DiagnosTear Technologies Announces FDA Pre-Submission for TeaRx(TM) Red Eye Diagnostic Test

Vancouver, British Columbia–(Newsfile Corp. – September 3, 2026) – DiagnosTear Technologies Inc. (CSE: DTR) (FSE: X8F) (“DiagnosTear” or the “Company“), a developer of innovative point-of-care eye diagnostic solutions, is pleased to announce the submission of a pre-submission request to the U.S. Food and Drug Administration (“FDA“) for its TeaRx™ Red Eye diagnostic test (the “Pre-Submission“).

The Pre-Submission represents an important regulatory milestone in the Company’s U.S. 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 healthcare 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 healthcare 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 Pre-Submission was prepared and submitted with the support of Hogan Lovells Cadwalader US LLP, which is serving as DiagnosTear’s U.S. 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 Pre-Submission for TeaRx™ Red Eye is an important milestone toward bringing our technology to the U.S. market,” said Dr. Shimon Gross, CEO of DiagnosTear Technologies Inc. “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, multi-parametric tear-based diagnostics that can be used directly at the point of care.

About DiagnosTear Technologies Inc.

DiagnosTear Technologies Inc. is focused on the development and commercialization of rapid, point-of-care, multi-parametric 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.

Cautionary Note Regarding Forward-Looking Statements

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements“) within the meaning of applicable Canadian securities legislation. All statements in this news release that are not purely historical are forward-looking statements and include statements regarding beliefs, plans, expectations and intentions of the Company. Forward-looking statements in this news release include, but are not limited to, statements regarding: the anticipated timing and content of FDA feedback on the Pre-Submission; the Company’s proposed Dual 510(k) and CLIA Waiver by Application regulatory pathway; the design, conduct and outcomes of planned analytical, clinical and usability studies; the potential submission of a future U.S. marketing application and receipt of 510(k) clearance and CLIA waiver; the intended use, performance and clinical utility of TeaRx™ Red Eye; and the Company’s business plans, development strategy and prospects for commercialization in the United States and elsewhere.

Forward-looking statements are frequently, but not always, identified by words such as “expects”, “anticipates”, “believes”, “intends”, “estimates”, “potential”, “possible”, “proposed”, “aims”, “plans”, “will”, “would”, “may” and similar expressions, or statements that events, conditions or results “will”, “may”, “could” or “should” occur or be achieved. Forward-looking statements are based on the opinions and estimates of management as of the date such statements are made and reflect management’s current expectations and assumptions, including assumptions regarding: the timing and nature of FDA feedback; the Company’s ability to design and complete required studies on acceptable timelines and budgets; the availability of sufficient financing; and the Company’s ability to retain key personnel and advisors.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others: the risk that FDA feedback may differ materially from the Company’s expectations or may require changes to the proposed regulatory pathway or study designs; the risk that the Company may not obtain 510(k) clearance, a CLIA waiver or any other regulatory clearance or approval on anticipated timelines, or at all; risks related to the design, enrollment, conduct and results of analytical and clinical studies; regulatory and legislative changes; reliance on third-party advisors, suppliers and partners; competition; the Company’s need for additional financing and the availability of such financing on acceptable terms; intellectual property risks; and general economic, market and business conditions. TeaRx™ Red Eye is an investigational device and has not been cleared or approved by the FDA or any other regulatory authority, and there can be no assurance that any such clearance or approval will be obtained.

Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this news release.

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