Iridex confirms effective adoption of LCD L37531, enhancing reimbursement for its laser glaucoma treatments.
Quiver AI Summary
Iridex Corporation announced that the Local Coverage Determination (LCD) L37531 for Micro-Invasive Glaucoma Surgery (MIGS) was successfully implemented on November 17, 2024. This new ruling clarifies that procedures using Iridex's laser consoles and probes do not fall under MIGS, allowing their Cyclo G6 products to remain unaffected by reimbursement limitations. The company believes the LCD will boost interest in their advanced laser-based glaucoma treatments, particularly in MicroPulse and Continuous Wave therapies. Medical professionals, such as Dr. Nathan M. Radcliffe, emphasize that the continued coverage of Transscleral Cyclophotocoagulation (TSCPC) under the new LCD is vital for treating various glaucoma forms, potentially preventing blindness for many patients. Patrick Mercer, the CEO of Iridex, noted that the LCD is likely to encourage physicians to consider more non-MIGS treatment options, further enhancing the role of Iridex's products in glaucoma management.
Potential Positives
- The adoption of Local Coverage Determination (LCD) L37531 confirms that Iridex's Cyclo G6 product family remains unaffected by new reimbursement limitations, positioning the company favorably in the glaucoma treatment sector.
- The LCD's limitations on MIGS procedures may shift physician focus toward Iridex's non-MIGS solutions, potentially increasing demand for its innovative laser therapies.
- Kevin LaMarche's statement suggests that the LCD could enhance physician interest in Iridex's advanced glaucoma treatments, indicating a positive market response.
- Positive anecdotal feedback from the recent American Academy of Ophthalmology conference indicates strong physician engagement with Iridex's offerings, suggesting potential growth in procedure adoption.
Potential Negatives
- The new Local Coverage Determination (LCD) specifically states that treatments using Iridex's products are not classified as Micro-Invasive Glaucoma Surgery (MIGS), which may limit their utilization in certain contexts.
- The restrictions outlined in the LCD could impact the overall market demand for MIGS procedures, potentially reducing the total available market for Iridex's products.
- The press release heavily leans on optimism and anecdotal evidence regarding physician interest, which may not translate into confirmed increased usage or sales, indicating potential uncertainty in future revenues.
FAQ
What is the new Local Coverage Determination for Micro-Invasive Glaucoma Surgery?
The new LCD, L37531, clarifies that certain treatments using Iridex's products are not classified as MIGS, effective November 17, 2024.
How does the LCD affect Iridex's glaucoma treatments?
The LCD creates reimbursement advantages for Iridex's treatments while increasing physician interest in their non-MIGS procedures.
What products does Iridex offer for glaucoma treatment?
Iridex offers the Cyclo G6 product family, including MicroPulse and Continuous Wave laser therapies, for managing glaucoma.
Who supports the efficacy of Iridex's laser therapies?
Physicians like Dr. Nathan M Radcliffe and Dr. Brian A Francis highlight the value and versatility of Iridex's laser therapies.
How many Cyclo G6 probes does Iridex sell annually?
Iridex sells more than 50,000 Cyclo G6 probes each year, indicating strong adoption among physicians.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$IRIX Hedge Fund Activity
We have seen 8 institutional investors add shares of $IRIX stock to their portfolio, and 11 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- AMH EQUITY LTD added 40,321 shares (+8.8%) to their portfolio in Q3 2024
- WOLVERINE TRADING, LLC removed 16,279 shares (-100.0%) from their portfolio in Q2 2024
- CITADEL ADVISORS LLC added 8,918 shares (+21.6%) to their portfolio in Q3 2024
- RENAISSANCE TECHNOLOGIES LLC removed 7,600 shares (-1.9%) from their portfolio in Q3 2024
- UBS GROUP AG added 6,251 shares (+64.8%) to their portfolio in Q3 2024
- SUSQUEHANNA INTERNATIONAL GROUP, LLP added 4,530 shares (+7.4%) to their portfolio in Q3 2024
- SIMPLEX TRADING, LLC removed 4,241 shares (-66.2%) from their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
MOUNTAIN VIEW, Calif., Nov. 19, 2024 (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 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:
MIGS is not considered a first line treatment for mild-moderate glaucoma.
A combination of a surgical MIGS procedure and an aqueous shunt cannot be performed at the same time of service in the same eye.
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 .
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 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, 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 Contact
Philip Taylor
Gilmartin Group
investors@iridex.com