MOUNTAIN VIEW, Calif., Feb. 2, 2015 /PRNewswire/ -- IRIDEX Corporation (Nasdaq: IRIX) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its first laser system designed solely for use in treating glaucoma and its symptoms. Specifically, the Company was granted 510(k) clearance for the IRIDEX Cyclo G6 Laser System (with delivery devices). The Cyclo G6 laser system is dedicated specifically to treat patients diagnosed with a range of glaucoma disease states and features the Company's proprietary MicroPulse tissue-sparing technology and a family of single use probes that connect to an intuitive, user-friendly laser console.
Glaucoma is the leading cause of irreversible blindness in adults. It is estimated that more than 4 million people in the U.S. and approximately 60 million worldwide are afflicted with glaucoma today and that number is increasing with the worldwide epidemic of obesity and diabetes. Of the millions that have the disease, it is estimated by the Glaucoma Research Foundation that less than half know they have it and are undergoing treatment. It is estimated that in terms of Social Security benefits, lost income tax revenues, and health care expenditures, the cost to the U.S. government is estimated to be more than $2 billion annually.
Glaucoma and cataract specialist Robert Noecker, MD of the Ophthalmic Consultants of Connecticut stated, "MicroPulse allows for a clinically effective and repeatable option that can slow the progression of the disease and delay both surgical intervention and ultimate blindness."
The Cyclo G6 Laser System will initially be sold with two disposable delivery probes, the MicroPulse P3™ probe and the G-Probe™, and the Company plans a series of additional new probe introductions in the coming year that allow for a broader range of application in glaucoma treatment.
"The Cyclo G6 system extends the reach of IRIDEX' proprietary MicroPulse technology to a broader group of ophthalmologists who are seeking better alternatives for treating glaucoma than drug regimens or invasive surgical procedures," said William Moore, IRIDEX President & CEO. "That added reach, combined with the recurring use of specialty probes associated with the Cyclo G6, is expected to help drive growth in an important recurring revenue component of our business."
About IRIDEX IRIDEX Corporation was founded in 1989 and 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. We maintain a deep commitment to the success of our customers, with comprehensive technical, clinical, and service support programs. IRIDEX is dedicated to a standard of excellence, offering superior technology for superior results. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 70 independent distributors into over 100 countries. For further information, visit the IRIDEX website at http://www.iridex.com/.
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 the markets in which the Company operates, trends in treatment and product usage, product plans and future product releases, regulatory approvals, usage and efficacy of Company products, future financial results and the Company's strategic plans and objectives. 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 Annual Report on Form 10-K for the fiscal year ended December 28, 2013, which was filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and will not be updated.
SOURCE IRIDEX Corporation