Regentis Biomaterials Appoints Ori Gon as Chief Financial Officer and Chief Business Officer as GelrinC Progresses Towards Commercial Launch in Europe and Advances in U.S. Phase III FDA Trial
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.
GelrinC 是唯一用於膝關節軟骨修復的再生產品,已在歐洲獲得 CE 標誌批准,並且目前正在美國進行關鍵性的 FDA III 期試驗的中期階段。
Ori Gon brings substantial public company, medtech, and capital markets experience
Ori Gon帶來了豐富的上市公司、醫療科技和資本市場經驗。
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. Mr. Gon will lead the Company's commercial and business development activities, as well as its financial strategy, planning, and reporting.
以色列赫茲利亞 / ACCESS 新聞專線 / 2026 年 2 月 4 日 / 再生醫學公司 Regentis Biomaterials Ltd.(「Regentis」或「公司」)(紐約證券交易所美國:RGNT),專注於創新組織修復解決方案,今天宣佈任命Ori Gon爲首席財務官兼首席商務官,立即生效。Gon先生將領導公司的商業及業務發展活動,以及其財務戰略、規劃和報告工作。
Mr. Gon joins Regentis at a pivotal time as GelrinC, the Company's proprietary hydrogel implant for knee cartilage repair, advances towards commercial launch in Europe following CE Mark approval and is being evaluated in a pivotal Phase III FDA clinical trial in the United States.
Gon先生在 GelrinC 這一公司專有的膝關節軟骨修復水凝膠植入物的關鍵時期加入 Regentis,該產品已獲得 CE 標誌批准,正在向歐洲市場邁進,同時正在美國進行關鍵性的 III 期 FDA 臨床試驗評估。
"Ori's appointment significantly strengthens our leadership team as we transition from a development-stage company toward commercialization," said Dr. Ehud Geller, Executive Chairman of Regentis. "His deep experience as a public company CFO, combined with his strategic business development expertise, will be instrumental as we evaluate strategic partnerships to launch GelrinC in Europe and build the foundation for sustainable, revenue-generating growth."
「Ori的任命大大增強了我們的領導團隊,因爲我們正從開發階段公司向商業化轉型,」Regentis 執行主席Ehud Geller博士表示。「他作爲上市公司首席財務官的深厚經驗,加上他在戰略業務發展方面的專業知識,將在我們評估戰略合作伙伴關係以在歐洲推出 GelrinC 和爲可持續、創收型增長奠定基礎時發揮關鍵作用。」
Mr. Gon brings over 15 years of financial leadership experience across public and private enterprises and medical technology. Most recently, he served as CFO at Tactile Mobility, a sensing and data analytics company focused on advanced automotive and mobility applications. Prior to that, he held senior financial leadership roles at ReWalk Robotics, Inc., now Nasdaq-listed Lifeward Ltd., a pioneer in wearable robotic exoskeletons for individuals with lower limb disabilities, where he served as CFO and Corporate Controller. Earlier in his career, he was Controller at On Track Innovations Ltd., a Nasdaq- and Neuer Markt-listed fintech company. He began his professional career as an auditor at KPMG Israel.
Gon先生在上市公司和私營企業以及醫療技術領域擁有超過 15 年的財務領導經驗。最近,他擔任 Tactile Mobility 的首席財務官,該公司是一家專注於先進汽車和移動應用的傳感與數據分析公司。在此之前,他在 ReWalk Robotics, Inc.,即現在納斯達克上市的 Lifeward Ltd. 擔任高級財務領導職務,該公司是可穿戴機器人外骨骼領域的先驅,致力於幫助下肢殘疾人士,他曾擔任首席財務官和公司財務主管。早期職業生涯中,他曾在金融科技公司 On Track Innovations Ltd.(納斯達克和新市場上市)擔任財務主管。他的職業生涯始於 KPMG 以色列的核數師。
Mr. Gon has led multiple secondary public offerings and financing transactions across various structures, raising over $150 million in aggregate capital. He is a Certified Public Accountant (CPA) in Israel.
Gon先生領導了多次二次公開發行和各種結構的融資交易,累計籌集資金超過 $1.5億。他是以色列註冊會計師 (CPA)。
"I am excited to join Regentis at such an important inflection point," said Ori Gon. "With GelrinC approaching commercialization in Europe and progressing through a pivotal FDA trial in the U.S., we believe Regentis is uniquely positioned to transform the treatment landscape for knee cartilage repair. I look forward to working with the team to execute our commercial strategy, build strategic partnerships, and create long-term value for patients and stakeholders."
「我很高興能在這樣一個重要的轉折點加入 Regentis,」Ori Gon表示。「隨着 GelrinC 即將在歐洲實現商業化並在美國進入關鍵性 FDA 試驗階段,我們相信 Regentis 在膝關節軟骨修復治療領域具有獨特的地位。我期待與團隊合作,執行我們的商業化戰略,建立戰略合作伙伴關係,併爲患者和利益相關者創造長期價值。」
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 Regentis' advancement towards commercialization. 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「前瞻性聲明」,這些聲明受到重大風險和不確定性的影響。除歷史事實陳述外,本新聞稿中的所有其他陳述均爲前瞻性聲明。新聞稿中的前瞻性聲明可以通過諸如「預期」、「相信」、「設想」、「可能」、「估計」、「期望」、「意圖」、「尋求」、「可能」、「或許」、「計劃」、「潛在」、「預測」、「項目」、「目標」、「旨在」、「應該」、「將要」、「將會」等詞語或這些詞語的否定形式來識別,儘管並非所有前瞻性聲明都包含這些詞語,幷包括關於 Regentis 向商業化推進的信念。前瞻性聲明基於 Regentis 的當前預期,並受固有的不確定性、風險和假設影響,這些因素難以預測。此外,某些前瞻性聲明是基於對未來事件的假設,而這些假設可能不準確。可能影響未來結果並導致這些前瞻性聲明不準確的因素包括但不限於:我們的臨床試驗能否證明 GelrinC 或任何未來候選產品的安全性和有效性以及其他積極結果;我們臨床前研究和臨床試驗的時間安排和重點,以及從中獲取的數據報告; GelrinC 或任何未來候選產品的市場規模機會,包括我們對患有我們所針對疾病的患者人數的估算;我們準確識別候選產品需求的能力;現有或即將出現的競爭療法的成功;我們候選產品的有益特性、安全性、有效性和治療效果;我們能否獲得 GelrinC 或任何未來候選產品的 FDA 批准,並取得和維持監管批准;我們能否從醫學界和第三方支付方那裏獲得 GelrinC 或任何未來候選產品的市場接受度;我們有關進一步開發 GelrinC 或任何未來候選產品的計劃,包括我們可能追求的額外適應症或疾病狀態;美國和其他司法轄區現有的法規和監管發展;我們保護知識產權權利的計劃和能力,包括在可用的情況下延長專利期限,以及避免侵犯他人的知識產權的能力;招聘更多人員的需求和吸引及保留此類人員的能力;我們對費用、未來收入、資本需求和額外融資需求的估算;我們對第三方的依賴;我們的財務表現和償還貸款及債務的能力;以及我們在協商有利條款方面的能力,包括我們可能參與的任何合作、許可或其他協議,並履行我們在這些合作中的義務。有關影響 Regentis 的風險和不確定性的更詳細描述,請參閱公司不時向證券交易委員會 (「SEC」) 提交的報告,包括但不限於最終招股說明書中題爲「風險因素」的章節,該章節與向 SEC 提交的公開發行相關的文件。本公告中的前瞻性聲明是在本文發佈之日作出的,Regentis 不承擔更新此類信息的義務,除非適用法律要求。
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。