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Kerberos Proximal Solutions, Inc.

Kerberos Proximal Solutions, Inc. Tom Goff Fred Khosravi John MacMahon Carl Simpson. Mar 01. Dec 01. Jun 03. Dec 04. Timeline. 1999-2001 Idea Generation & Evaluation. Carotid Embolic Protection Medical Device Design class (precursor to BioDesign) Company formation

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Kerberos Proximal Solutions, Inc.

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  1. Kerberos Proximal Solutions, Inc. Tom Goff Fred Khosravi John MacMahon Carl Simpson

  2. Mar 01 Dec 01 Jun 03 Dec 04 Timeline

  3. 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

  4. 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

  5. 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

  6. Audience Response Critical Decision #2: What should the company do next? • Redesign the product for easier usage in SVGs • Sell the company’s assets • Find a new application for the technology

  7. 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

  8. 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 company’s assets • Find a new application for the technology

  9. 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!

  10. Mar 01 Dec 01 Jun 03 Dec 04 Evolution Summary TechnologyProximal Embolic ProtectionRinspiration Thrombectomy

  11. Summary LessonBe 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

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