Regentis Expanding Pivotal Phase III GelrinC Clinical Site Network: Adding Several Leading Orthopedic Centers Across the U.S.
New sites expected to further accelerate patient enrollment, which surpassed 50% in Phase III study, as well as support future clinical programs
新試驗點的加入預計將加速患者招募進程，此前III期研究中的患者招募率已超過50%，同時爲未來的臨床項目提供支持。
GelrinC is set to transform cartilage repair market with off-the-shelf regenerative products
GelrinC有望通過現成可用的再生產品變革軟骨修復市場。
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.
以色列赫茲利亞 / ACCESS Newswire / 2026年1月29日 / Regentis Biomaterials Ltd.（「Regentis」或「公司」）(NYSE American:RGNT)是一家專注於創新組織修復解決方案的再生醫學公司，今日宣佈擴展其美國臨床試驗點網絡，進一步強化基礎設施以支持正在進行的關鍵性III期研究（針對膝關節軟骨修復用GelrinC），併爲未來臨床項目提供幫助。
"Building on our existing clinical collaborations, we are adding several new, highly regarded academic and clinical orthopedic centers to our network," stated Dr. Ehud Geller, Executive Chairman of Regentis. "This expansion is designed to further accelerate patient enrollment, increase the efficiency of our clinical strategy, leverage leading orthopedic expertise, and generate robust clinical data to support product development and future commercialization efforts following our company's recent IPO."
Regentis執行主席Ehud Geller博士表示：「在現有臨床合作的基礎上，我們正在將若干備受推崇的學術和臨床骨科中心納入我們的網絡。此次擴展旨在進一步加速患者入組、提高臨床策略效率、利用領先的骨科專業知識，並生成強有力的數據支持產品開發以及公司最近IPO之後的未來商業化工作。」
GelrinC is approved for knee cartilage repair in the European Union and is currently at midpoint in a pivotal FDA trial for the same indication to address a U.S. market of more than 470,000 potential cases annually.
GelrinC已在歐洲聯盟獲得膝關節軟骨修復批准，目前正處於FDA關鍵性試驗的中點階段，目標是每年解決美國市場超過470,000潛在病例的需求。
The expanded clinical site network brings together leading orthopedic surgeons and institutions with strong experience in cartilage repair, joint preservation, and sports medicine, ensuring high-quality clinical execution and data generation.
擴大的臨床試驗點網絡彙集了在軟骨修復、關節保護和運動醫學領域經驗豐富的頂級骨科醫生和機構，確保高質量的臨床執行和數據生成。
Among the Participating Clinical Sites Being Added Are:
新增參與的臨床試驗點包括：
NYU Langone Orthopedic & Sports Medicine, New York, NY
紐約大學朗格尼骨科與運動醫學中心，紐約州紐約市
A world-class academic orthopedic center consistently ranked among the top programs in the United States, known for surgical excellence and innovation. Dr. Laith Jazrawi is a leading authority in cartilage repair and joint preservation, bringing extensive academic leadership and clinical trial experience.
這是一所世界級的學術骨科中心，始終被列爲美國頂尖項目之一，在外科卓越性和創新方面享有盛譽。Laith Jazrawi博士是軟骨修復與關節保護領域的權威人士，擁有廣泛的學術領導能力和臨床試驗經驗。
The Ohio State University Wexner Medical Center, Columbus, OH
俄亥俄州立大學韋克斯納醫學中心，俄亥俄州哥倫布市
A premier academic health system with a high-volume orthopedic department and strong translational research capabilities. Dr. David Flanigan is an internationally recognized surgeon-scientist specializing in knee reconstruction and cartilage restoration.
一個擁有高流量骨科部門和強大轉化研究能力的頂級學術健康系統。David Flanigan博士是一位國際知名、專注於膝關節重建和軟骨修復的外科醫生兼科學家。
University of Cincinnati Medical Center, Cincinnati, OH
辛辛那提大學醫學中心，俄亥俄州辛辛那提市
A respected academic medical center integrating advanced orthopedic care with outcomes-driven research. Dr. Brian Grawe is known for his expertise in cartilage preservation and rigorous clinical research methodology.
一家受人尊敬的學術醫療中心，將先進的骨科護理與結果驅動型研究相結合。Brian Grawe博士以其在軟骨保護和嚴謹的臨床研究方法方面的專長而聞名。
Loyola Medicine Orthopedic, Maywood, IL
洛約拉醫學骨科，伊利諾伊州梅伍德市
An academic clinical program emphasizing innovation in joint preservation and participation in multicenter clinical studies. Dr. John Miller contributes deep clinical insight in cartilage and meniscal pathology.
一個注重關節保護創新並參與多中心臨床研究的學術臨床項目。John Miller博士在軟骨和半月板病理學方面提供了深刻的臨床見解。
Tulane University School of Medicine - Orthopedics, New Orleans, LA
杜蘭大學醫學院-骨科，路易斯安那州新奧爾良市
A distinguished academic institution with a long history of impactful musculoskeletal research and interdisciplinary collaboration, providing strong academic depth and research infrastructure.
一所具有悠久影響力的肌肉骨骼研究歷史和跨學科合作傳統的傑出學術機構，提供深厚的學術底蘊和強大的研究基礎設施。
UNC Orthopedics, University of North Carolina, Chapel Hill, NC
北卡羅來納大學教堂山分校骨科
A nationally recognized academic orthopedic department with a strong focus on clinical research and outcomes science. Prof. Joe Hart brings leadership in musculoskeletal research and experience in joint preservation studies.
一個全國知名的學術骨科部門，高度關注臨床研究和結果科學。Joe Hart教授在肌肉骨骼研究和關節保護研究領域展現了領導力，並具備豐富的經驗。
Rush University Medical Center, Chicago, IL
拉什大學醫學中心，伊利諾伊州芝加哥市
A top-tier academic medical center widely recognized for orthopedic innovation and evidence-based care. Dr. Adam Yanke is a leading expert in cartilage regeneration and knee preservation, contributing both surgical and research excellence.
一家廣受認可的頂級學術醫療中心，以其在骨科創新和循證護理方面的成就而聞名。亞當·揚克博士是軟骨再生和膝關節保護領域的領先專家，在外科和研究方面均有卓越貢獻。
About GelrinC
關於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.
Regentis的主打產品GelrinC是一種無需細胞、現成可用的水凝膠同步侵蝕吸收植入物，用於治療局部關節膝關節軟骨疼痛損傷。作爲一種創新型再生醫療產品，GelrinC提供了前所未有的解決方案，爲外科醫生和支付方提供了一個現成可用、易於操作、可靠且成本效益高的手術方案，根據目前的臨床研究結果，患者只需接受一次10分鐘的手術即可實現快速恢復、持久止痛及功能性改善，效果可持續超過四年。目前市場上尚無有效的現成可用治療膝關節軟骨缺陷的療法。GelrinC已在歐盟獲得CE標誌批准，目前正在一項關鍵性的美國食品藥品監督管理局（FDA）研究中進行評估，該研究已完成超過50%的入組。
About Regentis Biomaterials
關於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.
Regentis Biomaterials Ltd是一家再生醫學公司，致力於開發創新組織修復解決方案，恢復健康並提高生活質量。Regentis最初聚焦於骨科治療領域，其基於同步降解水凝膠植入技術的Gelrin平台技術可再生受損或病變的組織，包括髮炎的軟骨和骨骼。Regentis的主打產品GelrinC是一種無需細胞、現成可用的膝關節水凝膠，在膝關節中逐漸腐蝕並被吸收，允許周圍細胞以可控和同步的方式再生軟骨。GelrinC旨在解決美國每年約47萬例膝關節軟骨修復病例的市場，目前尚無現成可用的治療方法。
Forward Looking Statements
前瞻性聲明
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 the expansion of the Company's clinical site network. 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.
本新聞稿包含「前瞻性陳述」，此類陳述面臨重大風險與不確定性。除歷史事實陳述外，本新聞稿中所載的所有陳述均爲前瞻性陳述。本新聞稿中的前瞻性陳述通常可通過使用諸如「預期」「相信」「考慮」「可能」「估計」「期望」「打算」「尋求」「或許」「也許」「計劃」「潛在」「預測」「展望」「目標」「旨在」「應」「將」「會」或其否定形式，以及其他類似表述來加以識別——儘管並非所有前瞻性陳述都包含這些詞彙。前瞻性陳述還涵蓋了公司對臨床試驗基地網絡擴展的各類預期與信念。前瞻性陳述基於Regentis當前的預期，且受制於難以準確預判的固有不確定性、風險與假設。此外，部分前瞻性陳述系基於對未來事件的假設，而這些假設未必能夠完全成真。可能影響未來業績、並致使上述前瞻性陳述失真的因素包括但不限於：我們的臨床試驗能否充分證明GelrinC或任何未來候選產品的安全性和有效性，以及能否取得其他積極成果；我們臨床前研究與臨床試驗的開展時間與重點，以及相關研究與試驗數據的披露與報告進度；GelrinC或任何未來候選產品所面臨的市場機遇規模，包括我們對目標疾病患者人數的估算；我們精準把握候選產品市場需求的能力；現有或未來可能上市的競爭性療法的療效與優勢；我們候選產品的各項有益特性、安全性、有效性和治療效果；我們能否順利獲得FDA對GelrinC或任何未來候選產品的批准，並持續保持相關監管許可；我們能否贏得醫療界及第三方支付方對GelrinC或任何未來候選產品的市場認可；我們關於GelrinC或任何未來候選產品後續研發的規劃，包括我們可能拓展的適應症或治療領域；美國及其他司法管轄區現行及未來的監管法規與監管動態；我們在知識產權保護與獲取方面的規劃與能力，包括在條件允許的情況下爭取專利期限的延長，以及我們避免侵犯他人知識產權的能力；我們對額外人員的需求，以及我們吸引並留住優秀人才的能力；我們對各項費用、未來收入、資本需求及額外融資需求的預估；我們對第三方的依賴程度；我們的財務表現，以及我們償還貸款與債務的能力；還有我們在各類合作、授權或其他交易中能否協商達成有利條款，並切實履行相關合作義務。有關影響Regentis的各項風險與不確定性的更詳盡說明，請參閱公司不時向美國證券交易委員會（「SEC」）提交的各類報告，其中包括但不限於在向SEC提交的公開發行招股說明書「風險因素」章節中所詳述的風險。本公告中的前瞻性陳述僅截至本公告發布之日作出，Regentis除根據適用法律要求外，無義務對相關信息進行更新。
Contact:
聯繫方式：
acarlquist@medicavp.com
acarlquist@medicavp.com
SOURCE: Regentis Biomaterials Ltd
來源：Regentis Biomaterials Ltd
譯文內容由第三人軟體翻譯。
