IRIDEX Corporation Announces FDA Clearance for New DioPexy Probe for Treatment of Retinal Detachments.MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--July 25, 1996--IRIDEX Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :IRIX A Unix-based operating system from SGI that is used in its computer systems from desktop to supercomputer. It is an enhanced version of Unix System V Release 4. IRIX integrates the X Window system with OpenGL, creating the first real time 3D X environment. ) announced today that its wholly-owned subsidiary, IRIS Medical Instruments Inc., received clearance from the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to market the DioPexy Probe for use by ophthalmologists to treat conditions such as retinal detachments. The DioPexy Probe treats retinal problems through the sclera sclera: see eye. , the white part of the eye, employing a technique called transscleral retinal photocoagulation photocoagulation /pho·to·co·ag·u·la·tion/ (-ko-ag?u-la´shun) condensation of protein material by the controlled use of an intense beam of light (e.g. (TSRPC) which appears to have fewer side effects Side effects Effects of a proposed project on other parts of the firm. than cryotherapy Cryotherapy Definition Cryotherapy is a technique that uses an extremely cold liquid or instrument to freeze and destroy abnormal skin cells that require removal. , a freezing technique which has been commonly used for repair of retinal detachments. A multicenter clinical study was conducted to evaluate the ability of the IRIS Medical OcuLight infrared laser photocoagulator and the IRIS DioPexy Probe to achieve effective, safe transscleral chorioretinal adhesions during retinal detachment surgery. At six months follow-up, results showed 89% of retinas were successfully attached with one transscleral diode laser retinopexy procedure, and visual acuity either improved or remained unchanged within one line of baseline in 95% of eyes with successful outcomes. "The DioPexy Probe offers a new approach to retinal treatment because it allows photocoagulation of the retina through the sclera without damaging the scleral scleral pertaining to sclera. scleral annulus a thickened roll of sclera at the junction with the cornea. scleral ectasia see sclerectasia. tissue itself. Clinical studies have shown that TSRPC using the DioPexy Probe is as effective as cryotherapy, yet results in less inflammation and post-treatment discomfort than cryotherapy," announced Theodore A. Boutacoff, president and chief executive officer. The DioPexy Probe is an accessory to the OcuLight Models SL and SLx semiconductor-based infrared laser photocoagulators. The 14 lb. devices are used for treatment of glaucoma and retinal disease and are the smallest, most portable photocoagulators available. In addition to the DioPexy Probe, the OcuLight SL and SLx are compatible with a number of other delivery devices which can be used in operating rooms, outpatient clinics and private offices. IRIDEX is the leading worldwide provider of semiconductor-based photocoagulator systems used to treat eye disease, including the three leading causes of irreversible blindness: age-related macular degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. (AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ), diabetic retinopathy, and glaucoma. IRIDEX develops, manufacturers and markets products used by ophthalmologists in hospitals, private clinics, offices and major research centers in 64 countries. This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. Actual results could differ materially from those projected in the forward-looking statement regarding the marketing of the DioPexy Probe as a result of risk factors which include the successful introduction and market acceptance of new products and applications. For additional risks and uncertainties, the Company incorporates by reference the risks set forth under "Risk Factors" in the Company's Registration Statement (Commission File No. 333-00320-LA) and such other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements which may be made to reflect the occurrence of unanticipated events. CONTACT: IRIDEX Corp. Timothy A. Marcotte, 415/962-8100 |
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