Subcutaneous Infusion of Insulin

 

 

Background.  In 1993 the results of the Diabetes Complications and Control Trials (DCCT) clearly indicated that intensive control reduced the complications of insulin treated persons with diabetes (blindness, kidney failure, amputation and heart disease) by over 50%.  In further trials, these results were verified.  Intensive control was either in the form of an infusion pump or in multiple injections per day, a paradigm shift from the normal one or two injections of insulin a day.  To date, only 5% of the insulin dependent diabetics use a pump and less that 15% use intensive therapy.

 

The impact.  There are over 21 million persons with diabetes in the US today.  Over three million of these persons require insulin and 85% still use conventional therapy.  Adoption of intensive therapy would eliminate the complications of diabetes in 700,000 persons.  At an average cost of treating diabetes complications of $15,000 per year, adoption of intensive therapy would save the healthcare system over $10 billion per year.

 

The TheraFuse Disposable Insulin Patch

 

 

The TheraFuse Answer.  Proprietary technology developed by TheraFuse enables a family of products that would be introduced over time to provide a much more convenient treatment regimen for the diabetic.  Both are patch-like devices as shown above.  Each comprises three components—a disposable dose-pad that contains insulin, a reusable dose-chip that mates with the dose-pad at time of use and controls the delivery of the insulin, and a handheld programmer for telling the dose-chip what to do.  The first product would deliver insulin only, and would be a more convenient alternative to existing insulin pumps.  The second product would also measure glucose, thereby providing automatic control of glucose.

 

The Opportunity.  The potential market for the first product is 3 million diabetics times $10 per day, or just over $10 billion.  The potential market for the second product is at least double that because it includes the glucose monitoring and provides safer, more effective, and more convenient treatment.

 

 

Product Features: 

  • Freedom.   It’s a patch.  There is no catheter.  Body access is achieved from the bottom of the dose-pad after application.

  • Painless.  With remote and hidden needle deployment, needle insertion pain is nearly zero.

  • Low cost.  The system reuses the durable dose-chip and permits disposal of the inexpensive single-use dose-pad.

  • Payor Preference.  There is no “up-front” pump to purchase.  It’s a “pay-as-you-go” system.

  • Privacy.  It’s wirelessly programmed and is very small—easily concealed at many body locations

  • Sterility.  The flow path remains closed, even during filling, minimizing infections.

  • Dosing history.  The system measures the time and amount of the delivered dose.  In diabetes this permits time correlation of glucose values with insulin delivery to better guide therapy; in pain management this capability permits monitoring narcotic use.

  • Pediatric use.  Delivery accuracy is a few nanoliters.  Even small children can be managed accurately.     

  • Higher Potency Insulin.  With the highly accurate delivery, higher potency insulin can be used, permitting even smaller systems that can be worn longer between dose-pad exchange.