Burbank, CA October 11, 2016 (Globe Newswire) Imaging3™, Inc. (the “Company”) (OTCQB: IGNG) announced today that on September 26, 2016 the Company signed a Consulting Services Agreement (the “Agreement”) with Biologics Consulting Group, Inc. of Alexandria, VA (“Biologics”), by which Biologics agrees to provide consulting services to manage the planning for and drafting of the Company’s 510K application for its Volumetric Imaging Scanner (“VIS”) for submission to the United States Food and Drug Administration (the “FDA”). On October 3, 2016, Biologics accepted the first work order (the “Work Order”) under the Agreement: a regulatory assessment of the Company’s VIS in preparation for the 510K submission.
The Company retained Biologics in 2011 to review the Company’s 510K submission of 2009 after it was denied by the FDA in March, 2010. After discussions to determine why the 2009 510K application was denied and whether the concerns that caused the FDA to issue such denial could be remedied in a new filing, Biologics and the Company determined that such matters could be addressed in a new, strategically prepared and detailed application which could support FDA approval. On September 8, 2011, with substantial research and preparation, Biologics submitted a Pre–IDE request to initiate the process of the new FDA application. This effort was thwarted by the financial issues which led to the Company’s bankruptcy filing in September, 2012.
Dane Medley, Chairman/CEO of Imaging3 commented, “We are very pleased that Biologics has agreed to continue the work it commenced in 2011 in connection with the FDA 510K application and approval process for the VIS, even after our arduous reorganization process. Having a strong team with their proven success rate lends undeniable credibility to our project. To have a truly best-in-class firm like Biologics as our quarterback as we prepare to approach the FDA with our 510K application engenders confidence in the Company’s management and investors. Having already entered into our previously announced agreement with Critech concerning validation of our proprietary software, this step with Biologics further builds momentum toward our goal of FDA approval of our first imaging device utilizing our technology.”
Norman W. Baylor, PhD, Biologics President & CEO stated, “We look forward to resuming our relationship with Imaging3 to assist them in preparing and navigating their 510K through the U.S. FDA.”
About Biologics Consulting Group Biologics, an industry leader, is a full service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Founded in 1993 by Dr. James Kenimer, Biologics has become the go-to consulting partner for companies large and small seeking to bring innovative, safe and effective medical products to market throughout the world. For more information, please visit http://www.biologicsconsulting.com/
Imaging3, Inc., founded in 1993, has developed a patented medical imaging technology that will produce 3D medical diagnostic images in real time in each of single 3D Safe-Scan, Continuous 3D Scan and CT Safe-Scan mode. The Company’s technology will allow healthcare professionals utilizing Imaging3 lightweight portable devices to view 3D, high resolution images of virtually any part of the human body in real time, even as they are performing procedures. The technology utilizes high- resolution fluoroscopy to construct 3D images in real time. Such images are useful in helping health care professionals safely perform procedures on or in the human body. In addition, the Company’s technology exposes patients to significantly less harmful radiation than current imaging technologies such as CT scans. The Company believes this lower radiation exposure allow scans to be used in more pediatric applications than are currently prescribed. Perhaps most important, the Company believes that its technology will significantly reduce the cost of essential imaging to the healthcare system. The Company’s technology and imaging devices based upon it may not be used in human applications in the United States until the Company obtains FDA 510K approval of specific applications of its technology. However, the Company has not yet reapplied for FDA approval of any application of its technology (which FDA approval was denied in 2013) and there can be no assurance that the Company will obtain sufficient funding to reapply for any FDA approval or that, even if such funding is achieved, the Company will ever receive FDA approval of any possible application of its technology.
Visit the company’s website at http://www.imaging3.com for detailed information about the Company’s technology.
Safe Harbor Statement
Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words "anticipate," "believe," "estimate," "may" "intend," "expect" and similar expressions identify such forward-looking statements. 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. These include, but are not limited to, risks and uncertainties associated with: the impact of economic, competitive and other factors affecting the Company and its operations, markets, product, and distributor performance, technological obsolescence, competition from other medical instrument(s) and imaging companies, lack of capital, unexpected costs, failure or delay of FDA approval, failure to consummate desired business combinations or transactions, the impact on the national and local economies resulting from an economic recession or terrorist actions, and U.S. actions subsequently, unavailability of financing for the Company or its customers, product malfunction, potential product liability claims, and other factors detailed in reports filed by the Company.
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