This is intended to clarify the status of EMS and ER sites who have been involved in early-adoption or field trial of the F.A.S.T.1 Intraosseous Infusion System, and to clarify certain statements made on this site.
A. Completion of Pyng's field trials
A variety of EMS and ER sites were involved with Pyng Medical Corp. as field trial or early adopter sites. On April 9 Pyng issued a news release stating that “Pyng Technologies Corp. is pleased to announce that subsidiary; Pyng Medical Corp. has successfully completed field trials on the F.A.S.T.1 TM System for Adult Intraosseous Infusion."
On approximately April 16, every site that had worked with Pyng was sent a letter which began with the following …
“Some time ago we agreed to work with you and your colleagues as a field-trial or early adopter site, to be one of the first organizations to use the F.A.S.T. 1 Adult Sternal Intraosseous Infusion System. Our objectives in doing this were primarily:
1. To get feedback on the design of the F.A.S.T. 1, so that we might make beneficial changes to the design of the system prior to going into large scale volume production.
2. To expose the F.A.S.T. 1 to key members of the paramedical and emergency medical community, so that the new product and procedure would become known; and
These trials were a very important phase in the development of the F.A.S.T. 1 system, and your contributions have been very much appreciated. We are delighted to report that the trials have been a success to us in both respects. During the trials we incorporated some design changes in response to feedback. In all, we trialed 11 different versions of the F.A.S.T. 1 system. We have had a total of about 120 live patient uses in the field (not including military and cadaver evaluations).”
B. Decision to continue supplying product to a few sites.
For a few of the sites only, Pyng decided to continue to supply them with F.A.S.T.1 units, to allow them to continue using the system, and to continue the working relationship with them in case Pyng chose to request further information from them. For those sites, the letter continued …
“We anticipate another hundred or so field trial uses.
Since we at Pyng Medical feel that we've largely achieved our objectives in conducting the field trials, we are now winding them down.
We will probably be able to supply you with a small additional quantity of the latest version of the F.A.S.T. 1. We'll be in touch with you as to how many we can supply, and for how long.”
Among these sites, the last 3 to begin working with Pyng were 3 in the Orlando area … Kissimmee, St. Cloud, and Osceola. F.A.S.T.1 units to all sites in the Florida area were shipped in April, and in fact Osceola received them April 26. This is part of their own field trial.
C. Decision to not continue supplying product to the remaining sites.
For the remaining sites, Pyng decided not to supply any more pre-production product not be able to continue supplying product, the letter continued …
“Since we at Pyng Medical feel that we've largely achieved our objectives in conducting the field trials, we are now bringing them to an end. … We will be unable to provide you with any further product until volume production is available.“
The above should make it clear that Pyng has indeed successfully completed its field trials.
D. Sites continuing their own trials, including Kissimee, St.Cloud and Osceola.
At each early-adoption or trial site, use of the F.A.S.T.1 arose from a collaboration between Pyng and people at the site. While Pyng has met its objectives, some of the sites may not have met theirs, and may be continuing their own trials.
It should not be any surprise to find that though Pyng has finished its trials, some sites respond to questions by indicating they are continuing theirs.
We would be happy to discuss our interaction with the sites with any interested investor. Because answering questions from investors was not part of our deal with any of the sites, we would prefer that investors who wish further information contact David Johnson at Pyng (604 875 4526) before calling the sites. It's part of our job to supply accurate information to investors. It is not the job of our colleagues at the trial sites.
Thank you.
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