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SIMPLEX

SIMPLEX. Surgical Devices. SIMPLEX. Surgical Devices. "Simple to use for Complex needs". Jason Barr – Team Leader Sharon Valvona – Main Client Contact Marina Stavrakantonaki – Main Customer Contact Scott Junkin – Technology Specialist

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SIMPLEX

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  1. SIMPLEX Surgical Devices

  2. SIMPLEX Surgical Devices "Simple to use for Complex needs" Jason Barr – Team Leader Sharon Valvona – Main Client Contact Marina Stavrakantonaki – Main Customer Contact Scott Junkin – Technology Specialist Andy Dickson – Mentor Michael Sapienza – Mentor

  3. “a wayward spark… seared a tiny hole in her colon… malfunctioning bladder and disabling pain… 13 operations so far…prevent her from working or bearing children” New York Times, March 2006 “…died of massive uncontrolled and untreated bleeding as a result of the clips' having moved out of place. “ “Haaretz”, December 2006

  4. "Very little has changed since the first minimally- invasive surgeries in the early 1990s. The tools we use are still remarkably crude." Dr. Wayne Poll "It wouldn't surprise me in the least if it caused more than 100 deaths and 10,000 injuries annually," Dr. Alan Johns • Between 1996 and 2005, • 27 adverse events have been reported • 2 resulted in death - due to delayed postoperative bleeding. • clips apparently had been placed without issue • did not maintain control of the vessel. “Reported Failures Of The Polymer Self-Locking (Hem-O-Lok) Clip” • Urology / Nephrology Feb 2007

  5. Self-Articulating Coil Technology • Features • Compression Member • Outer surface • Hollow • Compressed under tension at designated areas • Tensioning Member • Inner material • Moves within compression member • Retainment member • Stops movement of tensioning member • Provides force transfer to compression members Compression Member Retaining Member Tensioning Member

  6. Solution

  7. Market Opportunity $10.6 Billion 3.7% = $389Million

  8. Unique Competitive Advantage

  9. Competition

  10. Market Penetration Strategic Success Tactical Success Market Entry 2011 – 2015 Exit thru Sale FDA Approval 2010 – 2011 Build Reputation of Excellence 2009 – 2010 Prove Value in Live Surgery From now until beginning of 2009 Get the Product to the Market

  11. Financials Total Investment Required to Breakeven

  12. The Team Andy Dickson, Executive Mentor • 16 years of professional experience as an investment professional. • Co-founder of a frim that helps early-stage companies successfully raise private equity. Scott Junkin • Sr. Product Engineer, Emerson Eric Foster • MS Engineering Advisory Board • TBD

  13. Short-term Goals • Product validation • Surgeon champions • IP negotiation • Early stage funding • Trial prototype • FDA 510K exemption

  14. Extra Slides Formats if Needed Questions? Thank You!

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