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[IP] human trials of long term implantable glucose sensor and implantable insulin

Got this info today:

>>SYLMAR, Calif., Nov 15, 2000 (BUSINESS WIRE) -- Medical Research Group, Inc 
(MRG) announced that it has begun human trials of its long term implantable 
glucose sensor and implantable insulin pump that together comprise the 
hardware of the MRG artificial pancreas. This first trial is being conducted 
under the direction of Professors Eric Renard and Jacques Bringer at the 
Montpelier University Hospital in Montpelier, France. The sensor is implanted 
intravenously and the insulin pump is implanted in the abdomen. The sensor's 
output provides continuous readings of blood glucose levels, but does not yet 
control insulin delivery. MRG also announced that it has obtained FDA 
approval to commence human trials of the system and that it intends to begin 
trials in the United States within 30 days.
These trials are the next clinical step intended to establish that the 
artificial pancreas system is a safe and effective form of therapy for 
patients with Type 1 diabetes. This particular trial is to demonstrate the 
accuracy and stability of the long term glucose sensor. Although the 
measurements are blinded to the user during the clinical study, once 
performance of the sensor is demonstrated, the glucose data will be displayed 
so that the patient can then utilize real time glucose values to control 
insulin delivery by programming the pump with a small pager-like radio 
telemetry device.

Ron Lebel, MRG's President, said, "While today we have only very early 
results from this human trial, those results combined with years of 
pre-clinical testing and our recent short term human trials give us great 
confidence that our device is working as designed. This initial trial is 
intended to collect at least six months of sensor data from fifty patients, 
and today we do not see any major obstacles in reaching that goal. The 
implanted insulin pump being used in this trial is very similar to the model 
2007A pump, an improved version of the implanted insulin pump that has 
already been implanted in over six hundred patients. The glucose sensor, 
under development for over ten years, utilizes proprietary technology which 
results in superior long term stability in the intravascular environment. If 
this trial continues to be successful, we will seek regulatory approval to 
download control algorithm software into the already implanted hardware to 
achieve automatic control of glucose, creating an "artificial pancreas." 
Automatic control has already been demonstrated in diabetic canines. This 
clinical trial is a major milestone in developing the artificial pancreas."

MRG's implanted insulin pump is exclusively marketed by MiniMed Inc. (Nasdaq: 
MNMD). MRG has also granted to MiniMed an option to exclusively market MRG's 
long term glucose sensor upon payment of $30 million. This option is to be 
exercised upon successful achievement of a milestone related to sensor 
performance in humans.

Medical Research Group, Inc. is a privately held company that designs, 
develops and manufactures implantable insulin pumps and glucose sensors for 
the intensive management of diabetes. Alfred Mann was the founder and is 
Chairman and a major stockholder in both MiniMed and MRG.

This Press Release contains statements that are forward-looking, including 
statements relating to future development, regulatory approval, manufacture, 
introduction, distribution, and commercial acceptance of new products, the 
conduct of clinical trials, the timing of any regulatory filings or approvals 
relating to new products (including, without limitation, MRG's implantable 
pump and glucose sensor, the special insulin and the automatic insulin 
delivery system), the ability to adequately fund new products, clinical and 
regulatory activities, the growth of the business, the ability of MRG to 
provide solutions for diabetes and its treatment, and the impact of the 
continuous glucose monitoring systems and the automatic glucose control 
systems on the treatment of diabetes, and these statements are made pursuant 
to the Safe Harbor provisions of the Private Securities Litigation Reform Act 
of 1995. Investors are cautioned that, although MRG believes that its 
expectations are based on reasonable assumptions, forward-looking statements 
involve risks and uncertainties which may affect MRG's business and 
prospects, including changes in economic and market conditions, the results 
of clinical trials, acceptance of MRG's products by the health care and 
reimbursement communities, health care legislation and regulation, new 
developments in diabetes therapy, the ability to obtain administrative and 
regulatory approvals for products currently in development, competitive 
developments, changes in MRG's capital requirements, the possibility and 
effect of MiniMed's exercise of the option for the marketing rights to MRG's 
sensor and other factors.

CONTACT: Medical Research Group, Inc., Sylmar

Ronald Lebel, 818/362-8084 x3441


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Linda V.
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