Polyrizon Moves Closer To First-In-Human Trials As New CRO Agreement Enables Comprehensive Testing For Its Intranasal Medical Device Technology Platform

Polyrizon Ltd., a pre-clinical biotechnology company focused on developing intranasal therapeutic solutions, announced that it has entered into an agreement with a leading global preclinical Contract Research Organization (CRO). This CRO is widely recognized for its expertise in biocompatibility testing and its ability to conduct studies that meet regulatory and industry standards.

The agreement supports Polyrizon’s broader clinical development activities, which have recently included the successful manufacturing of GMP-grade clinical trial material, the completion of a pre-submission meeting with the U.S. Food and Drug Administration (FDA), and encouraging preclinical results demonstrating effective allergen-blocking performance. Together, these steps reflect the company’s progress toward moving its technology into human studies.

As part of the new agreement, the CRO will carry out a full set of preclinical biocompatibility studies based on ISO 10993 guidelines and conducted under Good Laboratory Practice (GLP) conditions. These studies are scheduled to begin in the second quarter of 2026. The work will serve as a critical milestone in Polyrizon’s regulatory pathway and is intended to support the company’s planned initiation of clinical trials later in the year.

The preclinical testing package will evaluate several key safety parameters, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity. These assessments are essential to ensuring that the company’s intranasal technology meets regulatory expectations for safety before progressing to first-in-human studies.

Commenting on the agreement, Tomer Izraeli, Chief Executive Officer of Polyrizon, stated that this partnership marks an important advancement for the company. He noted that working with a globally recognized preclinical organization strengthens Polyrizon’s regulatory positioning and supports its goal of beginning clinical trials later in the year. Polyrizon continues to move forward with its development strategy as it works to advance its proprietary intranasal medical device technology platform toward clinical validation.