IRIDEX Announces FDA 510(k) and CE Clearance of New Laser Delivery System for Fast, Non-invasive Treatment of Serious Retinal Diseases TxCell™ Scanning Laser Delivery System capable of multi-spot, single spot, and Fovea-friendly™ MicroPulse Laser Therapy
MOUNTAIN VIEW, Calif., Dec. 3, 2012 /PRNewswire/ -- IRIDEX Corporation (NASDAQ: IRIX) today announced the FDA 510(k) and CE clearance of the TxCell Scanning Laser Delivery System. The new product saves significant time in a variety of laser photocoagulation procedures in allowing physicians to deliver the laser in a multi-spot scanning mode, a more efficient method for these procedures than the traditional single spot mode.
"Broadening market acceptance for medical technologies typically involves effective clinical results, ease of use for the physicians and more efficient use of time. TxCell can deliver all three benefits and is an important step in accelerating the adoption of our proprietary MicroPulse technology as it applies to several clinical procedures," stated Will Moore, IRIDEX President and CEO.
Giovanni Staurenghi, MD, Professor of Ophthalmology and Chairman of the Eye Clinic Ospedale Sacco at the University of Milan was the first to use the new system. Prof. Staurenghi stated, "TxCell Scanning Laser Delivery System with the IQ 577 offers an intuitive and versatile way to deliver several advanced laser modalities."
The TxCell Scanning Laser Delivery System combined with an IRIDEX IQ 532™ or IQ 577™ laser enabled with MicroPulse is designed to provide the ophthalmologist a highly versatile system with three laser modalities – multi-spot scanning, single spot standard, and MicroPulse Laser Therapy. Initial shipments have commenced with orders from a number of different countries.
About MicroPulse Technology
MicroPulse is a Fovea-friendly tissue-sparing laser delivery therapy that works by electronically "chopping" the laser emission into trains of microsecond pulses. This enhances the physician's ability to more precisely control the laser effects on target tissues, offering the potential for ocular treatment with less collateral effects than conventional laser treatments.
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, relating to the effectiveness and market acceptance of the TxCell Scanning Laser Delivery System and MicroPulse laser therapy, and IRIDEX' marketing and sales efforts. 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 31, 2011, and our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2012, June 30, 2012, and September 29, 2012, each of 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