Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
LIQUIDITY AND CAPITAL RESOURCES
Our total current assets decreased from $1,134,654 as of December 31, 2009 to $543,089 as of December 31, 2010, a difference of $591,565 or
52%. The cash account as of December 31, 2010 was $367,578, a decrease of $265,865 compared to December 31, 2009.
Our total current liabilities increased to $5,402,858 as of December 31, 2010 from $2,803,127 as of December 31, 2009. This increase is due in
large part to the Derivative Liability account of $2,243,466 reported for the first time. The Derivative Liability account derives from the Series
A, Series B, and Series C Warrants issued by us in a private placement on October 15, 2010.During the year ended December 31, 2010, we used $1,700,427 of cash for operating activities, as compared to $1,890,414 during the year
ended December 31, 2009. Cash provided by financing activities during the year ended December 31, 2010 was $1,434,562, as compared to
$2,450,410 during the year ended December 31, 2009.
ALL: The high rate of post deletions continue. Admin will Ban and/or limit post to those that continue to violate the Ihub rules. Please take the time to read them!
http://ihwiki.advfn.com/index.php?title=Handbook
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 39129
Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
Woodberry578 Share3 Thursday, January 20, 2011 6:57:09 PM
Re: None Post # of 39084
I just got home from the Imaging3 shareholders meeting. As promised, I wanted to let you all know my take on the meeting.
First off, I would agree there were closer to 100 people at the meeting vs. 50. As we all expected, all propositions easily passed. While Imaging3's CFO and an independent accounting firm tallied the votes, Dean gave all attendees a recap of where the company is at regarding the new FDA 510K resubmission process and opened up the floor for questions relating to anything Imaging3.
Here are some of the key points for me:
Dean is optimistic the new resubmittal will happen by either the end of February or March (I would not hold Dean to these specific dates. Remember: it is his best "guess-ta-mit"). The resubmission will be proceeded by a face-to-face meeting with the head of the FDA's Medical Devices unit and our FDA reviewer. On the Imaging3 side of the meeting, Dean will be there, Jim Cohen (lead attorney at MWE), and our Consulting Firm's Technical writer. The goal is to iron out key points needed to gain FDA approval once the new 510K is submitted. Again, the impression I got is: Dean is hopeful of a June answer from the FDA (again, an estimate on the timeline).
During the question and answer period, several other key questions and answers occured that I know the I-Hub Board members are interested in:
Is there enough cash to keep the company going through the new resubmittal process? Answer: several million dollars more are available (if needed) from the Investment firm who gave Imaging3 the recent million dollars. Money will not be a problem!
Will there be any new PPM's or dilution with the new approved shares in the mix? No new PPM's on the horizon. I'm assuming there would have to be some dilution should the Investment firm provide more cash! Also, the majority of the new approved shares will only be used in case of a potential "hostile takeover" occuring.
Are any OEM's still interested in the Dominion? ALL OEM'S are STILL interested in the Dominion and Imaging3! Also, Dean is prepared to manufacture (conservatively) 36 machines first year in Burbank. Cost to make each machine: $250,000. Sale price: $500,000 ($250,000 deposit to start each order). Possible 100 machines per year after that. Dean pointed out that the Burbank office / warehouse will be used for assembly only as all parts for the machine are subcontracted to outside vendors.
Are there any WORKING MACHINES in existence? Dean says there are TWO COMPLETE FULL WORKING MACHINES in existence! One was in the warehouse, and one is offsite (sounded like he has the other at his home so he can work on it after hours).
Anyway, those are the key points I can think of recapping at the moment. If anything else comes to me, I will post another message on the Board.
If anyone else who was at the meeting would confirm my recollection of events, please post so others will know I'm not "exaggerating! :)" Also, feel free to add to this. I think the more the shareholders know, the better for all of us!
Good luck to all!!!
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 37678
Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
Mr. Sano
I appreciate your efforts. I tend to look forward to the next 10K that should be released within the next 30 days for the most current information. "BTW Thank you Flash for the reminder"
Hopefully it will shed some light on the current Imaging 3 situation?
KF
Mr. Sano
It’s obvious that Dean did not profit from the fire. I feel he was underinsured was the reason for the litigation. Many here don’t use sound judgment when looking at the facts, or should I say all the facts!
Mr. Sano: I agree.
Hopefully the next 10K will yeild some information?
Mugs
King.......Here is Dean Janes showing the protoype. Why did the FDA allow him to do this demo??
That would be a question for Dean Janes or the FDA not me.
KF
BT, Good article thanks for posting.
KF
Lambster, I couldnt agree more.
KF
K
If that is what you think, no problem. As I said, its posted for all to read and make their own determination of what the FDA is stating in the letter. Pretty Simple......
KF
LOL
You CAN have a display unit to show the shareholders. The display unit must be clearly marked with “For display purposes only” and “Not for human use.”
You claim you went to the RSNA show. You know they had a display. They cannot use radiological emitting devices in public? What are you thinking?
I think each person can read the letter from the FDA and make their own interoperation. That’s why I posted it!
KF
AT
I’m not in the medical field but some that post here are. I suggest you look back through prussian4profit post. They posted information explaining this. I do think they would get the same results with the use of cadavers without the risk of harming humans.
KF
Britania
Read this letter I received from the FDA. They will not allow Dean to show the machine. I would like to see as much as anyone else.
KF
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60367647
Mugs
I just looked at the Imaging 3 web site. The 9/23/09 CC is posted on the site.
Link: http://www.imaging3.com/investors/conferencecalls.html
Flash
Your memory is in error. The only place the Manufacturing audit was touted as anything other than what is, was at this board. Dean set the record straight on a Money TV or CC on this subject. He stated any company that works on Radiological Emitting Devices has this audit by the FDA periodically for obvious safety reasons.
Lockedon6
Kingfisher7234 Share Sunday, February 27, 2011 9:29:45 AM
Re: None Post # of 38642
ALL: Here is a Letter from the FDA In response to my questions. This is why Dean cannot show the Dominion to shareholders. Read line 2 in the response very carefully.Only the FDA can clear for marketing! The emails have been posted in their entirety with the exception of my personal information being removed.
From: Eva.Ellsworth@fda.hhs.gov
To: xxxxxxxxxxxxxxx CC: DSMA@CDRH.FDA.GOV
Date: Fri, 25 Feb 2011 16:29:49 -0500
Subject: 02-589 eje CDRA Devices
Dear XXXXXXXXXXXX,
Only items currently undergoing 510(k) review can be demonstrated or marketed. No promotion or advertising activities can be performed before the device has been cleared for marketing. Demonstrations of the device on television, video, the internet, or any other medium are considered to be marketing. The same is true of still print displays and other information about the device that is made available to the public.
You can have a display unit to show the shareholders. The display unit must be clearly marked with “For display purposes only” and “Not for human use.”
After your company submits a new 510(k) application for the device, you can display samples of the product at trade shows if the following conditions are met:
Samples/display devices for trade shows:
• The labeling on the device indicates that the device is for display purposes only and is not to be used on human subjects.
• The import paperwork should clearly indicate that the item is not for commercial distribution in the USA but for display purposes only, and
• The import paperwork should also indicate when the item will be sent back to the foreign company afterwards or otherwise disposed of.
Additionally, you can not market the device at trade shows before it has received 510(k) clearance from the FDA. Marketing includes distributing brochures, taking “pre-orders,” getting contact information from potential customers, etc.
If you need further assistance, please don’t hesitate to call DSMICA at 1-800-638-2041 or email us at DSMICA@CDRH.FDA.GOV. You may also call me at 301-796-5855. You can email me at Eva.Ellsworth@fda.hhs.gov.
Cordially,
Eva Ellsworth
Eva Ellsworth
Consumer Safety Officer
Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health
Office of Communication, Education, and Radiation Programs, US FDA
Phone: 301-796-5855
Fax: 301-847-8149
This response represents to the best of my judgment how the device should be regulated, solely based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
You can now follow CDRH on Twitter at http://twitter.com/FDAcdrhIndustry
________________________________________
From: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Sent: Thursday, February 24, 2011 12:43 PM
To: CDRH Small Manu. Assistance
Subject: CDRA Devices
Dear Sir
My questions concerns a radiological emitting devices. If a manufacture has produced a device but has not received SE, nor is currently enrolled in an active 510K or PMA application. Can the manufacture show the device being operated and producing images to the shareholders? Can they use the internet, TV, or video to show the device in real time use? Is showing the device in operation to the public considered marketing?
If there are regulations in place by the FDA to prevent this for what ever reason can you provide those documents?
The statement below was in the NSE letter to the company.
You may not Market this device until you provided adequaic information described above and required by 21 CFR 807.67 (J) and you have received a letter from the FDA allowing you to do so. If you market the device without conforming to these requirements you will be in violation of the Act.
Any help you can provide will be greatly appreciated.
Thank you
XXXXXXXXXXXXXXX
xxx-xxx-xxxx
cabo2'
I posted the documents you speak of in the sticky notes. Maybe you can provide the information flash and I are speaking of? If so, step right up the to the plate and post it. There is a huge difference between facts and speculation. Imaging 3 is not the first or last company to receive a NSE letter. Many have gone on to receive FDA approval.
Please provide any document where Imaging 3 has been accused by the SEC of anything? Help us out, of all these great minds at this board we can’t find it.
Help US
You are correct in what the contract states . I do think you are intentionally overlooking any other possibilities. I find that odd with so many companies and so much paper work involved when it comes to the SEC filings with this many companies involved. I don’t think you have given thought to all the possibilities other than simply blaming Imaging3. I will wait and see what the outcome is rather than making a Wild Ass Guess.
Litigation is usually the last step not the first. Have you looked at the other links I provided? Suspension is normally the first step the SEC takes if a company is a Scam as you claim Imaging 3 is? The SEC acts swiftly in these cases. Days in most cases, not weeks.
I addressed your issue with the S-3 being declared effective in another post, but I will take the time to repeat it. There are 3 Institutional investors, Imaging3 and the SEC involved in this transaction. There are any numbers of reasons for this not to be found effective at this time. Until we here the final decision, anything you or I say is nothing more than a Wild Ass Guess.
I would not attempt to guess at a date. I was not at the SH meeting. Woodberry was. This is what he said in his account from the SH meeting. Look at the second paragraph.
Woodberry578 Share3 Thursday, January 20, 2011 6:57:09 PM
Re: None Post # of 38607
I just got home from the Imaging3 shareholders meeting. As promised, I wanted to let you all know my take on the meeting.
First off, I would agree there were closer to 100 people at the meeting vs. 50. As we all expected, all propositions easily passed. While Imaging3's CFO and an independent accounting firm tallied the votes, Dean gave all attendees a recap of where the company is at regarding the new FDA 510K resubmission process and opened up the floor for questions relating to anything Imaging3.
Here are some of the key points for me:
Dean is optimistic the new resubmittal will happen by either the end of February or March (I would not hold Dean to these specific dates. Remember: it is his best "guess-ta-mit"). The resubmission will be proceeded by a face-to-face meeting with the head of the FDA's Medical Devices unit and our FDA reviewer. On the Imaging3 side of the meeting, Dean will be there, Jim Cohen (lead attorney at MWE), and our Consulting Firm's Technical writer. The goal is to iron out key points needed to gain FDA approval once the new 510K is submitted. Again, the impression I got is: Dean is hopeful of a June answer from the FDA (again, an estimate on the timeline).
During the question and answer period, several other key questions and answers occured that I know the I-Hub Board members are interested in:
Is there enough cash to keep the company going through the new resubmittal process? Answer: several million dollars more are available (if needed) from the Investment firm who gave Imaging3 the recent million dollars. Money will not be a problem!
Will there be any new PPM's or dilution with the new approved shares in the mix? No new PPM's on the horizon. I'm assuming there would have to be some dilution should the Investment firm provide more cash! Also, the majority of the new approved shares will only be used in case of a potential "hostile takeover" occuring.
Are any OEM's still interested in the Dominion? ALL OEM'S are STILL interested in the Dominion and Imaging3! Also, Dean is prepared to manufacture (conservatively) 36 machines first year in Burbank. Cost to make each machine: $250,000. Sale price: $500,000 ($250,000 deposit to start each order). Possible 100 machines per year after that. Dean pointed out that the Burbank office / warehouse will be used for assembly only as all parts for the machine are subcontracted to outside vendors.
Are there any WORKING MACHINES in existence? Dean says there are TWO COMPLETE FULL WORKING MACHINES in existence! One was in the warehouse, and one is offsite (sounded like he has the other at his home so he can work on it after hours).
Anyway, those are the key points I can think of recapping at the moment. If anything else comes to me, I will post another message on the Board.
If anyone else who was at the meeting would confirm my recollection of events, please post so others will know I'm not "exaggerating! :)" Also, feel free to add to this. I think the more the shareholders know, the better for all of us!
Good luck to all!!!
I didn’t post any litigation releases. I posted links from the SEC where companies under SEC litigation, SEC Administrative Proceedings and SEC Suspensions. You can go all the way back to 1995 until present. The information provided by the SEC in the links is accurate and up to date.
I suggest any that even suspect Imaging 3 is going to have any action by the SEC save these links. You can check for yourself each day and not depend on rumors at this Board. Get it directly from the SEC.
AT
I just looked at these SEC sites again. I find no mention of IMGG?
How long has it been since you filed your complaint with them? I think it’s very possible they found your claims frivolous? I’m sure they receive hundreds of false claims each day. They act only on those with merit, and then they post them here for the public to see.
SEC Litigations:
http://www.sec.gov/litigation/litreleases.shtml
SEC Administrative Proceedings:
http://www.sec.gov/litigation/admin.shtml
SEC Suspensions:
http://www.sec.gov/litigation/suspensions.shtml
Mr. Sano
This was written by someone that attended the SH meeting. He discusses the resubmit date.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59013767
Not possible....
I don’t make many post but I’m here every day, It’s very possible, IMO more than likely.
The latest drug trials were for end of life patients. 30 days was what the trial proved. ARIA needs much more than that. Would I purchase the drug if I was granted 30 days more? NO, not at the price I have seen speculated.
KF
Imaging 3 closed in the Green again today. Thank you madtig6, for you dedication to the board with your charts. I know it takes quite a bit of your time to construct them.
KF
IH Admin [Dan] Share Thursday, February 10, 2011 1:47:00 PM
Re: None Post # of 37678
Folks please stay on topic. The only topic to be discussed here is IMGG.
There have been too many deletions here recently. Please take time to read these rules so that you will understand why posts have been deleted:
http://ihwiki.advfn.com/index.php?title=Handbook#Deletion_of_Posts
Any time you post about Users or reference groups of Posters (bashers, pumpers, cheerleaders, naysayers, Mods, etc.) in your post, this makes your post subject to removal as off-topic and/or personal attack. Posts about deletions are also Off Topic.
Your messages need to focus on the company and the stock and should not contain comments about people who post on the board. Other posters are never the topic of the board.
To those who received restricted posting here for their TOU violations. In order to have that released you need to post for two weeks without violating the rules, then ask for Admin to review.
If you have any questions send me a PM.
NO public replies please.
Thank you for the chart Madtig6 you are an asset to the board!
Looks like IMGG closed in the GREEN today.
Mr. Sano
I could be to find a suitor? I believe they have signed NDA with Toshiba, GE and one other. I can’t remember exactly what was stated on this subject in the past, is why I use the word believe.
We can only guess since its all behind closed doors. I would think Dean has some relationship with Toshiba, he worked for them for a number of years.
Dean would have to be willing to sell first?
KF
Flash
Thank you for providing the link:
I take your link as valid because we are all aware that editing any official correspondence from the Government is a Federal Crime.
I do think this statement in the correspondence you provided, is almost as strange as what we read here each day?
6 b_rogers :: 6/25/2010 9:21:41 AM
my grandpa used to say "be careful picking scabs, sometimes they bleed."
KF
Flash
My mistake if this is the case. It appeared that in your post you cut and pasted my response, especially with the bold letters in tact? Can you provide an original link to what you posted?
KF
Mugs
To answer your question: I contacted the FDA with viable questions and provided my real name and contact information. I sent my correspondence in a professional manner. I have found this goes a long way when seeking information.
KF
Flash that’s odd,
I read your response; Nowhere did I read what was in my response from the FDA in your example? I think our readers can see a clear difference in the responses from the FDA. It’s not a tag line as you state, or it would be included in each and every response from the FDA not just one. Your comparison was clearly lacking the same content.
KF
AT and Mugs
Did you happen to read this portion of the response from the FDA in the email I posted? Let me put it in bold for you.
KF
This response represents to the best of my judgment how the device should be regulated, solely based upon a review of the information you have provided. This response is not a classification decision for your device and does not constitute FDA clearance or approval for commercial distribution. Unless exempt from premarket notification submission (510(k)) requirements, the official classification for your device will appear on the final decision letter from any premarket review. All device types classified as exempt from the 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx refers to Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware, if I have indicated that I believe your device falls within a device category classified as exempt from premarket review requirements, that it is your responsibility to ensure that you meet the exemption criteria and your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
Mugs and AT
These are the reasons the FDA listed for the Domininion not receiving SE at this time.
1. CT emulation images, and a detailed description of the reconstruction algorithms used to create the 3D constructs
2. Sample Images from Predicate Device including soft tissue. Data sets associated with the sample image loops in the submission.
3. Clinical Study: Provide Solid-State X-ray Imager Data
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073780.htm#17
4. Detailed description of cone beam reconstruction.
5. Provide a more detailed description of your reconstruction technique.
6. Software Documentation: sufficient to determine the safety and effectiveness of the device.
7. Device Hazard Analysis.
8. Software Requirements Specifications(SRS)
9. Software Design Specification (SDS)
10. Traceability Analysis
11. Development Environment Analysis
12. Programmable Electrical Medical Systems Verification and Validation Documentation
13. Revision Level History: history of software revisions generated during the course of product development.
14. Off-the-Shelf Software: Please provide basic documentation for off-the-shelf software used in your device.
15. Vibration analysis.
16. Overheating analysis.
17. Lateral Patient Access analysis.
18. User Sync Detector Mode: data evidence from supplier and testing.
19. User's Manual: Deficiency: description of all post-processing features of this device.
20. Over-the-Counter Use: identify a predicate device for over the counter use. Demonstrate that your device meets the requirements of 21 CFR § 801 Subpart B (Labeling Requirements for Over-the-Counter Devices).
21. Electronic Copy: provided in accordance with the guidelines.
Mr. Sano
Thank you, I do remember in a CC or your favorite: Money TV, that Dean stated the FDA instructed him stop taking orders and contact information. This was some time ago, I believe sometime during 2009 or prior. It’s on record somewhere for any that want to verify.
I won’t argue the point. You have the same information verbatim from the FDA as I do. I thought they laid out their position on marketing very clearly.
KF
Mugs
Both emails are posted in their entirety with the exception of my personal information being removed. I fail to understand your confusion. I ran this by Ihub Administration prior to posting.
KF
This is true. Don’t twist the words to suite your needs. With a little common sense, I figured out what was said and why. The FDA told him to stop, and He did!
KF