MaybeMOM Only Saliva-Based Ovulation Test of Its Kind to Receive FDA Clearance and Prove It is 98% Accurate

LODI, N.J.--(BUSINESS WIRE)--Aug. 25, 2003--MaybeMOM(R) Mini Ovulation Microscope is the first, in the new product category of hand-held, OTC, cylindrical-shaped, saliva-operated ovulation devices, to receive 510(k) clearance from the Food and Drug Administration (FDA) and clinically prove it is 98% accurate. "MaybeMOM Mini Ovulation Microscope submitted clinical studies of the product for review in 2001 and officially received 510(k) FDA clearance on January 16, 2003, said Helen Denise, President, MaybeMOM, Inc. "Receiving FDA clearance is extremely important for over-the-counter devices, as it ensures consumers receive a safe and effective product that is properly represented." The original fertility microscope sold worldwide since 1990, MaybeMOM has offered a safe, natural, convenient and cost-effective aid to the millions of couples trying to conceive, for more than a decade. As such, MaybeMOM has had market presence longer than any other U.S. competitor. WHY IT IS THE SUPERIOR CATEGORY PRODUCT Utilizing medical lab quality glass lens, 52X strength microscopes, the same technology used for testing in Obstetrician/Gynecologist offices, MaybeMOM Mini Ovulation Microscope is the first, and only saliva-operated ovulation predictor of its kind available to consumers that has 510(k) clearance, is clinically proven 98% accurate and offers a lifetime replacement guarantee. "In my opinion, glass microscopes prove to have clearer, more readable results for a longer period of time," said Dr. Craig Lehmann, Dean of the School of Health Technology and Management at Stony Brook University, Stony Brook, NY. "While there are many saliva-operated ovulation predictors available in stores across the country, to my knowledge, only MaybeMOM has glass optics that resembles a traditional laboratory microscope which typically provides the clearest results possible." HOW IT WORKS MaybeMOM Mini Ovulation Microscope is a non-invasive over-the-counter device that identifies the most fertile days of a woman's menstrual cycle by the direct visualization of the characteristic ovulatory ferning pattern seen in dried saliva. This ferning occurs due to increased levels of ovulatory hormones. The fertile day(s) are detected through the observation of distinctive crystallization or ferning patterns seen on a glass slide. The test is self-administered and is completely portable. It requires no reagents or specific storage conditions and the testing can be performed with relative ease. The results may be interpreted as soon as saliva applied to the slide dries, usually within 2-6 minutes. DEVICE DESCRIPTION The Mini Ovulation Microscope is a hand-held, cylindrical shaped mini microscope containing a miniaturized focusing lens and slide. The slide serves as the platform upon which the saliva is placed and for viewing the dried saliva pattern. The device also includes a miniaturized light source (light emitting diode -LED) that serves as the light source and electronic circuitry. The battery is operated with a replaceable 1.5-volt battery. The Mini Ovulation Microscope is completely reusable, and requires only the cleaning of the mini microscope slide to be reused. CLINICAL/NON-CLINICAL DATA In a consumer study with 93 pre-menopausal women ages 13 to 53, the MaybeMOM Mini Ovulation Microscope was 98% accurate in identifying the impending ovulation as compared to the industry standard urinary LH kits. Salivary ferning was identified within 48 hours pre or post of the first day of the LH surge in 92/95 cycles. The readability of the MaybeMOM Mini Ovulation Microscope was validated in 28 untrained women. The consumers were able to identify salivary ferning on at least on of the days when a trained reader identified ferning in 25 of 28 cycles. Couples trying to conceive can buy their lifetime guaranteed MaybeMOM Mini Ovulation Microscope at any MEIJER or online at www.MaybeMOM.com for approximately $69.95. MaybeMOM, Inc. MaybeMOM, Inc., a leader in Women's Home Health Diagnostics products, develops, manufactures, and markets high-quality diagnostic devices to help women improve their chances of conception. MaybeMOM(R) Mini Ovulation Microscope is an easy-to-use saliva-operated ovulation predictor test produced in the U.S. and is the first-of-its-kind to receive FDA 510(k) certification--clearance to legally market a quality-approved over-the-counter device. For more information, visit www.MaybeMOM.com or call toll-free at 1-866-214-9900. EDITOR'S NOTE: A 510(k) is required when: Introducing a device into commercial distribution (marketing) for the first time. After May 28, 1976 (effective date of the Medical Device Amendments to the FD&C Act), anyone who wants to sell a device in the U.S. has been required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.