Integrated Sensing Systems (ISSYS) The First Annual Unither Nanomedical and Telemedical Technology...

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  • Integrated Sensing Systems (ISSYS)The First Annual Unither Nanomedical and Telemedical Technology Conference April 3, 2008Novel Wireless, Batteryless, Implantable Sensors for Chronic Disease Management

  • Integrated Sensing Systems (ISSYS)ISSYS was established in January 1995.One of the oldest independent MEMS companies in the U.S.Vertically Integrated Technical CompanyEntire sensing system Sensor, circuit, software, package, delivery, Full Bio-MEMS Manufacturing FacilityHigh Quality ManufacturingISO 9001: 2000 CertificationISO 13485-2003 Compliance (FDA)First FDA 510(k) Granted 2006Slide *

  • ISSYS Core TechnologiesWireless, batteryless, implantable pressure sensorsTremendous market potential in many emerging medial fields.

    Resonating micro-tubesComprehensive analysis of fluidic properties (density, concentration, viscosity, mass flow, and temperature). Unprecedented advantages in functionality, performance, size, and cost.Slide *

  • ISSYS Goal: To Greatly Improve Disease TreatmentWe 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 *

  • Slide *Wireless Sensing SystemTwo system components:Implantable pressure sensor(s)External handheld readout unit

    The components communicate using RF telemetry.

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

  • Slide *ISSYS Goal: To Greatly Improve CHF TreatmentImprove patient outcomes and lower cost of careDynamically tailor medication over timeModify patient behavior

  • Slide *Left Atrium PressureToday 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 *Left Atrium PressureISSYS left atrium implant platform:Minimum protrusion inside the left heart (extremely important)A practical anchorCatheter delivery (similar to current transcatheter patch atrial septal defect (ASD) occlusion implants)Outpatient procedure

    Left AtriumAtrial SeptumPressure SensorAnchorRight Atrium

  • Slide *Application: Tailored treatment of congestive heart failure (CHF)

    Implantation Locations: Left atriumAtrial Septum

    Delivery and Anchoring:Outpatient procedureCatheter basedSimilar to the current cardiac procedures Small Catheter Size: < 16 French (ideally

  • Slide *Monitored Pressure Waveforms:Look the same as the current catheterization waveformsNo new training requiredComplete waveformReal timeContinuousChronic use (over the patients life)Ability to read wide range of cardiac pressures-100 to +300 mmHgDetailedHigh-fidelity data with sensitivity of 0.3 mmHg and accuracy of 1mmHg,Fast (200+ samples/second) data gatheringCardiac Implant Specifications:

  • Slide *Cardiac Implant Specifications:Communication:Tele-communication distance over 10 cm (15 cm desirable)Tele-powering distance over 10 cm (15 cm desirable)RobustFDA & FCC compliant

    Handheld Readout UnitSmall sizeIn particular for home monitoring applications by patientsEasy to useMinimal trainingAntenna working with a wide angle relative to the implant location

  • ISSYS Wireless Probe vs Millar Catheter: Left Ventricle Slide *

  • ISSYS Wireless Probe vs Lumen Filled Catheter: Right Ventricle Slide *

  • ISSYS Wireless Pressure Probe vs Lumen Filled Reference Sensor Right Ventricle

    Slide *

  • 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 *

  • Histology Tests 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.External AreaInternal AreaCardiac Muscle TissueEnlarged Area BelowSlide *

  • Enabling PlatformISSYS 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 *

  • Slide *Other ApplicationsIntracranial Pressure MonitorsBladder Pressure Monitorsfor IncontinenceWireless Orthopedic Monitoring Concepts

  • Implication and Future DirectionsClosed LoopsPacemaker OptimizationDrug deliveryHome MonitoringOther Parameters:FlowTempPhCO2Oxygen SaturationSlide *

    ****Overall, the cost of treating CHF ((60% of the $38 billion in heart failure cost is due to the high number of hospitalizations with 40% for outpatient visits) is very high and involves many physician visitsIn 1993, the NIH reports visits to physicians offices for CHF at 2.9 million, and 65,000 people with home care.In 1991, the US Dept of Health and Human Services estimated that each CHF patient had 3.4 visits per year to the physicians office and 2.3 million hospitalizations.HHS states many hospitalizations could be prevented by improved outpatient care and by more appropriate use of diagnostic tests and treatments.

    Centers for Medicare & Medicaid Services believes that CHF can be successfully managed on an outpatient basis and recently announced new guidelines that reimburse for high quality outpatient care of CHF. One significant hurdle in accomplishing high quality outpatient care is the ability to measure the left ventricular filling pressures (LVFP) without a right heart catheterization in the cath lab.All of the cardiologists surveyed by ISSYS believed being able to measure LVFP noninvasively would change the practice of medicine in treating this disease

    Medical Benefits of Regular Monitoring of LVFP (direct assessment of a patients fluid or volume status on an outpatient basis)Too little volume decreases heart pumping efficiency and carries an additional risk of impairing kidney functionToo much volume leads to an overloaded heart and congestion

    Market need: a better method of assessing left ventricular filling pressure and monitoring heart function on an ongoing basis.