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[IP] From a Minimed Stockholder (very long)
- To: email @ redacted
- Subject: [IP] From a Minimed Stockholder (very long)
- From: Rmhb1126 <email @ redacted>
- Date: Fri, 24 Apr 1998 19:53:26 EDT
- Cc: email @ redacted, email @ redacted, email @ redacted, email @ redacted, email @ redacted, email @ redacted, email @ redacted, email @ redacted, email @ redacted, email @ redacted, email @ redacted
- Reply-To: email @ redacted
An earlier post asked if anyone had stock in Minimed...We do, solely
because when I was making calls for the JDF WALK 2 yrs ago, I spoke to a young
woman who strongly encouraged me to buy some..Seems she'd purchased it at
$7/share in'94 & watched it soar to $35....2 days ago it was $52 - almost
double what we purchased it for in '96!!!...
Anyway, this is not intended as a stock market analysis, but rather, having
received my "annual report" today, I'm copying here what's stated regarding
"In 1998, the company will also launch its model 507C pump with increased
memory & communications capabilities, and the Minimed Com-Station. The Com-
Station is an accessory product which will link Minimed's pumps (and once
commercially available, Minimed's sensors) with personal computers. It is
designed to facilitate physicians' retrieval and analysis of patients' glucose
levels & insulin delivery history."
"The driving force behind the development of Minimed's continuous
subcutaneous glucose sensor is to provide superior methods for diabetes
patients to manage their disease......(I omitted here the part about current
finger-pricking methods)....With this in mind, we continued to invest heavily
in our glucose sensor projects during 1997, conducting a series of clinincal
trials which evaluated the accuracy & stability of our sensor. Significant
data were collected, compiled and evaluated during these clinical trials,
which included more than 7,000 comparison blood glucose meter measurements
recorded over 1,100 patient days. These efforts resulted in the filing, on
December 17,1997, of an application to the FDA for 510(k) clearance of the
first continuous glucose monitoring system for ambulatory use."
"Minimed's sensor is designed to be inserted into the subcutaneous tissue,
similar to our infusion sets. The sensor monitors glucose levels every 10
seconds and records averages over 5 minute intervals, providing patients &
physicians with an accurate, virtually continuous glucose profile. In fact,
the results of the clinical studies took investigators by surprise, revealing
much more variability in glucose levels than expected. The data suggest that
even the most conscientious diabetes patient who tests aggressively is unable
to adequately maintain near normal glucose balance, experiencing
extraordinarily wide daily swings. Our trial pts. often experienced glucose
levels as low as 30 to 50 mg/dl and highs of 250 to 350 mg/dl or more. The
data also revealed a very high incidence of undetected hypoglycemic events,
especially at night. The breadth of variability is simply not detectable with
traditional intermittent measurement tools & confirms our belief that
continuous monitoring is not just useful, but necessary. We believe that the
wealth of information, which will be available to pts & their health care
professionals could revolutionize the way in which diabetes is treated."
"We intend to introduce our glucose sensing products in several stages.
The 1st stage involves 2 products, which we expect to commercialize in 1998:
a) physician diagnostic device: worn by the pt for 3 days to gather &
store continuous glucose readings that can then be downloaded to a personal
computer for analysis, similar to Holter monitors for cardiac pts.
b) hypoglycemia alert monitor: alarms when a pt's glucose level drops
below the limit established by the physician & will target selected pt.
populations such as small children & people with severe life-style
restrictions due to acute hypoglycemia.
After obtaining additional clinical experience with these initial
products, Minimed anticipates filing for FDA clearance for a consumer monitor
designed to directly address the market for glucose meters & strips, a
worldwide market currently estimated to be $3.1 billion with an annual
compound growth rate estimated at 13%. This monitor would enable pts to
regularly review their glucose profile, and, based upon those readings &
guidelines established by their physicians, administer more precise insulin
dosages needed to maintain both short & long term quality of life. As
continuous glucose measurement becomes available to diabetes pts, we believe
that insulin infusion pumps will become the preferred method of insulin
delivery by many more clinicians & pts. Insulin pumps, with the capability of
delivering hundreds of microdoses of insulin per day, can be more effective in
precisely managing the glucose swings which we believe will become evident
with continuous monitoring."
The only reference to the "closed loop system" we're all awaiting is in
the CEO Alfred Mann's opening remarks, in which he mentions..."we continue to
move closer to achieving our ultimate dream: the artificial pancreas."
As a parent of a 15 yr old, I was also pleased to see a quote from William
Tamborlane, M.D., Yale School of Medicine: "Over the past 2 years, we've had
more teenagers trying a pump for the first time than ever before and the
results have been spectacular!!"
Sorry for the length of this post, but there's been frequent discussion &
speculation of exactly where things stood with Minimed's research, so hope
this helps!!!.......Not exactly "just around the corner", methinks!!!.....
Regards, Renee (Melissa's mom)
Insulin-Pumpers website http://www.bizsystems.com/Diabetes/
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