Wow,

My opinion regards the need for clinical data to support commercialization of the beads is based on more than 25 years of management experience with established and start-up healthcare companies.

Regards your statement that the beads "...don't require the test" is incorrect; Dr G has informed us that an IVD Company will have to file a 510K with the FDA should they wish to replace the dark iron beads currently used in the FDA cleared diagnostic machines with Cardiogenics silver coated beads. IMO a prudent management team of an IVD company will require clinical data to support such a regulatory filing.

Ante