Regentis Biomaterials

RGNT

Market cap $16.7M

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, IL / ACCESS Newswire / 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.

HERZLIYA, IL / ACCESS Newswire / June 17, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced that it has entered into definitive securities purchase agreements with accredited and institutional investors for the issuance and sale of ordinary shares (or pre-funded warrants in lieu thereof) together with warrants , at a purchase price of $3.50 per ordinary share and accompanying ordinary warrant (or $3.4999 per pre-funded warrant and accompanying ordinary warrant), in a private placement, for expected aggregate gross proceeds of approximately $6.5 million, before deducting placement agent fees and estimated offering expenses payable by us.

GelrinC®, positioned as the first off-the-shelf cell-free hydrogel implant for knee cartilage repair, is approved for sale in the European Union Regentis is growing its network of European Centers of Excellence designed to support surgeon education, clinical guidance, and knowledge sharing around cartilage repair and the use of GelrinC GelrinC's 10-minute procedure offers a safe and effective alternative to traditional microfracture and complex cell-based therapies addressing a $3 billion U.S. market HERZLIYA, ISRAEL / ACCESS Newswire / June 8, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, announced today that in the third quarter of 2026, the Company plans to commence its European surgeon training activities, as it advances preparations for the commercial rollout of GelrinC® in Europe, where it has CE Mark approval.

Collaboration with leading European orthopedic center in Italy supports GelrinC® clinical adoption Renowned cartilage regeneration expert Prof. Elizaveta Kon to help lead Regentis Centers of Excellence network Strengthens surgeon engagement and expands Regentis' European commercialization infrastructure HERZLIYA, IL / ACCESS Newswire / April 16, 2026 / Regentis Biomaterials Ltd.

Breakthrough manufacturing process comes in preparation for upcoming commercial launch in Europe planned for later this year Proprietary process is already patented in several countries and is pending in the U.S. HERZLIYA, IL / ACCESS Newswire / March 17, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced it has developed a new manufacturing process for its lead product, GelrinC®, an off-the-shelf hydrogel synchronized erosion and resorbable implant for the treatment of painful injuries to focal articular knee cartilage.

$7.4 million in cash expected to provide runway to complete site expansion process and patient enrollment as part of pivotal Phase III FDA trial for GelrinC Already approved in Europe, GelrinC is expected to be rolled out in clinics across the continent in 2026 GelrinC is positioned to be the first ready-to-use, off-the-shelf product in the U.S. for knee cartilage repair HERZLIYA, IL / ACCESS Newswire / February 24, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company"), a regenerative medicine company focused on innovative tissue repair solutions, today reported financial results for the year ended December 31, 2025 and provided an update on corporate and clinical developments.

Dr. Reske has proven leadership in clinical development and regulatory affairs following key role in FDA approval of cartilage repair product Agili-C leading to CartiHeal's $330 million acquisition HERZLIYA, ISRAEL / ACCESS Newswire / February 19, 2026 / Regentis Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced the appointment of Dr. Galit Reske, PhD, as Chief Medical Officer (CMO).

GelrinC, the only restorative product for knee cartilage repair, has CE Mark approval in Europe and is currently at the midpoint of a pivotal FDA Phase III trial in the U.S. Ori Gon brings substantial public company, medtech, and capital markets experience HERZLIYA, ISRAEL / ACCESS Newswire / February 4, 2026 / Regentis Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced the appointment of Ori Gon as Chief Financial Officer and Chief Business Officer, effective immediately.

New sites expected to further accelerate patient enrollment, which surpassed 50% in Phase III study, as well as support future clinical programs GelrinC is set to transform cartilage repair market with off-the-shelf regenerative products HERZLIYA, ISRAEL / ACCESS Newswire / January 29, 2026 / Regentis Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced the expansion of its U.S. clinical site network, further strengthening its infrastructure to support its ongoing pivotal Phase III study of GelrinC® for knee cartilage repair as well as future clinical programs.

2 years after treatment, GelrinC-treated patients demonstrated layered cartilage architecture similar to native hyaline cartilage - widely regarded as the gold standard for durable joint function This rare outcome in cartilage repair suggests true biological cartilage regeneration, not merely defect filling Unlike traditional scaffolds, GelrinC limits fibrotic tissue overgrowth, supporting smoother joint motion and preserving natural biomechanics HERZLIYA, IL / ACCESS Newswire / January 20, 2026 / Regentis Biomaterials Ltd., ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced new long-term imaging data from its successfully completed European clinical trial of GelrinC®, demonstrating that regenerated cartilage exhibits internal structural organization closely resembling healthy, native hyaline cartilage.