Core Insights - Polyrizon Ltd. has submitted a Pre-Request for Designation (Pre-RFD) to the FDA for its PL-16 Viral Blocker, which has shown over 90% efficacy in protecting cells against viruses [1][2][7] - The PL-16 product is designed to create a physical barrier in the nasal cavity to reduce exposure to airborne respiratory viruses, addressing a significant public health challenge during the flu season [3][4][8] Product Overview - PL-16 is a metered-dose intranasal spray that forms a muco-adhesive hydrogel layer, mechanically reducing contact between airborne particles and the nasal epithelium [4][10] - The product is intended for local use only, with no systemic exposure or pharmacological activity [4] Supporting Evidence - The Pre-RFD submission is backed by in-vitro studies demonstrating that PL-16 preserves cell viability against influenza A and human coronavirus by preventing viral access [7] - Studies confirm that PL-16 acts purely as a mechanical barrier, with viruses remaining infective after being recovered from the hydrogel [7] Market Opportunity - The global nasal spray market was valued at USD 29.83 billion in 2024 and is projected to grow to USD 58.90 billion by 2032, with a CAGR of 8.9% [6] - Seasonal respiratory infections represent a recurring global market with significant economic impact due to lost productivity [6][8] Strategic Context - The PL-16 program is part of Polyrizon's broader strategy to develop non-medicated intranasal solutions, building on its Capture and Contain technology platform [5] - The company aims to address multiple respiratory indications through scalable, drug-free nasal technologies [5] Next Steps - Following feedback from the FDA on the Pre-RFD, Polyrizon will align on the next development steps for PL-16 and continue advancing its intranasal platform [9]
Polyrizon Submits Pre-Request for Designation to FDA for PL-16 Viral Blocker Designed to Reduce the Exposure to Influenza and Cold Viruses