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BURBANK, Calif., Feb. 14, 2018 (GLOBE NEWSWIRE) --

Imaging3, Inc. (IGNG); I joined Imaging3, a development stage company in Burbank, California, to target disruptive technologies in the medical imaging industry and help realize the potential of a revolutionary advancement in real-time 3D imaging. The Company has emerged from some difficult circumstances while trying to complete the pathway in pursuing a 510K submission with the FDA. Having been here for just over 45 days, I thought I would share some history and a glimpse of what Management plans to do moving forward.

Imaging3’s lead product, the Dominion Vi SmartScan™, is a patented fluoroscopic device with the capability of producing real-time 3D images, with multi-axis slice through views like a CT, but much faster and with significantly lower radiation exposure to patients. Additionally, the device is portable and powered by a standard 110 volt energy source. I’ve been able to run multiple demonstrations for visitors, utilizing human cadaver parts. In addition to imaging human parts, the Dominion has also scanned agricultural products over the past few months. These images can be seen on the company website at: http://www.Imaging3.com.

The Dominion was developed nearly 10 years ago. At the time, Imaging3 was a company that focused on refurbishing C-arms, the fluoroscopes that have been the industry standard over the past 40 years. The Dominion is a product developed off the detailed knowledge of how fluoroscopes work and how, potentially, they could be significantly improved. The Dominion differs from standard C-arms as it has an O-ring design, which allows the “eye”, or the cone X-ray, which emits a low level radiation, to entirely circle the subject or target object. During that revolution, which can happen as quickly as one revolution per second, the eye is taking and producing multiple images. A standard method is one image per degree for 360 degrees but could be many more, if required. The 3D image is then assembled and displayed through Imaging3’s proprietary software. The user then has the option to view the image in 2D and 3D having the ability to be rotated for viewing from any angle, as well as sliced through in any direction.

We believe the near-term potential uses for the Dominion to be quite broad. Wherever a very fast (one second of imaging time), portable, low radiation device that can display X-ray like or CT like images would be a benefit to both patients and healthcare providers, we believe therein lies an opportunity. Obvious examples can be found in the ER for triaging patients, in sports medicine clinics or sporting facilities, in any community (in the U.S. or abroad) where access to a CT is not readily available or the costs are prohibitive, and in settings where 3D images of a specific part of the body can enable the healthcare provider to do a better job or monitor progress more effectively. The Downstream potential use of this device in aiding real-time imaging for minimally invasive surgery (MIS) also presents a considerable opportunity.

Imaging3 received a great deal of attention seven years ago, as the Dominion was being developed. The promise of the device was clear to many and hopes of FDA approval were high. Unfortunately, the 510K submission was rejected after several years because prior management failed to provide adequate support to justify claims that exceeded the capabilities of the devices submitted as predicates (comparable devices used in the 510K process). The Founder/CEO of the company was found to have committed fraud by not divulging negative FDA feedback to the directors and officers of the company. After a period of such malfeasance by the previous CEO, the Company was forced to seek protection under the federal bankruptcy laws and to enter into a consent decree with the SEC which required the Company to undertake certain self-remediation procedures involving corporate governance and communications with shareholders and the public.
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The Company worked through the three year bankruptcy process, as well as the three year SEC mandated self-remediation period. Last year, both were completed. The Company has cut all ties with the Founder/former CEO. On November 21, 2017 the Company received a letter from the Division of Corporate Finance of the SEC stating that it, at that time, had no further comments on the Company’s post-bankruptcy periodic reports which had been under review for the previous 15 months. As a result of the completion of these remedial matters, the focus, once again, is on preparing the Dominion for FDA review. The company has completed the first half of our FDA preparation by enlisting one of the leading regulatory consulting companies to conduct an evaluation of the Dominion software. This step was completed in 2017. The hardware evaluation remains to be completed, which we have roughly estimated to be a three month process, followed by compiling the 510K and submission for review by the FDA.