Iridex Confirms Medicare Administrative Contractors Retired Local Coverage Determinations that Restricted Cyclophotocoagulation

MOUNTAIN VIEW, Calif., Dec. 28, 2023 (GLOBE NEWSWIRE) -- 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 announced all five Medicare Administrative Contractors (“MACs”) retired their local coverage determinations (“LCDs”) that were scheduled to take effect on January 29, 2024.   Iridex and other stakeholders opposing the LCDs have engaged with the MACs throughout the comment period to advocate for continued patient access to clinically proven safe and effective glaucoma treatments. The Company applauds the decision which effectively retains reimbursement and full access for Medicare patients to all Iridex cyclophotocoagulation products.

“We appreciate the engagement with us by the MAC administrators, from the initial correction of criteria for coverage to the conference call with the group to discuss appropriate broadening of qualifying patients. By retiring the LCDs, the MACs have supported continued access to advanced patient care like MPTLT,” said David I. Bruce, President & CEO, Iridex Corporation.

“We thank the numerous glaucoma surgeons across the country, as well as the various societies, notably the American Academy of Ophthalmology, the American Glaucoma Society, the American Society of Cataract and Refractive Surgery, and the Outpatient Ophthalmic Surgery Society for their support and advocacy throughout the process. The groundswell of reaction to the LCDs was critical in providing persuasive feedback during the Notice Period before effectiveness, leading to this action in support of glaucoma patient care."

Between October 24th, 2023 and November 9th, 2023, five of the seven MACs published LCDs targeting MIGS procedures, which also partially restricted criteria for coverage of cyclophotocoagulation reimbursement. Due to these proposed LCDs, the cyclophotocoagulation procedures performed by Iridex’s G6 laser system and probes would have been partially affected by restrictions of the criteria to deem the procedure medically necessary and provide coverage.

As of today, all five MACs, WPS Government Health Administrators, Palmetto GBA, Celerian Group Company, National Government Services, and Noridian Healthcare Solutions, have now issued statements that the final LCDs will not go into effect on January 29, 2024. As a result, there will be no change in January 2024 to the current Medicare coverage for MIGS procedures performed with Iridex MicroPulse® TLT.

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 .

Iridex, and MicroPulse® are registered trademarks of Iridex Corporation, Inc. © 2023 Iridex Corporation. All rights reserved.

Safe Harbor Statement

This 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, demand for and utilization of the Company's products and results and expected sales volumes. 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 20, 2023. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

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