FDA Approves IDE for Avisi Technologies’ VisiPlate® Glaucoma Device; SAPPHIRE Trial to Begin in the U.S.

Avisi Technologies, Inc., a clinical-stage ophthalmic medical device company developing sight-saving solutions, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for the VisiPlate® aqueous shunt, enabling the launch of the SAPPHIRE clinical trial in the United States.

The SAPPHIRE trial is a prospective, multicenter, open-label clinical study designed to evaluate the safety and effectiveness of VisiPlate® in glaucoma patients, with one-year follow-up.

A Novel Approach to Glaucoma Treatment

VisiPlate® is an ultra-thin aqueous shunt, made from a proprietary metamaterial that is thinner than a human hair. Its multiple, redundant microchannels are engineered to provide sustained aqueous flow while minimizing blockage and the need for re-intervention, two common causes of surgical failure in glaucoma management.

“VisiPlate® represents a truly novel approach to treating open-angle glaucoma. Its thin profile and multichannel design offer the potential for long-term intraocular pressure control with enhanced safety.”

• Dr. Eydie Miller-Ellis, Vice President of the American Glaucoma Society and Chief of Glaucoma Service at Scheie Eye Institute, University of Pennsylvania.

Dr. Miller-Ellis is also a Principal Investigator in the SAPPHIRE trial.

Building on Global Clinical Evidence

VisiPlate® has already demonstrated encouraging outcomes in the VITA Trial conducted outside the U.S.

• Six-month data were reported at the 2025 American Glaucoma Society Annual Meeting.
• One-year results will be presented by Dr. Jonathan Myers, Chief of Glaucoma Service at Wills Eye Hospital, during the American Academy of Ophthalmology (AAO) Annual Meeting in Orlando on October 19, 2025.

Addressing a Global Health Challenge

“Glaucoma affects more than 100 million people worldwide. VisiPlate® is designed to overcome the limitations of current treatments—such as scarring, noncompliance, and repeat interventions—offering patients a potentially transformative solution.”

• Rui Jing Jiang, Founder and CEO of Avisi Technologies.

Glaucoma remains the leading cause of irreversible blindness globally. Despite advances in medications, laser therapy, and surgical devices, many patients experience inadequate long-term pressure control or surgical failure.

About VisiPlate® and Avisi Technologies

• VisiPlate®: A patented, non-fibrotic metamaterial shunt designed for longevity, comfort, and aesthetic integration.
• Mechanism: Provides sustained aqueous drainage through a microchannel network to maintain intraocular pressure (IOP) control.
• Design Focus: Ease of implantation, reduced risk of occlusion, and long-term stability.

Avisi Technologies is a clinical-stage medical device company advancing novel ophthalmic solutions for glaucoma and related conditions. The company’s pipeline includes the V-001 sustained intraocular drug delivery platform and VisiPlate-S, a drainage system for use during cataract surgery.

Avisi has been recognized by the National Science Foundation, Glaucoma Research Foundation, Johnson & Johnson JLABS, MedTech Innovator, UCSF Rosenman Institute, and others.

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