Kerberos Proximal Solutions, Inc.

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Kerberos Proximal Solutions, Inc.

• Tom Goff
• Fred Khosravi
• John MacMahon
• Carl Simpson

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Timeline
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1999-2001Idea Generation Evaluation

• Carotid Embolic Protection
• Medical Device Design class (precursor to
  BioDesign)
• Company formation
• Technology evolution
• Engineering approach
• Competition / intellectual property
• Clinical trial/regulatory hurdles

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Audience Response
Critical Decision 1 What should the company
do next?

• Develop their own carotid stent for testing with
  the protection device
• Sell the company to a carotid stent developer
• Find a new application for the technology

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2001-2002Indication Reevaluation

• Refocus on saphenous vein graft (SVG)
• embolic protection
• Venture funding
• Further technology development
• Human clinical study under IDE
• Complexity of approach/workflow integration
  issues
• Product sizing requirements

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Audience Response
Critical Decision 2 What should the company
do next?

• Redesign the product for easier usage in SVGs
• Sell the companys assets
• Find a new application for the technology

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2003-2005Indication Reevaluation
Product Redesign

• Refocus on acute myocardial infarction
• (AMI)/thrombectomy
• Boston Scientific investment
• Product redesign
• 510(k) approval for peripheral indication
• Human clinical studies in AMI
• AMI competitor failures study design issues
• Difficulty of AMI sales

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Audience Response
Critical Decision 3 What should the company
do next?

• Keep the company focused on selling the product
  for AMIs
• Establish a corporate partnership for help in
  positioning/selling the product for AMIs
• Sell the companys assets
• Find a new application for the technology

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2005-2006Indication Reevaluation

• Refocus on peripheral arterial disease (PAD)
• PAD clinical study data not required
• Rapidly expanding market opportunity/easier sale
• Use in combination with stenting/angioplasty/
  atherectomy
• Revenue from AMI and PAD sales
• Company acquired!

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Evolution Summary
Technology Proximal Embolic Protection Rinspirati
on Thrombectomy
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Summary Lesson Be Nimble, Be Quick !

• Market and product configuration
• should not be set in stone upfront
• Need for constantly evaluate
• Intellectual property
• Clinical study design requirements
• Product design
• Work flow integration
• Clinical study results
• Competition
• Expanding market opportunities
• Need ability to refocus/evolve quickly