SHC sunshine heart, inc.

major, major milestone achieved. europe approv

  1. 279 Posts.
    Cant let today's announcement go by without putting it in perspective:

    Highly effective and efficacious medical device for treatment of advanced heart failure.
    Rigorously tested in 20 real-life, real case heart failure patients with outstanding peer-reviewed results that have been presented at world-leading cardiac and medical device conferences.
    Low risk device.
    NOW ........... just formally approved for COMMERCIAL SALE in Europe by granting of CE Mark (and other countries that accept CE mark)allowing access to market of 3.7 million advanced heart failure patients.

    Future:
    Feasibility trial already completed in US with positive feedback from FDA and further approval with FDA "Investigational Device Exemption" in preparation for final Pivotal Trial to obtain licensing to commercialise in US market.
    Further formal regulatory approval to continue research in Canada.
    Further device enhancements already in production.
    Company goals to obtain 20-30% of advanced heart failure market (current prevalance 3.7mill Europe, 1.5mill US, plus rest of world ?approx 6mill plus -> 20% = 1.5mill patients) at ?$16,000 price for each device. 1.5mill x 16,000 = $24 billion in sales initial patient population AND if assuming indidenc of new cases each year of 5% of current prevalence (my figures) then approx $1bill sales per year. Profit ?50% margin = $500mill
    Valuation of company (my valuation): with $500m ann. sales
    = $3-5 billion (Current mark cap = $65mill).
 
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