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Archimedes [aka The Arch]
Ventricular Regulation System
Justin P Henneman MS CPXi Competition Final Presentation
September 17th 2014
Hydrocephalus
Hydrocephalus: excess CSF in the brain � Causes: Congenital [1/500 newborns], Trauma, Hemorrhage,
Infection, Tumors, etc [75k annual cases]
Symptoms: Headache, vomiting, confusion, coma, death � Can progress in just hours
Treatment: CSF diversion via catheter from the brain to a distal site with a one-way valve regulating pressure/flow
Current Technology 3-4% of children with a shunt will die secondary to malfunction
90% of patients will require revision (average of 2-3)
Failure Rates • 30% in first year • 50% by year 2 • 90% by year 20
OLD SYSTEM NEW SYSTEM BENEFIT
Flow Rate Set By
Mechanical Pressure Valve
Live Pressure & Compliance Values/Trends
Keeps ventricles full and at normal pressure
Pressure Setting
Single Fixed Setting for “Max” pressure
Adaptive Settings, Sets high/low goals
Ignores impulses in pressure (e.g. cough)
Failure Warning
No Warning System (symptoms)
Advanced Warning System (senses increasing resistance)
Identify and fix the problem before the
pressure rises
Backup System None Contains mechanical failsafe
Buys patient time to repair/replace
Self Maintenance None Clears the line periodically Lengthens lifespan
External Maintenance &
Testing
Can stick a needle into the device to measure one time
pressure
Interrogation device captures: live pressure, flow rates,
volume, resistance, compliance & trending data
Troubleshoot non-invasively, treat infections, surgically intervene early
Proposed Fixes Decrease Failure Rates AND Reduce Adverse Outcomes by Early Warning
The Product
The Pump: • Simple design • Easy to implant • Rechargeable • Programmable • Easy to test • Quick to treat
The Software (Control Algorithm): • “Learns” the Patient/Disease • Adaptive to Changing Conditions
• Change in position/time • Self-fixing (‘clearing the line’) • Early warning system (int/ext)
• Programmable goals (‘weaning off’)
In-Line Embedded Sensors Peristaltic Pump Backup Parallel Valve Dual Motor/Encoder Unibody Design Controller
Wireless charging
Dual Chambers w/ Sampling Ports
The Market � Annual Market Size:
� 28k procedures, Average Cost $35k, Total Cost $1.1 billion
� Device Pricing: � Current Models = $3,000 [est. cost < $100] � Our Device Valuation = $10,000 [est. cost = $500-1000]
� Market Potential Sales of $280-400m annually � Secondary products sales: Interrogation Device, Charging Unit,
Smart Phone App, External Monitoring Software
� Cost Savings Potential [50% private insurance; 50% Medicare/Medicaid]:
� Pediatric Admissions: 30k annually, 400k days, $1.4-2 billion � Emergency Room Visit: $3,000-$6,000 � ICU per Day: $5,000-$10,000 � Productivity Lost = $8,000 per 3 day episode of illness
Strategy � Partnership w/ NorthShore-LIJ, Feinstein Institute & i360 Medical
� Primary prototype designed � Computational modeling complete w/ experimental setup designed � Device provisional patent filed
� Hofstra Competition [public disclosure]
� Next Steps � Find seed money & build experimental model & lab setup (est $32k) � Apply for US government small business grant & establish formal patent
� $250,000 for minimal dilution � Sell license to largest market share w/ similar tech [Medtronic] � Seek first round financing
� $5m for 50% dilution: Secondary prototype & Animal models
End Goal: 25% market share by year 5 (post FDA approval) Estimated $100m market potential
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