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Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
Pancreas Presentation
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Pancreas Presentation

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  • Is this an Energex Systems' or an Arbios Systems' concept? Or has Energex Systems merged with Arbios Systems?
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  • 1. The PancreAssist System<br />A Bioartificial Pancreas<br />
  • 2. Insulin-Glucose Relationship<br />Normal vs. Diabetic<br />Normal<br />Glucose<br />Insulin<br />Diabetic<br />Glucose<br />Insulin Injection<br />Insulin<br />B<br />L<br />D<br />S<br />
  • 3. Diabetes<br />Irregular blood glucose level control leads to complications; insulin injections are currently only practical therapy<br />Insulin therapy fails to achieve consistent blood glucose; reliance on patient self-monitoring limits effectiveness <br />PancreAssist™ System designed to provide automatic, continuous blood glucose level control<br />Unmet Medical<br />Need<br />Shortcomings of<br />Current Therapy<br />ArbiosSolution<br />
  • 4. PancreAssist SystemU.S. &amp; Europe Market Potential<br />No. of Patients Market Potential*<br />100% of “Brittle” Diabetics 40,000 $ 200 million<br />50% of All Type I Diabetics 700,000 $3,500 million<br />10% of All Type II Diabetics 1,400,000 $7,000 million<br /> * Assume one device/reseeding per patient, per year at $5,000 each<br />
  • 5. The PancreAssist System<br />A Bioartificial Pancreas<br />Objective<br />To develop an implantable device <br />containing pancreatic islets <br />to improve blood glucose control<br />in insulin-dependent diabetics<br />
  • 6. Bioartificial Pancreas<br />Device Types<br />I<br />I<br />I<br />Blood<br />G<br />G<br />I<br />Artery<br />Vein<br />I<br />I<br />Perfusion Device<br />Pancreatic Islets<br />Membrane<br />G = Glucose I = Insulin<br />G<br />G<br />I<br />I<br />I<br />I<br />G<br />G<br />Tissue<br />Diffusion Device<br />
  • 7. Insulin<br />Pancreatic Islets<br />Blood<br />Blood<br />Ultrafiltration Hollow Fiber<br />Glucose<br />in<br />Antibodies<br />out<br />White Cells<br />Insulin<br />PancreAssist™ System<br />Bioartificial Pancreas<br />Semipermeable<br />Membrane Coil<br />Islet <br />Seeding Ports<br />Porcine Islets<br />Device Housing<br />PTFE<br />Vascular Graft<br />Device Schematic<br />
  • 8. Reseedable PancreAssist™ System<br />
  • 9. Key Advantages of Technology<br />General<br /><ul><li>Biocompatible & Immunoprotective Membranes
  • 10. Non-transformed, Primary Cells
  • 11. Normal Cell Functions</li></ul>PancreAssist™ System<br /><ul><li> Direct Blood Contact for Optimum Oxygen Supply
  • 12. Rapid Insulin Release
  • 13. Physiological Blood Glucose Feedback
  • 14. No Anticoagulation or Immunosuppression</li></li></ul><li>Experimental Protocol<br />Total Pancreatectomy<br />Islet Isolation<br />(10-20 kg dog)<br />Seeding of<br />Seeding of<br />2-3 weeks<br />in vivo Device<br />in vitro Device<br />Device<br />Continuous<br />Implantation<br />Perfusion<br />Control of Hyperglycemia<br />Insulin Output<br />
  • 15. ARTIFICIAL PANCREASCanine Islets in Diabetic Dog<br />Pancreatectomy<br />Device Implanted<br />Single Gen. 8 / PS-10<br />
  • 16. ARTIFICIAL PANCREAS DEVICECanine Islets in Diabetic DogTwo Devices Implanted<br />Pancreatectomy<br />Devices<br />Devices<br />Implanted<br />Removed<br />PS-56<br />
  • 17. Device Implanted<br />Device Explanted<br />PancreAssist System<br />Xenogeneic Bioartificial Pancreas<br />Porcine Islets in Diabetic Dog<br />
  • 18.
  • 19. PancreAssist System<br />Pre-clinical Studies<br />Device Patency<br /><ul><li> Implanted 11 device designs in over 250 animals
  • 20. Achieved device patency for up to 4 years in large</li></ul> animal model without anticoagulation<br /><ul><li> Patency rate comparable to same size grafts in </li></ul> humans<br />Cells<br /><ul><li> Porcine islet process established</li></li></ul><li>PancreAssist System<br />Pre-clinical Studies<br />Device Function<br /><ul><li> Improved blood glucose control
  • 21. Reduced need by up to 75% for exogenous insulin </li></ul> for nine months in diabetic dogs<br /><ul><li> No immunosuppression required</li></ul>Summary<br /><ul><li> Because no immunosuppression is required, </li></ul> the BAP may be used prior to the development <br /> of diabetic complications<br />
  • 22. PancreAssist SystemDevelopment Plan<br /><ul><li> Establish joint development collaborations to share risk and expand capability in:</li></ul>- Pancreatic beta cell line development<br />- Implantable device technology<br />- Medical device marketing &amp; sales<br />

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