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I haven't been around for a long time but I thought I'd check in to see how things were going.
Based on what I've learned, anyone still holding stock should sell it now, while it still has some value, and forget about this obvious scam.
He's back on MoneyTV! Becky just sent me the following email message:
"Imaging3 is pleased to announce that Dean Janes will appear on MoneyTV. The interview will air on most cable and satellite stations, beginning Saturday, July 30, 2011. The show can also be viewed at www.moneytv.net, beginning Friday, July 29, 2011..."
So please explain why the FDA has not communicated this to IMGG.
DonKeyhoti,
I want to offer my thanks for sharing your information with regard to the FDA’s inspection team touring the IMGG facility last week and presumably inspecting the DViS.
Obviously, since you’re not in a position to provide definitive proof, it’s up to each individual investor to decide on the value of your statements with regard to their individual investment in IMGG.
Based on your past contributions to the IHub IMGG forum [dating back to 12/9/2009], it appears to me that you are a very knowledgeable and realistic person. Therefore, I do place credibility in your statements and it helps to solidify my reasons for staying with this stock.
I do have one question, which no one seems to have answered. Is it stated in any of the FDA’s documents that a physical inspection is required under the 510(k) process and, if so, can anyone supply a link to such document? TIA for any clarification on this point.
No, trading is not halted.
Current prices are:
Bid $0.202
Ask $0.205
So, at today’s price of around $0.30/share, Dean’s 59,576,328 shares would have a current market value of $17,872,898.
Therefore, each one cent movement in IMGG’s stock price equates to $595,763.
Now that’s some kind of leverage.
Response to joebari post # 18778:
Thanks for sharing this recent [6/23/2010] article. The key message for me is:
“…An initial report on revamping the FDA’s approval process for medical devices, including changes in the development of clinical trials, is expected to be released for public comment in the coming weeks. New procedures could take effect later this year in what is known in the industry as the 510(k) medical device approval process…”
My expectation [and hope] is that any changes in the FDA’s approval process/procedures will not take effect until AFTER the DViS has received a SE determination.
Response to hubris heyday’s comment in message # 18728:
:…it took 2 yrs post FDA 510 K for Breakaway to be acquired.. I wonder why it took so long??...”
According to Medtronic’s 10-Q filed 12/4/2007:
“…Prior to the acquisition [of the O-arm Imaging System from Breakaway Imaging, LLC], the Company [Medtronic, Inc.] had the exclusive rights to distribute and market the O-arm….”
FDA Advisory Committees:
docmts2,
The following paragraph is from the FDA’s web site:
“About Advisory Committees
The Food and Drug Administration, to assist in its mission to protect and promote the public health, uses 49 committees and panels to obtain independent expert advice on scientific, technical, and policy matters.”
These committees DO NOT determine whether a new drug or device is SE or NSE.
Therefore, the fact that the radiological device advisory committee doesn't meet until July 21st should have no relevance to when the FDA will render its opinion on the DViS.
As others on this forum have noted, decisions on devices are made and issued by the FDA on a daily basis.
Question for Cpbball3:
Can you share the source or basis for your statement?
“…GE thinks they can sell 1,000 devices the first year at $550K per machine…”
IMGGorBust:
Information on the OTC Bulletin Board, where IMGG stock trades, is provided below:
OTC Bulletin Board
From Wikipedia, the free encyclopedia
The OTC Bulletin Board or OTCBB is an electronic quotation system in the United States that displays real-time quotes, last-sale prices, and volume information for many over-the-counter (OTC) equity securities that are not listed on the NASDAQ stock exchange or a national securities exchange. Broker-dealers who subscribe to the system can use the OTCBB to look up prices or enter quotes for OTC securities.
Although FINRA oversees the OTCBB, the OTCBB is not part of the NASDAQ stock exchange. According to the SEC, "fraudsters often claim or imply that an OTCBB company is a Nasdaq company to mislead investors into thinking that the company is bigger than it is."[1]
Companies quoted on the OTCBB must be fully reporting (i.e. current with all required SEC filings) but have no market capitalization, minimum share price, corporate governance or other requirements to be quoted. Companies which have been "de-listed" from stock exchanges for falling below minimum capitalization, minimum share price or other requirements often end up being quoted on the OTCBB.
Stock of non-reporting companies (those without current SEC filings) may be quoted in the Pink Sheets. Most OTCBB companies are dually quoted, meaning they are quoted on both the OTCBB and the Pink Sheets.
Stocks traded in OTC markets such as the OTCBB or Pink Sheets are usually thinly traded microcap or penny stocks and are generally avoided by both retail and institutional investors due to fear that share prices are easily manipulated and there exists a potential for fraud. The SEC issues stern warnings to investors to beware of common fraud and manipulation schemes. As such, most companies choose to list on more established exchanges such as the AMEX, NYSE, or NASDAQ once eligible.
FDA CDRH Video:
I agree – a bit corny but none the less, quite informative.
This video does clarify several of the issues/concerns which have surfaced on this forum multiple times in the past.
I found it interesting that the video did not delve into the FDA’s review time performance goals/guidelines or the fast track approval process.
Once again, IMGGorBust, thanks for sharing with the IMGG investors.
Sticky Note?
Shaka, could IMGGorBust's compilation of the FDA’s 510(k) review process [post # 17895] be included as a ‘sticky note’ for this forum.
Perhaps this would eliminate [or at least reduce] the number of unnecessary requests for this valuable information.
Trading IMGG Stock:
It appears that today the IMGG market makers have increased the bid-ask spread to around 1-1/2 cents per share. [In the past it has tended to be around 1 cent per share or less.]
If they continue to maintain this spread, it will certainly discourage those day traders who want to short IMGG stock.
MESSAGE UPDATE: Wouldn't you know it. As soon as I posted my message the market makers narrowed the spread to 1 cent per share!
Short Selling IMGG:
I understand short selling and covering a stock but I fail to understand the high level of shorting when it comes to IMGG [51% short selling this past week; 41% short selling the prior week].
I’ve been following the IMGG trading data for the past few weeks.
When one considers the bid-ask spread [typically 1 cent] and the intra-day trading range [only 2-4 cents on the last 6 trading days], it’s hard to understand why shorting would be attractive.
If the short trader’s timing is nearly perfect, he/she might clear 0.5-1.0 cents per share on a favorable day [stock price drops from daily high to daily low].
On a 20,000 share trade, that translates to a $100-$200 profit.
To me that seems like a high risk – low reward approach to trade a stock which could explode to the upside on any new day.
Am I missing something here? Could some/much/most of this shorting be ‘naked shorting’?
BTW: fink, thanks for sharing the article on ‘naked shorting’.
Reply to Frank39:
Dr. Polk is one of the few posters on the Yahoo IMGG forum with worthwhile information and insights into IMGG.
He'd make an excellent addition to the InvestorsHub forum but, at this point, I think he's had it with all the bashers.
In reply to lanbec:
One company was Lintronics Technologies, Inc., which was acquired by Evro Financial Corp. [EVROD]. Back in 1992 Lintronics had developed two advanced breast examination technologies [the ‘LINTRO-SCAN’ and the ‘MAMMO-SCAN’]. These were imaging devices for detecting changes within the breast WITHOUT exposing the patient to radiation. I don’t recall the details of why these devices didn’t succeed but I do recall that I lost a bunch of money.
Another major disappointment was a company called DynaGen, Inc. [DYGN]. They developed ‘NicErase-SL’,a smoking cessation product back in 1995 and had made plans to license the product to Bristol-Myers Products [BMP], now known as Bristol-Myers Squibb Company [BMY]. When the licensing agreement with BMP fell thru, Dynagen’s highly inflated stock price tanked in a matter of minutes and never recovered.
Reflections on IMGG and this forum:
I simply wanted to share a few reflections:
1. I’ve been a recent believer in the IMGG story and this forum has been a big help. Many of you have provided leads and information which have accelerated my DD process and for that I say “Thank You!. I also want to thank the forum moderator [Shaka] and his assistant [prussian4profit] for keeping this board free of most useless chatter. [BTW I can’t stand to go to the IMGG forum on Yahoo. There may be some useful information buried there but I don’t have the time, patience, or interest in going through their endless rantings, ravings, attacks, etc.]
2. The DViS is the real thing. The health care industry needs a tool like this to provide real time information for doctors to accelerate diagnosis and treatment to those who need it….. Well, you all know this but it just shocks and saddens me that the FDA reviewers don’t seem to have an urgency to get new technology, like the DViS, into the field ASAP. Hopefully some changes are coming in the FDA’s operations but why has it taken so long!
3. I’m fairly confident the DViS will ultimately be cleared by the FDA and, hopefully the IMGG shareholders will be rewarded for their support and dedication. I know some of you have been invested in this company for several years and I’m sure this has been a painful wait.
4. I want to close my message with a caution. FDA clearance is never a slam-dunk, sure thing. Over the years I’ve invested in other small startup companies which had a great new product which, like the DViS, were clearly superior to anything else in the marketplace. But, for a variety of reasons, the invention never made it into commercial production. So, in closing, I just want to caution people to NOT bet all of your investment money on this one idea. If it doesn’t work out, it can have a very negative effect on your life going forward. Take it from someone who’s done that and had to live with the consequences.
Thanks for taking the time to read my morning reflections. Best of luck to you all.
Unbelievable!!! When did the FDA approve this?
IMGG Press Release from 7:00 AM this morning:
Imaging3 CEO Hosts a Virtual Tour Video of Facility and DViS Demonstration 05/24 07:00 AM
BURBANK, CA -- (MARKET WIRE) -- 05/24/10 -- Imaging3?, Inc. (IMGG:$0.405,0$0.070,020.90%) , developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, announced today that a new video has been provided on the company's Investor Forum website.
The video features a tour of the Imaging3 (IMGG:$0.405,0$0.070,020.90%) facility led by Mr. Dean Janes, Chairman and CEO of Imaging3, Inc. (IMGG:$0.405,0$0.070,020.90%) In the video, Mr. Janes also demonstrates the DViS's multi-modality capabilities, which include 2D, 3D real-time and CT slice imagery.
About Imaging3 (IMGG:$0.405,0$0.070,020.90%)
Imaging3, Inc. (IMGG:$0.405,0$0.070,020.90%) , founded in 1993, is a leading provider of advanced technology medical imaging devices. The Company has developed a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time. Because these 3D images are instantly constructed in real-time, they can be used for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body. Visit the company's website at http://www.imaging3.com for more information.
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, absence of revenue, 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 and potential product liability claims, and other factors detailed in reports filed by the Company.
Contact:
Imaging3, Inc. (IMGG:$0.405,0$0.070,020.90%)
Investor Relations
800-900-9729
Email Contact
www.imaging3.com
Tin Yeung,
Let’s get a couple of things straight.
First, I’m not trying to attack anyone on this board, especially IMGGorBust. Quite frankly I feel IMGGorBust has provided a great deal of useful information and opinions on IMGG.
Second, I don’t think this investor board gives points for stumping anyone else.
Third, I’m here to learn from others and, whenever possible, I’m trying to share my knowledge/information/insights with them.
And finally I’ll not waste anyone’s time with useless posts like:
“The .51's just got bought out in a couple minutes”. [Post # 15108],
“next wall to break through .59 “ [Post # 15128],
“.60s are going” [Post # 15221],
“250k shares just traded. something is up” [Post # 15445],
“Someone is sucking up the shares” [Post # 15119],
“Looks like someone just bought 100k shares in the last 2 minutes at .555” [Post # 15133],
etc., etc.
Real Time 3D Imaging in the Dental Industry:
IMGGorBust,
I’m not sure that your statement in post #16146, regarding IMGG’s patent, is totally correct.
I believe there are real-time 3D imaging systems currently in use in the dental industry.
See, for example, the PreXion 3D Cone Beam Computed Tomography scanner, described on the following web page:
http://www.prexion.com/dental/features.html
They claim “…It offers real-time 3D volume rendering with unsurpassed image quality for integration into medical, seismic, scientific, and other high-performance imaging systems…”
Operation of the DViS:
wallstreetgenuis,
Below is the description of the DViS, copied from IMGG’s latest Form 10-K filing with the SEC. Hopefully this will provide you with a little more insight as to how they have it configured.
“…ABSTRACT OF THE PATENT DISCLOSURE
A computing device in a three-dimensional imaging system utilizes a plurality of distance readings and reference readings from at least one subject sensor to determine a subject location and a subject volume and establish a base three-dimensional map of a subject. A plurality of two-dimensional image exposures along with a plurality of associated reference locations are created by rotating an image source and an image receptor around an inner circumference of an imaging gantry. The plurality of two-dimensional image exposures is digitized to create a plurality of digital two-dimensional image exposures. The computing device receives the plurality of digital two-dimensional image exposures and the plurality of associated reference locations. The overlaying, interpolating and pasting of the plurality of digital two-dimensional image exposures on the base three-dimensional map creates a base three-dimensional image exposure, which is displayed on a display device.
GENERAL DESCRIPTION
Real-time 3D medical diagnostic imaging will be accomplished by scanning the patient, either partially or completely in a 360-degree circumference under fluoroscopy (or other type of image exposure), utilizing a single or multiple x-ray source and image receptor. The information acquired under fluoroscopy (or other type of image exposure) will be digitized at a frame rate of between 30 to 60 frames per second. This information will be sent to a computer system to be incorporated into a three-dimensional image to be displayed on a computer monitor. The image created can then be manipulated and/or rotated to view the scanned image of the patient's anatomy in any direction or orientation desired by the user. The user could then choose a specific area of the image to update. Once an area is selected, the computer displaying the image would then "gang" or align the x-ray source(s) and image receptor(s) to begin updating scans of new images to be overlaid upon the existing three-dimensional model. This process would then be updated and/or repeated as many times as necessary for the specific procedure to be completed. At any time, a new reference area or scan could be selected or initiated.
THE "O" DEVICE
Part of the Company's invention is based on an "O" device to create a circular gantry similar to that used with CT to scan a patient a full 360 degrees with fluoroscopic radiation. This approach is expected to allow imaging of the patient from any frame of reference or angulation (current medical imaging devices are limited to 150 degrees to 360 degrees with mechanical orientation or manipulation). 3D imaging requires an "O" device to scan the patient in increments of 360 degrees to allow construction of a three-dimensional image. By scanning the patient in 360 degrees and acquiring images at 30 to 60 frames per second, management believes a three-dimensional image can be constructed.
IMAGING3 TECHNOLOGY DIFFERS FROM OTHER APPROACHES
The "O" device approach is similar to that used in a CT scan. The difference is CT is used to image a "slice" of the anatomy and not intended for real-time fluoroscopic imaging. The slice is obtained by using a fulcrum reference point and rotating the X-ray source and image receptor in reference to that point. This basic geometry creates a 2D image in any depth desired, in any region of the body. The "O" device would use a similar fulcrum point to reference depth, but the scan would not create a slice but instead a real-time image captured at 30 to 60 frames per second in 360 degrees. Further, management believes that the "O" device would be used for conventional fluoroscopic imaging with the advantage of positioning the X-ray source and receptor at any angulation desired.
Currently, 3D imaging is used only for reconstructive post processing reference images. Magnetic resonance imaging ("MRI"), CT and ultrasound currently have this capability. The 3D images are created by multiple scans of 2D images that require a long period of time to process into a three-dimensional image. The image created is then used only for reference, not real-time manipulation in the body. The Company anticipates that it's 3D images will be constructed almost instantly and will be available to be used as real-time references whenever multiple frames of reference are required to perform medical procedures on or in the human body….”
Short Selling of IMGG Common Stock:
Thanks again Kingfisher7234 for the information you’ve provided.
Upon reviewing the trading data on the finra.org website, it appears that over the past 12 trading days, 20-50% of the IMGG shares traded during regular trading hours have been short sales. [I assume that includes both selling short AND buying to cover transactions].
On average, nearly 34% of the IMGG trades over this 12-day period have been short sales.
This seems like a very high percentage but apparently that’s how many investors are making money on this stock.
obamas_always_long,
According to IMGG’s most recent FORM 10-K for the fiscal year ended: December 31, 2009:
“…The Company currently employs thirteen full-time individuals, all of whom are working at the Company's offices at 3200 W. Valhalla Drive, Burbank, California 91505. Eight of those thirteen full-time employees are employed in administrative, marketing, and sales positions, and the remaining five are technical employees employed in research, development and production positions…”
So, it would appear that IMGG has had 13 full-time employees for some time now.
Also, it doesn't seem likely to me that IMGG would be building any new DViS units at this time considering their financial condition and the fact that the FDA has not rendered its decision.
Arlo1945,
My understanding is that this FDA notification refers to two C-Arm devices which IMGG repairs/remanufactures.
It has no relationship to the DViS.
Kingfisher7234,
Can you explain the meaning of the following information, which appeared in your recent post?
“20100518|IMGG|966554|2346074|O”
‘20100518’ is obviously today’s date,
‘IMGG’ is the symbol for Imaging3, Inc., and
I assume ‘2,346,074’ is the number of IMGG shares which are short at the end of today’s trading day.
What is the ‘966,554’ and the symbol ‘O’?
Thanks, in advance, for helping me and others better understand what is happening with IMGG’s stock.
gdsgds,
There are many, many investors [including myself] who’ll be waiting to read what you have to say about your visit to IMGG tomorrow.
Perhaps you can try to get answers to the questions listed in recon’s post # 15938 and my question in post # 16024.
I’m sure you'll also have many questions of your own.
Thanks for taking the lead in obtaining some independent feedback for the IMGG shareholders and other interested parties.
recon,
I have one additional question for your list:
“Dean, did the FDA’s 30-day response timeframe reset when you submitted new information on Friday, April 23rd?
I ask this question based on a recent comment from a Dr. Polk on the Yahoo IMGG message board who wrote:
“…As stated earlier, numerous times, the last request for a change in 2 sentences and a format change was submitted 4/23. Look at your calendars. Sometime this week will be 30 days since submittal of such…”
If he’s correct, then the FDA’s 30-day response time could be 30 days from Monday, April 26th,, i.e., on Tuesday, May 25th.
Then, allowing 3-4 days for the written communication to reach IMGG, one might expect an announcement of the FDA’s decision on or around Monday, May 31st.
IMGGorBust,
If what recon’s written is not true, badly distorted, or outdated, then he’s obviously provided a disservice to IMGG stockholders and potential investors.
Like so many stockholders and potential investors, I’m struggling to understand why this 501(k) approval has taken so long.
The DViS, if it functions as described, will be a fantastic addition to the medical field and, if IMGG’s claims are true, it should have been rapidly embraced by the FDA.
But the FDA apparently has issues with the DViS or there are outside influences which have impeded the approval process.
I [like so many others] am simply searching for factual information.
recon,
I’m relatively new to the Imaging3 story and have been trying hard to find out what’s really happening with the company and its FDA 501(k) filing for the DViS.
I’ve read your ihub posts with great interest and have concluded that you are one of only a few posters who seem to have an understanding and/or explanation of the current situation.
For example, on April 14th you wrote:
“…They [IMGG] have had issues with software crashes among other things that in my opinion has been the reason for all of the delay. Dean [Janes, IMGG’s Chairman & CEO] just doesn't want you [the stockholders] to know that…”
On April 30th, you wrote:
“…I3 has had many issues regarding mechanics, vibration, software crashes and such that-in the end-could result in the DVIS being denied on their 510K submission…”
On May 1st you wrote:
“…’We [IMGG] are WORKING ON things like gantry to cart communication speed, gearing, gantry balance and other items that make a complete system that can be used reliably in operating room’. …it sounds like a work in progress to me [recon]. As I said, Dean tried to slide an “IDEA” a “CONCEPT “by the FDA and they called him out on it, THAT IS WHY ALL THIS DELAY! Because now he has to make it work! …He [Dean Janes] wanted to get his concept approved via a 510K submission and worry about making it work later…I [recon] have not heard anything from the Company SINCE then [within the last 60-90 days] so I cannot draw the conclusion that they have worked out these issues until I hear otherwise…”
Today you wrote:
“…I [recon] have an email from Mike Nessen [IMGG’s Vice President of Business Development] stating that ‘Dean is working seven days a week trying to get the DVIS to work properly’…”
If what you’ve said is indeed true, you’ve been of great service in helping investors make an informed decision on whether to invest or not invest in IMGG.
Thanks for the prompt clarification.
I know that some governmental agencies provide the public with access to information on submissions under review by that agency.
I was hoping that such information was available for 501(k)s.
FDA 501(k) Database:
Can anyone provide me with the 501(k) submission number for Imaging3’s filing with the FDA?
I’ve tried searching the FDA’s 501(k) database [using Imaging3, IMGG, DViS, Dominion, Janes, and Imaging] as search words but have not found any matches.
It could be that the FDA’s database only contains approved 501(k) submissions but I’d sure like to see some independent evidence of IMGG’s submission.
Thanks, in advance, to anyone who can help.
Significant Equivalence:
In order to meet the significant equivalence requirement, a new device must be shown to be at least as good as existing [approved] comparable devices.
Based on the information made available to us, the IMGG device appears to be clearly superior to anything else on the market.
Therefore, I highly doubt that the 'significant equivalence' requirement has anything to do with the delayed FDA approval.
Food and Drug Administration Approval Process:
Thanks recon for sharing the article on the FDA's approval process. Based on many years of interactions with other government agencies (specifically the EPA and FCC), I believe the author of this article is right on.
It's clear to me that IMGG has a superior product, which should have been approved by now.
Unfortunately, IMGG is a small company with very limited financial resources and no political clout.
There are bigger players out there that are clearly hindering/delaying approval of the DViS.
Although I'd love to see this new technology approved, I fear the FDA will continue to delay such approval until IMGG simply runs out of money and, once again, the shareholders are left holding an empty bag.