(RTTNews) - Polyrizon Ltd. (PLRZ) announced that it has submitted a Pre-Request for Designation to the U.S. FDA for its PL-16 Viral Blocker, a non-pharmacological intranasal product designed to reduce exposure to airborne respiratory viruses, including influenza and cold viruses.
The FDA submission initiates a formal dialogue with the agency on the appropriate regulatory pathway for PL-16.
Seasonal respiratory infections remain a significant public health challenge, causing millions of cases and tens of thousands of hospitalizations each year. Current preventive options are largely pharmaceutical, symptom-focused, or vaccine-dependent, leaving a gap for drug-free, locally acting solutions.
PL-16 is a metered-dose intranasal spray containing a biodegradable hydrogel formulation. Upon application, it forms a thin, muco-adhesive layer on the nasal mucosa, acting as a physical barrier to mechanically block viral particles from contacting epithelial tissue.
Preclinical studies demonstrated over 90% protection of cells against influenza A (H1N1) and human coronavirus 229E, confirming its barrier-based mechanism.
Polyrizon's broader pipeline includes PL-14 Allergy Blocker, which uses a similar hydrogel technology to reduce exposure to airborne allergens. Together, these programs reflect the company's strategy to develop scalable, drug-free nasal technologies for multiple exposure-driven respiratory indications.
PLRZ is currently trading at $9.90, down 2.08%.
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