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): August 19, 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 ................................1
SIGNATURES.....................................................................2
SECTION 8. OTHER EVENTS
Item 8.01. Other Events.
On August 19, 2011, Imaging3, Inc., a California corporation (the
"Company") conducted an open house for persons to come to the Company's
executive offices and observe a demonstration of the Company's prototype of its
three dimensional medical diagnostic imaging device ( the "Device"), and to have
a question and answer session with management. In the meeting, the Company
disclosed that (1) it plans to resubmit its application to the Federal Food and
Drug Administration (the "FDA") in 2011 after having a pre-filing meeting with
the agency reviewers, which the Company anticipates could occur within six weeks
of its request for such a meeting, (2) the Company plans to send a letter to the
FDA on or before August 29, 2011 requesting the pre-filing meeting with its
reviewers, and (3) the Company currently has engaged special consultants, legal
counsel, a radiologist and technical writers to assist management with the next
submission of its application to the FDA for the Device. While management is
confident that its re-submission to the FDA will be ready for filing before the
end of 2011, and that the pre-filing meeting with FDA reviewers will occur and
will improve the Company's prospects for eventual FDA approval of the Device,
there is no assurance that the FDA will grant the Company's request for the
pre-submission meeting (although they have indicated a willingness to do so by
telephone), or that the FDA will ultimately approve the Device.
In response to questions, management disclosed that (1) the Company is
contemplating a finance deal with an institutional investor of its securities to
raise additional capital to sustain its operations for the next eight to twelve
months, from which there is expected to be dilution to existing stockholders,
(2) the Company is seeking two independent directors to join its Board of
Directors, (3) management is not currently purchasing the Company's stock in the
open market, (4) management estimates the sale price of each machine to
prospective customers to be approximately $550,000 with an estimated gross
profit margin of 50%, (5) the Company plans to attend trade shows with the same
displays as in the past, (6) if approved by the FDA, the Company plans to launch
its marketing campaign with the stationing of up to twelve demonstration
machines in selected sites, and then ultimately work with a major manufacturer
for production and fulfillment of orders if orders are received by the Company,
(8) the FDA has not seen the machine in operation, so management plans to
include a video demonstration of the Device in its next submission to the FDA,
(9) the Company does not plan to hire a public relations firm at this time, (10)
the Company does not currently plan to do a reverse stock split of its
outstanding stock, but may consider one in the future, preferably near a time
when the Company achieves a major milestone, (11) two prototype Devices have
been built, one more is in production, and none are deployed in hospitals or yet
in commercial use, and (12) the re-submission to the FDA will include new images
and fresh data. In response to a question regarding the maintenance schedule of
the machine during each operating cycle, management estimated a time span of
three to six months of operation between routine periodic maintenance, resulting
in a 99% overall operational rate. The Company then conducted a live
demonstration of the Device for those attendees interested to see it.
SECTION 9. FINANCIAL STATEMENTS, PRO FORMA FINANCIALS & EXHIBITS
(a) Financial Statements of Business Acquired
Not Applicable.
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(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: August 19, 2011
/s/ Dean Janes, Chief Executive Officer
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Dean Janes, Chief Executive Officer
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