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

Rhea-AI Summary

Regentis Biomaterials (NYSE:RGNT) appointed Ori Gon as Chief Financial Officer and Chief Business Officer, effective immediately, to lead commercial, business development and financial strategy.

GelrinC holds CE Mark in Europe and is at the midpoint of a pivotal FDA Phase III trial in the U.S., as the company readies for European commercial launch.

Positive

• GelrinC holds a CE Mark and is advancing toward European commercialization
• GelrinC is at the midpoint of a pivotal FDA Phase III trial in the U.S.
• New CFO Ori Gon has led financings raising $150 million in aggregate
• Appointment combines financial leadership and commercial business development under one executive

Negative

• None.

Key Figures

Phase II MOCART score: 88.8/100 Pivotal trial size: 80 patients Enrollment level: >50% enrollment +5 more

8 metrics

Phase II MOCART score 88.8/100 24‑month Phase II GelrinC MRI durability results

Pivotal trial size 80 patients U.S. pivotal Phase III IDE study for GelrinC

Enrollment level >50% enrollment Pivotal FDA trial for GelrinC

U.S. addressable cases >470,000 annually U.S. cartilage knee repair cases targeted by GelrinC

Procedure time ~10-minute procedure Off-the-shelf GelrinC implant application

IPO shares sold 1,250,000 shares Initial public offering completed Dec 5, 2025

IPO price $8.00 per share Initial public offering pricing

IPO gross proceeds $10,000,000 Aggregate gross proceeds before discounts and expenses

Market Reality Check

Price: $5.80 Vol: Volume 5,744 is only 0.13...

low vol

$5.80 Last Close

Volume Volume 5,744 is only 0.13x the 20-day average of 42,925, suggesting limited pre-news positioning. low

Technical Shares at $5.81 are trading below the $6.75 200-day MA and about 30.42% below the 52-week high of $8.35.

Previous Clinical trial Reports

1 past event · Latest: Jan 29 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Jan 29	Clinical site expansion	Positive	-4.8%	Expanded U.S. Phase III GelrinC clinical site network to accelerate enrollment.

Pattern Detected

The only prior clinical-trial-tagged news saw a negative price reaction despite operationally positive content.

Recent Company History

Over recent months, Regentis focused on advancing GelrinC. A Dec 2025 IPO raised capital to fund the pivotal trial and PMA preparation. Subsequent updates highlighted long‑term MRI durability data and expansion of the U.S. Phase III site network, with enrollment surpassing 50% and a U.S. addressable market of >470,000 knee repair cases annually. That clinical‑trial expansion news on Jan 29, 2026 coincided with a -4.81% move, contrasting positive operational progress with a negative price reaction.

Historical Comparison

clinical trial

-4.8 %

Average Historical Move

Historical Analysis

Clinical‑trial news for RGNT has, on average, moved the stock -4.81%. Today’s leadership appointment still centers on the same pivotal GelrinC program, so investors may compare it to that prior reaction.

Typical Pattern

Tag-matched history shows continued execution around the pivotal U.S. Phase III GelrinC trial, progressing from site network expansion and >50% enrollment toward commercialization planning.

Market Pulse Summary

This announcement adds experienced financial and business leadership as GelrinC advances with CE Mar...

Analysis

This announcement adds experienced financial and business leadership as GelrinC advances with CE Mark in Europe and a pivotal U.S. Phase III trial already >50% enrolled. Recent history includes durable 24‑month MRI data with a MOCART score of 88.8/100 and expansion of the U.S. site network targeting >470,000 annual knee repair cases. Investors may watch trial milestones, commercialization steps, and capital deployment following the $10,000,000 IPO.

Key Terms

ce mark, phase iii, mri, pma, +1 more

5 terms

ce mark regulatory

"GelrinC, the only restorative product for knee cartilage repair, has CE Mark approval"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

phase iii medical

"currently at the midpoint of a pivotal FDA Phase III trial in the U.S."

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

mri medical

"long-term MRI data from a completed European trial of GelrinC"

Magnetic resonance imaging (MRI) is a medical scan that uses magnetic fields and radio waves to create detailed pictures of the inside of the body, like a high-resolution camera for tissues and organs. Investors care because MRI drives demand for imaging machines, hospital services, diagnostics and can be central to clinical trial results and regulatory decisions—changes in MRI use or technology can affect revenue, capital spending and reimbursement in healthcare and medical device markets.

pma regulatory

"including completion of the pivotal trial and PMA preparation for GerlinC"

PMA stands for Premarket Approval, the U.S. Food and Drug Administration’s highest-level review for high-risk medical devices. It’s a thorough evaluation to confirm a device is safe and effective before it can be sold, like a final safety inspection and license to operate. Investors care because receiving PMA can open a significant revenue stream, while delays or rejection can postpone sales and reduce a company’s value.

ide regulatory

"GelrinC is in a pivotal U.S. Phase III IDE study with 80 patients"

An IDE (Investigational Device Exemption) is a regulatory permission that allows a company to test an unapproved medical device in human clinical trials to gather safety and effectiveness data. Think of it as a temporary road permit for a new product: getting the IDE moves a technology from concept toward approval and market access, which can reduce uncertainty and increase value for investors, while delays or denials raise development risk and potential costs.

AI-generated analysis. Not financial advice.

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 / ACCESS Newswire / 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

SOURCE: Regentis Biomaterials Ltd

View the original press release on ACCESS Newswire

FAQ

Who is the new CFO and Chief Business Officer of Regentis (RGNT)?

The new CFO and Chief Business Officer is Ori Gon, effective immediately. According to the company, he brings over 15 years of financial leadership and experience across medtech and public company finance, including roles at Tactile Mobility and ReWalk Robotics.

What is the regulatory status of GelrinC for knee cartilage repair (RGNT)?

GelrinC currently holds a CE Mark in Europe, enabling commercialization there. According to the company, GelrinC is the only restorative product for knee cartilage repair mentioned and is progressing through a pivotal U.S. FDA Phase III trial.

What progress has Regentis (RGNT) reported on the U.S. FDA Phase III trial for GelrinC?

Regentis reports GelrinC is at the midpoint of a pivotal FDA Phase III trial in the United States. According to the company, the trial continues as GelrinC advances toward potential regulatory milestones and commercialization plans.

How will Ori Gon's appointment affect Regentis' commercial plans for GelrinC (RGNT)?

The appointment is intended to strengthen commercial and business development efforts as GelrinC approaches launch in Europe. According to the company, Gon will lead strategic partnerships and financial planning to support revenue-generation efforts.

What capital markets experience does the new Regentis CFO (RGNT) bring?

Ori Gon has led multiple secondary public offerings and financings totaling $150 million in aggregate. According to the company, his background includes CFO and controller roles and a CPA qualification in Israel.