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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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Kerberos Proximal Solutions, Inc.

Tom Goff

Fred Khosravi

John MacMahon

Carl Simpson


Mar 01

Dec 01

Jun 03

Dec 04

Timeline


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


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


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


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


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


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


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!


Mar 01

Dec 01

Jun 03

Dec 04

Evolution Summary

TechnologyProximal Embolic ProtectionRinspiration Thrombectomy


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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