Business UpdateJul 2, 2026, 07:33 AM
Polyrizon's NASARIXTM Allergy Blocker Biocompatibility Successful
AI Summary
Polyrizon Ltd. announced the successful completion of its biocompatibility evaluation program for NASARIXTM Allergy Blocker nasal spray. All required biological safety tests met their predetermined acceptance criteria, aligning with internationally recognized standards including ISO 10993 series, FDA guidance, and European regulatory requirements. This significant milestone strengthens the non-clinical package supporting NASARIXTM and advances its clinical and regulatory pathway towards potential commercialization as a novel nasal barrier technology for seasonal allergic rhinitis.
Key Highlights
- Polyrizon announced successful completion of NASARIXTM biocompatibility evaluation program.
- All required biological safety tests met predetermined acceptance criteria.
- Evaluation followed ISO 10993 series, FDA guidance, and European regulatory standards.
- Tests assessed cytotoxicity, sensitization, irritation, pyrogenicity, and acute systemic toxicity.
- Long-term systemic toxicity was assessed via ISO 10993-17 risk assessment.
- This strengthens the non-clinical package for NASARIXTM's potential commercialization.
- NASARIXTM is a drug-free mucoadhesive nasal spray for seasonal allergic rhinitis.
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