Product Strategy
Two product strategies to be considered for 3-D PCI Planner™
Bundled 3-D PCI Planner™ pre-installed on the touchscreen based computer device (iPad)
3-D PCI Planner™ software utility downloaded and installed on the existing computer by user
Target Market
Hospitals for Direct Patient Care
Individual Physician for Case Practice and Training
Medical Device Industry
Hospital Purchases for Direct Patient Care: approximately 1,100 PCI-qualified hospitals in the United States and 5% of the hospital would utilize the 3-D PCI Planner™
Individual Doctor Purchases for Case Practice and Training: there are 80,000 interventional cardiologists in the U.S. if 0.5% of doctors (i.e., 400 doctors) use the 3-D PCI Planner™
Medical Device Company Purchases: special customization requests of 3-D PCI Planner™ service per year from 10 industrial companies
Market Size
PCI Procedures Per Year: 1,000,000 (one million)
Total Cost Per Year: $12 billion
PCI-qualified Hospitals: 1,100
Number of Interventional Cardiologists: 80,00
Current Status
Current stage: Prototype, BDEG fund (11/26/2012) from the State of Colorado
Competitive Advantage
3-D PCI Planner™
- Works with virtually any existing x-ray imaging system
- Optimized for tablets with easy to use touch based interface
- Create 3-D coronary arterial tree
- Understand patient’s arterial conditions
- Optimize stent size selection
- Determine correct stent placement
- All based on the validated and CU patented “3-D coronary imaging technologies
- Use of Only Two X-ray Pictures
- Limited Radiation Exposure
- Reduced Contrast Dye Injection
- Decreased Procedural Time
- Help Doctors of Limited Training and Clinical Experience
Competing Software Packages
- Requires or is part of a specific x-ray imaging system
- Sub-optimal user interfaces, often tied to specific expensive workstations
- Cannot predict views to minimize vessel overlap
- Cannot quantify vessel shape change
- Cannot characterize vessel tortuosity, therefore unable to characterize areas of potentially difficult stent deployment
Regulatory Approval
Outside of US: None
US: FDA - Requires documentation that the technology works
- Validation studies completed and published
- No clinical outcomes studies necessary
Funding We Have Received
Whitaker Foundation Biomedical Engineering Grants
American Heart Association: Affiliated AHA Grant
National Institute of Health: NIH-RO1 Grant
Who We Have Worked With
FDA – Center for Devices and Radiological Health
Cordis Johnson & Johnson Company
Guidant Corporation
Abbott Vascular, Inc.
Medtronic AVE
Boston Scientific Corporation
Cook Medical
W&L Gore & Associates, Inc.
Medical Simulation Corp.
Edwards Life sciences
Philips Healthcare
Long Term Plan
