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Gold/Mining/Energy : PYNG Technologies -- Ignore unavailable to you. Want to Upgrade?

To: esxtarus who wrote (415)	12/18/1997 8:40:00 PM
From: esxtarus	Read Replies (1) \| Respond to of 8117

Subj: Overview of Field Trials Date: 97-12-18 19:08:44 EST From: pyngmed@axionet.com (Pyng Medical Employee) To: pyngmed@axionet.com ('pyngmed@axionet.com') OVERVIEW OF FIELD TRIALS for the F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM INTRODUCTION TO THE F.A.S.T. 1 FIELD TRIALS Over the past several years, Pyng Medical Corp. has developed the F.A.S.T. 1 Intraosseous Infusion System---the first medical product designed specifically to achieve safe, rapid vascular access under pre-hospital emergency conditions. In April 1997 the product received FDA clearance to market. The product is also cleared through the Health Protection Branch for sale in Canada. Neither agency required Pyng to conduct clinical trials on live subjects. For a variety of reasons, Pyng has chosen to organize and conduct field trials of the system. PURPOSES OF THE FIELD TRIALS There are three primary reasons why Pyng has chosen to conduct field trials of the F.A.S.T. 1 prior to open marketing. 1. To provide direct evidence to satisfy the company that in "real-life" use in the field the product is as safe, effective, reliable and desirable as the regulatory agencies and we believe it is. Though the company already has extensive test data, more than 100 cadaver trials, and FDA and HPB approval to market, we would prefer to see twenty or so successful uses of the system in real patients under real field conditions before releasing it for open marketing. 2. To help introduce and promote the F.A.S.T. 1 to civilian and military paramedics and emergency physicians who will use it. It is generally recognised that when any new medical product or procedure appears on the scene there will be early adopters, and late adopters. Early adopters will be attracted by the opportunity to use a product that may significantly increase their life-saving effectiveness, and by the opportunity to participate in the early introduction and use of the system. Late adopters will prefer to see many of their colleagues using the system, and to read the published results of in-depth trials before recommending purchase. 3. To provide quick direct evidence to potential investors and strategic partners that practicing paramedics in the pre-hospital setting can use the F.A.S.T. 1 and will want to buy and use it. Most investors and strategic partners take the same position as Pyng itself is taking---they simply want to see a few successful uses by real paramedics in real pre-hospital environments before committing themselves. CURRENT STATUS AND PLANS FOR THE FIELD TRIALS Pyng Medical anticipates conducting up to three sets of field trials (two of these are already under way). The University of Maryland Medical Center (UMMC) multi-site trials. When the paramedical community in North America learned that Pyng was seeking appropriate sites for field trials, about forty EMS services responded with interest in participating. The trauma center at Baltimore's prestigious University of Maryland Medical Center and University of Maryland Medical School offered to coordinate a multi-site trial in the USA. Pyng is working in conjunction with UMMC to conduct a field trial that will involve about a dozen sites. The Vancouver, B.C. trials. Pyng received a Science Council of B.C. research grant of almost $100,000 to conduct a three phase, in-depth study of the F.A.S.T. 1 performance in the emergency rooms of two Vancouver hospitals, and susequently with the British Columbia Ambulance Service. The F.A.S.T. 1 performance will be compared with that of the current methods of trying to get reliable vascular access. The "independent site" trials. Several EMS services have already gained approval of their medical directors, are eager to use the system immediately, and are not particularly keen on being involved in a study which requires recordkeeping and reporting of all results. Pyng may choose to work closely and personally with these sites, to train their personnel, and then release product to them for immediate use in the field. EXPECTED TIMETABLE AND FIELD TRIAL RESULTS The Baltimore and Vancouver trials. Both these trials are under way already. Prior to using the system on patients, both sites require formal protocols and data recording processes are in production now, and dates within the next few weeks are being set for staff training (which takes between half a day and a couple of days). At both sites, initial responses have been received from the ethical review boards, and Pyng has replied to whatever questions they raised. Final approvals are expected within days. At both sites, a small initial study will be conducted within the hospitals' emergency departments, prior to going out to the paramedics and ambulances of the field EMS services. These initial studies will provide the reassurance needed by Pyng, by the early adopters to commit themselves to use of the product, and by investors to investing the funds needed to enter large scale production and distribution. At both sites, following the small initial studies, in-depth studies will be conducted in the pre-hospital paramedical field over the following several months, and later published in professional journals. The results of these studies will provide the late adopters with the evidence they need to commit themselves to purchase. By that time, Pyng's large-scale production will be in place to meet the resulting demand. The "independent site" trials. Should Pyng choose to work directly with these sites, the company will train and support high quality, high volume EMS services in beginning field use of the product. At such sites, experience with a few dozen patients will be acquired in a few weeks from start of training. As with the early data from the Baltimore and Vancouver sites, the independent site data will be directly effective in attracting other early adopters, strategic partners and investors to use and support the product while large scale production is put in place.