Core Insights - Polyrizon Ltd. has initiated preliminary work on the GMP manufacturing process for its PL-14 allergy blocker, preparing for a clinical trial planned for 2025 [1][2] - The collaboration with Eurofins CDMO Amatsiaquitaine S.A.S. aims to ensure high-quality production and compliance with regulatory standards for the clinical trial material [2][3] - The global nasal spray market is projected to exceed $23 billion by 2029, indicating significant growth potential for innovative solutions like Polyrizon's PL-14 [3] Company Overview - Polyrizon is a development stage biotech company focused on innovative medical device hydrogels delivered as nasal sprays, which create a barrier against viruses and allergens [4] - The proprietary Capture and Contain TM hydrogel technology is designed to function as a "biological mask," providing a thin shield in the nasal cavity [4] - The company is also developing the Trap and Target ™ technology for nasal delivery of active pharmaceutical ingredients, currently in pre-clinical development [4] Industry Context - Eurofins CDMO is a prominent Contract Development & Manufacturing Organization (CDMO) that provides comprehensive outsourcing services for preclinical and clinical phases, specializing in both Drug Substance/API and Drug Product development [5]

Core Insights - Polyrizon Ltd. has announced the publication of a national phase patent application by the USPTO, covering its two core platform technologies: Capture and Contain (C&C) and Trap and Target (T&T) [1] Group 1: Company Overview - Polyrizon is a development-stage biotech company focused on innovative intranasal hydrogels, which serve as a barrier against viruses and allergens in the nasal cavity [4] - The C&C platform utilizes a natural 3D polymeric network that adheres to the nasal mucosa, forming a barrier to capture airborne biological threats [2] - The T&T platform is designed for prolonged residence time and effective drug delivery, customizable for various molecules to enhance therapeutic efficacy [3] Group 2: Technology Details - The C&C hydrogel technology acts as a "biological mask," providing a thin shield in the nasal cavity to protect against pathogens [4] - The T&T technology is still in pre-clinical development, focusing on the nasal delivery of active pharmaceutical ingredients (APIs) [4]

Company Announcement - Polyrizon Ltd appoints Dr Michal Meir as Senior Director of Regulatory and Clinical Affairs as part of preparations for the PL-14 clinical trial expected to commence in 2025 [1] - Dr Meir brings over a decade of experience in medical device and pharmaceutical industries with expertise in regulatory strategy, clinical affairs management and product development [1] Dr Michal Meir's Background - Dr Meir has extensive experience in planning and executing clinical studies that comply with stringent regulatory requirements [2] - She has held leadership roles at Medtech SME Ltd, Keystone Heart and Alma Lasers, successfully navigating complex regulatory landscapes and spearheading clinical initiatives [2] - Notable achievements include managing global regulatory submissions, developing clinical strategies for new medical devices and authoring critical regulatory and clinical documents [3] Company Leadership Commentary - Polyrizon CEO Tomer Izraeli believes Dr Meir's experience will be invaluable in advancing the company's mission to deliver cutting-edge solutions [3] - Her strategic insights and leadership are expected to strengthen capabilities and play an important role in successful product development and approval [3] About Polyrizon - Polyrizon is a development stage biotech company specializing in innovative intranasal hydrogel medical devices [4] - The company's proprietary Capture and Contain (C&C) hydrogel technology forms a thin shield barrier in the nasal cavity to protect against viruses and allergens [4] - C&C technology is delivered via nasal sprays and functions as a "biological mask" with potential for intranasal drug delivery [4] - The company is further developing aspects of C&C technology such as bioadhesion and prolonged retention at nasal deposition sites [4] - Polyrizon is also developing Trap and Target (T&T) technology focused on nasal delivery of active pharmaceutical ingredients (APIs) in pre-clinical stages [4]

The engagement with an EU-based GMP manufacturing facility enables timely production and preparation for clinical trial. The EU-based GMP manufacturer has large-scale commercial production capabilities, to support Polyrizon in future commercialization efforts Raanana, Israel, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, previously announced that it entered into a manufa ...

The engagement with an EU-based GMP manufacturing facility enables timely production and preparation for clinical trial. The EU-based GMP manufacturer has large-scale commercial production capabilities, to support Polyrizon in future commercialization efforts Raanana, Israel, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, previously announced that it entered into a manufa ...

Raanana, Israel, Dec. 13, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the "Company" or "Polyrizon"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announces today the appointment of Asaf Azulay, the Managing Director of Eurofins’ Li-Med team, to its leadership as its VP of Regulatory Affairs and Quality Assurance (RA/QA). This strategic appointment reflects Polyrizon’s ongoing commitment to maintaining the highest industry standards as it ...