Polyrizon Ltd. (NASDAQ: PLRZ) shares gathered steam to begin Thursday trading. The 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.
“We are pleased to report the successful completion of the NASARIXTM biocompatibility program,” said CEO Tomer Izraeli.
“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.”
PLRZ shares gained 75 cents, or 5.9%, to $13.35.
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