1st February 2007

Synova Healthcare says that Synova Pre-Natal Healthcare., a wholly owned subsidiary, and development partner BioPad. have successfully produced the initial set of antepartum fetal-movement monitors for use in their first "in-home" clinical trial. The device is designed to provide a non-invasive means of monitoring fetal movement during the last trimester of pregnancy. Unlike ultrasonic instruments, this non-invasive fetal monitor does not expose either the pregnant mother or her fetus to radiant energy.

Clinical data supporting the value of antepartum fetal movement monitoring is both compelling and growing. Reduced fetal movement has been associated with a variety of tragic and preventable outcomes including stillbirth. Reports of fetal movement declining in advance of a cessation in fetal heart-sounds and fetal death illustrate the value of fetal movement monitoring .

The monitoring of fetal movement is routinely done during the last trimester (and often earlier), and can be performed at-home manually by the mother herself. Manual fetal monitoring is currently done while the mother lies quietly on her side and counts the number of fetal movements within a given time frame, or the time necessary to detect a given number of fetal movements. The non-invasive fetal movement monitor currently being co-developed by Synova and BioPad is aimed at improving this practice by increasing the accuracy agreement of the measurement via this non-invasive device versus manual measurement by the expectant mother, when compared with ultrasound. The Company believes this will reduce maternal anxiety (as the fetal monitor is expected to identify fetal movement the mother may miss) and may contribute to improved outcomes by assisting in identifying real emergencies when they occur and potentially providing the time necessary to intervene successfully.

In the U.S., there are more than 4 million live births annually. Benefits of fetal movement counting extend well beyond fetal welfare and maternal peace of mind. Health-economic analyses have demonstrated the value of enhanced prenatal care. Any intervention that results in a decreased likelihood of premature birth and low birth weight infants will almost assuredly decrease public healthcare expenditures.

"We anticipate that this non-invasive fetal monitor will be the first of its kind for affordable in-home use," states Dr. Ron Spangler, Ph.D., Chief Scientific Officer, Synova Healthcare, Inc. "It is our belief that this device will provide women with added assurance that their fetus is exhibiting normal activity throughout the last trimester of their pregnancy."

BioPad is a non-invasive device that accurately monitors fetal activity in pregnant women from week 24 through birth. The device is intended to augment a clinician’s care of the expectant mother by providing a reliable means of monitoring fetal activity at home. The device provides the expectant mother with peace of mind by indicating that either the baby's activity is within normal range, or fetal movement has declined and that she should see her clinician. The expectant mother will use the disposable pads (up to three times a day) for a period of 20-30 minutes each time, starting in the relevant week of pregnancy. The mother will receive a real time indication regarding her fetus’ movements. Her physician can download the collected data to a desktop using BioPad’s special cradle and or directly from the device itself. The product is passive and emits no radiation.

http://www.biopad.com