Ann: Quarterly Activities Report, page-6

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    Closer to home, the terrible scenes and news coming out of India in recent weeks have compelled
    us to focus our relationship efforts on that country to help where possible. Typically, India requires
    FDA approval to operate; however, we have begun initial discussions, through representatives,
    with the Indian government to discover if it is possible to operate with CE Mark approval in the
    short term, given the urgency of the situation.
 
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