Rise Health Nano Optics Achieves FDA Clearance Milestone Following Successful Biocompatibility Testing for EYEGUARD Lenses

September 17, 2025 at 04:00 AM EDT

Vancouver, British Columbia--(Newsfile Corp. - September 17, 2025) - Rise Health Nano Optics Inc. ("Rise" or the "Company"), a health-tech innovator specializing in advanced, preventative optical solutions, is pleased to announce a major milestone in its regulatory pathway toward global market entry.

Following a formal review meeting with the U.S. Food and Drug Administration ("FDA") on April 3, 2025, the FDA confirmed:

Classification Agreement: EYEGUARD™ lenses are confirmed as Class I, exempt medical devices.
Intended Use Approval: Protection from 400-600 nm blue light and UV without compromising vision clarity.
Next Steps: FDA authorized Rise to complete required biocompatibility testing before registration.

Rise has now successfully completed cytotoxicity (biocompatibility) testing on both its EYEGUARD-T (Transition) and EYEGUARD-OD (Outdoor) lens configurations. Independent testing conducted at Eurofins Biolab S.r.l. under GLP standards concluded that both products are NOT cytotoxic and fully compliant with ISO 10993-5:2009, clearing the final FDA requirement for registration:

CytoToxicity Test - OD 06092025

CytoToxicity Test -T 06092025

With all regulatory prerequisites satisfied, Rise will now proceed with FDA product registration under self-declaration, unlocking the ability to begin its go-to-market strategy in North America in October 2025 as planned.

Concurrently, the Company will pursue CE approval in Europe by year-end 2025, with the goal of launching its European commercialization strategy in early 2026.

"This milestone marks a transformational point for Rise," said Inas Said, Founder & CEO of Rise Health Nano Optics. "We have cleared every FDA requirement, passed biocompatibility testing with flying colors, and are now only one registration step away from market entry. For our investors, this is the inflection point where years of R&D and regulatory preparation are about to translate into commercial momentum. With our U.S. launch on track for October, and European approval targeted by year-end, we are poised to enter a global market worth more than US$160 billion in eyewear annually, including a US$1.6 billion diabetic lens segment that is urgently seeking preventative solutions. We are ready to move into full execution mode as we progress with our go-to-market plan."

About Rise Health Nano Optics Inc.

Rise is a health technology company specializing in nano-optic solutions that address preventable vision stress and eye disease. Its patented EYEGUARD™ technology is at the intersection of innovation, preventative care, and consumer health - targeting the global eyewear market, with strong relevance to diabetes-related vision impairments and the rapidly growing wellness wearables space.

To learn more, visit: www.risenanooptics.com

Investor Contacts: ir@risenanooptics.com

Cautionary Statements

This press release contains "forward-looking statements or information". Forward-looking statements can be identified by words such as: anticipate, intend, plan, goal, seek, believe, project, estimate, expect, strategy, future, likely, may, should, will and similar references to future periods. Examples of forward-looking statements in this press release include statements made regarding information about future plans, expectations and objectives of the Company overall.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The Company may not actually achieve its plans, projections, or expectations. The forward-looking statements and information are based on certain key expectations and assumptions made by the Company. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: the adequacy of our cash flow and earnings, the availability of future financing and/or credit, developments and changes in laws and regulations, consumer sentiment towards the Company's products, failure of counterparties to perform their contractual obligations, government regulations, competition, loss of key employees and consultants, and general economic, market or business conditions, the impact of technology and social changes on the products and industry.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Except as required by applicable securities laws, we undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/266788

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Rise Health Nano Optics Achieves FDA Clearance Milestone Following Successful Biocompatibility Testing for EYEGUARD Lenses

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