Star Metro - Regentis Implements Strategy for Commercial Deployment of GelrinC(R) in Europe Through Collaboration with Humanitas Hospital and Leading Cartilage Repair Expert Prof. Elizaveta Kon

HERZLIYA, IL / ACCESS Newswire / April 16, 2026 / Regentis Biomaterials Ltd. ("Regentis" or the "Company") (NYSE American:RGNT), a regenerative medicine company focused on innovative tissue repair solutions, today announced a collaboration with Humanitas Research Hospital in Milan, Italy, one of Europe's leading academic medical centers in orthopedics and sports medicine. This collaboration is currently in the process of being formalized, is expected to support the Company's expanding clinical activities in Europe where GelrinC® already has CE Mark approval in the treatment of knee cartilage repair and further strengthen engagement with leading orthopedic surgeons across the European Union.

Humanitas is widely recognized for its advanced clinical infrastructure, high surgical volumes, and strong track record in translational research and innovation in orthopedic care. The collaboration reflects Regentis' focus on engaging leading European orthopedic experts to support the swift adoption of GelrinC^® as a preferred clinical solution. Humanitas has the ability to support the introduction of new orthopedic and cartilage repair treatment approaches into real-world clinical practice.

Prof. Elizaveta Kon, who serves as full Professor of Orthopaedic Surgery at Humanitas University and Chief of Translational Orthopedics Unit, Center of Functional and Biological Reconstruction of the knee and Director of Residency Program in Orthopedic Surgery at Humanitas Research Hospital, is internationally known for her pioneering work in cartilage regeneration and her leadership in advancing innovative orthopedic treatments into clinical practice. Her previous experience includes roles as orthopaedic surgeon and researcher at the Rizzoli Institute, where she also coordinated the Nano-Biotechnology Laboratory. She has carried out extensive research in both basic and clinical science. Principal Investigator of numerous research projects and clinical trials regarding biotechnology applications in orthopaedics, into the framework of European and national research. Author of over 382 scientific articles in peer-reviewed journals (H-index 100 Google Scholar) and over 40 chapters in textbooks in orthopedic surgery Editor of 5 Orthopaedic Surgery textbooks.

Winner of several awards: Award Cum Laude ICRS World Congress 2022, 2019, 2015 and 2013; Best rated abstract ICRS World Congress 2022; Biologic Association Research Award 2021; Best virtual communication SIOT 2021; Most cited and Most downloaded publication 2011-2016 in Arthroscopy Journal; Leading article Knee Surgery Sports Traumatology Arthroscopy Journal 2013 and 2016; Most cited publication 2009-2010 in American Journal of Sports Medicine; Scientific exhibit award of excellence AAOS Annual Meeting 2011.

Prof. Kon will help lead the development of Regentis' Centers of Excellence network in Europe, working with leading orthopedic surgeons across the continent to build clinical expertise, provide professional guidance, and support the responsible adoption of GelrinC^® in clinical practice. In parallel, Humanitas Research Hospital is anticipated to be involved as a site in the upcoming pivotal clinical trial, supporting the continued accumulation of clinical experience and expertise.

"This collaboration represents an important step in executing our European commercial roll out and accelerating the clinical adoption of GelrinC^® throughout the EU," said Dr. Ehud Geller, CEO and Executive Chairman of Regentis. "Partnering with Humanitas and Prof. Kon, one of the leading voices in cartilage regeneration, positions us to build a strong foundation for surgeon education, clinical excellence, and responsible adoption as we advance toward broader commercialization across Europe."

"I am pleased to partner with Regentis in advancing GelrinC^® toward broader adoption across Europe," said Prof. Kon. "There is a clear need for solutions that are both biologically effective and practical for everyday clinical use. An off-the-shelf product combined with a straightforward, 10-minute procedure represents a meaningful step forward for surgeons, simplifying treatment while expanding access for patients. With continued clinical experience and growing awareness among physicians, I believe this approach has the potential to evolve into a new standard of care in cartilage repair which will be readily available to patients in Europe."

As part of its European strategy, Regentis is establishing a network of European Centers of Excellence designed to support surgeon education, clinical guidance, and knowledge sharing around cartilage repair and the use of GelrinC^®. These centers are intended to serve as leading clinical hubs where experienced orthopedic surgeons will help train and support other physicians across Europe as the technology is introduced into clinical practice. Regentis already has CE Mark approval in the treatment of knee cartilage repair for GelrinC^® and intends to initiate commercialization in Europe in the near future.

Cartilage injuries of the knee represent a significant clinical challenge, particularly for active patients, where treatment options remain very limited and often fail to restore durable, functional cartilage tissue. GelrinC^®, Regentis' proprietary acellular hydrogel designed to enable and support cartilage regeneration, is positioned to address this substantial unmet medical need.

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' advancement towards commercialization and its cash runway. 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 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:

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SOURCE: Regentis Biomaterials Ltd

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