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History of Device Development: Past, Present and Future 1
MY CONFLICTS OF INTEREST ARE
Approaches to Establish Funding ,[object Object],[object Object],[object Object],2
Angel Funding ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],3
Venture Funding ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],4
Corporate Funding ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],5
Funding Stages Company Stage Concept Company Sales / Profits Liquidity Product Devt and Commercialization 6 Funding Type Seed Stage (Series A) Startup (Series B) Expansion (Series C) Mezzanine (Series D) IPO or  Merger RISK Higher Lower $$$ VALUE $$$ Lower Higher
Important Startup Rule #1 The more $$ you spend The more $$’s you have to raise The more of your opportunity you have to sell The less return you provide to investors… 7
The Team  &  The Company ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],8
[object Object],[object Object],[object Object],[object Object],[object Object],9
Anatomy of a Start-up… IPO FDA Approval; Product Launch Distribution Agreement Hired CEO; Key management in place FDA submission Animal studies completed; Start clinical trials Prototype completed; Funds raised Patents Disclosed Time (years) Valuation  ($) 10
[object Object],[object Object],[object Object],[object Object],Window of Opportunity 11
[object Object],[object Object],[object Object],[object Object],12
Goals of Startups Balancing  13
Understanding of the  Opportunity  14 Very high Moderate - high Importance of Expense Control Lower Higher Likely Exit Value Shorter Longer Adoption Curve Novel Idea IP protection Customer willingness to  change/adopt  Technical/Clinical Market adoption timeliness Longer Higher Experienced team Laser focus Most Important  for Success Execution timeliness and quality  Competition Biggest Risks Shorter Time to Liquidity Lower Investment  Dollars Needed Iterative Idea
Golden Rules ,[object Object],[object Object],[object Object]
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006 16
History of  Interventional Cardiology 1977
Coronary Angioplasty (PTCA) Andreas Gruntzig
History of  Interventional Cardiology 1977 1984
Directional Coronary Atherectomy (DCA) John Simpson
History of  Interventional Cardiology 1977 1984 1988
Rotational Atherectomy (PTCRA) David Auth
History of  Interventional Cardiology 1977 1984 1988 1989
Coronary Stenting Julio Palmaz
History of  Interventional Cardiology 1977 1984 1988 1989 1997
In- Stent Restenosis
Brachytherapy
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000
Drug Eluting Stents
Event-Free Survival at Two Years    following procedure Freedom from events (%) Days after initial procedure 92% 76%
ARTS I: Three-year outcome after Stenting vs. CABG for the Treatment of Multivessel Disease ,[object Object],100 99 98 97 96 95 94 93 92 91 90 0  120  240  360  480  600  720  840  960  1080  1200 Days since randomization % Survival Stent CABG Van Domburg, et al., Circ. 2004:109, 1114-20
 
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002
Percutaneous Treatment of Carotid Artery Stenosis
Percutaneous Aortic Valve Therapy Alain Cribier
Percutaneous Valve Therapy Edwards LifeSciences
Self-expanding Nitinol multi-level frame Porcine pericardium Tissue Valve Disposable Loading  System Delivery Catheter  18 French  12 Fr  body The CoreValve Revalving™ System Self-Expanding Support Frame
 
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003
Percutaneous “Mitral” Valve Repair ,[object Object],[object Object]
Coronary Sinus Annuloplasty Edwards LifeScience Handle Sliding Knob Location of Implant (Internal) Distal Anchor Proximal Anchor Bridge
Mitral Valve  Edge-to-Edge Repair
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004
Atrial fibrillation is a major source of cardiogenic embolism-related stroke Source:  Neurology, 1978; Stroke, 1985; European Heart Journal, 1987; Lancet, 1987 ,[object Object],[object Object]
WATCHMAN ®  Device ,[object Object],[object Object],[object Object],[object Object],[object Object],Barbs 160 µ PET fabric ,[object Object],[object Object],[object Object],[object Object]
Left Atrial Appendage Closure
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005
The Next Frontier in Coronary Stenting
Treating Bifurcation Lesions Limitations of Current DES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Gap Multiple Layers
The TAXUS Petal TM Boston Scientific Coroporation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Chronic Total Occlusion (CTO) .
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006
Why Degradable Stents? Degradable Stents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Bioabsorbable Stent Design . Core: Polymer A Undercoat: Polymer B Topcoat: Polymer B Drug Layer: Polymer B + Sirolimus Coating Layers
Multi-Layer, Combination Drug Delivery
Biodegradable Stents ,[object Object]
[object Object],[object Object],[object Object]
Future Opportunities in Interventional Cardiology Peripheral Vascularization -Claudication -Limb Salvage -Angiogenesis Structural Heart/ Stroke Prevention - PFO/ASD Closure -Left Atrial Appendage closure - Atrial Fib. Ablation   Cerebral Revascularization - Carotid Stenting  -Embolic Protection Devices -Acute Stroke Intervention Congestive Heart Failure -Resynchronization Therapy -Impulse Modulation -Implantable Pressure Regulators

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History of device development: Past, Present, Future History of device development: Past, Present, Future

  • 1. History of Device Development: Past, Present and Future 1
  • 2. MY CONFLICTS OF INTEREST ARE
  • 3.
  • 4.
  • 5.
  • 6.
  • 7. Funding Stages Company Stage Concept Company Sales / Profits Liquidity Product Devt and Commercialization 6 Funding Type Seed Stage (Series A) Startup (Series B) Expansion (Series C) Mezzanine (Series D) IPO or Merger RISK Higher Lower $$$ VALUE $$$ Lower Higher
  • 8. Important Startup Rule #1 The more $$ you spend The more $$’s you have to raise The more of your opportunity you have to sell The less return you provide to investors… 7
  • 9.
  • 10.
  • 11. Anatomy of a Start-up… IPO FDA Approval; Product Launch Distribution Agreement Hired CEO; Key management in place FDA submission Animal studies completed; Start clinical trials Prototype completed; Funds raised Patents Disclosed Time (years) Valuation ($) 10
  • 12.
  • 13.
  • 14. Goals of Startups Balancing 13
  • 15. Understanding of the Opportunity 14 Very high Moderate - high Importance of Expense Control Lower Higher Likely Exit Value Shorter Longer Adoption Curve Novel Idea IP protection Customer willingness to change/adopt Technical/Clinical Market adoption timeliness Longer Higher Experienced team Laser focus Most Important for Success Execution timeliness and quality Competition Biggest Risks Shorter Time to Liquidity Lower Investment Dollars Needed Iterative Idea
  • 16.
  • 17. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006 16
  • 18. History of Interventional Cardiology 1977
  • 19. Coronary Angioplasty (PTCA) Andreas Gruntzig
  • 20. History of Interventional Cardiology 1977 1984
  • 21. Directional Coronary Atherectomy (DCA) John Simpson
  • 22. History of Interventional Cardiology 1977 1984 1988
  • 24. History of Interventional Cardiology 1977 1984 1988 1989
  • 26. History of Interventional Cardiology 1977 1984 1988 1989 1997
  • 29. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000
  • 31. Event-Free Survival at Two Years following procedure Freedom from events (%) Days after initial procedure 92% 76%
  • 32.
  • 33.  
  • 34. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002
  • 35. Percutaneous Treatment of Carotid Artery Stenosis
  • 36. Percutaneous Aortic Valve Therapy Alain Cribier
  • 37. Percutaneous Valve Therapy Edwards LifeSciences
  • 38. Self-expanding Nitinol multi-level frame Porcine pericardium Tissue Valve Disposable Loading System Delivery Catheter 18 French 12 Fr body The CoreValve Revalving™ System Self-Expanding Support Frame
  • 39.  
  • 40. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003
  • 41.
  • 42. Coronary Sinus Annuloplasty Edwards LifeScience Handle Sliding Knob Location of Implant (Internal) Distal Anchor Proximal Anchor Bridge
  • 43. Mitral Valve Edge-to-Edge Repair
  • 44. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004
  • 45.
  • 46.
  • 48. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005
  • 49. The Next Frontier in Coronary Stenting
  • 50.
  • 51.
  • 53. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006
  • 54.
  • 55. Bioabsorbable Stent Design . Core: Polymer A Undercoat: Polymer B Topcoat: Polymer B Drug Layer: Polymer B + Sirolimus Coating Layers
  • 57.
  • 58.
  • 59. Future Opportunities in Interventional Cardiology Peripheral Vascularization -Claudication -Limb Salvage -Angiogenesis Structural Heart/ Stroke Prevention - PFO/ASD Closure -Left Atrial Appendage closure - Atrial Fib. Ablation Cerebral Revascularization - Carotid Stenting -Embolic Protection Devices -Acute Stroke Intervention Congestive Heart Failure -Resynchronization Therapy -Impulse Modulation -Implantable Pressure Regulators