History of Device Development: Past, Present and Future 1
MY CONFLICTS OF INTEREST ARE
Approaches to Establish Funding <ul><li>Angel </li></ul><ul><li>Venture </li></ul><ul><li>Corporate </li></ul>2
Angel Funding <ul><li>Pros </li></ul><ul><ul><li>Less Expensive </li></ul></ul><ul><ul><li>Industry Expertise </li></ul></...
Venture Funding <ul><li>Pros </li></ul><ul><ul><li>Deep Pockets </li></ul></ul><ul><ul><li>Professional Expertise </li></u...
Corporate Funding <ul><li>Pros: </li></ul><ul><ul><li>Less Expensive </li></ul></ul><ul><ul><li>Value Add </li></ul></ul><...
Funding Stages Company Stage Concept Company Sales / Profits Liquidity Product Devt and Commercialization 6 Funding Type S...
Important Startup Rule #1 The more $$ you spend The more $$’s you have to raise The more of your opportunity you have to s...
The Team  &  The Company <ul><li>Management: </li></ul><ul><ul><li>Do You Have a CEO? </li></ul></ul><ul><ul><li>Is He/She...
<ul><li>Intense Competition </li></ul><ul><li>Intellectual Property </li></ul><ul><li>Capital Requirement </li></ul><ul><l...
Anatomy of a Start-up… IPO FDA Approval; Product Launch Distribution Agreement Hired CEO; Key management in place FDA subm...
<ul><li>Timing is everything </li></ul><ul><li>It is often, but not always best to be first </li></ul><ul><li>Some markets...
<ul><li>Rigor of randomized clinical trials </li></ul><ul><li>Clinical adoption </li></ul><ul><li>Ease of use </li></ul><u...
Goals of Startups Balancing  13
Understanding of the  Opportunity  14 Very high Moderate - high Importance of Expense Control Lower Higher Likely Exit Val...
Golden Rules <ul><li>Device or procedure must be simple to apply an can be adopted by the average practitioner </li></ul><...
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 <ul><li>. </li></ul>100 99 98 ...
 
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...
 
History of  Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003
Percutaneous “Mitral” Valve Repair <ul><li>Coronary Sinus Annuloplasty </li></ul><ul><li>Edge-to-Edge Repair </li></ul>
Coronary Sinus Annuloplasty Edwards LifeScience Handle Sliding Knob Location of Implant (Internal) Distal Anchor Proximal ...
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; Europ...
WATCHMAN ®  Device <ul><li>Frame:  Nitinol (shape memory) </li></ul><ul><ul><li>Contour shape accommodates most LAA anatom...
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 <ul><ul><li>Stents are tubular structures  </li></ul></ul><ul><ul>...
The TAXUS Petal TM Boston Scientific Coroporation <ul><ul><li>Stent Advantages </li></ul></ul><ul><ul><li>Special stent fe...
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 <ul><li>No late adverse events </li></ul><ul><ul><li>Late thrombosis </li></ul></...
Bioabsorbable Stent Design . Core: Polymer A Undercoat: Polymer B Topcoat: Polymer B Drug Layer: Polymer B + Sirolimus Coa...
Multi-Layer, Combination Drug Delivery
Biodegradable Stents <ul><li>Could also be the ideal vehicle for several other applications: non-obstructive vulnerable pl...
<ul><li>“ Biodegradable Stents:  </li></ul><ul><li>They Do Their Job and Disappear” </li></ul><ul><li>Ron Waksman </li></ul>
Future Opportunities in Interventional Cardiology Peripheral Vascularization -Claudication -Limb Salvage -Angiogenesis Str...
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History of device development: Past, Present, Future History of device development: Past, Present, Future

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

    1. 1. History of Device Development: Past, Present and Future 1
    2. 2. MY CONFLICTS OF INTEREST ARE
    3. 3. Approaches to Establish Funding <ul><li>Angel </li></ul><ul><li>Venture </li></ul><ul><li>Corporate </li></ul>2
    4. 4. Angel Funding <ul><li>Pros </li></ul><ul><ul><li>Less Expensive </li></ul></ul><ul><ul><li>Industry Expertise </li></ul></ul><ul><ul><li>Provides Upstart to build value and more leverage </li></ul></ul><ul><li>Cons: </li></ul><ul><ul><li>Hassle Factor </li></ul></ul><ul><ul><li>One/Two Round Only </li></ul></ul><ul><li>When does it make sense? </li></ul><ul><ul><li>Less Cash intensive opportunities </li></ul></ul><ul><ul><li>Low regulatory hurdles </li></ul></ul><ul><ul><li>Fast-followers </li></ul></ul><ul><ul><li>First-timers putting an experienced executive team together </li></ul></ul>3
    5. 5. Venture Funding <ul><li>Pros </li></ul><ul><ul><li>Deep Pockets </li></ul></ul><ul><ul><li>Professional Expertise </li></ul></ul><ul><ul><li>Extensive Business Network </li></ul></ul><ul><li>Cons </li></ul><ul><ul><li>More Expensive </li></ul></ul><ul><ul><li>Return / Liquidity Requirements </li></ul></ul><ul><ul><li>In-Depth Due Diligence </li></ul></ul><ul><li>When does it make sense? </li></ul><ul><ul><li>Large Opportunities </li></ul></ul><ul><ul><li>Markets > $500 million </li></ul></ul><ul><ul><li>Cash and time intensive </li></ul></ul><ul><ul><li>First-timers unable to assemble a solid executive team together </li></ul></ul>4
    6. 6. Corporate Funding <ul><li>Pros: </li></ul><ul><ul><li>Less Expensive </li></ul></ul><ul><ul><li>Value Add </li></ul></ul><ul><ul><li>Credibility </li></ul></ul><ul><li>Cons: </li></ul><ul><ul><li>Hidden Agenda/Special Rights </li></ul></ul><ul><ul><li>Questionable Follow-On Dollars </li></ul></ul><ul><ul><li>Exit Strategy Limited </li></ul></ul><ul><ul><li>Business Alignment </li></ul></ul><ul><li>When does it make sense? </li></ul><ul><ul><li>Funding Needs beyond VC’s </li></ul></ul><ul><ul><li>Close to commercialization…looking for a commercial partner </li></ul></ul>5
    7. 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. 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. 9. The Team & The Company <ul><li>Management: </li></ul><ul><ul><li>Do You Have a CEO? </li></ul></ul><ul><ul><li>Is He/She Qualified, Experienced as CEO? </li></ul></ul><ul><ul><li>Can They Raise Money? </li></ul></ul><ul><li>Team: </li></ul><ul><ul><li>Functional Disciplines? </li></ul></ul><ul><ul><li>No-compromise on hiring great people? </li></ul></ul><ul><ul><li>Team Chemistry? </li></ul></ul><ul><li>Bottom Line: </li></ul><ul><li>Risk in the team…. COSTLY </li></ul><ul><li>The timing of the right functional teams coming together …. CRITICAL TO SUCCESS </li></ul>8
    10. 10. <ul><li>Intense Competition </li></ul><ul><li>Intellectual Property </li></ul><ul><li>Capital Requirement </li></ul><ul><li>Engineering </li></ul><ul><li>Regulatory Environment </li></ul>9
    11. 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. 12. <ul><li>Timing is everything </li></ul><ul><li>It is often, but not always best to be first </li></ul><ul><li>Some markets change quickly; others very slowly </li></ul><ul><li>New market development is expensive </li></ul>Window of Opportunity 11
    13. 13. <ul><li>Rigor of randomized clinical trials </li></ul><ul><li>Clinical adoption </li></ul><ul><li>Ease of use </li></ul><ul><li>Learning curves </li></ul>12
    14. 14. Goals of Startups Balancing 13
    15. 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. 16. Golden Rules <ul><li>Device or procedure must be simple to apply an can be adopted by the average practitioner </li></ul><ul><li>Invention addresses an otherwise unmet clinical need </li></ul><ul><li>Device regulatory path is associated with a “reasonable” chance for success in an otherwise well defined study with a finite sample size </li></ul>
    17. 17. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006 16
    18. 18. History of Interventional Cardiology 1977
    19. 19. Coronary Angioplasty (PTCA) Andreas Gruntzig
    20. 20. History of Interventional Cardiology 1977 1984
    21. 21. Directional Coronary Atherectomy (DCA) John Simpson
    22. 22. History of Interventional Cardiology 1977 1984 1988
    23. 23. Rotational Atherectomy (PTCRA) David Auth
    24. 24. History of Interventional Cardiology 1977 1984 1988 1989
    25. 25. Coronary Stenting Julio Palmaz
    26. 26. History of Interventional Cardiology 1977 1984 1988 1989 1997
    27. 27. In- Stent Restenosis
    28. 28. Brachytherapy
    29. 29. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000
    30. 30. Drug Eluting Stents
    31. 31. Event-Free Survival at Two Years following procedure Freedom from events (%) Days after initial procedure 92% 76%
    32. 32. ARTS I: Three-year outcome after Stenting vs. CABG for the Treatment of Multivessel Disease <ul><li>. </li></ul>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
    33. 34. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002
    34. 35. Percutaneous Treatment of Carotid Artery Stenosis
    35. 36. Percutaneous Aortic Valve Therapy Alain Cribier
    36. 37. Percutaneous Valve Therapy Edwards LifeSciences
    37. 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
    38. 40. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003
    39. 41. Percutaneous “Mitral” Valve Repair <ul><li>Coronary Sinus Annuloplasty </li></ul><ul><li>Edge-to-Edge Repair </li></ul>
    40. 42. Coronary Sinus Annuloplasty Edwards LifeScience Handle Sliding Knob Location of Implant (Internal) Distal Anchor Proximal Anchor Bridge
    41. 43. Mitral Valve Edge-to-Edge Repair
    42. 44. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004
    43. 45. Atrial fibrillation is a major source of cardiogenic embolism-related stroke Source: Neurology, 1978; Stroke, 1985; European Heart Journal, 1987; Lancet, 1987 <ul><li>500,000 strokes per year </li></ul><ul><li>AHA estimates that 15 – 20% of strokes/year are related to AF </li></ul>
    44. 46. WATCHMAN ® Device <ul><li>Frame: Nitinol (shape memory) </li></ul><ul><ul><li>Contour shape accommodates most LAA anatomy </li></ul></ul><ul><ul><li>Barbs engage the LAA tissue </li></ul></ul><ul><li>Fabric Cap: Polyethyl terephthalate (PET) Fabric </li></ul><ul><ul><li>Prevents harmful emboli from exiting during the healing process </li></ul></ul>Barbs 160 µ PET fabric <ul><li>Device available in various sizes: </li></ul><ul><ul><li>21, 24, 27, 30 and 33 mm (diameter) </li></ul></ul><ul><ul><li>Device diameter is measured across face of device </li></ul></ul><ul><ul><li>Device Length = Device Diameter </li></ul></ul>
    45. 47. Left Atrial Appendage Closure
    46. 48. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005
    47. 49. The Next Frontier in Coronary Stenting
    48. 50. Treating Bifurcation Lesions Limitations of Current DES <ul><ul><li>Stents are tubular structures </li></ul></ul><ul><ul><ul><li>not intended for Y-shaped anatomy </li></ul></ul></ul><ul><ul><li>Side branch jailing </li></ul></ul><ul><ul><li>Limited ostial coverage (“Gaps”) </li></ul></ul><ul><ul><li>Technically demanding </li></ul></ul><ul><ul><li>Multiple layers of metal </li></ul></ul><ul><ul><li>Increasing risk of thrombosis </li></ul></ul><ul><ul><li>Myriad of Techniques </li></ul></ul>Gap Multiple Layers
    49. 51. The TAXUS Petal TM Boston Scientific Coroporation <ul><ul><li>Stent Advantages </li></ul></ul><ul><ul><li>Special stent feature to cover ostium of side branch (~2mm) </li></ul></ul><ul><ul><li>Reduces / eliminates side branch “gap” </li></ul></ul><ul><ul><li>May reduce frequency of 2nd stent </li></ul></ul><ul><ul><li>Placing 2nd stent, when necessary, is technically more straight forward </li></ul></ul><ul><ul><li>Delivery System Advantages </li></ul></ul><ul><ul><li>Side Branch wire lumen aids in alignment at ostium </li></ul></ul><ul><ul><li>Side branch “pre-wired”, no need to re-access through stent </li></ul></ul><ul><ul><li>Final Petal size determined by post dilatation balloon </li></ul></ul>
    50. 52. Chronic Total Occlusion (CTO) .
    51. 53. History of Interventional Cardiology 1977 1984 1988 1989 1997 1999 2000 2002 2003 2004 2005 2006
    52. 54. Why Degradable Stents? Degradable Stents <ul><li>No late adverse events </li></ul><ul><ul><li>Late thrombosis </li></ul></ul><ul><ul><li>Hypersensitivity reactions (chronic inflammation) </li></ul></ul><ul><ul><li>Stent fractures </li></ul></ul><ul><li>Does not restrict arterial remodeling </li></ul><ul><li>Permits non-invasive imaging of artery </li></ul><ul><li>Permits bypass surgery in future </li></ul>
    53. 55. Bioabsorbable Stent Design . Core: Polymer A Undercoat: Polymer B Topcoat: Polymer B Drug Layer: Polymer B + Sirolimus Coating Layers
    54. 56. Multi-Layer, Combination Drug Delivery
    55. 57. Biodegradable Stents <ul><li>Could also be the ideal vehicle for several other applications: non-obstructive vulnerable plaque, gene transfer for infract repair and angiogenesis….. </li></ul>
    56. 58. <ul><li>“ Biodegradable Stents: </li></ul><ul><li>They Do Their Job and Disappear” </li></ul><ul><li>Ron Waksman </li></ul>
    57. 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

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