Rise Health Nano Optics Provides Corporate Update on FDA Approval Process and Product Development Milestones
Rise Health Nano Optics Inc. (“Rise” or the “Company”), a health-tech innovator specializing in advanced, preventative optical solutions, is pleased to provide a corporate update highlighting progress on its patented, innovative technology and regulatory path for market entry into the global eyewear and diabetic health markets.
Rise is redefining how we protect and optimize eye health through scientifically driven nano-optical technology. Contrary to common coating techniques with chemical materials that reflect the full range of visible light, Rise’s diffused nano structures absorb light in specific wavelengths and ranges.The Company’s mission is to deliver proactive, preventative vision care solutions, beginning with its proprietary EYEGUARD™ lens technology designed to address growing visual health risks from blue and UV light exposure — an issue especially critical for people managing diabetes, macular degeneration, and other light-sensitive conditions.
Product Innovation: EYEGUARD™ Technology
Rise has developed a breakthrough optical filter, the EYEGUARD™, that provides holistic protection against harmful light exposure while maintaining visual clarity. The filter is engineered to:
- Provide eye protection from bright sunlight by filtering 100% UV, more than 90% of wavelengths between 400-600 nm and blue light
- Filter up to 3x more blue light at 450 nm than competitors
- Provide 100% protection from UV rays
- Significantly lower the pressure exerted on the eye thereby increasing the level of comfort
- Improve the sharpness of the field of vision and the sharpness of colors
- Lenses start filtering side light (non-vertical) at 25 degrees while competitors start filtering at 40 degrees. This reduces the amount of light thereby reducing light sensitivity.
- Significantly lower the level of glare
The EYEGUARD™ filter is designed to be integrated into two distinct configurations:
- EYEGUARD-T (Transition):A photochromic lens that adapts to indoor and outdoor light conditions without distorting the field of view.
- EYEGUARD-OD (Outdoor):A fixed-color lens for constant outdoor use, ideal for high-sensitivity environments.
These configurations are positioned to meet the increasing consumer and clinical demand for advanced, non-invasive vision care solutions — particularly relevant for diabetic populations and other at-risk groups who suffer from light sensitivity and retinal stress.
FDA Regulatory Progress
Rise Nano Optics is advancing regulatory pathways to bring its EYEGUARD™ lenses to the U.S. market. On January 17, 2025, the Company submitted a pre-submission application to the U.S. Food and Drug Administration (FDA) under the device classification “Sunglasses – Sec. 886.5850” for both EYEGUARD-T and EYEGUARD-OD.
Following a formal review meeting held on April 3, 2025, the FDA provided the following feedback
- Classification Agreement:The FDA confirmed Class I, exempt status.
- Intended Use Approved:Protection from 400–600 nm blue light and UV without compromising vision clarity.
- Next Steps:Rise may proceed to register products upon completion of required biocompatibility testing.
Rise submitted its meeting minutes to the FDA shortly after the review meeting, in compliance with regulatory protocol. The Company expects FDA registration in the United States by September 2025.
“We have developed an innovative, disruptive technology with the mission of providing proactive preventative vision care solutions for customers globally. The global addressable eyewear market is US$160Bn, and of that, the market for diabetic lenses is US$1.6Bn – this presents a significant opportunity for our product to make a meaningful impact globally,” commented Inas Said, Founder and CEO of Rise. “We are very pleased with the progress we have made to date, including the collaborative engagement with the FDA and their confirmation of our proposed classification and product use. With a clear regulatory path and testing underway, we are well-positioned to bring our revolutionary eyewear technology to market and unlock significant value for our stakeholders.”
Capital Markets Strategy
The Company is preparing to go public on the Canadian Stock Exchange (“CSE”) via reverse takeover (“RTO”) and is making strong process. The final prospectus offering will be submitted in August. Pending approval of the prospectus, the Company anticipates it will begin trading at the end of August under the ticker “EYE”. Following the listing on the CSE, Rise plans to list on the Frankfurt stock exchange and then achieving an OTC listing (DTC eligible) in the fall.
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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