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Regentis Receives Japanese Patent allowance, Strengthening its Global GelrinC Intellectual Property Portfolio with New Proprietary Manufacturing Technology

(Very Positive)
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Regentis (NYSE American: RGNT) announced that the Japan Patent Office has issued a Notice of Allowance for a patent covering its proprietary organic solvent-free manufacturing process and ready-to-use liquid formulation used in GelrinC, its regenerative hydrogel treatment for focal articular knee cartilage injuries.

The allowed patent protects protein‑polymer conjugate compositions and methods that eliminate organic solvents while enabling stable liquid formulations, delivering about a 5x increase in manufacturing yield, improved environmental profile, simplified production and scalability. According to Regentis, this strengthens its global IP portfolio as it prepares GelrinC’s European commercial launch, advances a pivotal U.S. FDA trial with over 50% enrollment, and evaluates additional international markets. GelrinC holds CE Mark approval, targets a Japanese cartilage repair market projected near $289 million by 2030, and addresses a U.S. opportunity of about 470,000 knee cartilage repair cases annually where no off‑the‑shelf treatment is available.

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Positive

  • Japanese patent allowance for GelrinC solvent-free manufacturing technology
  • Manufacturing process delivers about 5x increase in yield
  • GelrinC holds CE Mark approval in the European Union
  • Pivotal U.S. FDA study of GelrinC has over 50% enrollment
  • Japanese cartilage repair market projected near $289 million by 2030
  • GelrinC targets approximately 470,000 U.S. knee cartilage repair cases annually

Negative

  • None.

Market reaction after Japanese patent allowance: RGNT -15.97% in the Jul 20 session

-15.97% 1.6x vol
21 alerts
-15.97% Session close to close
+6.2% Peak Tracked
-32.5% Trough Tracked
$16.72M Market Cap
1.6x Rel. Volume

In the Jul 20 session, RGNT declined 15.97%, reflecting a significant negative market reaction. Argus tracked a peak move of +6.2% during that session. Argus tracked a trough of -32.5% from its starting point during tracking. Our momentum scanner triggered 21 alerts that day, indicating elevated trading interest and price volatility. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -16.0% in the session following this news. A comparable July 15 European manufactu...
Analysis

The stock dropped -16.0% in the session following this news. A comparable July 15 European manufacturing-process announcement recorded -4.33% over 24 hours. The current patent allowance adds jurisdictional protection, but that precedent documents reaction variability; the platform also shows RGNT had low short positioning.

Key Figures

Procedure Duration: ~10 minutes Manufacturing Yield: 5x increase Japanese Cartilage Repair Market: Nearly $289 million +5 more
8 metrics
Procedure Duration ~10 minutes GelrinC treatment procedure
Manufacturing Yield 5x increase Proprietary manufacturing technology
Japanese Cartilage Repair Market Nearly $289 million Projected by 2030
Japanese Radiographic Knee Osteoarthritis Approximately 25 million people People over age 40 in Japan
Japanese Symptomatic Knee Osteoarthritis Roughly 8 million patients Patients with symptomatic disease in Japan
Clinical Benefit Duration More than 5 years Pain relief and functional improvement based on clinical results
U.S. Trial Enrollment Over 50% Pivotal FDA study
Annual U.S. Cartilage Repair Cases Approximately 470,000 cases Annual U.S. market opportunity

Historical Context

5 past events · Latest: Jul 15 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 15 Manufacturing approval Positive -4.3% European approval for solvent-free GelrinC manufacturing process and higher production yield
Jun 17 Private placement Negative -9.1% Company priced private placement with shares, warrants, and approximately $6.5 million proceeds
Jun 08 Surgeon training Positive +7.6% European surgeon training planned ahead of GelrinC commercial launch preparations
Apr 16 European partnership Positive +3.2% Humanitas collaboration and Centers of Excellence strategy supported European GelrinC deployment
Mar 17 Manufacturing process Positive +5.9% Solvent-free GelrinC process increased production yield and supported European launch plans

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Comparable positive manufacturing and commercialization announcements produced mostly aligned positive reactions, with one notable divergence.

Key Terms

notice of allowance, organic solvent-free, protein-polymer conjugates, cell-free hydrogel, +2 more
6 terms
notice of allowance regulatory
"Japan Patent Office has issued a Notice of Allowance"
A notice of allowance is an official confirmation from a patent office that a patent application has met all necessary requirements and is approved for granting. It signals that the invention is likely to receive legal protection soon, which can be important for investors considering the value and exclusivity of a new product or technology. Think of it as a green light indicating that the invention is on track to become legally protected.
organic solvent-free technical
"its proprietary organic solvent-free manufacturing process"
A production or manufacturing process described as organic solvent-free uses no volatile organic solvents (like hexane, toluene, or ethanol) to dissolve, extract, or carry chemicals; instead it relies on water, mechanical means, supercritical fluids, or solventless techniques. For investors, this signals potential regulatory, safety, cost, and environmental implications—similar to replacing an open fire with an electric stove, it can reduce cleanup, permits, worker risks, and liability but may require different equipment or processes.
protein-polymer conjugates technical
"Organic Solvent Free Compositions Comprising Protein-Polymer Conjugates"
Proteins chemically linked to synthetic polymers to form hybrid molecules that combine the biological function of the protein with the physical properties of the polymer. Think of it like attaching a protective coat or tag to a tiny biological machine to change its size, stability, solubility, or circulation time. Investors care because these modifications can alter a therapy’s delivery, dosing, manufacturing complexity and regulatory path, which affect development timelines, costs and commercial potential.
cell-free hydrogel medical
"GelrinC is a cell-free, off-the-shelf hydrogel implant"
A cell-free hydrogel is a soft, water-rich polymer scaffold designed to support healing or deliver therapeutic molecules without containing living cells. Think of it as a sponge-like bandage soaked with growth factors or drugs that can be injected or placed in the body to aid tissue repair; for investors it matters because products without live cells often simplify manufacturing, storage and regulatory pathways, which can affect development cost and commercial scalability.
articular cartilage medical
"injuries to focal articular knee cartilage"
A smooth, flexible tissue that covers the ends of bones where they meet in joints, acting like a low-friction bearing and shock absorber so bones glide and share load. It has limited ability to heal, so damage or wear can lead to pain, stiffness and progressive joint disease. Investors care because treatments, implants or diagnostics aimed at protecting, repairing or replacing this tissue drive clinical trials, regulatory decisions and commercial markets in orthopedics and biotech.
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.

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Patent expands intellectual property protection in one of the world's largest cartilage repair markets

GelrinC is a cell-free hydrogel delivered in a single ~10-minute procedure eliminating the need for cell harvesting, lab processing, and surgeries-potentially setting a new standard of care for knee cartilage repair

HERZLIYA, IL / ACCESS Newswire / July 20, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, announced today that the Japan Patent Office has issued a Notice of Allowance for the Company's patent application titled "Organic Solvent Free Compositions Comprising Protein-Polymer Conjugates and Uses Thereof" for its proprietary organic solvent-free manufacturing process and ready-to-use liquid formulation used in GelrinC®, the Company's regenerative treatment for articular cartilage injuries.

The allowance further strengthens Regentis' expanding global intellectual property portfolio supporting GelrinC in the treatment of painful and debilitating injuries to focal articular knee cartilage. This comes as the Company advances commercialization activities in Europe, has surpassed 50% enrollment in its pivotal U.S. trial, and is evaluating opportunities to expand into additional international markets.

"Our proprietary manufacturing technology is a key competitive advantage for GelrinC, and this Notice of Allowance significantly strengthens our intellectual property position in one of the world's most important orthopedic markets," said Ehud Geller, CEO and Executive Chairman of Regentis. "As we prepare for the commercial launch of GelrinC in Europe, expanding patent protection in major international markets reinforces the long-term value of our technology platform and supports future commercialization opportunities."

The allowed patent covers proprietary protein-polymer conjugate compositions and manufacturing methods designed to eliminate the use of organic solvents while enabling stable, ready-to-use liquid formulations. The technology offers important manufacturing advantages, including improved process efficiency - 5x increase in yield, enhanced environmental profile, simplified production, and additional scalability for commercial manufacturing.

The patent complements Regentis' growing worldwide intellectual property portfolio protecting GelrinC across product composition, manufacturing methods and therapeutic applications.

Japan represents one of the world's largest and fastest-growing markets for cartilage repair technologies. Independent market research estimates the Japanese cartilage repair market will grow to nearly $289 million by 2030, driven by an aging population and increasing demand for joint-preserving therapies.

Published research estimates that approximately 25 million people in Japan over the age of 40 have radiographic knee osteoarthritis, including roughly 8 million patients with symptomatic disease, underscoring the growing need for innovative cartilage repair treatments.

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 expand into additional international markets. 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:

ori@regentis.co.il

SOURCE: Regentis Biomaterials Ltd



View the original press release on ACCESS Newswire

FAQ

What does the Japanese patent allowance mean for Regentis (RGNT) and GelrinC?

The Japanese patent allowance secures protection for Regentis’ solvent-free manufacturing and liquid GelrinC formulation. According to Regentis, this strengthens its intellectual property in a key orthopedic market and supports commercialization by safeguarding proprietary compositions, processes, and ready-to-use formulations for knee cartilage repair.

How does Regentis’ new GelrinC manufacturing patent improve production efficiency for RGNT?

The allowed patent covers technology that delivers about a fivefold increase in yield for GelrinC. According to Regentis, the solvent-free, ready-to-use liquid process also simplifies production, enhances environmental profile, and improves scalability for commercial manufacturing of its cartilage repair hydrogel.

What stage is Regentis (RGNT) at with GelrinC clinical development in the United States?

GelrinC is being evaluated in a pivotal U.S. FDA study that has passed 50% enrollment. According to Regentis, this trial builds on existing clinical results showing more than five years of sustained pain relief and functional improvement in focal knee cartilage injuries.

Is GelrinC from Regentis (RGNT) already approved or commercialized in Europe?

GelrinC has CE Mark approval in the European Union for focal knee cartilage repair. According to Regentis, the company is preparing for commercial launch in Europe, leveraging its off-the-shelf, single 10-minute procedure hydrogel implant as a new regenerative treatment option.

How large is the Japanese cartilage repair market relevant to Regentis (RGNT) and GelrinC?

Independent research estimates the Japanese cartilage repair market could reach nearly $289 million by 2030. According to Regentis, around 25 million Japanese over 40 have radiographic knee osteoarthritis, including about 8 million symptomatic patients, highlighting demand for innovative cartilage repair therapies.

What clinical benefits does GelrinC offer patients, according to Regentis (RGNT)?

GelrinC is described as a cell-free, off-the-shelf hydrogel delivered in a single 10-minute procedure. According to Regentis, clinical studies show faster recovery, sustained pain relief, and functional improvement for more than five years in focal articular knee cartilage injuries.

What unmet need in the U.S. knee cartilage repair market is Regentis (RGNT) targeting with GelrinC?

Regentis targets about 470,000 annual U.S. knee cartilage repair cases where no off-the-shelf solution exists. According to Regentis, GelrinC’s ready-to-use, single-procedure hydrogel aims to fill this gap by enabling controlled cartilage regeneration in focal articular knee defects.