Regentis Biomaterials Granted New U.S. Patent for its Off-the-Shelf Regenerative Cartilage Repair Product GelrinC

Rhea-AI Summary

Regentis Biomaterials (NYSE:RGNT) received a U.S. patent titled "Organic Solvent Free Compositions Compromising Protein-Polymer Conjugates and Uses Thereof" for its lead product GelrinC, covering the liquid, ready-to-use formulation and solvent-free production processes.

The patent protects the liquid GelrinC that cures with UV into a temporary elastomeric implant, supports an ~10-minute procedure, and extends protection through 2038 with potential future extensions. Regentis reports a 35‑patent global portfolio and says it has surpassed 50% enrollment in its pivotal FDA trial; GelrinC also has regulatory approval in the EU.

Positive

• U.S. patent issued for GelrinC liquid formulation
• Protection through 2038 with potential extensions
• 50%+ enrollment reached in pivotal FDA trial
• Regulatory approval in EU for GelrinC
• 35 issued patents in global IP portfolio

Negative

• None.

Key Figures

Pivotal trial enrollment 50% GelrinC pivotal U.S. FDA trial

Patent term 2038 GelrinC U.S. patent protection through 2038

Issued patents 35 patents Worldwide issued patents in Regentis IP portfolio

U.S. patents 9th U.S. patent Most recent GelrinC-related U.S. patent

Procedure time 10-minute procedure Approximate duration of GelrinC knee cartilage repair

IPO shares 1,250,000 shares Ordinary shares sold in IPO at $8.00

IPO price $8.00 per share Regentis IPO offering price

IPO gross proceeds $10,000,000 Aggregate gross proceeds from IPO before expenses

Market Reality Check

$6.40 Last Close

Volume Volume 3,181 vs 20-day average 51,360 (relative volume 0.06), indicating subdued trading ahead of this news. low

Technical Price $6.15 is trading below the 200-day MA at $7.03 and 20.11% below the 52-week high.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 05	IPO completion	Neutral	-2.1%	Closed IPO raising $10M with over-allotment option following NYSE American listing.

Pattern Detected

Limited history: post-IPO trading showed a mild negative reaction to the offering announcement; no clear pattern yet for operational news.

Recent Company History

In early December 2025, Regentis completed its IPO, issuing 1,250,000 shares at $8.00 for gross proceeds of $10,000,000, with an additional 187,500-share over-allotment option. The stock fell 2.14% in the first session after that event. Today’s announcement adds an issued U.S. patent protecting GelrinC’s liquid formulation through 2038, alongside progress past 50% enrollment in its pivotal FDA trial, extending the company’s IP and clinical execution story shortly after listing.

Market Pulse Summary

This announcement strengthens Regentis’ position by adding a new U.S. patent covering GelrinC’s liquid, ready-to-use formulation, extending protection through 2038 within a portfolio of 35 issued patents. The company reported surpassing 50% enrollment in its pivotal FDA trial for knee cartilage repair. Together with IPO proceeds of $10,000,000 earlier in 2025, investors can track trial completion, further IP grants, and regulatory milestones as key markers of execution risk and opportunity.

Key Terms

off-the-shelf medical

"world's first off-the-shelf regenerative treatment for knee cartilage repair"

Off-the-shelf describes products, software, medical devices, or solutions that are commercially available and ready to use without custom design or development. Investors care because off-the-shelf items typically cost less and reach the market faster than bespoke alternatives, reducing project risk and expense; like buying a ready-made appliance instead of commissioning a custom-built one, they offer predictable performance and clearer regulatory and cost forecasts.

pivotal trial medical

"GerlinC is in a pivotal FDA trial, has received regulatory approval"

A pivotal trial is a key test of a new medicine or treatment to see if it works and is safe enough to be approved by health authorities. It's like a final exam for a new product, and passing it is essential for bringing the treatment to the public.

uv light technical

"and is then cured using UV light to form an elastomeric"

Ultraviolet (UV) light is invisible radiation from the sun and artificial lamps that sits just beyond the visible color spectrum; think of it as a higher-energy version of the light you see. Investors care because UV is used as a practical tool for disinfecting surfaces, treating water, curing inks and coatings, and in medical devices, which can create market demand, regulatory scrutiny, safety requirements and product durability issues that affect sales and costs.

organic solvents technical

"improved processes for its production that avoid the use of organic solvents"

Organic solvents are liquid chemicals, often derived from carbon-based compounds, used to dissolve, thin or carry other substances in manufacturing, cleaning, or laboratory processes—think of them as the liquid equivalent of a universal paint thinner. They matter to investors because their use influences production costs, product quality, workplace safety, regulatory compliance and environmental liability, all of which can affect a company’s profitability and legal risk.

patent regulatory

"the U.S. Patent and Trademark Office has issued the Company a patent titled"

A patent is a government-granted right that gives an inventor exclusive control to make, use, sell or license a specific invention for a limited time, usually in exchange for publicly describing how it works. For investors it matters because a patent can act like a time-limited lock on a product or process — reducing competition, protecting future sales or licensing income, and often increasing a company’s value, while still being defeasible, time-bound and subject to legal challenge.

AI-generated analysis. Not financial advice.

Patent protects ready to use liquid formulation of GerlinC which improves efficiency and focus for surgeons, resulting in a 10-minute procedure

Robust IP portfolio includes 35 issued patents to date worldwide

GerlinC is in a pivotal FDA trial, has received regulatory approval in the EU, and is the world's first off-the-shelf regenerative treatment for knee cartilage repair

HERZLIYA, IL / ACCESS Newswire / December 18, 2025 / Regentis Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced that the U.S. Patent and Trademark Office has issued the Company a patent titled "Organic Solvent Free Compositions Compromising Protein-Polymer Conjugates and Uses Thereof" for its lead product, GerlinC^®, addressing the liquid, ready to use version of the product, as well as improved processes for its production that avoid the use of organic solvents.

This patent's primary claims are focused around GelrinC's liquid ready-to-use formulation, reflecting Regentis' focus on simplifying procedures for surgeons while improving patient experience. GelrinC is delivered in liquid form to conform precisely to the geometry of the cartilage wound and is then cured using UV light to form an elastomeric, temporary, programmed implant. The straightforward, approximately 10-minute procedure eliminates complex preparation steps and distractions for surgeons and enables a brief, convenient office visit for patients.

"This most recent patent, our ninth in the U.S., comes at an important time as we recently surpassed 50% enrollment in our pivotal U.S. Food and Drug Administration ("FDA") trial for GelrinC in the treatment of knee cartilage repair," stated Regentis' Executive Chairman, Dr. Ehud Geller. "The patent provides broad protection for GelrinC through 2038, with the potential for additional extensions tied to future innovations. Our IP strategy pairs continuous patenting of new innovations with broadly drafted claims that strengthen and extend protection around our platform's core technology."

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 the potential for extending Regentis' patent estate. 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

What does the new U.S. patent mean for Regentis (RGNT) shareholders?

The patent secures intellectual property around GelrinC's liquid formulation and processes, extending protection through 2038, which may strengthen competitive position.

How far along is GelrinC's FDA pivotal trial for RGNT and why does it matter?

Regentis reports it has surpassed 50% enrollment in the pivotal U.S. FDA trial, a milestone that advances the path toward potential U.S. approval.

What is GelrinC's procedure time and how might that affect adoption?

GelrinC's liquid, ready-to-use format is designed for an approximately 10-minute procedure, which may simplify surgeon workflow and improve outpatient convenience.

Does GelrinC already have any regulatory approvals outside the U.S. for RGNT?

Yes, GelrinC has received regulatory approval in the EU.

How extensive is Regentis' patent portfolio for GelrinC and related tech?

The company cites a global IP portfolio of 35 issued patents to date, including this ninth U.S. patent.