Regentis Biomaterials Secures Key U.S. Patent for GelrinC, Protecting 10-Minute Off-the-Shelf Cartilage Repair Formulation

Regentis Biomaterials Ltd. (NYSE American:RGNT), a regenerative medicine company, announced on December 18, 2025, that the U.S. Patent and Trademark Office (USPTO) has issued a new patent for its flagship product, GelrinC®. The patent protects the ready-to-use liquid formulation of the product, which is designed to streamline the surgical process for knee cartilage repair, allowing for a procedure time of just 10 minutes.

The newly issued patent, titled “Organic Solvent Free Compositions Compromising Protein-Polymer Conjugates and Uses Thereof,” is critical as it addresses the improved production processes for GelrinC® that avoid the use of organic solvents. This technological advancement is expected to enhance manufacturing efficiency and product safety while solidifying the company’s competitive position in the rapidly evolving regenerative medicine sector.

Strategic Importance of the Ready-to-Use Formulation

The core innovation protected by the new U.S. patent lies in the liquid, ready-to-use version of GelrinC®. This formulation is a significant step forward for surgeons, offering improved focus and efficiency in the operating room. The ability to perform the entire regenerative procedure in approximately 10 minutes positions GelrinC® as a highly attractive option compared to more complex or time-consuming cartilage repair techniques.

GelrinC® is recognized as the world's first off-the-shelf regenerative treatment for knee cartilage repair. Its availability as a ready-to-use product eliminates the need for complex preparation steps often associated with biological or cell-based therapies, which typically require specialized handling or lengthy preparation times.

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

Furthermore, the patent’s focus on avoiding organic solvents in production suggests potential benefits related to manufacturing scalability and cost reduction, key factors for commercial success once the product achieves full market clearance.

Regulatory Progress and Robust IP Portfolio

The issuance of this U.S. patent significantly strengthens Regentis’s intellectual property (IP) framework as the company progresses toward potential U.S. market entry. The company confirmed that its IP portfolio is now robust, including 35 issued patents worldwide.

The timing of the patent grant is strategic, coinciding with the product’s advanced regulatory status:

• Pivotal FDA Trial: GelrinC® is currently in a pivotal clinical trial with the U.S. Food and Drug Administration (FDA). Successful completion of this trial is the final major hurdle before seeking pre-market approval in the United States.
• EU Approval: The product has already received regulatory approval in the European Union (EU), providing a foundation for international commercialization and validating its clinical efficacy and safety profile.

The combination of strong IP protection and advanced regulatory progress positions Regentis Biomaterials to capitalize on the substantial market opportunity for treating damaged knee cartilage, a common orthopedic issue affecting millions globally. The off-the-shelf nature of GelrinC® is expected to provide a competitive advantage over autologous (patient-derived) cell therapies, which often involve higher costs and longer treatment timelines.

Market Implications for Regenerative Medicine

The regenerative medicine space is highly competitive, making strong patent protection essential for market dominance. By securing the patent for the liquid formulation, Regentis has protected a key differentiator—the ease and speed of application—which is crucial for driving adoption among orthopedic surgeons. The move reinforces the company’s commitment to innovative tissue repair solutions and provides investors with greater certainty regarding the long-term commercial viability of GelrinC® in the U.S. market following potential FDA clearance.