Medical Device Regulatory Specialists to Support FDA Activities
BURBANK, CA, March 27, 2018 (GLOBE NEWSWIRE) -- Imaging3, Inc. (OTCQB: IGNG) (OTCQB: IGNGD), a development stage company introducing disruptive technologies in the medical imaging industry, is pleased to announce the signing of an agreement with Experien Group, a Silicon Valley-based medical device consulting firm. Experien Group will provide regulatory strategy and execution in the company’s efforts to secure marketing authorization from FDA for the Dominion SmartScan™.
“Enlisting the assistance of Experien Group reflects our commitment to this critical step towards commercialization. Michael, Darlene and the rest of Experien Group’s team are seasoned veterans of medical device regulatory efforts,” said CEO John Hollister.
Experien Group (http://experiengroup.com/), founded by Michael J. Billig and Darlene Crockett-Billig, is a regulatory consultancy with offices in San Jose and San Diego, California. They provide a full range of Regulatory, Quality and Clinical consulting services to medical device companies of all sizes. Experien Group’s senior team has more than 250 years of collective experience and will serve as a new extension of Imaging3’s organization, setting their regulatory strategy, compiling documentation, leading interactions with FDA and executing to major milestones, such as the filing and review of their 510(k) pre-market notification.
“Experien Group remains deeply committed to helping commercialize paradigm-changing devices that improve patient care and people’s lives. After speaking with John, it became clear to our firm that Imaging3 has an incredibly innovative technology and a crucial renewed commitment to taking a prudent, thoughtful and transparent approach with FDA,” said CEO Michael Billig.
About Imaging3 Inc.
Imaging3, Inc., founded in 1993, has developed a patented medical imaging technology, called the Dominion SmartScan™, that produces 3D x-ray images, effectively in real time. The SmartScan technology has the potential to allow healthcare professionals to perform diagnostic and therapeutic procedures more quickly and accurately, which may result in higher throughput for the clinicians and fewer safety risks for patients. Imaging3’s technology exposes patients to less harmful radiation than current equivalent imaging technologies such as CT scans. The company believes this will allow scans to be used in many settings where scanning is currently limited by concerns about radiation exposure. The technology also notably allows for reasonably convenient portability, easier installation and use-readiness, and a significantly reduced cost burden suitable for novel settings and for healthcare systems across varied global settings. Imaging3 plans to submit a 510(k) application to FDA during 2018 to gain marketing authorization for initial applications for the SmartScan technology.
Visit the company’s website at http://www.imaging3.com for detailed information about the company’s technology.
Safe Harbor Statement
Imaging3 cautions you that any statement included in this press release that is not a description of historical facts is a forward-looking statement. Many of these forward-looking statements contain the words "anticipate," "believe," "estimate," "may" "intend," "expect" and similar expressions. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the company and are subject to a number of risks and uncertainties inherent in Imaging3’s business, including, without limitation: the company may not ever obtain FDA clearance or approval for any of its devices; the company may not be able to secure the funds necessary to support its product development plans; and the company may not ever achieve the market success to sustain a profitable business. In addition, there are risks and uncertainties related to economic recession or terrorist actions, competition from much larger imaging companies, technological obsolescence, unexpected costs and delays, potential product liability claims, and many other factors. More detailed information about Imaging3 and the risk factors that may affect the realization of forward-looking statements is set forth in the company’s filings with the Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and its Quarterly Report on Form 10-Q. Such documents may be read free of charge on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Imaging3 undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.