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 December 5th, 1960

Wade-Dahl-Till Valve - 1964

Summer 2014

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

Remote Access: Staying informed

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

QUESTIONS?