UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 18, 2011
IMAGING3, INC.
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(Exact name of registrant as specified in its charter)
CALIFORNIA
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(State or other jurisdiction of incorporation)
000-50099 95-4451059
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(Commission File Number) (I.R.S. Employer Identification No.)
3200 W. VALHALLA DR., BURBANK, CALIFORNIA 91505
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (818) 260-0930
NOT APPLICABLE
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(Former name, former address and former fiscal year, if changed since last
report)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions.
[_] Written communications pursuant to Rule 425 under the Securities Act (17
CFR240.14d-2(b))
[_] Soliciting material pursuant to Rule 14a-12 under Exchange Act (17
CFR240.14a-12)
[_] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR240.14d-2(b))
[_] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR240.13e-4(c))
TABLE OF CONTENTS
SECTION 8. OTHER EVENTS.....................................................1
Item 8.01 Other Events................................1
SECTION 9. FINANCIAL STATEMENTS AND EXHIBITS ...............................2
SIGNATURES....................................................................2
SECTION 8. OTHER EVENTS
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Item 8.01. Other Events.
On October 28, 2010, the Company received a letter from the United
States Food and Drug Administration (the "FDA"), responding to the Company's
application to the FDA for clearance of its 3D medical imaging technology and
device. In its application to the FDA under Section 510(k) of the applicable
federal legislation, the Company states that its medical device is substantially
equivalent to devices marketed in interstate commerce prior to May 28, 1976 and
therefore should be approved for commercial sale and use as a Class II device,
without the necessity for clinical trials. The FDA responded by rejecting the
Company's position that its medical device is substantially equivalent to such
prior devices. The Company disagrees with the FDA's position and plans to
re-file its application with additional information supporting the Company's
application for clearance.
Upon receipt of the deficiency letter from the FDA denying its
application to market its Dominion DViS product in the United States, the
Company hired the law firm McDermott Will & Emery, a Washington D.C. law firm
with expertise in FDA filings and their resolution. Since the process has taken
longer than management anticipated, management felt it prudent to engage outside
consultants with sufficient experience to assist the Company in the process.
Upon review and discussion of its FDA application and response letters with the
consultants, the Company's management feels confident in their ability to assist
the Company with the preparation and follow-up of the re-filing of its 510(k)
application. The consultants expressed the view that each deficiency cited by
the FDA in its letter could be resolved and that FDA approval was achievable,
although not guaranteed.
In summary, the deficiencies cited by the FDA in its most recent letter
to us include (i) the inadequacy of the comparative clinical images that we
submitted from other existing predicate devices in the market, some of which we
obtained from websites rather than directly from the devices because the
websites gave us a broader selection of images (we will submit original images),
(ii) we did not provide our own Dicon image viewer that the FDA could use to
better view our submitted images (we will supply our own Dicom image viewer),
(iii) the format of our hazard and software analysis was not acceptable (we will
reformat our submission), (iv) our discussion of vibration issues was not
adequate (we will supplement our discussion of this issue and believe our design
mitigates it), (v) the explanation of our solution to overheating was not
adequate (we will expand our discussion of this issue and feel our design solves
it), (vi) our description of predicate CT scanners needs to be more detailed (we
will add more detail in our re-filing), (vii) the explanation for the speed of
the acquisition of information by our device exceeding the published
specifications of the off-the-shelf detector we use is not sufficiently
justified (we believe that we can explain and justify our claim), (viii) our
technical user manual needs to be re-written in certain areas (we will do so),
and (ix) we need to supplement and strengthen our argument in favor of the fact
that there are predicate devices already on the market, justifying approval by
the FDA of our device as a Class II device.
In light of the nature of the FDA 510(k) process and the Company's
right to continually re-file its application after denial, the Company has an
opportunity to succeed with an approved application. The Company may also hire
and has been in discussions with several technical writing consultants to
further assist and expedite the application process, improve the quality of the
re-submission, and improve the chances of receiving approval of the application.
Management estimates the cost of these consultants to be between $50,000 to
$100,000, depending upon whether approval is achieved on the initial submission
or if further information is requested by the FDA. Although this is a
significant expense, it is imperative that the Company eventually achieve
approval for this device from the FDA to enable the Company to achieve its long
term business goals.
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While we remain confident of eventually achieving FDA approval of the
Company's medical device as a Class II device, there is no assurance that such
approval will be obtained or that the Company may not ultimately be required to
file it under Class III where clinical trials would be required.
In the absence of FDA approval for our medical device, the Company
currently does not and cannot rely upon it as a future source of sales and
revenue. The Company is subject to the uncertainty of not knowing whether or
when its proprietary medical device will be approved and can be sold. Under
those circumstances, management believes that the Company will continue its
current trend of incurring operating losses, possibly requiring it to raise
additional capital or financing from outside sources. There is no assurance that
the Company will be able to raise sufficient capital or financing to maintain
its business while it is incurring operating losses, and there is no assurance
that the Company will become profitable if its proprietary medical device is
approved by the FDA.
SECTION 9. FINANCIAL STATEMENTS, PRO FORMA FINANCIALS & EXHIBITS
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(a) Financial Statements of Business Acquired
Not Applicable.
(b) Pro Forma Financial Information
Not Applicable.
(c) Shell Company Transactions
Not Applicable.
(d) Exhibits
None.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
IMAGING3, INC.
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(Registrant)
Date: January 18, 2011
/s/ Dean Janes, Chief Executive Officer
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Dean Janes, Chief Executive Officer
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