Imaging3 Provides Year-End Corporate UpdateImaging3, Inc. (OTCQB:IGNG, “Imaging3” or the “Company”), a development stage company introducing disruptive technologies in the medical imaging industry, today provided an update on Company progress during 2018 and discussed goals for 2019.
John Hollister, Imaging3’s CEO, summarized key accomplishments: “Over the past year, the Company has completed a critical transition in leadership, recruiting a top-tier professional team, has established strategic partnering with leading regulatory, marketing and medical device R&D consulting organizations to support our objective of gaining 510(k) marketing clearance from the FDA for our lead product, the Dominion SmartScan™ system, and has advanced constructive debt renegotiation with existing lenders. While encouraging progress has been made on these fronts, with the support of interim funding from existing and new investors, the Company has continued to develop investor discussions for its targeted $2.5M+ financing necessary to accelerate and complete the process of achieving a 510(k) submission to the FDA. Management remains optimistic and committed to timely completion of this crucial objective.”
Hollister explained: “One year ago, having completed several major post-bankruptcy recovery objectives under Dane Medley as CEO, Imaging3’s Board of Directors recruited me to join the Company and the Board, successfully completing the transition of the CEO role back into an instrument development, clearance and commercialization focus. My prior experiences brought nearly 30 years of diverse healthcare industry management to the Company, most recently as CEO of other public healthcare companies. My first priority was to continue the leadership transition, to recruit and build out a team and partners capable of guiding and executing the work phases required to bring the Dominion SafeScan™ system to market.”
Hollister highlighted critical evolution in the team: “Our first additions were announced in January, with the formation of our Scientific Advisory Board. Our first two members, Doctors Douglas P. Beal and Brooke Spencer, bring valuable different practice and research perspectives from the radiology community. Both are highly successful and respected leaders, and are frequent presenters at important medical and radiology meetings. In early March, we announced the appointment of Joe Biehl as Chief Financial Officer. Joe brought highly relevant experience to the Company from both smaller and larger companies and important hands-on financial leadership experience in rapidly expanding companies.”
Continuing on to Board evolution, Hollister noted: “In an effort to build a strong, independent board with relevant technical and commercial experience to guide and accelerate the Company through its next phase, we announced in March the addition of Jeffrey N. Peterson to the Board, and his appointment as Chairman. Mr. Peterson received BSChE and MSChE engineering degrees from MIT, and brought broad, global senior management experience from diverse businesses within GE, Abbott Laboratories and consulting roles. More recently, he continues to serve in the leadership of both public and private earlier stage life sciences companies, both as CEO and Chairman. He served for a dozen years on the Board of BayBio, a leading life sciences trade association, and chaired the entrepreneurially-focused BayBio Institute, while developing a tremendous network across the healthcare community. The following month, we added Dr. George Zdasiuk to the Board and to the Scientific Advisory Board. Dr. Zdasiuk earned a PhD in applied physics from Stanford, and continued into a 30-year career at Varian Medical Systems, including 15 years as their Chief Technology Officer and VP of R&D. His deep scientific understanding spanning all medical imaging modalities is an invaluable resource for Imaging3 going forward.”
In May, the Company announced the resignations of Dane Medley and Xavier Aguilera from the President and CFO positions and from the Board. CEO Hollister acknowledged our thanks to them both for their service in managing Imaging3 through a very challenging period of restructuring and rebirth.
Turning to key new consulting partners, Mr. Hollister enumerated several: “In January, we engaged the highly-regarded technology, strategy and marketing consultants of Haltares Associates to help define and lead the Company through critical strategy planning. In March, we announced the selection of the Experien Group, a renowned medical device regulatory consultancy, to help lead our regulatory preparation and submission activities. The Experien Group have successfully assisted hundreds of companies like Imaging3 with their FDA submissions. Since the announcement, Experien has selected their team and we have initiated preliminary planning efforts. In November, we commenced work with a highly-experienced contract consulting team with particularly relevant radiology product R&D experience, on the evaluation and further instrument development planning around the Dominion SmartScan’s uniquely distinguishing algorithmic and software capabilities.”
Finally, reviewing financing progress, CEO Hollister reported: “In preparation for fund-raising and a step-wise progression towards a later uplist to a major stock exchange, the Company announced the successful completion of a 1:20 reverse split in April. This was an important step in our efforts to address the Company’s capital and debt structure as we improve our ability to attract new capital. In May, three of our note holders chose to complete the conversion of their debt investments entirely over into equity. In July, the Company received disappointing news, as the US District Court for the Southern District of New York granted summary judgment to two note holder plaintiffs in a case brought against the Company. We are working on an agreeable settlement, and have achieved excellent progress with all of our remaining note holders regarding fair settlement and/or conversion of the balances of their outstanding notes, upon arrangement of our targeted $2.5M+ equity financing.”
Hollister concluded: “The Company has raised approximately $700K since last December, used to fund essential operations both internally and through consulting activities noted above. The Company is diligently continuing efforts on multiple fronts to secure the targeted $2.5M+ equity investment bolus necessary to fund development, creation and submission of an appropriate 510(k) filing seeking FDA clearance for initial claims and marketing of the Dominion SmartScan™ system. We continue to anticipate that the 510(k) submission should follow approximately two quarters after completion of this key financing event. With 2019 at our doorstep, our prime focus remains fixed on securing this enabling financing as soon as possible. We are confident that we now have in place the leadership team needed to guide our execution of instrument development, clearance and commercialization plans, upon successful financing. We remain optimistic regarding securing acceptable terms for the targeted financing in the near future, and will issue updates accordingly.
About Imaging3, Inc.
Imaging3, founded in 1993, has developed a patented medical imaging technology, called SafeScan™, that will produce 3D x-ray images, virtually in real time. The SafeScan technology will allow healthcare professionals to perform diagnostic and therapeutic procedures more quickly and accurately, resulting in higher throughput for the clinicians and fewer safety risks for the patient. In addition, Imaging3’s technology exposes patients to significantly less harmful radiation than current imaging technologies such as CT scans, which the company believes will allow scans to be used in more pediatric applications than are currently prescribed. The technology also allows for greater portability, easier installation, and a significantly reduced cost burden for the healthcare system overall. Imaging3 is planning to submit a 510K application to the FDA in order to gain approval to commercialize the SafeScan 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 the Imaging3’s business, including, without limitation: the company may not ever obtain FDA 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.
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