Dr. Shimon Gross reports

DIAGNOSTEAR TECHNOLOGIES ANNOUNCES FDA PRE-SUBMISSION FOR TEARX RED EYE DIAGNOSTIC TEST

Diagnostear Technologies Inc. has submitted a presubmission request to the U.S. Food and Drug Administration (FDA) for its TeaRx Red Eye diagnostic test.

The presubmission represents an important regulatory milestone in the company's United States development strategy for TeaRx Red Eye. Diagnostear is seeking FDA's input on the product's regulatory pathway and data development plan.

TeaRx Red Eye is being developed as a rapid, point-of-care test to aid health care professionals in differentiating between adenoviral conjunctivitis, ocular herpes simplex virus (HSV) infection, and allergic conjunctivitis in symptomatic adult and paediatric patients presenting with red-eye symptoms. TeaRx Red Eye is being developed for use in point-of-care settings by general practitioners, ophthalmologists, optometrists and trained health care personnel.

Red eye is one of the most common reasons for visits to primary care and ophthalmology clinics, yet different causes can present with overlapping symptoms while requiring substantially different treatment and infection-control approaches. TeaRx Red Eye is designed to provide rapid results at the point of care to support differential diagnosis and help clinicians make more informed treatment decisions.

The presubmission was prepared and submitted with the support of Hogan Lovells Cadwalader U.S. LLP, which is serving as Diagnostear's United States regulatory counsel. The firm's team involved in the submission includes experienced legal and regulatory professionals supporting medical device and in-vitro diagnostic regulatory matters.

"The submission of our first FDA presubmission for TeaRx Red Eye is an important milestone toward bringing our technology to the U.S. market," said Dr. Shimon Gross, chief executive officer of Diagnostear Technologies. "By engaging with FDA at this stage, we aim to establish a clear regulatory pathway and align our clinical and analytical development program with the agency's expectations. We are pleased to be working with the experienced Hogan Lovells Cadwalader team as we advance this process."

TeaRx Red Eye builds on Diagnostear's strategy to develop rapid, multiparametric tear-based diagnostics that can be used directly at the point of care.

About Diagnostear Technologies Inc.

Diagnostear Technologies is focused on the development and commercialization of rapid, point-of-care, multiparametric diagnostic tests for ocular diseases. By leveraging the analysis of tear fluid composition, Diagnostear provides innovative solutions for diagnosing conditions including dry eye and red eye. The company is committed to improving patient outcomes and transforming ophthalmic care through advanced, accessible diagnostic technologies.

We seek Safe Harbor.