FW: MID-CM

[Robert Cole <EMCOLERS@adaweb.net>]

TO all that may be concerned,
Please read the attached regarding the MID-CM device. This was the device
that would increase cardiac output to 50-80 % during arrest situations,
approved by the FDA for experimental trials, but unfortunately it seems no
US IRB had the you know what to let it be done. I guess it goes to show the
good guys don't always win.

Robert S. "Steve" Cole
Paramedic, CCEMTP
Education Department
Ada County Paramedics 
208-375-7079
emcolers@adaweb.net

"...A mind stretched with new ideas never regains its former shape"


-----Original Message-----
From: Jessica Droge [mailto:jdroge@theracardia.com]
Sent: Wednesday, May 22, 2002 2:27 PM
To: Robert O'Connor; Jerry Castellano Pharm. D.; Tracy Hitchner; Sharon
Vickers; Michael R. Sayre M.D.; Lynn White; Craig B. Key; 'Jill Fortin';
David Gerstner; Thomas A. Sweeney (E-mail); 'Gary. Anderson@Wright.
Edu'; David - HFD Persse; Jim Brown MD; Ashlee McCulloch; Robert Bass;
Richard Chiacchierini; Bill Chung; dunnww@yahoo.com; 'Karl Kern'; Robert
French; Paul Pepe; Jim Menegazzi; Peter Lane; Laurence Katz; Roger J
Lewis MD PhD; Kerry Lee; Ross Megargel; Laurie Morrison; Frank Nagy;
Edward Newton M. D.; Brian O'Neil; Jon Puryear; Emanual Rivers; Jane
Wigginton; Ksporer@itsa.ucsf.edu; 'Froman, Philip'; Dan O'Brien; Mary
Nan Mallory; Christopher Colwell; Craig Gravitz; Jim Manson; Robert
Cole; Bill Dino; Ginger Mangolds; restuccm@ummhc.org; James Dunford;
Edward Racht MD; Tom Blackwell
Cc: Beth Cohen; Linda Smith; Bryon Moore; Keith Serzen; Don Kolehmainen
Subject: MID-CM


Dear all, 

I am writing to inform you that, unfortunately, we will not be starting
the MID-CM trial in North America. 

We just heard the news yesterday that, even though our device shows
promise, our investors have decided that the duration and cost of the
trial required to generate statistically significant results is too long
for their funding to support.  Based on our experience, the procedure is
of benefit to certain cardiac arrest patients, so it is yet to be
determined if this promising technology will be sold to a larger company
that can devote the resources required to develop it to its full
potential.  

The success of the study, I believe, is that this procedure has proven
to be safely applied by paramedics in the pre-hospital setting, when
that was thought to be an impossible feat.  I hope our experiences set
the stage for future progress in resuscitation.

Whatever the outcome, we are all grateful for the support of everyone
involved.  We appreciate your patience with us and are happy to have had
the opportunity to not only meet all of you, but to really get to know
some of you.  

Again, thank you all for your support.  I will be here for the next few
weeks closing up shop, so please feel free to contact me if you have any
comments or questions.  I hope our roads cross in the future.

All the best, 

Jessica Droge

Jessica Droge, Ph.D.
Director of Clinical Affairs
TheraCardia, Inc.
U.S.A.
Tel: (949) 366-6640 x229
Fax: (949) 366-3050 
jdroge@theracardia.com


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