Immuno-Genic Corporation (IGC) has conducted a "Proof of Concept" pilot study to prove efficacy and safety. This study and the data collected through the veterinary usage of the product have been analyzed. The results have been submitted to the Food and Drug Administration (FDA) in the form of a 510(k) submission for FDA Clearance to Market the product to the human market.
The FDA 510(k) or PMN (Pre-Market Notification) program is a method to obtain expedited regulatory approval, i.e. permission to market a medical device without the extensive costly and time consuming Pre-Market Approval or PMA processes that are required for a new drug application. The 510(k) system is based on substantial equivalence to a previously PMA approved or 510(k) Cleared device that is similar or substantially equivalent to a new device for which a Clearance to Market is being requested. A previously approved or Cleared device is referred to as the predicate device.
The FDA has two product classification codes for laser or light therapy devices: 1) ILY which means the device is thermal and is permitted to be reviewed under the Third Party Review system which substantially shortens the 510(k) review time or, 2) NHN which means the device is non-heating and not eligible for Third Party Review. The Ig2000™ product code is NHN. Additional classification of the Ig2000™ technology is Regulatory Class II under the Review and Advisory Committee of "Physical Medicine".
IGC is in constant review of the FDA's rules and regulations and is fully prepared to market its products in accordance with all regulatory requirements thereby protecting the company, its shareholders, its product, and its corporate reputation.1
The Ig2000™ is considered a therapeutic laser medical device per the FDA. As such, the Company has chosen to obtain an initial Clearance to Market certification under the 510(k) program offered by the FDA to expedite the ability/timeline for IGC to generate revenue from the product.
IGC has already successfully completed part of the FDA 510(k) review process. The initial application for the device in human medicine will be for Pain Management. Under the 510(k) program there must be a substantially equivalent product for IGC's initial laser device to piggy-back on, in this case a therapeutic laser or light therapy device previously approved or granted Clearance to Market by the FDA.
The FDA has reviewed IGC's initial 510(k) submission subsequently granting IGC's device a "Non-Significant Risk and Athermic Classification". Additionally, the device carries a "Non-Ocular Hazard classification thus resolving the issue of safety.
The FDA is requiring the issue of efficacy be addressed as there is no predicate device previously Cleared by the FDA that generates the wavelength of infrared of the Ig2000™ device, as IGC holds patent coverage on the therapeutic usage of its specific wavelength of infrared light. Therefore, IGC has been directed by the FDA to conduct a Phase 2(b) efficacy study which the FDA will evaluate in order to grant the company a Clearance to Market the Ig2000 in the field of human pain management.
IGC plans on conducting studies to define the product as having efficacy in the treatment of a disease process, in addition to the treatment of pain, under the FDA's Pre-Market Approval (PMA) process. The PMA program will afford the Ig2000™ device with the distinction of being the only therapeutic laser technology that can mediate and or ameliorate a disease process. Each PMA garnered will allow the company to greatly expand its market share.
In the United States the device is classified as Class II by the FDA whereas it is classed as Class I in several foreign countries, including the E.U. where the technology is widely patented. The Class I designation allows for reduced regulatory approval times and costs for foreign market commercialization as the regulatory process is reduced to a registration process that is less burdensome. Additionally, a medical device that has regulatory approval in one E.U. country has reciprocal approval status per Mutual Recognition Agreements (MRA) in the entire E.U. Therefore, entry into the foreign markets where the technology is patented will offer an opportunity to expand the marketplace and create additional revenue. IGC has interest from Ireland and other E.U. member states and has formed an entity in Ireland, Immuno-Genic Ireland Ltd., which will become operational at the appropriate time and with appropriate funding. An associate of IGC and Corporate Secretary/Director of Immuno-Genic Ireland Ltd. is a manufacturer and distributor of health products throughout the E.U. and several of his existing clients, practicing healthcare practitioners, are extremely interested in the Ig2000™ technology for human clinical application in their clinics.
The biophysical differences between the Ig2000™ technology and present day therapeutic laser technology FDA Cleared to Market are distinct and numerous. The specific intrinsic properties of the wavelength of light generated by the Ig2000 are at the core of this biophysical difference; 1) the presently commercialized therapeutic lasers and light therapy devices are classified as an Ocular Hazard by the FDA and the International Electrochemical Commission, the IEC, regulations. The law requires that specialized eye protection be worn by both the patient and the operator of these devices. The Ig2000™ is classified as Ocular Safe/Non-Ocular Hazard by the FDA per Laser Notice "50" and the IEC, and no protective eyewear is required for the operator or patient and the eye can be directly treated with the device without ocular damage.
The presently commercialized devices are contra-indicated (not to be used) 1) treatment of the eyes and protective required for the patient or the provider, 2) where cancer is present, 3) or where infection is present, 4) can not treat the genitals, 5) and can not treat over the area of any internal organs. In contrast, the Ig2000™ is not contra-indicated in these instances and can and is being applied successfully in all of the above listed circumstances.
1Several of the device companies that are marketing light therapy devises have been investigated by the FDA for misbranding and have had "Cease and Desist" letters sent to them by the FDA for false claims, i.e. "systemic and treats emphysema", etc. as was the case with the Anodyne Therapy System, PainX and Erchonia. All "laser" and LED