IRIDEX Receives FDA Marketing Clearance For The New IRIDERM Apex 800 Hair Removal Laser

Business Wire, Dec 21, 1999

Business Editors and Health/Medical Writers

MOUNTAIN VIEW, Calif.--(BW HealthWire)--Dec. 21, 1999

IRIDEX Corporation (Nasdaq/NM:IRIX) announced today that it has received FDA clearance for the IRIDERM(TM) Apex(TM) 800 diode laser system for hair removal.

The Apex 800 is the first fiber-optically delivered, high-powered, diode laser system to be granted clearance for hair removal. The Apex 800 will offer dermatologists, plastic surgeons and cosmetic surgeons a reliable and affordable laser system to expand their practice as well as provide patients with a fast and technologically advanced treatment for hair removal. It is the first semiconductor diode laser-based system to deliver 600 Watts of laser power to tissue out of a lightweight fiber-optic handpiece.

"Patient demand for laser hair removal is strong," commented Bradley J. Renton, Vice President of Aesthetics for IRIDEX Corporation. "We believe faster, effective treatments allowed by the IRIDERM Apex 800 will expand the market by enabling more competitive patient fees. Proprietary technology developed at IRIDEX allows the Apex 800 to combine the benefits of reliable semiconductor laser technology with speed, clinical efficacy and ergonomic delivery. These features differentiate the Apex 800 and make it a formidable competitor in the rapidly growing $200 million per year hair removal laser market."

"Hair removal continues to be one of the most frequently requested laser procedures from patients in my practice," said Christopher Nanni, MD, Clinical Instructor of Dermatology at New York University School of Medicine and in private practice in New York City. "Physicians have been waiting for a hair removal laser that is fast and has a low cost of ownership, while maintaining clinical efficacy and reliability. The Apex 800 exactly satisfies these needs."

The Apex 800 (formerly called the IRIDERM 810) is a 600 Watt, solid-state laser based upon 800 nm semiconductor diode lasers. The laser console weighs only 22 pounds (10 kg) and measures 6" x 12" x 17" (15 cm x 30 cm x 44 cm). The product is compact and easily portable between treatment rooms or offices. Laser energy is delivered from the console to the patient via fiber-optic cables and a lightweight handpiece, which weighs only six ounces (170 grams).

"This latest FDA clearance further validates IRIDEX's investment in research and development as the leader in diode laser technology," commented Theodore A. Boutacoff, President and CEO for IRIDEX Corporation. "The Apex 800 leverages an already outstanding technological platform established through our ten years of developing diode laser systems, including the successful DioLite(TM) 532 laser system for vascular and pigmented lesions. We expect that the Apex 800 will be in production during the first quarter of next year and are expanding both our international distribution network and our direct aesthetics sales force in the U.S."

IRIDEX Corporation is the leading worldwide provider of semiconductor-based laser systems used to treat eye disease for ophthalmology and skin lesions for the aesthetics market. The Company markets its products using three brand names: IRIS Medical to the ophthalmic market, IRIDERM to the aesthetics market, and Light Solutions to the research market. Additional information can be obtained by calling 650/940-4700 or visiting the Company web site at www.iridex.com.

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 statements. Risks and uncertainties to which the company is subject may include, but may not necessarily be limited to dependence on development of new products and new applications, continued market acceptance of products, competitive markets, risks of manufacturing, dependence on key manufacturers and suppliers, dependence on international sales, and fluctuating quarter to quarter operating results. Other risks and uncertainties include, but are not limited to, managing growth, dependence on collaborative relationships, patents and propriety rights, governmental regulation, product liability risks, volatile stock price, and the year 2000 issue. The Company incorporates by reference the risks set forth in the Company's 1998 Form 10-K which was filed on April 1, 1999, and Form 10-Q which was filed on November 15, 1999, 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 events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.