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Novasys Medical Announces New Chief Medical Officer, Charles S. Carignan, M.D.

08 / 09 / 2005

Leader in clinical and medical affairs from Boston Scientific and Conceptus

Newark, Calif., - Novasys Medical, Inc., a developer of innovative therapies in women's health, announced today that Charles S. Carignan, M.D., has joined the company as Chief Medical Officer and Vice President, Business Development, Clinical and Regulatory Affairs. Dr. Carignan brings extensive experience in clinical, regulatory and medical affairs, acting in leadership capacities at Boston Scientific and Conceptus. He is also credited with numerous peer-reviewed publications focused on women's health.

"The addition of Charles Carignan to our executive team is perfectly timed with our market introduction of the Renessa T System for the treatment of stress urinary incontinence for women," said Debra Reisenthel, President and Chief Executive Officer of Novasys Medical. "Charles is a key strategic player in women's health who is dedicated to providing our physician customers, patients and health care payers with the support they need."

As Chief Medical Officer, Endosurgery and Minimally Invasive Therapies at Boston Scientific, Dr. Carignan led all aspects of medical and clinical affairs for the Endosurgery group, including women's health, urology, gastroenterology, pulmonology, and oncology. His team supported sales, reimbursement and regulatory strategies with well-designed clinical trials, peer-reviewed journal publications and physician support to increase the speed of new product development and assessments of new medical device technology. As a strategic executive, Dr. Carignan evaluated new technologies and companies for potential alliances, partnerships and acquisitions to expand the breadth of the company's offerings.

Dr. Carignan has significant expertise in the introduction of new technologies, conducting physician training in more than 50 countries and participating on various committees of the World Health Organization, the Population Council, the United Nations and the U.S. Agency for International Development. At Conceptus, Inc., he was Vice President, Clinical Research and Medical Affairs, responsible for large multicenter clinical trials involving more than 750 patients, leading to expedited review and PMA approval by the U.S. Food and Drug Administration (FDA) of a new female contraceptive device. Prior to Conceptus, Dr. Carignan was a leader in the field of reproductive health and contraceptive development for 15 years as a research associate for the Population Council and as Vice President and Medical Director of EngenderHealth (formerly AVSC International), a non-profit organization focused on reproductive health and family planning.

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Dr. Carignan earned his undergraduate degree from Yale University, received his M.D. degree from the College of Physicians and Surgeons of Columbia University and trained in general surgery at Columbia-Presbyterian Medical Center.

Peter S. Edelstein, M.D., the company's previous Chief Medical Officer and Vice President, Clinical Affairs, has accepted the position of President and Chief Executive Officer for a venture-backed medical technology company.

"We wish Peter all the best in his new endeavors," Debra Reisenthel said. "He has been a significant contributor to the success of Novasys Medical, and we are indebted to him for his numerous contributions." Dr. Edelstein successfully designed and led a large multicenter randomized controlled clinical study which was the basis for recent FDA clearance of the company's Renessa System for the treatment of stress urinary incontinence.

About Novasys Medical
Novasys Medical, Inc. is a privately held, venture-backed company which develops innovative therapies in women's health. The company's initial focus is the development and commercialization of the Renessa System, a proprietary, non-surgical approach to the treatment of female stress urinary incontinence (SUI). The Renessa treatment can be performed in a physician's office or an outpatient center.

SUI is the involuntary leakage of urine associate