To: beats_the_s_p500 who wrote (119806 ) 5/4/2000 9:22:00 AM From: Shadow Read Replies (1) | Respond to of 119973
ESON gets FDA approval (BSNS WIRE) EndoSonics Receives FDA Approval to Begin Human Clinical Trials EndoSonics Receives FDA Approval to Begin Human Clinical Trials of Directional Radiation Device for Diabetics and In-stent Restenosis Business Editors/Health & Medical Writers RANCHO CORDOVA, Calif.--(BW HealthWire)--May 4, 2000--EndoSonics Corporation (Nasdaq:ESON), a leading developer and marketer of diagnostic assessment and therapeutic treatment devices, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) application to begin human clinical trials of its directional radiation (brachytherapy) device to advance the treatment of cardiovascular disease. The device, named BRIGADE(TM) (Beta Radiation with IVUS Guidance and Directed Energy), was developed in conjunction with the Cleveland Clinic Foundation (CCF). The principal investigator for Phase I study is Dr. Patrick Whitlow, Director of Interventional Cardiology at the Cleveland Clinic. The clinical trial is the first in the world to target diabetic patients who have shown a 60-70% restenosis rate in the types of blockages to be investigated. "We are excited to be getting underway with human clinical trials, as we believe this device will be of significant benefit to many cardiovascular disease patients suffering from both new coronary artery blockage and in-stent restenosis following intervention," said Reinhard J. Warnking, Chairman and CEO of EndoSonics. "We believe that exact radiation dosing designed to be provided by BRIGADE will demonstrate the distinct advantages of IVUS-guided radiation, just as we have demonstrated the improved long-term outcomes possible through IVUS-guided stenting." EndoSonics Corporation, headquartered in Rancho Cordova, is a leading developer, manufacturer and marketer of intravascular ultrasound (IVUS) imaging products and functional assessment products to assist in the diagnosis and treatment of cardiovascular and peripheral vascular disease. Visit EndoSonics on the Internet at www.endosonics.com. Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. Actual results may differ significantly from the discussion of such matters in the forward-looking statements. Factors that may cause such difference include, but are not limited to, delays by regulatory authorities, scientific advances by the company or third parties, the timely availability and acceptance of the company's new products, the impact of competitive products and pricing, dependence on key personnel, as well as those factors set forth in EndoSonics' Annual Report on Form 10-K for the year ended December 31, 1999, Quarterly Report on Form 10-Q for the quarter ending September 30, 1999, and other filings with the Securities and Exchange Commission. --30--kwp/sf* CONTACT: EndoSonics Corporation