[Previous Months][Date Index][Thread Index][Join - Register][Login]
[Message Prev][Message Next][Thread Prev][Thread Next]

[IP] MiniMed Inc. Comments On Initiation of Human Clinical Trials of Long-Term Implantable Glucose Sensor and Other Sensor Developments

MiniMed Inc. Comments On Initiation of Human Clinical Trials of Long-Term
Implantable Glucose Sensor and Other Sensor Developments


NORTHRIDGE, Calif., Nov. 15  MiniMed Inc. (Nasdaq:MNMD) today commented on
the initiation of human clinical trials of a long-term implantable glucose
sensor developed by an affiliated company, Medical Research Group, Inc.
       The sensor is implanted intravenously and is connected to, but does
not at this time control, an implantable insulin pump located in the
abdomen. In the first phase of this trial, the sensor continuously reads
blood glucose levels but the data is blinded to the patient. MiniMed has
entered into an agreement with MRG whereby MiniMed may acquire the worldwide
exclusive marketing rights to this implantable sensor for $30 million
pending the preliminary results of these clinical trials. The implantable
insulin pump is manufactured by MRG and licensed exclusively to MiniMed.
       Alfred E. Mann, Executive Chairman of MiniMed Inc., commented, "This
clinical trial marks a major milestone in progress toward achieving our
ultimate vision of an implanted artificial pancreas. While the current trial
is not yet evaluating automatic control of insulin delivery in humans, the
sensor is connected to the implantable pump, which has been extensively
validated in over 600 patients over almost ten years. If the first phase of
this trial establishes the safety and accuracy of the sensor, MRG intends to
seek regulatory authorization to download control algorithm software into
the already implanted hardware to achieve automatic control. The objective
of such an artificial pancreas is to lessen the burden of today's
extraordinary rigors of glucose control without the fear of the long term
complications such as blindness, kidney failure, amputations and diabetes
related cardiovascular disease. Aside from the implants, our hope is that a
patient would simply see his or her physician every three months for a
check-up and a refill of insulin."
       Terrance H. Gregg, President and Chief Operating Officer of MiniMed,
commented, "We are very pleased and excited that the development of the
long-term implantable glucose sensor is advancing down the regulatory
pathway. We will be watching these clinical trials with great interest. The
initial data we are receiving is quite promising and, if the data continues
to show the sensor accurately and continuously measuring blood glucose
levels, we expect to exercise our option to obtain the exclusive worldwide
marketing rights from MRG." Mr. Gregg plans to disclose some of the initial
results from the long-term sensor clinical trials at the Merrill Lynch Med
Tech Fundamentals Conference in New York City on November 16, 2000.
       In a separate but related development, Mr. Gregg expects to disclose
some preliminary results of animal studies conducted with a closed-loop
system, or artificial pancreas, utilizing MiniMed's traditional core
product, its external insulin pump, in combination with its external
continuous glucose monitoring system. The data from both of these studies
presented at the conference will also be available on MiniMed's website at
       MiniMed Inc. designs, develops, manufactures and markets advanced
infusion systems with a primary emphasis on the intensive management of
diabetes. The Company's products include external pumps and related
disposables, a first generation continuous glucose monitoring system, as
well as an implantable insulin pump for which MiniMed has exclusive
marketing rights. This implantable insulin pump is currently approved for
distribution in the European Community and has not yet been cleared for
marketing in the U.S. The Company is also developing new infusion systems to
deliver compounds designed to treat a variety of other medical conditions.
       Any statements made by MiniMed in this press release that are
forward-looking, including statements relating to future results of clinical
trials of the implantable long-term glucose sensor, the exercise of
MiniMed's option to acquire the exclusive worldwide marketing rights for the
implantable long-term glucose sensor, the accuracy or effectiveness of the
implantable long-term glucose sensor, the ability of MRG to download control
algorithm software into the already implanted hardware, the disclosure by
MiniMed executives of data relating to animal studies of an "artificial
pancreas" utilizing an external insulin pump, or data relating to the
implantable long-term glucose sensor, the ability of MiniMed to successfully
commercialize the implantable long-term glucose sensor, the ability of the
implantable insulin pump to be combined with an implantable long-term
glucose sensor to create an "artificial pancreas," the ability of Medical
Research Group to successfully develop a fully implanted glucose sensor, the
ability of the system to effectively eliminate most risks and complexities
of diabetes and the ability of an artificial pancreas to reduce a patient's
therapy to quarterly physician visits and insulin refills are made pursuant
to the Safe Harbor provisions of the Private Securities Reform Act of 1995.
Investors are cautioned that forward-looking statements involve risks and
uncertainties which may affect MiniMed's business and prospects, including
changes in economic and market conditions, acceptance of MiniMed's products
by the health care and reimbursement communities, health care legislation,
new developments in diabetes therapy, administration and regulatory approval
and related considerations, and other factors discussed in the Company's
filings with the Securities and Exchange Commission.

Why pay for something you could get for free?
NetZero provides FREE Internet Access and Email
for HELP or to subscribe/unsubscribe, contact: HELP@insulin-pumpers.org
send a DONATION http://www.Insulin-Pumpers.org/donate.shtml