Welcome to our dedicated page for Regentis Biomaterials news (Ticker: RGNT), a resource for investors and traders seeking the latest updates and insights on Regentis Biomaterials stock.
Regentis Biomaterials Ltd. (RGNT) is a regenerative medicine company whose news flow centers on the development and clinical progress of GelrinC, its cell-free, off-the-shelf hydrogel implant for focal articular knee cartilage injuries. Company announcements describe how GelrinC is based on a degradable hydrogel matrix and is designed to be delivered in liquid form, cured with ultraviolet light into a temporary implant, and gradually eroded and resorbed as surrounding cells regenerate cartilage.
News updates from Regentis highlight clinical trial milestones, including Phase II and pivotal Phase III studies conducted under an FDA investigational device exemption. The company has reported peer-reviewed publication of Phase II data in the journal Cartilage, using MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) as a quantitative MRI-based measure of cartilage repair. According to Regentis, these results show repaired cartilage that appears very close to normal healthy tissue at 24 months, with ongoing tissue maturation over time.
Investors and observers can also find regulatory and intellectual property developments in Regentis news. The company has announced CE mark approval in Europe for GelrinC as a device for articular knee cartilage injuries, as well as U.S. patents that cover the liquid, ready-to-use formulation of GelrinC and production processes that avoid organic solvents. Additional releases cover progress in its pivotal U.S. FDA trial, including enrollment updates.
Capital markets activity is another theme in Regentis communications, including the pricing and closing of its initial public offering on the NYSE American under the symbol RGNT. For readers following RGNT, the news stream provides insight into clinical outcomes, regulatory status, patent protection, and financing events related to the Gelrin platform and GelrinC cartilage repair product candidate.
Regentis (NYSE:RGNT) reported long-term MRI data from a completed European trial of GelrinC, showing regenerated knee cartilage with a layered architecture comparable to native hyaline cartilage at 24 months. Analysis used validated MRI methodologies accepted by both the U.S. FDA and EMA. Images showed progressive tissue maturation from 1 week to 24 months, with improved structural organization and high MOCART scores, suggesting true biological cartilage regeneration rather than fibrotic fill. Regentis noted these results support its advancing Phase III U.S. FDA study and ongoing commercialization in Europe where GelrinC holds CE Mark approval.
Regentis (NYSE:RGNT) reported peer‑reviewed, 24‑month Phase II results for GelrinC showing durable cartilage regeneration by quantitative MRI. Mean MOCART score improved to 88.8/100 at 24 months with lesion‑type means of 86.8 (chondral) and 94 (osteochondral). Quantitative MRI indicated maturation toward hyaline‑like cartilage and ongoing tissue maturation over time. Regentis says it is the first to prospectively use MOCART as a predefined imaging endpoint with FDA acceptance. GelrinC is approved in Europe and is in a pivotal U.S. Phase III IDE study with 80 patients and >50% enrollment.
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.
Regentis Biomaterials (NYSE:RGNT) closed its initial public offering on December 5, 2025, selling 1,250,000 ordinary shares at $8.00 per share for aggregate gross proceeds of $10,000,000 before underwriting discounts and offering expenses. The shares began trading on the NYSE American on December 4, 2025 under the symbol RGNT. The company granted a 45-day option to purchase up to 187,500 additional shares for over-allotments.
Net proceeds are intended primarily for development activities including completion of the pivotal trial and PMA preparation for GerlinC, and for corporate purposes including repayment of certain debt and deferred compensation.
Regentis Biomaterials (NYSE American: RGNT) priced its initial public offering of 1,250,000 ordinary shares at $8.00 per share, for aggregate gross proceeds of $10,000,000, with a 45-day underwriter option to purchase up to an additional 187,500 shares. The Ordinary Shares are expected to begin trading on December 4, 2025, and the Offering is expected to close on or about December 5, 2025, subject to customary closing conditions.
The company intends to use net proceeds primarily for development activities, including completing its pivotal trial and preparing the PMA submission for GerlinC, and for corporate purposes including repayment of certain debt and deferred compensation. ThinkEquity is sole book-running manager.
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