IRIDEX Receives CE Mark for Cyclo G6™ Laser System for the Treatment of Multiple Stages of Glaucoma
European Roll-Out Follows Successful Launch in US Market; System Placements and Utilization Surpass Expectations
MOUNTAIN VIEW, Calif., Feb. 16, 2016 /PRNewswire/ -- IRIDEX Corporation (Nasdaq: IRIX), a leading global provider of innovative laser systems, delivery devices and consumables in ophthalmology, today announced that it has received its CE Mark to commercialize across Europe its first laser system in its class designed solely for use in treating glaucoma and its symptoms. 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.
"This regulatory approval marks a milestone for the glaucoma community and strengthens our portfolio to treat patients with difficult glaucoma conditions who need fast relief from uncontrolled eye pressure" said Dr. Keith Barton, Consultant Ophthalmologist, Glaucoma Service, Moorfields Eye Hospital, London, England. He continued, "Some studies of the Cyclo G6 have shown a 30-40% reduction in intraocular pressure (IOP) so this is a very promising therapy for our patients. In addition, the ability to reduce IOP without incisions nor using implants in a quick procedure is very attractive, as is the repeatability, potentially extending the time before more invasive measures are required."
The Cyclo G6 Laser System will be sold with two disposable probes, the MicroPulse P3™ probe for use with a broad range of glaucoma patients and the G-Probe™ for later stage patients. The Company plans to introduce a series of additional new probes in the coming year that allow for additional applications in glaucoma treatment.
"We are thrilled to receive CE Mark approval for the Cyclo G6 System in Europe and welcome this significant step forward in making this system available to patients on a global scale," said Will Moore, President and Chief Executive Officer of IRIDEX. "The Cyclo G6 is a new and effective option for those patients who have been unsuccessful with the burden of frequent administration of eye drops and do not wish to have surgical intervention or implants. Underscoring that point, a recently published study of surgical implant patients found that the decision to implant the device was based on the wish of the patient to reduce or possibly eliminate the burden of topical glaucoma medications – we feel that the MicroPulse solution provides that ability, while precluding or delaying the need for surgical implants."
Glaucoma is a group of diseases that cause damage to the optic nerve and can lead to vision loss or blindness. Approximately 65 million people worldwide suffer from the disease. Prior to the Cyclo G6 System, treatment options for patients were limited to incisional surgery or topical medications that are often administered multiple times per day.
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 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 usage and efficacy of Company products, product plans and future product releases, changes in the Company's product portfolio, the markets in which the Company operates, trends in treatment and product usage, demand for the Company's products 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 the Company's Annual Report on Form 10-K for the fiscal year ended January 3, 2015, 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.
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SOURCE IRIDEX Corporation