SHC sunshine heart, inc.

one horse race..

  1. 10,009 Posts.
    Followi g on feom the two horse race.... Another article from Seeking Alpha, Robert Honeywell....

    Summary

    The target market for NYHA Class IV heart failure (HF) in the US and EU is around 250,000 patients and is strongly contested by Thoratec (THOR) and HeartWare (HTWR).
    NYHA Class III heart failure, with ~5 million patients in the US and EU, is a much larger and hugely coveted prize with a tiny percentage share worth $billions.
    Sunshine Heart (SSH) C-Pulse is the only long-term mechanical circulatory support (MCS) device to successfully complete a pilot trial showing safety and efficacy in Class III HF patients.
    The Thoratec HeartMate II Revive-It trial and the Sunshine Heart C-Pulse Pivotal trial are the only current FDA approved trials of MCS devices for NYHA Class III Heart Failure.
    The C-Pulse trial, being a Pivotal trial leading to PMA application, is a quantum leap ahead of the HeartMate II Pilot trial which requires a subsequent Pivotal trial.
 
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