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

(MENAFN- Newsfile Corp) 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 : EYEGUARDTM 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 EYEGUARDTM 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.

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SOURCE: Rise Health Nano Optics

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