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

Kerberos Proximal

Solutions, Inc.

Kerberos Proximal

Solutions, Inc.Tom Goff

Fred KhosraviJohn MacMahon

Carl Simpson

Tom GoffFred Khosravi

John MacMahonCarl Simpson

Pre-Funding A Round B Round C Round

FundingCredit Cards/ Personal Debt RCT

Boston Scientific Three Arch

Headcount 2.5 8 22 60

Goal Funding!DevelopTechnology Clinical trials Commercialization

Milestone 1st Pre-Clinical FIM Positive Data Sales

Carl Simpson Fred Khosravi

TimelineTimeline TimelineTimeline

Dec

01

Jun

03

Mar

01

Dec

04

1999-20011999-2001

Idea Generation & EvaluationIdea Generation & Evaluation

1999-20011999-2001

Idea Generation & EvaluationIdea Generation & EvaluationCarotid Embolic ProtectionCarotid Embolic Protection

- Medical Device Design class Medical Device Design class (precursor to BioDesign)(precursor to BioDesign)

- Company formationCompany formation- Technology evolutionTechnology evolution

● ““Engineering” approachEngineering” approach● Competition / intellectual Competition / intellectual

propertyproperty

- Clinical trial/regulatory hurdlesClinical trial/regulatory hurdles

Carotid Embolic ProtectionCarotid Embolic Protection- Medical Device Design class Medical Device Design class

(precursor to BioDesign)(precursor to BioDesign)- Company formationCompany formation- Technology evolutionTechnology evolution

● ““Engineering” approachEngineering” approach● Competition / intellectual Competition / intellectual

propertyproperty

- Clinical trial/regulatory hurdlesClinical trial/regulatory hurdles

Audience Audience ResponseResponse Audience Audience ResponseResponseCritical Decision #1: Critical Decision #1: What should the company do What should the company do next?next?

Critical Decision #1: Critical Decision #1: What should the company do What should the company do next?next?

1.1. Develop their own carotid stent for Develop their own carotid stent for testing with the protection devicetesting with the protection device

2.2. Sell the company to a carotid stent Sell the company to a carotid stent developerdeveloper

3.3. Find a new application for the Find a new application for the

technologytechnology

1.1. Develop their own carotid stent for Develop their own carotid stent for testing with the protection devicetesting with the protection device

2.2. Sell the company to a carotid stent Sell the company to a carotid stent developerdeveloper

3.3. Find a new application for the Find a new application for the

technologytechnology

2001-20022001-2002

Indication ReevaluationIndication Reevaluation

2001-20022001-2002

Indication ReevaluationIndication ReevaluationRefocus on saphenous vein graft Refocus on saphenous vein graft

(SVG) (SVG) embolic protectionembolic protection

- Venture fundingVenture funding- Further technology developmentFurther technology development- Human clinical study under IDEHuman clinical study under IDE- Complexity of approach/workflow Complexity of approach/workflow

integration issuesintegration issues- Product sizing requirementsProduct sizing requirements

Refocus on saphenous vein graft Refocus on saphenous vein graft (SVG) (SVG)

embolic protectionembolic protection- Venture fundingVenture funding- Further technology developmentFurther technology development- Human clinical study under IDEHuman clinical study under IDE- Complexity of approach/workflow Complexity of approach/workflow

integration issuesintegration issues- Product sizing requirementsProduct sizing requirements

Critical Decision #2: Critical Decision #2: What should the company do What should the company do next?next?

Critical Decision #2: Critical Decision #2: What should the company do What should the company do next?next?

1.1. Redesign the product for Redesign the product for easier usage in SVGseasier usage in SVGs

2.2. Sell the company’s assetsSell the company’s assets

3.3. Find a new application for Find a new application for the technologythe technology

1.1. Redesign the product for Redesign the product for easier usage in SVGseasier usage in SVGs

2.2. Sell the company’s assetsSell the company’s assets

3.3. Find a new application for Find a new application for the technologythe technology

Audience Audience ResponseResponse Audience Audience ResponseResponse

2003-20052003-2005

Indication Reevaluation Indication Reevaluation

2003-20052003-2005

Indication Reevaluation Indication Reevaluation

Refocus on acute myocardial infarction Refocus on acute myocardial infarction (AMI)/thrombectomy(AMI)/thrombectomy

- Boston Scientific investmentBoston Scientific investment- Product redesignProduct redesign- 510(k) approval for peripheral indication510(k) approval for peripheral indication- Human clinical studies in AMIHuman clinical studies in AMI- AMI competitor failures & study design AMI competitor failures & study design

issuesissues- Difficulty of AMI salesDifficulty of AMI sales

Refocus on acute myocardial infarction Refocus on acute myocardial infarction (AMI)/thrombectomy(AMI)/thrombectomy

- Boston Scientific investmentBoston Scientific investment- Product redesignProduct redesign- 510(k) approval for peripheral indication510(k) approval for peripheral indication- Human clinical studies in AMIHuman clinical studies in AMI- AMI competitor failures & study design AMI competitor failures & study design

issuesissues- Difficulty of AMI salesDifficulty of AMI sales

& Product Redesign & Product Redesign & Product Redesign & Product Redesign

Critical Decision #3: Critical Decision #3: What should the company do What should the company do next?next?

Critical Decision #3: Critical Decision #3: What should the company do What should the company do next?next?

1.1. Keep the company focused on Keep the company focused on selling the product for AMIsselling the product for AMIs

2.2. Establish a corporate partnership Establish a corporate partnership for help in positioning/selling the for help in positioning/selling the product for AMIsproduct for AMIs

3.3. Sell the company’s assetsSell the company’s assets4.4. Find a new application for the Find a new application for the

technologytechnology

1.1. Keep the company focused on Keep the company focused on selling the product for AMIsselling the product for AMIs

2.2. Establish a corporate partnership Establish a corporate partnership for help in positioning/selling the for help in positioning/selling the product for AMIsproduct for AMIs

3.3. Sell the company’s assetsSell the company’s assets4.4. Find a new application for the Find a new application for the

technologytechnology

Audience Audience ResponseResponse Audience Audience ResponseResponse

2005-20062005-2006

Indication ReevaluationIndication Reevaluation

2005-20062005-2006

Indication ReevaluationIndication ReevaluationRefocus on peripheral arterial disease Refocus on peripheral arterial disease

(PAD)(PAD)- PAD clinical study data not requiredPAD clinical study data not required

- Rapidly expanding market Rapidly expanding market opportunity/easier saleopportunity/easier sale

- Use in combination with Use in combination with stenting/angioplasty/ atherectomystenting/angioplasty/ atherectomy

- Revenue from AMI and PAD salesRevenue from AMI and PAD sales

- Company acquired!Company acquired!

Refocus on peripheral arterial disease Refocus on peripheral arterial disease (PAD)(PAD)- PAD clinical study data not requiredPAD clinical study data not required

- Rapidly expanding market Rapidly expanding market opportunity/easier saleopportunity/easier sale

- Use in combination with Use in combination with stenting/angioplasty/ atherectomystenting/angioplasty/ atherectomy

- Revenue from AMI and PAD salesRevenue from AMI and PAD sales

- Company acquired!Company acquired!

Pre-Funding A Round B Round C Round

FundingCredit Cards/ Personal Debt RCT

Boston Scientific Three Arch

Headcount 2.5 8 22 60

Focus Carotid SVG AMI Peripheral

Goal Funding!DevelopTechnology AMI - trials Commercialization

Milestone 1st Pre-Clinical FIM Positive Data Sales

Carl Simpson Fred Khosravi

Evolution Evolution SummarySummary

Evolution Evolution SummarySummary

Dec

01

Jun

03

Mar

01

Dec

04

Technology Proximal Embolic Protection Rinspiration Thrombectomy

Summary LessonSummary Lesson Be Nimble, Be Be Nimble, Be

Quick !Quick !

Summary LessonSummary Lesson Be Nimble, Be Be Nimble, Be

Quick !Quick !Market and product configuration Market and product configuration should not be set in stone upfront should not be set in stone upfront Need for constantly evaluate:Need for constantly evaluate:

- Intellectual propertyIntellectual property- Clinical study design requirementsClinical study design requirements- Product designProduct design- Work flow integrationWork flow integration- Clinical study resultsClinical study results- CompetitionCompetition- Expanding market opportunitiesExpanding market opportunities

Need ability to refocus/evolve quicklyNeed ability to refocus/evolve quickly

Market and product configuration Market and product configuration should not be set in stone upfront should not be set in stone upfront Need for constantly evaluate:Need for constantly evaluate:

- Intellectual propertyIntellectual property- Clinical study design requirementsClinical study design requirements- Product designProduct design- Work flow integrationWork flow integration- Clinical study resultsClinical study results- CompetitionCompetition- Expanding market opportunitiesExpanding market opportunities

Need ability to refocus/evolve quicklyNeed ability to refocus/evolve quickly