EchoCath's Portable Blood Velocity Measurement System Receives FDA 510K Clearance-To-Market.Business Editors PRINCETON, N.J.--(BUSINESS WIRE)--March 26, 2001 EchoCath, Inc. (NASD-OTC:ECHTA) announced today it has been granted permission by the U.S. Food and Drug Administration to market its EchoFlow(TM) battery powered, portable blood velocity measurement system (EchoFlow PEF-1). EchoFlow PEF-1 is a battery powered and portable angle-independent blood velocity measuring system that enables physicians to evaluate and quantify blood flow in vessels using ultrasound technology. Blood velocity is an important parameter of circulatory system circulatory system, group of organs that transport blood and the substances it carries to and from all parts of the body. The circulatory system can be considered as composed of two parts: the systemic circulation, which serves the body as a whole except for the health. In addition to EchoCath's EchoFlow(TM) BVM-1 system designed for use in the operating room operating room n. Abbr. OR A room equipped for performing surgical operations. for blood velocity measurement, the EchoFlow(TM) PEF-1 extends the usefulness of EchoCath's proprietary ultrasound technology. Intensive care units, dialysis facilities and clinics are areas of hospitals where physicians have had the need for accurate blood velocity measurement but have not had cost effective readily available equipment. The EchoFlow(TM) PEF-1 system addresses these needs. EchoCath President, Frank DeBernardis commented, "We are pleased that surgeons who have been using our EchoFlow(TM) BVM-1 in clinical evaluations clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy have been impressed with the systems and have identified a number of applications for the technology outside of the operating room. The EchoFlow(TM) PEF-1 is EchoCath's response to their input." The Company will be exhibiting this technology at the Society for Clinical Vascular Surgery Vascular surgery is a subspecialty of general surgery in which diseases of the vascular system, or arteries and veins, are managed, largely via surgical intervention. The vascular surgeon is trained in the diagnosis and management of diseases affecting all parts of the vascular 29th Annual Symposium in Boca Raton, Florida Boca Raton ("bōkə rə-tōn") is a city in Palm Beach County, Florida incorporated in May 1925. As of the 2000 census, the city had a total population of 74,764; the 2006 population recorded by the U.S. Census Bureau was 86,396. on April 5-7th. Certain statements herein constitute "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. " within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, including without limitation statements regarding acceptability by vascular surgeons and physicians of the Company's technology. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: limited commercial operations; no assurances of success; need for additional financing; uncertainty of market acceptance; failure to receive or delays in receiving regulatory approval; lack of a distribution channel for the Company's products; and limitations on third party reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. . Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion