To: Barry Moss who wrote (468 ) 2/5/1998 10:42:00 PM From: Mark S. Schroeder Read Replies (1) | Respond to of 8117
Barry....here's today's news release F.A.S.T.1TM Receives Ethical Approval to Proceed with USA Field Trials Coordinated by the University of Maryland Medical Center Pyng Technologies Corp. News Release PYT.V February 5, 1998 Pyng Technologies Corp. is very proud to announce that subsidiary Pyng Medical Corp has received Ethical Approval for the F.A.S.T. 1TM System for Intraosseous Infusion from the University of Maryland Medical Center. Ethical Approval was required in order to proceed with full field trial evaluation of the F.A.S.T. 1TM Intraosseous Infusion System in live patients, in actual emergency room and pre hospital conditions. The University of Maryland Medical Center (UMMC), one of America's major trauma centers, has agreed to conduct field trials and be the central data collection center for the F.A.S.T. 1TM System in the USA. Pyng Medical Corp is now cleared to proceed with UMMC on live trials at Maryland as well as many other sites selected for field trials in the USA and coordinated by UMMC. This news release follows our recently announced approval from the Ethical Review Board of the University of British Columbia, Canada, to conduct field trials on the F.A.S.T. 1TMsystem at St. Paul's Hospital in Vancouver and Royal Columbian Hospital in New Westminster. Pyng Medical Corp. has consistently met the stringent requirements of both regulatory and ethical approvals necessary to take this life saving medical device to market. Pyng Medical Corp's. dedicated team is preparing to deliver the F.A.S.T. 1TM System and the training tools as quickly as site visits can be arranged . Over the last few months Pyng Medical Corp. has also achieved: Canadian Health Protection Branch approval U.S. FDA clearance #K970380 24 locations in America, including UMMC, selected for field trials subject to Ethical Approval (Cleared). Canadian Hospitals selected for field trials subject to Ethical Approval (Cleared) Grant for $100,000.00 from the B.C. Science Council for field trials. Full presentation to the US Military at the Special Operations Medical Association. F.A.S.T. 1TM System featured article in January 1998 issue of Journal of Emergency Medicine.. For additional information contact: Michael W. Jacobs (604) 875-4526 (Tel) (604) 875-5390 (fax), email: pyngmed@axionet.com The V.S.E. has neither nor reviewed the contents of this news release.