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Integrated Sensing Systems (ISSYS)

Implantable Sensor. Pressure sensor for the implant on a penny. Integrated Sensing Systems (ISSYS). Novel Wireless, Batteryless, Implantable Sensors for Chronic Disease Management. The First Annual Unither Nanomedical and Telemedical Technology Conference April 3, 2008.

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Integrated Sensing Systems (ISSYS)

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  1. Implantable Sensor Pressure sensor for the implant on a penny Integrated Sensing Systems (ISSYS) Novel Wireless, Batteryless, Implantable Sensors for Chronic Disease Management The First Annual Unither Nanomedical and Telemedical Technology Conference April 3, 2008

  2. Integrated Sensing Systems (ISSYS) • ISSYS was established in January 1995. • One of the oldest independent MEMS companies in the U.S. • Vertically Integrated Technical Company • Entire sensing system • Sensor, circuit, software, package, delivery, … • Full Bio-MEMS Manufacturing Facility • High Quality Manufacturing • ISO 9001: 2000 Certification • ISO 13485-2003 Compliance (FDA) • First FDA 510(k) Granted 2006 Slide 2

  3. ISSYS Core Technologies ISSYS Wireless BioPressure Sensors ISSYS Flow Sensor Chip • Wireless, batteryless, implantable pressure sensors • Tremendous market potential in many emerging medial fields. • Resonating micro-tubes • Comprehensive analysis of fluidic properties (density, concentration, viscosity, mass flow, and temperature). • Unprecedented advantages in functionality, performance, size, and cost. Slide 3

  4. ISSYS Goal:To Greatly Improve Disease Treatment We believe that the treatment of many diseases can be greatly improved by dynamically tailoring the medication via monitoring through frequent and non-invasive measurements using ISSYS’ products. Slide 4

  5. Wireless Sensing System Two system components: Implantable pressure sensor(s) External handheld readout unit The components communicate using RF telemetry. Slide 5

  6. Congestive Heart Failure (CHF) Many experts consider CHF to be the largest emerging medical market Slide 6

  7. ISSYS Goal:To Greatly Improve CHF Treatment • Improve patient outcomes and lower cost of care • Dynamically tailor medication over time • Modify patient behavior Slide 7

  8. Left Atrium Pressure • Today there are other companies that are developing miniature wireless implant products for monitoring pulmonary artery pressures. • While PA pressure is beneficial, compared to no input, it is not the most useful waveform for CHF. • The left atrium pressure is the holly grail for the treatment of CHF. • Today, ISSYS offers the only viable technology for miniature wireless monitoring of the left atrium pressure. Slide 8

  9. Left Atrium Pressure • ISSYS left atrium implant platform: • Minimum protrusion inside the left heart (extremely important) • A practical anchor • Catheter delivery (similar to current transcatheter patch atrial septal defect (ASD) occlusion implants) • Outpatient procedure Anchor Atrial Septum Pressure Sensor Right Atrium Left Atrium Slide 9

  10. Application: Tailored treatment of congestive heart failure (CHF) Implantation Locations: Left atrium Atrial Septum Delivery and Anchoring: Outpatient procedure Catheter based Similar to the current cardiac procedures Small Catheter Size: < 16 French (ideally <14 French) Cardiac Implant Specifications: Slide 10

  11. Monitored Pressure Waveforms: Look the same as the current catheterization waveforms No new training required Complete waveform Real time Continuous Chronic use (over the patients’ life) Ability to read wide range of cardiac pressures -100 to +300 mmHg Detailed High-fidelity data with sensitivity of ± 0.3 mmHg and accuracy of ±1mmHg, Fast (200+ samples/second) data gathering Cardiac Implant Specifications: Slide 11

  12. Cardiac Implant Specifications: Communication: Tele-communication distance over 10 cm (15 cm desirable) Tele-powering distance over 10 cm (15 cm desirable) Robust FDA & FCC compliant Handheld Readout Unit Small size In particular for home monitoring applications by patients Easy to use Minimal training Antenna working with a wide angle relative to the implant location Slide 12

  13. ISSYS Wireless Probe vs Millar Catheter: Left Ventricle Slide 13

  14. Implantable Sensor ISSYS Wireless Probe vs Lumen Filled Catheter: Right Ventricle Slide 14

  15. Implantable Sensor ISSYS Wireless Pressure Probe vs Lumen Filled Reference Sensor Right Ventricle Slide 15

  16. Sensor Placed in RV Outflow Tract After 78 days of implant in the right ventricle, there was no measurable cell growth on top of the MEMS pressure sensor. Slide 16

  17. External Implant Sensor Area Implant Sensor Area Implant Sensor Area 10x 20x 40x Histology Tests External Area Enlarged Area Below • Wayne State University has been performing comprehensive histology tests on ISSYS’ implants at different cardiovascular locations. • All the histology tests up to now have shown outstanding results. Cardiac Muscle Tissue Internal Area Slide 17

  18. Enabling Platform • ISSYS has intentionally created a flexible platform for the design, prototyping, and manufacturing of new implantable products. • ISSYS implantable products include an electronics chip As a result, the modification of the implant to include other sensors (or functionalities) can be easily accomplished by redesigning this electronics chip. • Proprietary, biocompatible, hermetic sealing technique that ISSYS has developed allows the integration of other components into the implantable device. • ISSYS implantable products can be easily modified to measure other parameters than pressure. Slide 18

  19. Other Applications Intracranial Pressure Monitors Bladder Pressure Monitors for Incontinence Wireless Orthopedic Monitoring Concepts Slide 19

  20. Implication and Future Directions • Closed Loops • Pacemaker Optimization • Drug delivery • Home Monitoring • Other Parameters: • Flow • Temp • Ph • CO2 • Oxygen Saturation Slide 20

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