in Israel.
“I am excited to join Regentis at such
an important inflection point,” said Ori Gon. “With GelrinC® approaching commercialization in Europe and progressing
through a pivotal FDA trial in the U.S., we believe Regentis is uniquely positioned to transform the treatment landscape for knee cartilage
repair. I look forward to working with the team to execute our commercial strategy, build strategic partnerships, and create long-term
value for patients and stakeholders.”
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
Regentis’ advancement towards commercialization. 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
