MedNexis, Inc.

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Medical Equipment Business Plan

Regulatory Issues

While it is expected that FDA approval will be gained quickly based on the approval of similar devices, MedNexis' products will be produced and marketed prior to this approval.  By clearly labelling the device "For Investigational Use Only," MedNexis will be able to market and sell the device to interested parties prior to FDA approval.  An example of such expedited market entrance can be seen with the laser vision correction procedure LASIK.  Prior to its approval by the FDA in Winter of 1999, LASIK had been performed on 900,000 patients through labeling the laser as "For Investigational Use Only." We hope to similarly expedite market entrance. 

Once FDA approval is obtained for MedNexis' products, the market is expected to expand dramatically and entrance into foreign markets will be possible.  At this stage, as well, it is expected that insurance companies will begin reimbursing for magnetic therapy, greatly increasing demand for MedNexis' products.  There is past precedent in 510k approvals (in an average of 3 months) in documented cases.