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Omnisonics Medical Technologies Announces Results of Preclinical Study in Stented Coronary Vessels.

Business Editors/Health/Medical Writers

TCT 2003


Initial Results Demonstrate Safety of Novel Acoustic Energy Device

When Used with Stents in Coronary Arteries

OmniSonics Medical Technologies, developer of products to treat vascular occlusive disease, announced results of a preclinical study demonstrating the safety of its patented acoustic energy when used on stented coronary arteries. This data will be showcased at the Transcatheter Cardiovascular Therapeutics meeting held September 15th through 19th in Washington, D.C.

Dr. Elazer Edelman and Adam Groothuis, of Brigham and Women's Hospital, Boston, tested the safety of OmniSonics' acoustic technology in swine coronary vessels that were implanted with stents. The results from initial studies indicate that the application of acoustic energy is safe and will not create adverse side effects when used in stented coronary arteries.

OmniSonics is developing a novel acoustic technology to treat life-threatening occlusions that block blood vessels throughout the body. Based on the OmniWave(TM) Technology platform, the Resolution(R) System is designed to resolve occlusions which occur as a result of coronary artery disease, deep vein thrombosis and peripheral artery disease. The device, consisting of a thin, titanium wire that is placed into a clogged artery or vein, delivers low power, acoustic energy in all directions to resolve blood clots into minute particles approximately the size of red blood cells.

"The removal of blood clots prior to angioplasty and stenting has been associated with better outcomes for coronary patients. Cardiologists must be able to safely remove blockages in coronary arteries that have previously been stented, and to that end, the results of this safety study are promising," said Dr. Edelman.

The data will be presented during a talk entitled, "A Novel 0.006" Therapeutic Ultrasonic Wire (Omnisonics)" which will be presented by Adam Groothuis during the "Innovative Devices and Futuristic Therapies" symposium on September 18th in Room 202B.

"Cardiovascular occlusive disease affects millions of people worldwide and presents a $10 billion market opportunity for OmniSonics," said Robert Rabiner, President and Chief Executive Officer of OmniSonics. "We are pleased with the progression of our preclinical work in the coronary vasculature and look forward to initiating clinical trials internationally this year."

Coronary Artery Disease is a leading cause of death in the developed world. This disease occurs as a result of the narrowing or the blocking of the arteries of the heart. These blockages can take many forms including blood clots, plaque or calcific materials. OmniWave Technology has the potential to be used as a treatment of blockages that occur during heart attacks as well as for the treatment of complete blockages of the coronary arteries. OmniSonics believes that OmniWave Technology will be complementary to current interventional treatments, such as balloon angioplasty, pharmaceutical treatments and the placement of coronary stents.

OmniSonics has performed bench and animal testing for the use of the Resolution System to treat occlusions in coronary arteries, and Dr. Sung Choi of Tufts-New England Medical Center presented early results at the Society for Cardiac Angiography and Interventions scientific sessions in May of 2003. OmniSonics plans to commence clinical trials internationally in the coronary vasculature in late 2003 and in 2004 in the United States. The Resolution System bears the CE Mark for treatment of peripheral vascular disease and is limited to investigational use in the U.S.

About OmniSonics Medical Technologies, Inc.

OmniSonics Medical Technologies, Inc., based in Wilmington, MA, is a privately held medical device company focused on bringing breakthrough products for vascular occlusive disease to market. These products are based on the Company's patented OmniWave(TM) Technology, the first technology that enables the delivery of acoustic energy over the active length of a small diameter wire in an occluded blood vessel. OmniWave Technology is designed to have broad applications in peripheral and coronary vascular occlusive conditions, which afflict millions of people worldwide. Robert Rabiner, Co-Founder and CEO of OmniSonics, was recently honored by the World Economic Forum as a "Technology Pioneer for 2003" for the innovation of this "radical and transformational" technology. Rabiner was also named as one of Fast Company's "Fast 50" Champions of Innovation in 2002. The Resolution(R) System bears the CE Mark and is available for sale in Europe. The Resolution System is the subject of an ongoing clinical investigation in the United States and is not commercially available in the U.S. For more information on OmniSonics Medical Technologies, visit the Company's Website at

Certain statements made by the Company which are not historical facts may be considered forward-looking statements, including, and without limitation, statements as to trends, management's beliefs, expectations and opinions, which are based upon a number of assumptions concerning future conditions that ultimately may prove to be inaccurate. Such forward-looking statements are subject to risks and uncertainties and may be affected by various factors, which may cause actual results to differ materially from those forward-looking statements.
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Publication:Business Wire
Geographic Code:1USA
Date:Sep 18, 2003
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