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Sunshine Heart Inc. Message Board

  • networthdev networthdev Feb 23, 2013 2:19 PM Flag

    New (Feb. 2013) SSH presentation available on website

    Good info, PARTICULARLY like, "No known competition", & " UNIQUE disruptive technology", couple highlights:

    Class III Competitive Landscape • No current solution for patients
    • CRT – intended for rhythm not mechanical heart issues like C-Pulse
    • Circulite – mini pump technology placed in bloodstream • LVAD’s – used and reimbursed primarily for Class IV heart
    • CardioKinetix – MI in the LAD region at least 60 days prior to implant
    • No known competitive technology outside of bloodstream
    • Minimallyinvasiveprocedure–mini-thoracotomy(typically 4 to 7 days in hospital)
    - This compares to final clinical data from two LVAD studies that indicate median hospital stays of 19 and 25 days

    Investment Summary
    • Unique, disruptive technology with large patent estate
    • Large, poorly treated market
    • Anticipated favorable economics to providers with or without “Obamacare”
    • CE Mark approved for sales in Europe
    • U.S. pivotal trial initiated
    • Preliminary one-year feasibility data presented at TCT in October 2012
    • Experienced cardiovascular device management team
    Fully Implantable C-Pulse System
    • • •
    Initial company patents based on this concept Completed animal feasibility 5/31 at Texas Heart with TET system Provided full support

    U.S. Pivotal Trial Site Selection Progress
    • IDE unconditional approval announced 11/20/12 • Trial Manager hired 10/2012 • 80 U.S. centers contacted • 7 sites are in approval process
    • 27 sites have expressed interest • 30-40 centers are anticipated for trial • First enrollments/implants on target in Q1 • First two expected sites participated in feasibility trial • Enrollment Factors:
    – – –
    Sites reimbursed by CMS and most private insurance Lack of competitive trials Resources in place to assist in increasing trial awareness

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