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[IPk] Human Trials of Implantable Long Term Glucose Sensor

Thought this might be of interest....
Medical Research Group Begins Human Trials of Implantable Long Term Glucose

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 gluc!
ose, 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 - news). 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. 


Medical Research Group, Inc., Sylmar
Ronald Lebel, 818/362-8084 x3441
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