重大事件
外國發行人報告
6-K
2026-07-02
Polyrizon完成NASARIX鼻噴霧生物相容性評估 推進人體臨床試驗
AI 繁中摘要
Polyrizon（納斯達克：PLRZ）今日宣佈，其專利鼻噴霧產品 NASARIX™ Allergy Blocker 的生物相容性評估計劃已圓滿完成，所有必要的生物安全測試均達到預定接受標準，為推進首次人體臨床試驗再下一城 🎯。
該評估計劃嚴格參照國際醫療器材生物安全標準（ISO 10993 系列、FDA 指引及歐盟法規），針對 NASARIX™ 的最終產品配置進行測試，涵蓋細胞毒性、致敏反應、刺激性/皮內反應、材料介導熱原性及急性全身毒性五項關鍵指標。此外，根據 ISO 10993-17 進行的毒理風險評估亦顯示，產品在預期使用條件下具備充分安全邊際。
NASARIX™ 是一種不含藥物的黏膜黏附鼻噴霧，旨在鼻腔內形成保護屏障，減少空氣中的過敏原接觸鼻黏膜，為季節性過敏性鼻炎患者提供非藥物管理方案。該產品採用公司專利的 Capture & Contain™ 水凝膠技術，由天然成分組成。
行政總裁 Tomer Izraeli 表示：「成功完成生物相容性評估是我們開發計劃的重要里程碑，進一步確立 NASARIX™ 的安全特性，並支持我們繼續推進其臨床與監管路徑。」此項成果強化了非臨床資料包，為產品未來商業化作好準備。
Polyrizon 目前仍處於開發階段，上述結果雖正面，但投資者應留意該產品尚未獲批上市，實際商業化時間及監管審批存在不確定性。公司將持續向 SEC 提交相關風險披露。
展開英文正文
EX-99.1 2 ea029686301ex99-1.htm PRESS RELEASE TITLED: "POLYRIZON ANNOUNCES SUCCESSFUL RESULTS FOR NASARIX BIOCOMPATIBILITY PROGRAM, SUPPORTING ADVANCEMENT TOWARDS FIRST IN HUMAN CLINICAL TRIAL" Exhibit 99.1 Polyrizon Announces Successful Results for NASARIX™ Biocompatibility Program, Supporting Advancement Towards First in Human Clinical Trial Raanana, Israel, July 02, 2026 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development-stage biotech company specializing in the development of innovative intranasal hydrogels, today announced successful results from its biocompatibility evaluation program for its proprietary NASARIXTM Allergy Blocker nasal spray, with all required biological safety tests meeting their predetermined acceptance criteria. The comprehensive evaluation program was designed in accordance with internationally recognized standards for biological safety assessment of medical devices, including the ISO 10993 series, FDA guidance, and applicable European regulatory requirements. The program was developed to assess the safety and biocompatibility profile of NASARIXTM, a drug-free mucoadhesive nasal spray intended to help reduce exposure to airborne allergens associated with seasonal allergic rhinitis. The completed testing program evaluated key biological safety endpoints identified for the device, including: ●Cytotoxicity ●Sensitization ●Irritation / Intracutaneous Reactivity ●Material-Mediated Pyrogenicity ●Acute Systemic Toxicity In addition, long-term systemic toxicity was assessed through a toxicological risk assessment conducted in accordance with ISO 10993-17, demonstrating substantial safety margins across the product’s constituent materials under intended conditions of use. The biocompatibility evaluation was based on the final NASARIXTM product configuration and supported by extensive toxicological assessments of the formulation components, manufacturing processes, packaging materials, and intended patient exposure. According to the Biological Evaluation Plan, the product consists of well-characterized materials with established safety profiles and utilizes a manufacturing process designed to minimize biological risk. “We are pleased to report the successful completion of the NASARIXTM biocompatibility program,” said Tomer Izraeli, CEO of Polyrizon. “Achieving positive results across all required biological safety assessments represents a significant milestone in our development program and further supports the biocompatibility safety profile of NASARIXTM as we continue advancing its clinical and regulatory pathway.” The biocompatibility evaluation program was developed under a risk-management framework consistent with ISO 10993-1 and ISO 14971 and included assessment of physical and chemical characteristics, material safety data, toxicological literature, manufacturing controls, and endpoint-specific biological testing. The successful completion of the biocompatibility program further strengthens the non-clinical package supporting NASARIXTM and represents an important step toward potential commercialization of the product as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies. About NASARIXTM NASARIXTM is Polyrizon’s proprietary nasal spray designed to create a protective barrier within the nasal cavity, helping to prevent contact between inhaled allergens and the nasal mucosa. The product is being developed as a non-drug approach for the management of seasonal allergic rhinitis. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain aspects of our C&C hydrogel technology such as the bioadhesion and prolonged retention at the nasal deposition site for intranasal delivery of drugs. Polyrizon refers to its additional technology, which is in an earlier stage of pre-clinical development, that is focused on nasal delivery of active pharmaceutical ingredients, or APIs, as Trap and Target, or T&T. For more information, please visit https://polyrizon-biotech.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the the timing and progress of its clinical trials, advancing the clinical and regulatory pathway of NASARIXTM and the potential commercialization of NASARIXTM as a novel nasal barrier technology designed to help individuals suffering from seasonal allergies. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, 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 Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Polyrizon is not responsible for the contents of third-party websites. Contacts: Michal Efraty Investor Relations [email protected]