IRIDEX Announces FDA Clearance to Introduce Updated TruFocus LIO Premiere™ Laser Accessory to the U.S. Market
MOUNTAIN VIEW, Calif., Sept. 06, 2018 (GLOBE NEWSWIRE) -- IRIDEX Corporation (Nasdaq: IRIX) today announced the introduction of its updated TruFocus LIO Premiere™ laser accessory following U.S. Food and Drug Administration (FDA) 510(k) review and clearance.
The TruFocus LIO Premiere is a light combination and reflection viewing system used with IRIDEX retina laser systems and is worn on the physician’s head. The product combines a laser treatment beam from an IRIDEX laser source with the illumination beam of a binocular indirect ophthalmoscope into a mixed optical beam used by a physician with a handheld ophthalmic examination lens to enter a patient’s pupil and to view and treat a patient’s retina. It provides a portable alternative to patients who cannot be examined or treated with a fixed slit lamp adapter. The device can be used to evaluate and treat patients of all ages, including infants, in an office, operating room and ambulatory surgical center setting.
“We are pleased to again be offering our full portfolio of laser delivery devices to doctors in the U.S.,” said William M. Moore, President and Chief Executive Officer. “We would like to thank our team and the FDA for their diligent attention to this matter.”
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, 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 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 Company’s TruFocus LIO Premiere product and the timing of launching the updated product. 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 30, 2017, and Quarterly Reports on Form 10-Q for subsequent fiscal quarters, 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.
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