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introduction•  proprietary*   evolution in sternal closure technology•  conceived   by experts in sternal reconstruction• ...
our team•  W.   Thomas McClellan, MD  Harvard / Tufts / Duke/ Emory Plastic & Hand Surgery•  Johnny   Chang, MD, MSME  Bro...
advisors•  Gary   Fanton, MD   Stanford Director of Orthopedic Sports Medicine   Founder of Sapphire Medical & Oratec Inte...
the problemtwisted steel wires
the problemtwisted steel wires
backgroundtwisted steel wires
backgroundtwisted steel wires
backgroundexpensive, complex reconstructions
the problem                             twisted steel wires•  what’s    wrong with steel wires?  •    prone to failure at ...
background                              twisted steel wires•  what’s    wrong with steel wires?  •    imprecise & operator...
why a new closure?•  600,000 elective median sternotomies per year, closed with dated,     rudimentary steel wires•  40,00...
alternatives to wire    Synthes Plates    ($3000 - $6000/pt)                         Talon System ($2900/pt + tools)Myowir...
existing sternal closure devices•  why    haven’t these alternatives caught on?  •    complicated & time-consuming to use ...
figure 8 solution …
why figure 8 is better•  lower   cost•  easier   to apply using the same technique and equipment•  same    amount of time•...
why figure 8 is better•  can   go through manubrium•  multiple   configurations available•  reversable•  easy   re-entry
why figure 8 is better•  wider   footprint + less vertical force to place     = less cut-through•  more    stable in multi...
configurations
benchtop data – cyclic failure                                                       3x	                        7x	       ...
benchtop data – cut-through
benchtop data – cut-through
benchtop data – pull to failure
figure 8               partial sternotomy solutions             Apply Device	Figure “8”
figure 8               partial sternotomy solutions             Apply devices	Two Single  bands
clinical trialUsability, Safety, and Efficacy of the Figure       8 Sternotomy Closure Device     Early Snapshot of Result...
clinical trial: details•  prospective,   randomized•  patient   blinded•  single   CT surgeon – board certified•  as   of ...
Age	  -­‐	  Years	  	  (avg)	                      70	                                62.5	                               ...
Body	  Mass	  Index	  –	  (avg)	  40	  35	            30.08	                                               29.41	  30	  25...
Bypass	  Time	  –	  Minutes	  (avg)	                                                           99.33	  100	             95...
Bypass	  Off	  to	  Case	  End-­‐	  Minutes	  (avg)	  100	    90	    80	                  70.82	    70	    60	             ...
Length	  of	  Stay	  –	  Days	  (avg)	  8	                                                                        7.58	  7...
Pain	  on	  Visual	  Analog	  Scale	  (0-­‐10)	  (avg)	     5	  4.5	                4.5	     4	  3.5	     3	              ...
Surgery to Discharge Cost (Dollars)9000085000800007500070000                                        8289665000            ...
where are we•  FDA 510(k)     approved•  IRB    approval Clinical Trial in progress•  FDA Certified    manufacturer in pla...
figure 8
Figure 8 Presentation
Figure 8 Presentation
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Figure 8 Presentation

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See the next evolution in sternal closure technology. It will become the new gold standard and replace stainless steel twisted wire.

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Figure 8 Presentation

  1. 1. introduction•  proprietary* evolution in sternal closure technology•  conceived by experts in sternal reconstruction•  driven by experienced medical device entrepreneurs•  endorsed by leading academic surgeons•  a Delaware corporation, self-funded since inception * multiple patent applications filed
  2. 2. our team•  W. Thomas McClellan, MD Harvard / Tufts / Duke/ Emory Plastic & Hand Surgery•  Johnny Chang, MD, MSME Brown Plastic Surgery & MIT Mechanical Engineering•  Cortland Bohacek, MBA•  John Krumme, BSME, MSME Medical Device Development•  Scott Heneveld Product Design & Testing, FEA/CAD
  3. 3. advisors•  Gary Fanton, MD Stanford Director of Orthopedic Sports Medicine Founder of Sapphire Medical & Oratec Interventions•  Gordon Murray, MD Immediate Past President, Society of Thoracic Surgeons•  Kee Lee, MD Board Certified Cardiothoracic Surgeon•  Tom Fogarty, MD Surgeon, Entrepreneur, Investor
  4. 4. the problemtwisted steel wires
  5. 5. the problemtwisted steel wires
  6. 6. backgroundtwisted steel wires
  7. 7. backgroundtwisted steel wires
  8. 8. backgroundexpensive, complex reconstructions
  9. 9. the problem twisted steel wires•  what’s wrong with steel wires? •  prone to failure at multiple stress points •  damages bone = cut-through
  10. 10. background twisted steel wires•  what’s wrong with steel wires? •  imprecise & operator-dependent •  “tightness” & security is subjective •  does not provide multi-axis stability
  11. 11. why a new closure?•  600,000 elective median sternotomies per year, closed with dated, rudimentary steel wires•  40,000 sternal complications•  Future – Older, Sicker (Diabetic, Renal Failure, Smokers), Redo’s•  Never Event – Medicare no longer pays for complications ($80k - $100k)
  12. 12. alternatives to wire Synthes Plates ($3000 - $6000/pt) Talon System ($2900/pt + tools)Myowire ($800/pt) Pioneer Cable System ($300/pt + tool)
  13. 13. existing sternal closure devices•  why haven’t these alternatives caught on? •  complicated & time-consuming to use •  unfamiliar techniques •  significant additional training & equipment •  targeted for small secondary markets only •  extremely expensive
  14. 14. figure 8 solution …
  15. 15. why figure 8 is better•  lower cost•  easier to apply using the same technique and equipment•  same amount of time•  lower profile and off midline•  standard and reproducible by different surgeons
  16. 16. why figure 8 is better•  can go through manubrium•  multiple configurations available•  reversable•  easy re-entry
  17. 17. why figure 8 is better•  wider footprint + less vertical force to place = less cut-through•  more stable in multiple directions•  security mechanism doesn’t weaken construct•  able to solve partial sternotomy•  primary closure market
  18. 18. configurations
  19. 19. benchtop data – cyclic failure 3x 7x 200x 13x Transverse Wire Transverse 8 Fig8 Wire Fig8 Device
  20. 20. benchtop data – cut-through
  21. 21. benchtop data – cut-through
  22. 22. benchtop data – pull to failure
  23. 23. figure 8 partial sternotomy solutions Apply Device Figure “8”
  24. 24. figure 8 partial sternotomy solutions Apply devices Two Single bands
  25. 25. clinical trialUsability, Safety, and Efficacy of the Figure 8 Sternotomy Closure Device Early Snapshot of Results: Aug – Dec 2011 Investigator: Kee Lee, M.D.
  26. 26. clinical trial: details•  prospective, randomized•  patient blinded•  single CT surgeon – board certified•  as of december 2011 •  18 pts figure 8 device group •  15 pts #7 ethicon wire group
  27. 27. Age  -­‐  Years    (avg)   70   62.5   62.75   60   50   40  Axis  Title   30   20   10   0   Fig8     Wires  
  28. 28. Body  Mass  Index  –  (avg)  40  35   30.08   29.41  30  25  20  15  10   5   0   Fig8   Wires  
  29. 29. Bypass  Time  –  Minutes  (avg)   99.33  100   95.23   90   80   70   60   50   Fig8   Wires  
  30. 30. Bypass  Off  to  Case  End-­‐  Minutes  (avg)  100   90   80   70.82   70   60   53.16   50   40   30   20   10   0   Fig8   Wires   Closure occurs during this time.
  31. 31. Length  of  Stay  –  Days  (avg)  8   7.58  7  6   5.66  5  4  3  2  1  0   Fig8     Wires   Shortest and Longest admission dropped from each group
  32. 32. Pain  on  Visual  Analog  Scale  (0-­‐10)  (avg)   5  4.5   4.5   4  3.5   3   2.8   Fig8  2.5   2   Wires   40% less pain1.5   1.55   1   1   1  0.5   0.22   0   D/C   30  days   60  days  
  33. 33. Surgery to Discharge Cost (Dollars)9000085000800007500070000 8289665000 73187600005500050000 Fig8 Wires 12% less cost
  34. 34. where are we•  FDA 510(k) approved•  IRB approval Clinical Trial in progress•  FDA Certified manufacturer in place•  Full clinical release ~ 3 weeks•  bench top testing completed•  white paper + cadaver evaluations completed•  excellent patent position 3 non-provisionals, 3 provisionals
  35. 35. figure 8

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