Its been very quite around here for the past year. Thought I'd get some information posted and maybe some dialogue..
Burbank, CA, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Imaging3, 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 SmartScan™ 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.
