Regentis Biomaterials (NASDAQ: RGNT) plans European surgeon training as GelrinC launch nears

Rhea-AI Filing Summary

Regentis Biomaterials Ltd. plans to begin European surgeon training for its GelrinC knee cartilage repair implant in the third quarter of 2026, advancing preparations for commercial rollout in Europe, where the product holds CE Mark approval. Initial hands-on training will occur at Humanitas Research Hospital in Milan, with additional sessions across other European markets. The company is building a network of European Centers of Excellence to support surgeon education, clinical guidance, and knowledge sharing around GelrinC. GelrinC is an off-the-shelf, cell-free hydrogel implant with a roughly 10-minute, single-step procedure, positioned as an alternative to microfracture and complex cell-based therapies. Regentis is targeting an estimated $3 billion U.S. market of about 470,000 annual knee cartilage repair cases, and GelrinC is also being evaluated in a pivotal FDA study that has completed more than 50% of enrollment.

Key Figures

Target market size: $3 billion U.S. market Annual knee cartilage repair cases: 470,000 cases Pain improvement vs microfracture: ≈100% greater pain improvement +4 more

7 metrics

Target market size $3 billion U.S. market Estimated market for knee cartilage repair cases

Annual knee cartilage repair cases 470,000 cases Estimated annual U.S. knee cartilage repair volume

Pain improvement vs microfracture ≈100% greater pain improvement Clinical data compared with standard microfracture

Procedure time 10 minutes Approximate duration of GelrinC implantation procedure

Durability of outcomes More than 5 years Sustained pain relief and functional improvement in studies

FDA pivotal study enrollment Over 50% enrollment Pivotal U.S. study status for GelrinC

Start of EU surgeon training Q3 2026 Planned commencement of European training activities

Key Terms

CE Mark approval, Centers of Excellence, microfracture, pivotal U.S. Food and Drug Administration (FDA) study, +1 more

5 terms

CE Mark approval regulatory

"GelrinC®, positioned as the first off-the-shelf cell-free hydrogel implant for knee cartilage repair, is approved for sale in the European Union"

Centers of Excellence medical

"Regentis is growing its network of European Centers of Excellence designed to support surgeon education"

Centers of excellence are specialized teams or departments within an organization that focus on developing and applying expert knowledge or skills in a particular area. They serve as hubs for best practices, innovation, and high-quality performance, much like a master chef’s kitchen dedicated to perfecting a specific cuisine. For investors, these centers can signal a company’s commitment to excellence and innovation, potentially influencing its long-term success and stability.

microfracture medical

"GelrinC’s 10-minute procedure offers a safe and effective alternative to traditional microfracture and complex cell-based therapies"

A microfracture is a surgical technique used to repair damaged joint cartilage by creating tiny holes in the underlying bone to trigger the body’s natural healing response, like aerating soil so new tissue can grow. It matters to investors because the procedure affects demand for orthopedic devices, implants, biologic treatments and rehabilitation services, influences clinical outcomes and reimbursement decisions, and can shape the commercial prospects of related medical products.

pivotal U.S. Food and Drug Administration (FDA) study regulatory

"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"

forward-looking statements regulatory

"This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

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Form 6-K: How Foreign Companies Report to the SEC →

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

For the month of June 2026

Commission file number: 001-41523

REGENTIS BIOMATERIALS LTD.

(Translation of registrant’s name into English)

60 Medinat Hayehudim Street, 4676652, Israel

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

CONTENTS

On June 8, 2026, Regentis Biomaterials Ltd. issued a press release entitled “Regentis to Commence European Surgeon Training for GelrinC in Knee Cartilage Repair as Commercial Launch Preparations Accelerate.” A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Exhibit Index

Exhibit No.		Description
99.1		Press Release dated June 8, 2026.

1

SIGNATURES

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.

	Regentis Biomaterials Ltd.
Date: June 8, 2026	By:	/s/ Ori Gon
	Name:	Ori Gon
	Title:	Chief Financial officer

2

Exhibit 99.1

Regentis to Commence European Surgeon Training for
GelrinC in Knee Cartilage Repair as Commercial Launch
Preparations Accelerate

GelrinC®, positioned as the first off-the-shelf cell-free hydrogel implant for knee
cartilage repair, is approved for sale in the European Union

Regentis is growing its network of European Centers of Excellence designed to
support surgeon education, clinical guidance, and knowledge sharing around
cartilage repair and the use of GelrinC

GelrinC’s 10-minute procedure offers a safe and effective alternative to traditional
microfracture and complex cell-based therapies addressing a $3 billion U.S. market

HERZLIYA, Israel, June 8, 2026 - Regentis Biomaterials Ltd. (“Regentis” or the “Company”) (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, announced today that in the third quarter of 2026, the Company plans to commence its European surgeon training activities, as it advances preparations for the commercial rollout of GelrinC® in Europe, where it has CE Mark approval.

The hands-on training program is designed to train orthopedic surgeons in the use of GelrinC, providing practical experience with the implantation procedure and supporting physician readiness ahead of market launch. The first training activities are expected to take place in Milan, Italy, at Humanitas Research Hospital, one of Europe’s leading academic medical centers in orthopedics and sports medicine. Additional sessions are planned in other European markets.

GelrinC is a cell-free implant for the treatment of knee cartilage lesions. The procedure utilizes a ready-to-use implant and a straightforward single-step implantation process, which takes approximately 10 minutes, and fits into the surgeon’s workflow.

“The initiation of surgeon training activities represents an important commercial milestone for Regentis in Europe,” said Dr. Ehud Geller, Chief Executive Officer of Regentis. “With commercialization activities now underway, physician training is a critical next step. Building surgeon experience and confidence with GelrinC will support market adoption and help bring this technology to patients throughout Europe.”

As part of its European strategy, Regentis is establishing a network of European Centers of Excellence designed to support surgeon education, clinical guidance, and knowledge sharing around cartilage repair and the use of GelrinC. These centers are intended to serve as leading clinical hubs where experienced orthopedic surgeons will help train and support other physicians across Europe as the technology is introduced into clinical practice.

Regentis is targeting an estimated $3 billion U.S. market of 470,000 annual knee cartilage repair cases, where no approved off-the-shelf regenerative solution currently exists. Clinical data have shown approximately 100% greater pain improvement versus standard of care microfracture, alongside MRI-confirmed regeneration of near-native cartilage and durable multi-year outcomes.

About GelrinC^®

Regentis’ lead product, GelrinC^®, is a cell-free, off-the-shelf hydrogel implant having synchronized erosion and resorption for the treatment of painful and debilitating 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 5 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’ plans to commence European surgeon activities and the timing thereof. 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 our Annual Report on Form 20-F filed with the SEC on February 24, 2026 and other public reports 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

FAQ

What did Regentis Biomaterials (RGNT) announce in this Form 6-K?

Regentis Biomaterials announced plans to start European surgeon training for GelrinC in Q3 2026, supporting its commercial rollout in Europe. Training will begin at Humanitas Research Hospital in Milan and expand to additional European markets as part of a broader commercialization strategy.

What is GelrinC and how is it used in knee cartilage repair?

GelrinC is a cell-free, off-the-shelf hydrogel implant for treating focal knee cartilage lesions using a single-step implantation. The procedure takes about 10 minutes and is designed to fit into standard surgical workflows, offering an alternative to microfracture and complex cell-based therapies.

What regulatory status does GelrinC have in Europe and the United States?

GelrinC has CE Mark approval in the European Union, allowing it to be marketed there. In the United States, it is being evaluated in a pivotal FDA study that has surpassed 50% enrollment, an important step toward potential future regulatory approval if trial results support it.

What market opportunity is Regentis Biomaterials (RGNT) targeting with GelrinC?

Regentis is targeting an estimated $3 billion U.S. market with about 470,000 annual knee cartilage repair cases. The company highlights that no approved off-the-shelf regenerative solution currently exists in this space, positioning GelrinC as a potential new treatment option if fully approved.

What clinical results has GelrinC shown so far according to Regentis?

Regentis reports clinical data showing approximately 100% greater pain improvement versus standard microfracture, MRI-confirmed regeneration of near-native cartilage, and durable outcomes over multiple years. These results come from clinical studies to date and underpin the company’s push toward broader commercialization.

What are Regentis Biomaterials’ plans for European Centers of Excellence?

Regentis is establishing European Centers of Excellence to support surgeon education, clinical guidance, and knowledge sharing for cartilage repair with GelrinC. These hubs are intended to train experienced orthopedic surgeons, who can then support and train additional physicians as the technology enters clinical practice.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED JUNE 8, 2026 12.9 KB