Integrated Sensing Systems (ISSYS)

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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)

• 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

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ISSYS Core Technologies

• 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.

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ISSYS GoalTo 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.
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Wireless Sensing System

• Two system components
• Implantable pressure sensor(s)
• External handheld readout unit
• The components communicate using RF telemetry.

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Congestive Heart Failure (CHF)
Many experts consider CHF to be the largest
emerging medical market
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ISSYS GoalTo Greatly Improve CHF Treatment

• Improve patient outcomes and lower cost of care
• Dynamically tailor medication over time
• Modify patient behavior

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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.

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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
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Cardiac Implant Specifications

• 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 lt 16 French (ideally lt14
  French)

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Cardiac Implant Specifications

• 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

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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

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ISSYS Wireless Probe vs Millar Catheter Left
Ventricle
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ISSYS Wireless Probe vs Lumen Filled Catheter
Right Ventricle
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ISSYS Wireless Pressure Probe vs Lumen Filled
Reference Sensor Right Ventricle
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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.
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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
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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.

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Other Applications
Intracranial Pressure Monitors
Bladder Pressure Monitors for Incontinence
Wireless Orthopedic Monitoring Concepts
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Implication and Future Directions

• Closed Loops
• Pacemaker Optimization
• Drug delivery
• Home Monitoring
• Other Parameters
• Flow
• Temp
• Ph
• CO2
• Oxygen Saturation

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