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Regentis Biomaterials (NYSE American: RGNT) wins EU okay for 400% GelrinC yield

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Rhea-AI Filing Summary

Regentis Biomaterials Ltd. received approval from a European Notified Body to manufacture GelrinC using a new solvent-free process that increases production yield by approximately 400% and delivers five times more product from the same volume ahead of its European commercial launch.

The next-generation process lowers manufacturing costs, improves occupational and environmental safety, and is designed for scalable commercial production, with clinical testing validating consistent product quality and clinical performance. GelrinC is an off-the-shelf, cell-free hydrogel implant for focal knee cartilage repair, performed in a single 10-minute procedure and positioned as an alternative to microfracture and complex cell-based therapies in a U.S. market valued at $3 billion. GelrinC already holds CE Mark approval in Europe and is being introduced through Centers of Excellence and surgeon training programs, while a pivotal FDA study in the United States has completed over 50% enrollment to support potential future regulatory clearance.

Positive

  • European Notified Body approval for a new solvent-free GelrinC manufacturing process that increases production yield by approximately 400%, delivers five times more product from the same volume, lowers manufacturing costs and supports scalable commercial production ahead of the European launch.

Negative

  • None.
Production yield increase approximately 400% Increase in GelrinC output from new solvent-free manufacturing process
Production multiple five times more product GelrinC units delivered from the same manufacturing volume using new process
U.S. cartilage repair market size $3 billion Market value for knee cartilage repair therapies in the U.S. alone
GelrinC procedure duration 10-minute Time required to perform the GelrinC knee cartilage repair procedure
Clinical benefit duration more than 5 years Sustained pain relief and functional improvement seen in clinical study results
FDA pivotal study enrollment over 50% enrollment Enrollment progress in U.S. FDA pivotal study of GelrinC
Annual U.S. cartilage repair cases approximately 470,000 cases Estimated annual focal knee cartilage repair cases in the United States
European Notified Body regulatory
"received approval from the European Notified Body to manufacture GelrinC"
A European notified body is an independent, accredited organization that checks whether medical devices, certain medicines' manufacturing processes, or other regulated products meet European safety and quality rules before they can be sold in EU markets. For investors, their approvals act like a gatekeeper: a product needs a notified body’s green light to gain access to large European markets, so delays, refusals or changes in their standards can directly affect a company’s sales, timelines and regulatory risk.
solvent-free manufacturing process technical
"to manufacture GelrinC using its next-generation solvent-free manufacturing process"
CE Mark approval regulatory
"GelrinC® has CE Mark approval in the European Union"
CE mark approval is a declaration that a product meets European safety, health and performance requirements and may be placed on the market in the European Economic Area; for regulated items such as medical devices this follows required testing or a conformity assessment. Think of it as a passport or safety sticker that opens access to European customers; for investors it reduces regulatory roadblocks and can materially expand addressable market and revenue potential, though it is not a guarantee of commercial success.
pivotal U.S. Food and Drug Administration (FDA) study regulatory
"now being evaluated in a pivotal U.S. Food and Drug Administration (FDA) study"
hydrogel implant medical
"an off-the-shelf cell-free hydrogel implant designed to regenerate cartilage"
A hydrogel implant is a soft, water-containing medical device made from a jelly-like polymer that is placed into the body to replace or support tissue, cushion structures, or slowly release medicines. For investors it matters because these implants can open new treatment markets or revenue streams but also carry clinical trial, regulatory approval, manufacturing and reimbursement risks; think of it as a sponge-like patch inside the body whose success depends on safety, effectiveness and adoption.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FAQ

What regulatory milestone did Regentis Biomaterials (RGNT) achieve for GelrinC in Europe?
Regentis Biomaterials received European Notified Body approval for a new solvent-free GelrinC manufacturing process. The upgrade boosts production yield by approximately 400%, delivering five times more product from the same manufacturing volume ahead of European commercial launch.

How does the new GelrinC manufacturing process benefit Regentis Biomaterials (RGNT)?
The new solvent-free process increases production yield by about 400%, delivering five times more units per batch. It also lowers manufacturing costs, improves occupational and environmental safety, and is designed for scalable commercial production to support broader GelrinC availability.

What clinical and safety profile does GelrinC from Regentis Biomaterials (RGNT) offer?
GelrinC is a cell-free, off-the-shelf hydrogel implant used in a single 10-minute procedure for focal knee cartilage repair. Clinical data show faster recovery, sustained pain relief and functional improvement for more than 5 years, with consistent quality from the new process.

How large is the target market for GelrinC from Regentis Biomaterials (RGNT)?
GelrinC targets a focal knee cartilage repair market valued at about $3 billion in the U.S. alone. The company estimates approximately 470,000 cases annually in the U.S., where no off-the-shelf, ready-to-use treatment for these cartilage defects is currently available.

What is the U.S. regulatory status of GelrinC for Regentis Biomaterials (RGNT)?
GelrinC is being evaluated in a pivotal U.S. FDA study that has completed over 50% enrollment. The trial is intended to demonstrate safety and efficacy in support of potential future FDA approval, complementing existing CE Mark approval in the European Union.

 

 

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 July 2026

 

Commission file number: 001-42834

 

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 July 15, 2026, Regentis Biomaterials Ltd. issued a press release entitled “Regentis Receives European Regulatory Approval for New GelrinC Manufacturing Process, Increasing Production Yield by 400% Ahead of European Commercial Launch.” 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 July 15, 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: July 15, 2026 By: /s/ Ori Gon
  Name:  Ori Gon
  Title: Chief Financial Officer

 

 

 

2

 

 

Exhibit 99.1

 

Regentis Receives European Regulatory Approval for New GelrinC Manufacturing Process, Increasing Production Yield by 400% Ahead of European Commercial Launch

 

European Notified Body approves next-generation manufacturing process that increases production

5-fold, lowers manufacturing costs, improves safety and enables scalable commercial production

 

GelrinC®, which is approved for sale in the European Union, is pioneering knee cartilage repair with an off-the-shelf cell-free hydrogel implant

 

HERZLIYA, Israel, July 15, 2026 - Regentis Biomaterials Ltd. (“Regentis” or the “Company”) (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, announced today it has received approval from the European Notified Body to manufacture GelrinC® using its next-generation solvent-free manufacturing process.

 

The approval comes as Regentis prepares for the commercial launch of GelrinC® in Europe, enabling the Company to manufacture commercial product using a process that increases production yield by approximately 400%, delivering five times more product from the same manufacturing volume while improving manufacturing efficiency and scalability. The solvent-free process also improves occupational and environmental safety. Extensive clinical testing of the new manufacturing process has validated consistent production quality and clinical performance.

 

“This approval represents an important commercial milestone for Regentis as we prepare to bring GelrinC® to orthopedic surgeons across Europe,” said Dr. Ehud Geller, CEO and Executive Chairman of Regentis. “Our new manufacturing process substantially improves production efficiency while maintaining the same product quality and clinical performance. Receiving European regulatory approval now allows us to move into commercialization with a manufacturing platform that is substantially more efficient, more scalable and better suited to support long-term global growth.”

 

GelrinC® is a proprietary, cell-free, ready-to-use hydrogel implant designed to regenerate durable, healthy cartilage through a synchronized erosion process. Unlike cell-based cartilage repair procedures that require tissue harvesting, laboratory processing and multiple surgeries. The 10-minute GelrinC procedure offers a safe and effective alternative to traditional microfracture and complex cell-based therapies addressing a market valued at $3 billion, in the U.S. alone.

 

The product has already received CE Mark approval in Europe and is being prepared for commercial introduction through Regentis’ expanding network of European Centers of Excellence, surgeon training programs and collaborations with leading orthopedic institutions, including Humanitas Research Hospital in Milan.

 

 

 

 

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. To the Company’s knowledge, there is no effective off-the-shelf, ready to use treatment for focal knee cartilage defects that 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, as amended on February 27, 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:

 

Ori@regentis.co.il

 

 

 

 

 

Source: View Original Filing on SEC EDGAR

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