|
|
|
|
• August 2008
We would like to update you on our progress with the FDA. We are continuing to work with the FDA to resolve issues and answer questions in regards to our 510(k) filing. Currently we are working through issues with device classification and substantial equivalency and we may be asked to re-file our 510(k) submission deleting or adding devices to compare the Dominion Vi Scanner as substantially equivalent. This is neither good nor bad news, even if we had to re-file our 510(k) submission, it would already include the information and progress we have already made to date. It is unclear at the moment whether this will be necessary and we are having difficulty receiving a straight answer from the FDA. We know this process has continued longer than anticipated, though we feel as confident as ever that we will eventually receive approval.
Some have wondered why we haven't begun marketing the Dominion Vi Scanner under FDA IDE regulations. Doing this would not be in the best interest of the company as we would be locked into a process that could last many years and should only be considered as a last resort. Many medical device manufactures that have taken this path typically have done so only because their devices were so unique they had nothing on the market to compare substantial equivalence. Under IDE regulations the device being marketed cannot be sold, it cannot generate revenue for the medical facility or physician and can only be used on specific patients and used for specific procedures under stringent guidelines. By marketing the Dominion Vi Scanner under IDE we could not generate any income or profit for the company and only add substantial costs.
Another area we would like to report on is the internal funding program with UBS Financial Services. As many of you already know, the company filed an 8K, explaining this process, of which we have placed some of Dean Janes' shares into the open market for sale. As described in the 8K, these shares are being sold for the sole purpose of funding the company, not for Mr. Janes' personal financial gain. Many of you may have seen the Form 4 filings as they occur as this process must be open to the public. To date we have generated over $375,000 and we will continue to do so as this program raises money for the company in the least dilutive way possible. If you wish to view these filings you may do so by visiting the SEC's website at www.sec.gov and select the EDGAR filings and enter Imaging3 in the search criteria.
Many of you have invested or followed the progress of Imaging3, some of which for many years and we would personally like to thank each and every one of you for your interest and especially your patience. We know it can be frustrating when it seems no progress is being made, but rest assured, the entire management team and all of Imaging3's employees are working hard to make this company and its revolutionary, breakthrough, one of a kind product, the Dominion Vi Scanner a success. We promise to keep all of you informed, not only of our progress with the FDA but with any news or new developments as they occur.
Sincerely,
Dean Janes, Chairman/CEO
Imaging3, Inc
3200 W. Valhalla Drive
Burbank, CA 91505
(800)900-9729
(818)260-0445 Fax
http://www.imaging3.com
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, the impact on the national and local economies resulting from terrorist actions, and U.S. actions subsequently; and other factors detailed in reports filed by the Company.
|
