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