IRIX IRIDEX Corporation

Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and procedure probes for the treatment of glaucoma and retinal diseases, today confirms that Local Coverage Determination (LCD) L37531, relating to Micro-Invasive Glaucoma Surgery (MIGS), was adopted as scheduled and will be effective for services performed on or after November 17, 2024. The Company has previously reported that it believes the reimbursement limitations created by the new LCD has potential to significantly increase physician interest in and use of Iridex’s advanced laser-based treatments for glaucoma.

The new LCD clarifies that treatments performed using Iridex’s laser consoles and probes are not MIGS procedures, and thus, Iridex’s Cyclo G6® product family is unaffected by the new reimbursement limitations. Iridex’s proprietary MicroPulse® and Continuous Wave laser therapies for glaucoma have been adopted by physicians around the globe as effective tools for managing and slowing the progression of glaucoma. Currently, Iridex sells more than 50,000 Cyclo G6 probes per year.

“In addition to creating some reimbursement advantages for Iridex’s glaucoma treatments in the United States, the LCD creates opportunity to capture more physician attention to the significant clinical benefits of our products, particularly MicroPulse Transscleral Laser Therapy (MPTLT),” said Kevin LaMarche, Iridex’s Senior Director of Clinical Affairs. “Our laser procedures are noninvasive, repeatable, and can be utilized to treat patients across a far broader range of glaucoma’s progression, whether before, after, or even coincident to MIGS procedures.”

Nathan M Radcliffe, MD, of New York Eye and Ear Infirmary, commented, “Glaucoma is a non-curable disease. It is important that we have coverage for as many glaucoma treatments as possible. Transscleral Cyclophotocoagulation (TSCPC) is one of the very few glaucoma procedures that can be utilized in several disease states and almost all glaucoma types. Thousands of patients could have faced permanent blindness were this procedure limited by coverage.”

Brian A Francis, MD, Associate Professor of Ophthalmology at the Doheny Eye Institute, added, “I am encouraged that TSCPC remains unaffected by the recent glaucoma LCD. TSCPC is a valuable and versatile laser therapy within the glaucoma treatment paradigm.”

The final LCD, L37531, which went into effect on November 17, 2024, provides the following reimbursement limitations:

1. MIGS is not considered a first line treatment for mild-moderate glaucoma.
2. A combination of a surgical MIGS procedure and an aqueous shunt cannot be performed at the same time of service in the same eye.
3. Phacoemulsification/intraocular lens placement performed with a combination of MIGS procedures, (e.g., cataract + stent + canaloplasty or goniotomy) at the same time of service in the same eye is non-covered.

Patrick Mercer, Iridex’s CEO, commented on the implications of the LCD for physicians treating glaucoma, “The community has been focused on pursuing more MIGS procedures, even to the point of stacking one form of treatment on top of another. The LCD appears designed to end this, and physicians evaluating treatment options will increasingly look for non-MIGS procedures, such as Iridex’s MicroPulse and Continuous Wave TLT, as they seek to mitigate progression of the disease.”

Mr. Mercer continued, “At the recent American Academy of Ophthalmology (AAO) conference in Chicago, we saw significant anecdotal evidence that physicians already appreciate the increased role Iridex’s Cyclo G6 product family will play in their practices. We observed a steady stream of physicians visiting our booth and participating in our wet lab trainings that initiated discussion with our clinical and sales representatives on their intention to increase the number of MicroPulse and Continuous Wave TLT procedures they will perform. We are very encouraged by these developments,” Mr. Mercer concluded.

About Iridex Corporation

Iridex Corporation is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. The Company’s proprietary MicroPulse® technology delivers a differentiated treatment that provides safe, effective, and proven treatment for targeted sight-threatening eye conditions. Iridex’s current product line is used for the treatment of glaucoma and diabetic macular edema (DME) and other retinal diseases. Iridex products are sold in the United States through a direct sales force and internationally primarily through a network of independent distributors into more than 100 countries. For further information, visit the Iridex website at www.iridex.com.

MicroPulse® is a registered trademark of Iridex Corporation, Inc. in the United States, Europe and other jurisdictions.  © 2024 Iridex Corporation.  All rights reserved.

Safe Harbor StatementThis announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning clinical expectations and commercial trends, market adoption and expansion, value-maximizing transactions, demand for and utilization of the Company's products and results and expected sales volumes. The Company can provide no assurance that it will complete any value-maximizing transactions on behalf of its stockholders. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2024. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

Investor Relations ContactPhilip TaylorGilmartin Groupinvestors@iridex.com