Investment Funding

The Company is seeking $26,000,000 of capital funding to be used over a 36-month period to further develop, test, and market the ZRO and related products on a global basis.  During the first 18 months of Phase I, the company intends to allocate approximately $1,000,000 to conduct an international human clinical trial (10-20 patients).  This will establish device approval in the international markets and include the start of international sales and promotional activities.  Additionally, during Phase I, the Company will take steps in the U.S. to conduct a Phase I Safety and Efficacy Human Trial (20-40 patients) with $5,000,000 in funding.  This is a pre-requisite for a Phase II Investigational Device Exemption (IDE) study to establish a Pre-Market Approval (PMA) for marketing approval for the ZRO device from the U.S. FDA.  The Phase II U.S. IDE study completion is anticipated by 2010 and will require an estimated $8,000,000 in funding to complete during months 12 through 36.  Provided the initial Phase I studies are successful, the Company intends to conduct ongoing educational and marketing programs.  We will also seek approval of the product for use in Europe and the United States.

 

This device is not FDA approved. Not for sale in the U.S.