VivoMetrics® LifeShirt® To Be Studied in Multi-Center Cystic Fibrosis Trial

May 16, 2005

Applied Clinical Trials

Study Involving Children May Contribute to New Therapies for Early Treatment of Cystic Fibrosis

VENTURA, Calif. - May 16, 2005 - The LifeShirt System from VivoMetrics will be used in a multi-site clinical trial to measure and gather data on the breathing patterns of children with cystic fibrosis (CF) between the ages of three and six. Because of its ease-of-use and non-invasive measures, the LifeShirt will be examined in this trial, supported by the Cystic Fibrosis Foundation, as a promising method to establish clinical outcome measures in this age group.

Lung disease is the most life-threatening complication of CF and efforts to reduce lung complications must begin early in life. Tthere is an urgent call for more accurate and useful measurements of lung function in preschool children with CF. This awareness led to the investigator-initiated multi-center trial to evaluate lung function measurements in three to six year old children, with support from the CF Foundation. Development of sensitive, reproducible clinical outcome measures are critical to properly evaluating new therapies to treat CF lung disease in preschool children.

CF is a genetic disease affecting approximately 30,000 children and adults in the United States alone. A defective gene causes the body to produce abnormally thick, sticky mucus that blocks the airways, leading to life-threatening lung infections, and that obstructs the pancreas, resulting in difficulty absorbing food. The median life expectancy of people with CF has improved from early childhood to the mid-30s today, but many individuals battle lung disease for years.

The LifeShirt along with two other measures of lung function, spirometry and forced oscillometry, will be evaluated as potentially promising "endpoints" for clinical trials in this age group. The LifeShirt collects respiratory data while the patient sits quietly reading a book or watching a video. Preschool children may be more easily able to comply with the LifeShirt measurement than with other measures that involve breathing into a mouthpiece while wearing a nose clip.

The LifeShirt is a non-invasive, light-weight garment used to monitor respiratory and cardiopulmonary function. The LifeShirt System to be used in the multi-site research is based on a miniaturized, ambulatory version of respiratory inductance plethysmography - a technique for measuring breathing. Breathing is measured via wires embedded in the garment that surround the rib cage and abdomen. High resolution wave forms are stored on a data card for analysis using VivoLogic software to decrypt and process data acquired by the LifeShirt System.

"We expect that using the LifeShirt will enable us to collect useful respiratory data in young children," commented Oscar Mayer, MD from the Division of Pulmonary Medicine at The Children's Hospital of Philadelphia, who is serving as a consultant to the study. "We are excited about the potential results of the study because the earlier we can detect changes in lung function in patients with cystic fibrosis, the more effectively we can care for them."

The study objectives include: 1) Obtaining pulmonary function data that can be used for planning future multi-center clinical trials in preschool children with CF; and 2) Better characterizing the natural history of CF lung disease.

For more information about VivoMetrics and the LifeShirt System, visit www.vivometrics.com

About the LifeShirt System
The LifeShirt System is the first non-invasive, ambulatory monitoring system that continuously collects, records and analyzes a broad range of cardiopulmonary parameters. Users wear a lightweight, machine washable garment with embedded sensors that collect pulmonary, cardiac, posture and activity signals. Data collected by integrated peripheral devices measure blood pressure, blood oxygen saturation, EEG/EOG, periodic leg movement, temperature, end tidal CO2 and cough. An electronic diary captures subjective user input and all physiologic and subject data are correlated over time. The LifeShirt System has received clearance by the U.S. Food and Drug Administration (FDA) and EMEA approval (CE Mark).

About VivoMetrics
VivoMetrics, founded in 1999, develops and markets an ambulatory monitoring device and provides services for the collection, analysis and reporting of subject-specific physiologic data. Pharmaceutical companies use VivoMetrics' technologies to improve the speed and economics of clinical research. The company's offerings also enable academic researchers to discover new clinical signatures of disease, and U.S. government agencies to protect the lives of military and civilian first responders.

About the Cystic Fibrosis Foundation
The mission of the Cystic Fibrosis Foundation is to assure the development of the means to cure and control CF and to improve the quality of life for those with the disease. With money raised through donations from individuals, corporations and foundations since its establishment in 1955, the CF Foundation supports research and care to continue adding tomorrows every day for people with CF. More than two dozen potential therapies are in the CF Therapeutics Development Pipeline - in hopes that at least one will result in a new therapy to extend and improve the lives of those with CF. For more information about CF and the CF Foundation, call (800) FIGHT CF or visit www.cff.org.

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