- Company successfully emerges from three-year bankruptcy process to relaunch its proprietary imaging system and once again seek FDA approval
- Medical imaging industry is expected to grow to more than $55 billion by 2025
- The Dominion VI SmartScan™ has virtually infinite potential applications not only for medical imaging and diagnostics, but also in multiple other industries
Imaging3, Inc. (OTCQB: IGNG), a development stage company targeting disruptive technologies in the medical imaging industry, is set to revolutionize the market via proprietary technology offering significant advancements in real-time 3D imaging. The unique technology could prove to be a game changer in the growing medical imaging market, which is expected to reach $55.7 billion worldwide by 2025 as a result of an exponential increase in the use of portable diagnostic devices and the growing prevalence of chronic and sedentary lifestyle diseases (http://ibn.fm/LCXqA).
Founded in 1993, Imaging, Inc. has successfully overcome some difficult challenges to pursue a 510K with the Food and Drug Administration. The Burbank, California-based company might sound familiar to seasoned investors, as it was a popular stock with more than 14,000 investors trading a few years ago. Its lead product and proprietary technology, the Dominion VI SmartScan™, is a patented fluoroscopic device with the capability of producing real-time 3D images, including multi-axis slice through views like a CT, but much faster and with significantly lower radiation exposure to patients. The system is fully portable and works off of any standard 110-volt energy source. In addition to imaging human parts, the Dominion has also imaged agricultural products over the past few months. These images are available on the company’s website (http://ibn.fm/wc2i6).
The Dominion was developed nearly 10 years ago, when Imaging3 was primarily focused on refurbishing C-arms, the fluoroscopes that have been the standard in the imaging industry over the past 40 years. Created with detailed knowledge of how fluoroscopes work and how they could be significantly improved, the Dominion differs from standard C-arms, as it has an O-ring design. The O-shape allows the “eye” – the cone x-ray which emits the low-level radiation – to entirely encircle the target subject or object. During that revolution movement, which can happen as quickly as one revolution per second, the eye is able to take multiple images. The standard approach is one image per degree for 360 degrees, but the number could be higher if required. The images are then assembled into a 3D image, which is displayed via proprietary software. Users can view the image in both 2D and 3D, and they can rotate it to view it from different angles, as well as slice through it in any direction.
The near-term potential uses for the Dominion VI SmartScan™ are virtually infinite, with opportunities available wherever a very fast (one second of imaging time), portable, low-radiation device that can display images like an x-ray or a CT would be to the benefit of a patient or health care provider. Obvious examples include the emergency room 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 getting a better 3D view of a part of the body can enable the health care provider to do a better job or monitor progress. Additionally, there is significant potential for the device to aid in real-time imaging for minimally-invasive surgery.
The Imaging3 team is confident that it can revolutionize the imaging space with the Dominion VI SmartScan™. The company has already been approached by several industries outside of the medical arena, with security, agriculture, food, transportation and veterans’ organizations each expressing interest in the product.
Imaging3’s work on the revolutionary device several years ago raised a great deal of attention in the industry, and hopes for FDA approval were high. However, the company’s 510K submission was rejected at the time because it 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. Furthermore, it was discovered that the company’s founder and CEO had committed fraud by not divulging negative FDA feedback to the directors and officers of the company. As a result, the company was forced to seek protection under federal bankruptcy laws.
The company worked through a three-year bankruptcy process and a Securities and Exchange Commission-mandated self-remediation, both of which were completed last year. In November of 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. With that behind it, the company once again focused on preparing the Dominion for FDA review. The company completed the first half of the FDA preparation last year by enlisting one of the leading regulatory consulting companies to conduct an evaluation of the Dominion software. The hardware evaluation, expected to include hazard testing and take roughly three months, is yet to be completed. Once these assessments are finalized, the company will compile the new 510K and submit for review by the FDA. The company hopes to file in the first half of the year.
Subsequent to its emergence from bankruptcy and completion of the SEC self-remediation process, the Imaging3 board recognized the need to start building out a team capable of managing the FDA 510K process to successful completion. With 30 years of health care experience in pharmaceutical, biotech and device companies, including management of public companies listed on the OTC, new CEO John Hollister is prepared to lead this effort. Last month, Hollister and Imaging3 announced the formation of a scientific advisory board, with the first two members being well-respected and experienced radiologists.
Parallel to its FDA efforts, Imaging3 will be busy assessing which of the many potential markets will be the first target for its proprietary technology, while also focusing on designing the final product. The current working model is a prototype that facilitates testing and development, but it is not meant for final production. The company’s management believes that these efforts will result in the first commercial placements in the first quarter of 2019.
For more information, visit the company’s website at www.Imaging3.com
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