Human applications of The Ig2000™ technology are presently in Regulatory Process. The U.S. Food and Drug Administration, FDA, has reviewed IGC’s fist submission under a 510(k) application. The FDA has classified the Ig2000 device as:
- Non-Significant Risk Device, i.e. Safe for application on humans.
- Athermic Device, i.e. No heating of tissue. Therapeutic effect is accomplished via chemical reactions, not heat that increases circulation as a heating pad.
- The Device additionally is “eye” safe, fully compliant with FDA Laser Notice “50”. The device generates laser light that is 100% absorbed in water and as such the laser light absorbs into the aqueous humor of the eye and does not penetrate the retina.
The FDA is requiring IGC to conduct a clinical trial to demonstrate efficacy of the wavelength generated by the Ig2000 device as there is no predicate device holding FDA Clearance for commercialization nor any historical data in the literature demonstrating therapeutic efficacy of the wavelength range the device is generating, i.e. 1791nm thru 2043nm approximately.
Boca Raton Orthopedic Group, Inc., under the direction of Dr. Joseph Purita, will be conducting the clinical trial, phase 2(b) efficacy study, which will focus on musculoskeletal pain.
IGC is in discussions with the Dr. Roberta Gausus at Scheie Eye Institute pertaining to an ocular study focusing on inflammation of the eye.
IGC is developing a platform of medical devices centering on its Immune system Modulation Therapy.
IGC will be expanding its market presence within human medicine in the E.U. thru Immuno-Genic, Ireland, Ltd.
IGC will provide updates in the Press section of its website.