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FDA CLEARS NATUS MEDICAL'S ALGO® 3 |
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Next-generation ALGO system to decrease testing costs, improve testing accuracy SAN CARLOS, Calif. (October 17, 2001) - Natus Medical Incorporated (NASDAQ NM: BABY) ("Natus") today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration to market its new ALGO® 3 Newborn Hearing Screening system. The new system is expected to lower screening costs through improved test accuracy, and reduced testing time. The ALGO 3 screener is also expected to reduce parental anxiety with a false positive rate that is 50% lower than other screeners. A variety of new, ease-of-use features will decrease the testing time. The ALGO 3 system consists of new Flexicoupler™ disposable earphones, Jelly Tab™ sensors, specially calibrated cables and the ALGO 3 screener itself. Like other ALGO newborn hearing screeners, the new ALGO 3 uses exclusive AABR® technology that screens the newborn's entire hearing pathway - from the outer ear to the brainstem. Only ALGO screeners use completely standardized pre-set screening parameters and fully automated pass/refer results so a trained clinician is not required to conduct the test. In numerous published peer-reviewed studies, ALGO screeners are shown to be the most clinically accurate newborn hearing screeners available. ALGO devices are the only newborn hearing screeners clinically proven to achieve the American Academy of Pediatrics' guidelines, even within the 24-hour newborn discharge window. "We believe Natus is maintaining its position as the market leader in newborn hearing screening by continuing to provide the most accurate and baby-friendly devices available. The ALGO 3 system is the result of more than 12 years experience screening approximately 7 million babies and extensive dialogue with physicians, nurses, audiologists and other screening personnel," said Tim Johnson, president and chief executive officer of Natus. "With the majority of states now implementing mandates that babies be screened for hearing loss, and the new ALGO 3 being priced comparably to our existing ALGO 2eColor system, we believe the ALGO 3 system will be well received" added Mr. Johnson. The Company has a number of domestic and international patents pending for the new screener and the disposable earphones. The new Flexicoupler earphones and Jelly Tab sensors are compatible with all previous generations of ALGO screening equipment. The ALGO 3 screening system will be launched at the American Academy of Pediatrics annual meeting being held October 20-24, 2001 in San Francisco. Natus Medical develops, manufactures and markets proprietary, non-invasive, easy-to-use, crib-side screening devices for the detection and/or monitoring of common disorders in babies. In addition to the ALGO product line, Natus also manufactures and distributes MiniMuffs® Neonatal Noise Attenuators and the CO-Stat® End Tidal Breath Analyzer, a technology that non-invasively detects the rate of hemolysis in newborns. Additional information can be found at www.natus.com. This press release contains forward-looking statements, including expected benefits and anticipated reception of the ALGO 3 screener. These statements involve known and unknown risks, uncertainties and other factors that may cause Natus' actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements are only predictions and the actual events or results may differ materially. Natus cannot provide any assurance that its future results will meet expectations. Natus' operating results could differ materially due to a number of factors, including the continued growth of demand for newborn hearing screening equipment, continued acceptance of Natus' existing products and the successful introduction and widespread market acceptance of Natus' new products, such as the ALGO 3 screener. For additional information and considerations regarding the risks faced by Natus, see the Company's Registration Statement on Form S-1, as filed with the Securities and Exchange Commission, as well as periodic reports on Forms 10-Q and 10-K to be filed with the SEC. Although Natus believes that the expectations reflected in the forward-looking statements are reasonable, Natus cannot guarantee future results, levels of activity, performance or achievements. In addition, historical information should not be considered a predictor of future performance. Moreover, neither Natus nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. Natus disclaims any obligation to update information contained in any forward-looking statement. |
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