History
In the spring of 2006, Dr. Rizzo established EPIC™ Research & Diagnostics, Inc. (“EPIC™”) as a privately held company to further develop and commercialize her proprietary research. EPIC is headquartered in Scottsdale, Arizona, as an Arizona C Corporation.
The company is working towards commercializing its proprietary EPIC ClearView™ device, a specially engineered bioelectromagnetic measurement instrument that includes EPIC’s proprietary software.
ClearView is a non-invasive (painless), easily administered scan that provides a simple report form assessing body systems/organs. ClearView can be administered by physicians and trained staff, and will be economical for physicians and hospitals to operate.
Regulatory Matters and the FDA Approval Process
EPIC is in clinical trials and pursuing FDA clearance to ultimately deliver a medical device for in-office use by doctors and hospital emergency rooms.
Clinical Data Path
EPIC Research & Diagnostics was started as an independent research clinic to establish efficacy of galvanic skin response measurement in a clinical setting. After two years of patient consultations, a substantial amount of data and experience was acquired supporting the use of the technology on a wide-scale basis. The data and experience have proven to be invaluable precursors to the development of commercial software and hardware that can be used by healthcare professionals.
In 2002, The National Institutes of Health initialized international proceedings on bioelectography. The results included the development of a protocol to correlate electromagnetic emissions from the body with the evaluation of disease. Inferior instrumentation suspended the protocol efforts, while investigators await the release of ClearView to begin their studies anew. Additionally, University of California, Davis created a division for conducting biophotonic research on the cellular level, as one element of an investigation on how DNA classification can lead to disease identification.
Patients who have been scanned with this device present with a wide variety of underlying conditions. A small compilation of typical clinical scenarios is important to understand in order to appreciate the potential utility of the ClearView device in a clinical setting. The presentations of the patients that sought an evaluation are varied. The most common threads throughout the clinical testing phase consisted of two approaches: one involved patients who had been to all of the well-known conventional medical establishments, but were left with no answer about what was wrong with them, and no direction for re-establishing ‘health’, and the other involved patients seeking to affirm the overall status of their well being as a preventative measure.
Both Duke University and University of California, Los Angeles are conducting similar research efforts. Enhanced measurement technology coupled with modern computing power and the company’s proprietary software, now make it possible to harness the biophotonic science and provide a new generation diagnostic appliance. With this new computing power, scientists are now able to measure the action potentials along the body surface similarly to EKG and EEG technology, with the added capability of registering the measurements and correlating them to whole body functions.
Live clinical study efforts are underway in physician/clinic settings including a 350 subject study at Greater Baltimore Medical Center, a Johns Hopkins affiliate.
