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The dummmies at IMDS would literally make up PR's. They would pick countries at random to put in them. I mean, who says they are selling their products to known countries on the terrorist watch list like Iran and Syria? Only Deb O and mommy are that stupid. IMDS had to retract that lie afer the SEC, DHS, and FDA investigated the claim. Think that was about 10 years ago.
You could write a book on this scam. It lasted longer than any other penny scam I've seen.
What is laughable is after the first PMA disaster, Linda not only kept her daughter/niece Deb O on in charge of hte PMA, she gave her a promotion to SVP and a raise. You can't blame Linda, seeing how Deb O's experience as a hostess(was it Chili's or TGIF?) and no college degree made here the perfect candidate to run an FDA submission.
They didn't want her back.In fact, the independent BOD told Linda no. Linda had Hicks threaten to pull the plug on financing unless they reinstated Grable. The same day she came back, every BOD member "resigned".
They never replaced any of the BOD members or compensation committee until the end. The one independent BOD member they hired in 2011 resigned within a year and wrote a damming resignation letter.
My Lord. Can't any of these Grable tell the truth in their bio?
Mr. Grable has more than 13 years marketing experience having served as Marketing Manager and Director of Marketing for public [IMDS] and private companies in the medical and other global industries. He began his career as a Marketing Manager in 2000 for one of the world's largest and oldest publishers in the maritime industry, The Maritime Group. From 2010 until 2013, Mr. Grable worked for IDSI as the Company's Director of Marketing. Grable earned a bachelor's degree in psycholgy from the Florida Atlantic University in 1998.
Director of Marketing at Imaging Diagnostic Systems, Inc.
Past
Technical Marketing Specialist at Imaging Diagnostic Systems, Inc. Marketing Manager at National Marine Suppliers Graphic Designer at The Maritime Executive
January 2007 – October 2007 (10 months) Marketing Manager The Maritime Group
Yep. Big promotion for Dickie Jr. from answering the phones at Linda's other company- while she was CEO of IMDS- Sigma Investment Group.
Are you really surprised at anything Grable does? Nepotism reigns supreme at her companies, including her niece/daughter Deb O,and other daughter Trish. Don't forget Blue Water Logistics, the shipping company IMDS used for the CTLM's- owned by Trish's husband.
I wouldn't say that. Who asked to have their daughter's license altered? Remember that? Wasn't Linda. They are both dishonest scum who made millions off of women dying with breast cancer.
Talk about stating the obvious. Can you think of another reason? Who would buy a dirty shell that has IRS liens, millions in liabilites, no viable product, a technology that has never worked as claimed, and a patent expirirng next year. The entire management team is gone. No transition time whatsoever. The company that acquired majority is six months old and ran out of a store front in Orlando, along with other companies in the same space by an ex CPA. This reeks of a sham like most of IMDS "distributors" they set up over the years.
You would think that the new owners would have made some announcement as to the direction of the company or the reason for the purchase.
Are we sure the "new owners" really exist? Surely through the years the Grables stashed plenty of money offshore. It is at all possible that the purchase of the company is simply some of this money coming back home to keep people out of jail?
Did you know the SEC has internal IMDS emails between Deb,Linda, and Allan that are VARY interesting? Read the deposition- seems Deb know they didn't have enough scans, but they told the public they were still on track for the PMA in 2008.
No one picked up on the fact IMDS sent the IRS $250,000 which is exactly 10% of the amount of the purchase price of IMDS. We know where $100,000 came from. Want to bet the other $150,000 was a second "installment" as well? Let's see.. The "purchase" of IMDS was for 2.5MM dollars. Grable and IMDS owe the IRS about half that. So now $250k comes into IMDS and then goes to the IRS, as well as future "installment" payments to purchase IMDS.
Nothing happens by coincidence with IMDS.
item 1.01 Entry into a Material Definitive Agreement; Item 3.02 Unregistered Sales of Equity Securities; Item 5.01 Changes in Control of Registrant
On August 4, 2014, pursuant to the Securities Purchase Agreement (the “SPA”) dated as of June 27, 2014, among Imaging Diagnostic Systems, Inc. (the “Company”), Viable International Investments, LLC, a Florida limited liability company (the “Investor”) and certain affiliates of the Company, Investor purchased 250 shares of the Company’s Series M convertible preferred stock (the “Preferred Stock”) for an aggregate purchase price of $2,500,000 ($10,000 per share) of which $100,000 was paid pursuant to a non-refundable deposit on June 27, 2014. This was the First Closing under the SPA (disclosed in the Company’s Form 8-K Report filed July 1, 2014), which was scheduled for July 31, 2014; however, the closing date was extended to August 4 by mutual agreement of the parties. As a result of the Investor’s purchase of the Preferred Stock, Investor’s owns a 78.9% voting and economic interest in the Company’s capital stock, which represents a change in control of the Company.
Multipe False and misleading IMDS press releases. NONE of these sales ever materialized. IMDS NEVER received FDA approval.
MEDICAL INDUSTRY TODAY August 23, 1995, Wednesday Laser Mammography Breast-Imaging Units Sold to Asia An initial order valued in excess of $1 million has been received by IMAGING DIAGNOSTIC SYSTEMS (IDSI; Fort Lauderdale, FL) for its CT Laser Mammography breast-imaging laser system. "We've been issued a PO for five systems, and we anticipate delivery in the first quarter of 1996," IDSI Executive Vice President Allen Schwartz told Medical Industry Today. Schwartz said the initial order was from Asia and that the order is in line with foreign demand for the system which detects breast abnormalities in the early stages. "We have so much demand for the machine in Europe and Asia, we are going to continue our sales efforts there." The firm began scanning patients with the system in February in the U.S. The laser system employs a cross-sectional imaging technique which does not use ionizing X-rays. Schwartz said clinical testing is now underway, but doesn't expect U.S. marketing to get underway in the immediate future. "We have six beta test sites right now, and it will take quite some time to collect all the clinical data, evaluate it and then initiate premarketing with the FDA," Schwartz said. The firm, in a press release, said it names Business Asia Consultants as its distributor for the Asia Pacific Rim. It is an export management company based in Miami. CONTACT: Allan Schwartz (305/746-0500)
International Buying Power Corp. News Release: IMAGING DIAGNOSTIC SYSTEMS ANNOUNCES LETTER OF INTENT FOR DISTRIBUTION IN RUSSIA, SWITZERLAND AND AUSTRIA: 1st DEVICE AT THE MOSCOW RESEARCH INSTITUTE AND DIAGNOSTICS AND SURGERY For Immediate Release FORT LAUDERDALE, FL. - December 4, 1995 - Imaging Diagnostic Systems, Inc. (symbol IMDS OTC Electronic Bulletin Board), has announced a letter of intent with one of Europe's largest distributors, Medical Development East (17 offices in Russia, 3 offices in Switzerland and 2 offices in Austria) to place a CT Laser Mammography TM Device at the Moscow Research Institute for Diagnostics in July of 1996. The Company met with August Steiner (of MDE) and Vladimir P. Khartchenko (honoured scientist of the Russian Federation Corresponding, Member of the Russian Academy of Medical Sciences and Professor and Director of all the hospitals in Moscow), at the Radiological Society of North America Convention in Chicago. The first machine to be distributed to the Moscow Institute will be used as a demo machine for Eastern Europe as well as a clinical device to determine breast cancer
REUTERS FINANCIAL SERVICES Imaging Diagnostics Sees $22.5 MLN Sales FORT LAUDERDALE, FLA., JAN. 16 [1996] -- Imaging Diagnostic Systems Inc said it projects sales of $22.5 million for its non-invasive breast cancer detection device based on orders and a surge of inquiries. The device is not yet in production. Imaging president Linda Grable said. But the company is hopeful the Food and Drug Administration will soon give it an investigational device exemption (IDE). Grable said she has initial orders in place with Russia, Austria, and Switzerland for June [1996] delivery."
IMAGING DIAGNOSTIC SYSTEMS RECEIVES ADDITIONAL OVERSEAS ORDERS TOTALING OVER $4 MILLION July 23, 1996 In making the announcement, Linda Grable, President of IDSI, stated, "IDSI is receiving serious inquiries from all over the world and that the contract with E.T.F. is in addition to existing orders previously received from Russia, Asia and the Middle East." Ms. Grable noted that with the recent technological breakthroughs of the company's state-of-the-art imaging system, delivery of overseas orders will begin the first quarter of 1997
REUTERS FINANCIAL Imaging Diagnostic Gets OK to Begin Trials SUNRISE, FLA., FEB 20 [1996] - Imaging Diangostic Systems Inc said Tuesday that it received U.S. Food and Drug Administration approval of its Investigational Device Exemption application and can begin clinical testing of its Computed Tomography Laser Mammography. …When its IDE application is received and accepted, the company said it expects to recoup its costs for clinical trials by selling its CT Laser Mammography machines for clinical use in the United States, while it fulfils orders from the Far East, Middle East and Europe. The company said it projects more than $5 million in sales this year [1996]. In January, the company projected sales of $22.5 million for the device based on orders, though it had not yet begun production of the device. When reached by telephone, a spokeswoman for the company noted that the $5 million projected sales figure is the total expected for the IDE in 1996. The $22.7 million projection [is] for sales of the product on the international market through 1997.
Imaging Diagnostic Signs OEM Agreement With Imation (3M) FORT LAUDERDALE, Fla., Jan. 21 [1998] /PRNewswire/ -- Imaging Diagnostic Systems, Inc. (OTC Bulletin Board: IMDS) announced today that it has signed an OEM purchase agreement with Imation Corporation (NYSE: IMN), a $2.3 billion worldwide leader in the imaging and information industry. Imation is borne of 3M's imaging businesses and has a market presence in more than 60 countries. Imation operates 17 manufacturing, research and distribution facilities. This OEM agreement positions Imaging Diagnostic Systems to market and partner its revolutionary CT Laser Mammography device with Imation's DRY FILM technology described as "the most rapidly adopted system in the history of Medical Laser Imaging." The DRY FILM technology produce by Imation will provide IDSI's end users with the most efficient, economical, and ecological product line in the medical industry. In addition, Imaging Diagnostic Systems will immediately begin to market this DRY FILM technology through its existing distributor network internationally and domestically, through its own marketing efforts. "This relationship can provide immediate revenues as well as generate additional revenues when packaged with the CTLM," stated Linda B. Grable,
IMDS had a history of announcing "sales" every year at the time of the RSNA meeting to move the stock price.
Imaging Diagnostic Systems Expands International Distribution Network As A Result Of RSNA Success FORT LAUDERDALE, Fla., Jan. 23 [1998] /PRNewswire/ -- As a result of unprecedented success due to the images displayed at the 1997 RSNA Conference, Imaging Diagnostic Systems Inc. (OTC Bulletin Board: IMDS) announced today that they have added EMTRON, a leading medical equipment distributor based in the Republic of Turkey to their rapidly expanding international distribution network.EMTRON currently represents products for companies such as Summit Technology, Sunrise Technology, Iris Medical Instruments, Telsar, and Medlab, among many others. "Based on due diligence material received from EMTRON, it appears they have a strong presence in the industry with 30 university hospitals, the Social Security System (which has over 100 hospitals) and larger private hospitals which will give us tremendous exposure in that region," said Linda Grable, President of Imaging Diagnostic Systems. "We feel that the concept of laser mammography fits well in our product scope," stated Dr. Mehmet Melek, President of EMTRON. According to the company, EMTRON will have exclusive rights to market the CTLM(TM) device in the Republic of Turkey for a term of 18 months with an option to renew for an additional one-year term. The company has already secured exclusive distributors for the following territories: Italy, France, South Korea, the Pacific Rim including China, Switzerland, Moscow, Germany, Austria, and Ecuador.
Imaging Diagnostic Signs 9th International Distributor FORT LAUDERDALE, Fla., April 7 [1998]/PRNewswire/ -- Imaging Diagnostic Systems, Inc. (OTC BULLETIN BOARD: IMDS) announced today that it has entered into an exclusive three-year International Distribution agreement with Focus Surgical LTD. Walter Solomon, Managing Director of Focus Surgical LTD has signed an exclusive agreement to market and distribute the CTLM device to hospitals and clinics throughout the United Kingdom and Ireland. The terms of the agreement is for three years, with a minimum purchase requirement of 1O CTLM devices the first year, 12 the second year and 15 for the third year, following Pre-Market Approval (PMA). The Company estimates the value of the contract to be worth no less than eleven million dollars. Mr. Solomon has over 20 years of experience in marketing surgical lasers and has installed over 700 laser systems in hospitals and clinics throughout the United Kingdom. Focus Surgical has entered into Distribution agreements with other companies such as Sunrise Medical Technologies and Baltec to market and sell non-competitive laser products.
SOURCE: Imaging Diagnostic Systems Inc. Imaging Diagnostic Systems Reports Sales at RSNA Medical Conference For the Millennium FORT LAUDERDALE, Fla., Dec. 1 [1999] /PRNewswire/ -- Imaging Diagnostic Systems Inc. (OTC Bulletin Board: IMDS - news) announced today that it has received the first signed and funded orders for its CT Laser Mammography system. The corporation Cycle of Life Technologies, based in Toronto, Canada, has signed an agreement for two systems totaling $500,000 in revenues with the delivery of two additional systems immediately following. The Cycle of Life Technologies has signed a three-year distribution agreement with a commitment of fifty systems to be delivered within two years. Their distribution channel encompasses an extensive network of international hospitals and physician practices. They are the primary suppliers for various medical services and equipment throughout Canada, Europe, South Africa and the Middle East. Cycle of Life Technologies is also involved in the development of DNA diagnostics and gene therapy with ACGT Corporation of Canada and Harvard Medical School.
"Imaging Diagnostic Systems Receives Purchase Orders From Syncor For Three CTLM(R) Systems: 10% Deposit Received For Three Systems" FORT LAUDERDALE, Fla., Jan. 11, 2001/PRNewswire/ -- Imaging Diagnostic Systems, Inc. (OTC Bulletin Board: IMDS) announced today that Haig Bagerdian, President of Syncor Overseas LTD, a subsidiary of Syncor International Corporation SCOR has signed an agreement to deploy three Computed Tomography Laser Mammography (CTLM)(R) systems, accompanied by a 10% deposit to Imaging Diagnostic Systems on January 11, 2001. "Syncor has been a distributor of ours since 1997 covering the areas of the Pacific Rim, China and Puerto Rico. We initiated negotiations for the three CTLM(R) systems at RSNA 2000 but were unable to make the announcement until all terms were finalized and deposits were received. These purchase orders further support Imaging Diagnostics' objective to advance in the arena of a medical manufacturing company for commercial use. We have waited a long time for this moment and will continue our efforts to bring to the industry a much needed and consumer desired medical imaging system," said Linda B. Grable, President. Syncor is a leading provider of high technology health care services concentrating on nuclear pharmacy services, medical imaging, niche manufacturing and radiotherapy. Syncor's medical imaging services are provided through an integrated network of 55 domestic and 11 international owned or operated facilities.
"We actually are going to start marketing internationally first because we just received our CE marking, which allows the company to sell product and market its product in the European markets, also in other markets internationally because it's like an FDA, it's a regulatory system like the FDA But it's the FDA for the European market. Since we just received the CE and we have distributors that we've set up in certain countries we are now able to aggressively promoting and marketing the product to the European markets, while we wait for the FDA approval process to be completed." -- Deborah O'Brien, IDSI VP for Investor Relations - The Wall Street Transcript Co., Feb. 19, 2001.
"We actually are going to start marketing internationally first because we just received our CE marking, which allows the company to sell product and market its product in the European markets, also in other markets internationally because it's like an FDA, it's a regulatory system like the FDA But it's the FDA for the European market. Since we just received the CE and we have distributors that we've set up in certain countries we are now able to aggressively promoting and marketing the product to the European markets, while we wait for the FDA approval process to be completed." -- Deborah O'Brien, IDSI VP for Investor Relations - The Wall Street Transcript Co., Feb. 19, 2001
An Internet search could not find any evidence that Cycle of Life was a major supplier of medical services and equipment anywhere. Around the time of the news release, a Cycle of Life web site popped up, but it appeared to be a sham site with broken links and links that led in circles. The site then disappeared. IMDS's SEC filings showed that the company never received any sales revenues. IMDS revealed a few months after this press release the two "orders" and the $500,000 "sale" was a loan. Most of IMDS distributors are no longer in business, and or have never sold a medical device other than the CTLM.
IDSI INKS $26 MM CHINA CONTRACT- NOT - Another lie put out to sell stock. There are more of these phony sales PR's IMDS put out than you can shake a stick at!
Tuesday, September 28, 2004 :: Fort Lauderdale, Florida, September 28, 2004—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS), announced that it has signed a multi-year agreement with China Far East International Trading Corporation (CFETC) for the exclusive sale of the CT Laser Mammography System (CTLM®) in the People's Republic of China. Superseding a previous distribution contact, this new agreement also includes clinical research and collaboration programs.
"We are extremely pleased to have received this major contract especially with the recent approval from China's State Food and Drug Administration to begin commercialization within the PRC," stated Tim Hansen, CEO of Imaging Diagnostic Systems, Inc.
IDSI's exclusive distributor, CFETC has already received 4 CTLM systems under the previous agreement and expects additional units before year-end as part of this $26 million dollar multi-year agreement. CFETC is one of China's top 500 Enterprises in import and export volume. CFETC operates under the control of State-owned Assets Supervision and Administration Commission of the State Council. CFETC is located in Beijing with branches in Guangdong, Zhejiang, Jiangsu, Hainan, Fujian, Shenzhen, and Zhuhai.
Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast imaging system. The CTLMâ system is the first patented breast-imaging system that utilizes state-of the-art laser technology and patented algorithms to create 3-D cross- sectional images of the breast. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLMâ system to be used as an adjunct to mammography. The CTLMâ system is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression.
In conjunction with the provisions of the Safe Harbor section of the Private Securities Litigation Reform Act of 1995, this news release may contain forward-looking statements pertaining to future anticipated projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company's filing with the Securities Exchange Commission.
Investor Relations: Public Relations: Rick Lutz Margie Adelman 404-261-1196 561-347-6768 lcgroup@mindspring.com madelman@adelmancommunications.com
You asked for a transcript of my Richard Grable interview. Here it is with pictures, sound, and other supporting material.
-Andrew A. Skolnick ----------------------------------------------------------------- -----------------------------------------------------------------
Transcript of My Interview with Richard Grable and Rebecca Del Medico September 10, 1998
GRABLE: Hi. This is Richard Grable.
AAS: Hi. Andrew Skolnick from JAMA Medical News.
GRABLE: Yes, how are you?
AAS: Fine. I want to ask you about a number of things. First, were you aware that the FDA has been investigating complaints filed against your company, in particular, allegations were made by Diane Strait. Were you aware of this?
Richard Grable: Not directly.
AAS: She's filed an affidavit which states she was ordered by you to fraudulently alter clinical images that were displayed at RSNA [Radiological Society of North America's 1997 annual meeting] and provided the SEC and the FDA.
GRABLE: Oh, that's news to me.
AAS: She said she was ordered to use a computer program to augment, to alter the photographs to make them more dramatic. She says she was ordered to scan an image from a medical text book. There was an image of a woman's breast. She says in her affidavit to the FDA that she was told to move the tumor from below, low down on the breast to higher up on the breast using Photoshop, in order to correspond with one of the CTLM images you have.
GRABLE: Andrew, how are you getting your information. We're not even aware of this.
AAS: Diane Strait sent me the affidavit. I also have copies of complaints that were sent to the SEC by some -- Diane Strait also sent the affidavit to the SEC -- but also from investors. So that's what I want to talk to you about, to get your side.
REBECCA DEL MEDICO: Andrew, my name is Rebecca Del Medico. I am the company counsel. Actually, we [sounded like "aren't] aware of all these things. However, the company has nothing to hide. We would welcome any governmental bureau to come in here, to look at our images, to compare the images that we have, any other documentation. We invite you to come over here and see our product. You know the company is a public company. It is an open book except for proprietary information. We have a disgruntled employee who has been making allegations all over, who has been libeling and slandering the company we believe. And she's on a mission.
AAS: O.K.
DEL MEDICO: O.K.? Have I been reading your little things on the Internet?
AAS: On the...
DEL MEDICO: Silicon Investors..
AAS: Yes, you have.
DEL MEDICO: O.K., and I know that Diane Strait then has probably been feeding you information for those inquiries all along.
AAS: No, the vast majority of that comes from the FDA. I filed an FOIA request with the FDA and got documents.
DEL MEDICO: Yeah, Andrew, but you also paraphrased it so that certain sections popped out but the other sections didn't.
AAS: Well, if anything I did was misleading, point it out to me and I will correct it on that bulletin board.
DEL MEDICO: O.K. We would be happy to once we get some other things done here. But Andrew, actually, why don't you come down and see the company. It's an open invitation to you. If you're going to put out a story, I think that you have an obligation to come down here, see the company, see our product. We'll show you the images that Ms. Strait allegedly had to enhance, which is nothing more than what you do is enhance images and they were clearly labeled as enhanced. And basically what happened is--
AAS: I'm sorry, I didn't see them labeled enhance at the RSNA or in the CD-ROM I have, the IDSI Future in CT Laser Mammography CD-ROM, which was distributed at RSNA, it does not say enhanced.
GRABLE: Andrew, I think if you look at the file name, you're going to find an "e" there for enhanced. But that's O.K.. We're not going to get into solving these issues now. You and I have a running battle.
-------------------------------------------------------------------- -------------------------------------------------------------------- [As if putting an "e" in the file name of a graphic image file would inform patients, physicians, and potential investors that the images were enhanced by a graphic artist! There are 6 graphic files on the CD-ROM, Imaging Diagnostic Systems, Inc.: The Future of CT Laser Mammography. The file names on the CD-ROM are: Cancera.tif Cancerb.tif Cancerc.tif Cysta_.tif Cystb.tif Cystc.tif
NOT ONE file name has an "e" for "enhanced."] -------------------------------------------------------------------- --------------------------------------------------------------------
AAS: Now, I took a look at the image on the IDSI, it was a photograph of a woman's breast, which was displayed at the RSNA. It's also in the handout literature that was distributed at RSNA and it's on this CD-ROM. She [Diane Strait] says she scanned it from a textbook. And I took a look at the image here, enlarged it, and I saw the halfscreen [halftone] dots – the dot pattern of a [halftone] image which is consistent with an image taking from a textbook as opposed to an actual photograph. So it seems to support Diane Straits' statement to the FDA, in her affidavit, that this was scanned from a textbook and not a photograph. Do you have a photograph of this woman's breast with that tumor in this position.
DEL MEDICO: Since we don't have a picture of anything that you happen to be discussing we can't make a comment on that Andrew.
AAS: Well, it's the only photograph of a woman's breast with a tumor that IMDS distributed at RSNA. There's only one. And it's a picture of a woman's breast with a tumor. Diane Strait in her affidavit said she was ordered to scan it from a textbook.
GRABLE: Let me interrupt you for a second.
AAS: Sure.
GRABLE: What's the significance of that picture? Clinically, what's the significance of that picture.
AAS: A....a.. wait, a second. I'm a little confused by the question
GRABLE: You shouldn't be. Let's take a hypothetical case. Let's say the picture wasn't the exact woman, but the woman under physical examination and visual examination had a dimpling directly over the tumor. O.K.?
AAS: Well, I...
GRABLE: Is that a possible situation?
AAS: Was the image taken from a textbook and altered or not? Is Diane Straits' statement in the affidavit true or false?
GRABLE: I haven't seen her affidavit. If you want to fax it to me, I'd take a look at it.
AAS: Sure. I'll fax the affidavit. Let me ask you some other questions. In the videotape display at the RSNA meeting last year, Deborah O'Brien, whom I believe was the host, the narrator. She stated that, the company has successfully imaged or scanned colorectal and neonatal.
GRABLE: You'll have to show me that. You're going to have a hard time showing us that. That was never said. That was never said.
AAS: All right, let me get the exact quote.
GRABLE: I would love to see that.
AAS: I'll get the exact quote. Just a second please. Here's the quote: In addition ... we are successfully examining other soft tissue in the body with CT laser techniques, including neonatal imaging and colorectal scanning.
GRABLE: I don't recall that statement. I'll have to go back and look at it.
AAS: It's on the videotape.
-------------------------------------------------------------------- -------------------------------------------------------------------- Here's the exact quote from the videotape:
"In addition to CTLM, we are discovering new applications for our technology. We are successfully examining other soft tissue areas in the body with CT laser techniques, including neonatal imaging and colorectal scanning."
I digitized this quote into a WAV file and uploaded it to my web site. You can hear Deborah O'Brien make these claims by downloading the file from: http://www.aaskolnick.com/imds/imds.wav -------------------------------------------------------------------- --------------------------------------------------------------------
GRABLE: Well, I'll have to look at it. I don't recall that wording.
AAS: That's [videotape statement] not true. You haven't gotten any permission--
GRABLE: I haven't seen what she said, O.K.?
AAS: Well, let me just ask you, have you imaged any neonates or patients with colorectal cancer?
GRABLE: No.
AAS: O.K. Well, take a look at that videotape. I'd like you to explain to me why she said that.
GRABLE: I don't recall those words. I know we planned to do that and I thought that's exactly what we said. I'll look at the video tape.
AAS: Good. Let me give you my phone number. Well, I'll put it on the fax.
[To date, neither Grable nor attorney Del Medico have explained why the false statement about neonatal and colorectal studies was made on IMDS' videotape shown at the Radiological Society of North America annual meeting.]
GRABLE: O.K.
AAS: I want to ask also about the previous companies that you –
GRABLE: I have no comment to make on those companies, at all. Period.
AAS: O.K. The documents I got from the FDA, which I guess you're aware of from '83 through ‘90—
GRABLE: I'm aware of them. I lived through the history and I know exactly what happened and I know how you paraphrased it and how you made a real nice spin on what happened.
AAS: Well, I'd like to have your side of if you want to tell me. You know, if you think I spun it in any way that is misleading or deceptive, please, I'd like to have your side.
GRABLE: It's going to take more than a telephone conversation because documents tell one side of an issue. I will tell you one thing, that the statement that you claimed the FDA inspector said that I agreed with him, that's crap. Because if you know anything about medical inspections by FDA, you know first of all, you never review the affidavit. You don't even look at it, because it's only going to be a report, and you don't know if there's going to be any action taken or not. So you're going to find the industry will not even look at the affidavit. So how can I make a comment on something in the affidavit I never even saw.
AAS: All I have is the statement of the investigator who filled out the report back in '88 or whenever it was [it was 1986] that you said this. Now I have your statement that you said you never said that.
GRABLE: That's correct.
AAS: O.K. That's all I can do, is to show both sides. -------------------------------------------------------------------- -------------------------------------------------------------------- [It think the statement that Richard Grable is objecting to was a statement in the FDA investigator's report dated June 27, 1986 (quoted in my Silicon Investor reply #1606). The investigator, Leon L. Law, of the Orlando District Office wrote this:
"Mr. Grable was informed that items listed on FDA-483 may be violations of the Federal Food, Drug & Cosmetic Act. Mr. Grable stated that he agreed with my observation and promised to respond to FDA in writing on each item that was listed."
If I understand Richard Grable ‘s statement correctly, he denies he ever agreed with the investigator's observations that his company (Lintronics) may be in violation of the Federal Food, Drug & Cosmetic Act..] -------------------------------------------------------------------- --------------------------------------------------------------------
DEL MEDICO: Andrew, let's make sure that we do that very fairly and everything, because from your past actions and everything, I know that it seems like you have a personal vendetta against this company and Richard and please be advised that we have been reviewing your emails and everything like that. We did review what you put on about the FDA. Some of the things I think were very misleading on it and everything.
AAS: Well please, I invite you, please, to correct me, anything that I stated that I misconstrued in anyway.
DEL MEDICO: [unintelligible] gone to outside counsel already. But I would certainly invite you again to come down here and see what we have. I understand that you know about imaging that you are pretty in on the techniques and stuff like that. And again, I think that it would be most unfair of you based on the conversations and on what was provided to you by an ex-employee who has her own agenda, to put out any kind of a story without seeing what we actually have here. Because the possibility of you putting out a story that is incorrect and me having to go through all the problems of having you print a retraction or suing you or whatever is not going to help either one of us with our agenda. And our agenda is to get these images out there, get FDA approval. My mother died from breast cancer. I believe in this company and I believe it is really going to help women. O.K. This is not a scam corporation. This is not a company that doesn't have a facility here, that's not doing the active scanning to fulfill its requirements or anything like that. This is a company that ultimately is going to benefit millions of women across the United States and in other countries. And you need to come here and see what we actually have here.
AAS: You know that many journalistic investigations are not conducted on site. They can be conducted by various forms of communication.
DEL MEDICO: I understand that. But what I'm saying to you is that no matter what we sit here and say to you, you will not get the full extent of what we have here unless you actually come down and you're able to inspect and see the images and see what's here. I mean I'm really serious about this Andrew. Because right now, if you put out a one-sided biased report.
AAS: I'm not going to put a one-sided, biased report out. Right now, I really don't think I would be able to convince my bosses to send me down there.
DEL MEDICO: I'll tell you what. We'll buy the ticket.
AAS: Oh, no. That, you know, is absolutely taboo. No way is that permitted. [It is unethical – at least in the United States -- for a journalist to accept pay, any substantial gift, or transportation expenses from a company that the journalist is planning to write about..] But, I'll just say that I would broach this question about going down to my supervisor, but I'm not optimistic, because the information that I'm trying to get is not going to be gotten from looking at the images. You greatly overestimate my knowledge of radiology. I know some things, but I'm not in any position to evaluate the potential of a new technology like this. But what I'm looking, at and have been looking at, I think I am very good at looking at, is the validity of claims made, of statements to find the truth. For instance, I can evaluate whether that image, as Diane Strait said, was lifted from a textbook and altered, or not. That I don't need to come down for.
DEL MEDICO: What's the materiality of that? It was a picture of a woman there. I'm sorry. I don't know what you're talking about because I've never seen it myself personally. But is it material?
AAS: I think it is. When I saw the material presented last year at RSNA, I thought that woman was a patient whose breast was imaged by your company's device.
GRABLE:. Did you see the images of the lesion produced by the scanner itself? Did you see the lesion? Was it pointed out to you in the booth?
AAS: a... a...I believe nobody pointed anything out to me. But I believe it's the same image that's in the brochures.
GRABLE: Well let me say something to you Andrew. I'm holding a silver pointer in my pocket that I had at RSNA where I stood there and I pointed to it on the film itself to you. So I know that I pointed it out to you.
AAS: O.K. I don't remember being –
GRABLE: I do remember. I do remember all of these things.
AAS: That very likely could be. But I know the image.
GRABLE: What I'm saying to you is that the images we showed of the cancer are a cancer and those images were produced by the CTLM. Period.
AAS: And they were not enhanced? And artifacts removed as Diane Strait said in her affidavit?
GRABLE: Well, let me ask you a question. Are you familiar with the technique called window and centering?
AAS: No.
GRABLE: Well window and centering is a very common technique that's used in radiology to enhance the image. It's done with digital images all the time. It's the basis for being able to see detail in computed tomography on the x-ray side of the screen. So if I put an image in Photoshop and I vary the contrast, if I change the window and centering of the contrast and brightness, that's image enhancement. That's perfectly acceptable. That removes artifact. That's perfectly acceptable. O.K.? So Ms. Diane Strait doesn't have all the knowledge in the world about how images are created in radiology. She uses what she believes is true and misrepresents it and makes it sound like it was some kind of horrendous crime, when if fact it's done all the time. That's how CT works. So if you want to check the facts you ought to go out and find out about window and centering on computed tomography images [unintelligible] what that means
AAS. O.K. I will
GRABLE: and do. You'll find out the so called enhancement that we did is nothing more than what's routinely done. You can change the contrast and brightness to change the background. It's routinely done. That's called windowing and centering.
--------------------------------------------------------------------- --------------------------------------------------------------------- [I have been reporting on radiology for almost 9 years. I never before heard of radiology images being enhanced by a graphic artist using Photoshop. Such enhancements are hardly "routine." Here's an excerpt from (Kenita) Diane Strait's Feb. 11, 1998 FDA affidavit:
Cancer patient: Mr. Grabel indicated that this CTLM image was not acceptable because it looked to [sic] splotchy and had scalloped edges. He directed me to make the bright cancer area brighter and to smooth out the darker areas so they would appear to be in less contract [sic; contrast] with the grey areas. These alterations made it appear as if the CTLM breast imaging system had produced better resolved images for the cancer in this case study than what had actually been produced.
Mr. Grable and I also scanned a photograph of a breast with cancer from a medical book into the computer. Because the cancer in this photograph was not in the correct location, Mr. Grabel directed me to cut and paste the cancer to a location the better matched the case history.
The above altered images were posted at the IDSI [Imaging Diagnostic Systems, Inc.] booth at the RSNA [1997 Radiological Society of North America Meeting]. None were identified with the statement "images enhanced." The following publications, which I composed, also included these altered images: the CD entitled "Imaging Diagnostic Systems, Inc. The Future of CT Laser Mammography" and the brochure with the same title. These publications have been sent out to prospective investors, shareholders and potential clinical cites.
Also, these altered images were used during IDSI's presentation to Nasdaq on January 29, 1998. That presentation was made by Deborah O'Brien, Investor Relations (and daughter of Mr. and Mrs. Grable) and Rebecca Del Medico, Attorney for IDSI.] -------------------------------------------------------------------- --------------------------------------------------------------------
AAS: O.K. One of my last questions for now is the IRB, the Institutional Review Board: FDA policy states that members of the IRB cannot have a conflict of interest. Yet it appears that 1 of your 5 [actually there are 8] members of your IRB is married to your software designer.
GRABLE: Let me ask you a question. Do you have the IRB regulations? Did you download them from the FDA web?
AAS: Yeah. I can quote them.
GRABLE: Well, I have them too. I have a whole book full of them and I don't see the same allegation you have. The IRB is looking at the efficacy of the test and the safety for the patient and it's not made of one member. It's got several members that vote. They all vote. Now if it's a unanimous vote, you want me to exclude one member, fine. We can do that. That's not a problem. We didn't see it as a problem at all, a conflict of interest because she wasn't making any decision on does the machine work or not work. It was based on the scientific efficacy of the testing and what the safety of the patient would be for the testing.
AAS: You've lost me. Let me get the FDA requirement here and see if you can--
GRABLE: Get it for me [unintelligible]. Tell me, who else are you investigating so thoroughly?
AAS: Are you kidding? About 20 different doctors and 10 different licensing boards I've been given hell to.
GRABLE: I see. Do you have a particular vendetta against me or this company? Did you lose money in the stock market?
AAS: No, I never invest in the stock market.
GRABLE: I have to wonder what your motivation is was to be so zealous about this.
AAS: That's the way you approach I all my journalistic investigations—
GRABLE: I would have to ask you why you had to hide behind an alias on a bulletin board—
AAS: That is my name. I didn't give my last name. A lot of people do that.
GRABLE: The problem is when you make statements and you don't identify yourself so that someone can't email you directly back and talk to you, you're hiding behind an alias.
[Not true: Email could have been sent to me.]
You've got that benefit of people not knowing who you are. If you're so journalistically perfect, why not just identify yourself and say email me.
AAS: I didn't want give my full name until I talked with you.
DEL MEDICO: Did Ms. Strait tell you how she managed to get property of the company without like removing it from the premises or—?
AAS: I think it's in the, I think that's detailed in the affidavit. It's a pretty detailed affidavit. She explains to the investigators what had happened.
DEL MEDICO: Did she also tell you she was a disgruntled employee?
AAS: Oh, yeah. She first contacted me while she was still working for the company and told me she was disgruntled and planning to leave and wanted to file a complaint.
GRABLE: Did she also inform she had an agreement to maintain confidentiality about company business and company business plans?
AAS: No, I don't recall that.
GRABLE: You should be aware that that exists as well.
DEL MEDICO: Of course, Andrew, we're not saying that because we believe she doesn't have a right if there's a valid reason to make a complaint with any regulatory agency that she wants to. So don't take that comment incorrectly.
AAS: I understand.
DEL MEDICO: However, on things that she has done and removal of property from the office basically amounts to a theft of property.
AAS: I believe that the stuff she took she turned over to the FDA, so I'm not sure whether you have—
GRABLE: If she took it off of the company's property, it's still theft. I don't care who ended up with it. It's still theft.
AAS: Yeah, but I have a feeling you're not going to have much luck with that if it was taken for the purpose of whistleblowing.
GRABLE: Whistleblowing on what? I haven't heard a thing from the FDA. I talk to them practically every 2 weeks. I'm really surprised. So I'll wait to see how this falls out.
AAS: O.K. I'm really sorry, but I buried this section from the FDA.
GRABLE: I have it. I'll look it up.
AAS: If my memory is correct, the FDA states that members of an IRB cannot have a conflict of interest in matters dealing with – I mean if you an IRB that makes many decisions about many different products and many different actions, that IRB member can have a conflict but then must remove him or herself from making a decision on that. But you have only one product. This IRB is set up to do just one thing and that is to give approval for your clinical studies on your one product.
GRABLE: You have to understand as well though. We have FDA approval on the protocol as well. It's not just our IRB.
AAS: I understand that. But that doesn't address the issue of the IRB regulation of the FDA.
GRABLE: I think it does because if the IRB stood alone and made the decision to do scans of women and the FDA wasn't involved, that's a different matter. If the FDA looks at the same protocol and deems it to be safe and effective for its intended purpose, that of doing a clinical study, I think there's a problem here. It will fall out. Let's see where it comes.
[Here is the section from the FDA Regulation regarding who may or may not participate on Institutional Review Board decisions. (Section 56.107 (e) of Appendix C-Part 56-Institutional Review Boards):
"No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB."
One of IMDS' IRB members, Dr. Banchik, is married to the company's software designer. The sole purpose of the company's IRB is to review protocols for clinical trials of its CTML device. Because the FDA regulation excludes Dr. Banchik from participating in any review of IMDS' projects, why is she on the IRB?
In addition, it appears that another member of the IRB may have been a consultant for the company. According to the company's April 23, 1998 PR Newswire press release, Patrick Lilam, Ph.D, assistant professor of electrical and computer engineering, Center for Research and Education in Optics and Lasers is also an IRB member. In some older IMDS material provided investors, Patrick Li Kam Wa, Ph.D, professor of physics and electrical engineering at the Center for Research in Electro-Optics and Lasers (CREOL) at the University of Central Florida, Orlando, is listed as a consultant for IMDS.
On Sept. 11, 1998, I called the Center for Research and Education in Optics and Lasers and asked if they had a faculty member named Patrick Lilam. I was told no, but they do have a Patrick Lik Kam Wa on the faculty.
That same day, I sent a letter to Rebecca Del Medico, IMDS' general counsel inquiring about this apparent conflict. I never received an answer.] -------------------------------------------------------------------- --------------------------------------------------------------------
AAS: O.K. I would like to continue our dialogue further, obviously. I'm not about to jump off and write an article at this point. O.K.? Let me fax you the affidavit. And I do invite you to bring to my attention anything I posted on the bulletin board that is incorrect or misleading and I will, one, get myself corrected and, two, put a correction up on the bulletin board., because it certainly wasn't my intent to put anything misleading. O.K.?
GRABLE: O.K.
AAS: I'll put the fax and email and phone number on the fax. I'll send that in the next half -hour or so. O.K.?
DEL MEDICO: Thank you.
AAS: Oh, you're going to look at the videotape where Deborah O'Brien states the thing about neonates—
DEL MEDICO: Yeah, we'll look at it.
AAS: O.K. Thanks.
DEL MEDICO: Uh huh.
AAS: Bye-bye.
IMDS infomercial
5:30 AM TV broadcast of "First Business" and on Tuesday morning (January 27, 1998) there was a 2 min. 15 sec. featured segment on IMDS called "Laser Mammograms". Here is the transcript:
News Anchor: "A Florida imaging company has developed a new painless way to detect breast cancer. The disease is the second leading killer of women in the United States. As First Business correspondent Trish McShane reports, this new laser technology is promising to reduce those numbers through early detection."
Trish McShane: "The National Cancer Institute estimates 1 in 9 women will develop breast cancer during her lifetime and 46,000 women will die of the disease this year. Thousands of those lives could be saved by early detection through mammography, a procedure many women find painful and avoid. But now the medical technology company Imaging Diagnostic Systems has unveiled a breast test that uses lasers to scan for cancer instead of radiation. It's called CT Laser Mammography."
Deborah O'Brien (of IMDS): "This is a huge breakthrough. This breakthrough is enormous. The theory of this technology is called Optical Tomography. It's about 10 years old. But actually putting it all together, and putting the parts together; the laser, the computer algorithms and having everything work to produce an image, we are the only ones right now in the industry. We feel we have about a year and a half jump ahead of everyone else."
Trish McShane: "Imaging Diagnostic Systems is hoping the advanced technology will bring the company back in the black. Since the companies inception in 1993 it has incurred net loses of over 16 million dollars."
Deborah O'Brien: "Mammography as well as the ultrasound, as well as MRI worldwide is a couple billion dollar industry and we hope to tap into about 5 or 10% of that."
Trish McShane: " O'Brien said that Laser Mammography will substantial cut healthcare costs."
Deborah O'Brien: "There are 800,000 needle biopsies performed every year. 700,000 of those are unnecessary. If we can reduce the need for those needle biopsies because we can tell them whether or not they need it, based on that breast examination, you're going to tap into saving the health care (system) about 2.4 billion dollars."
Trish McShane: " Imaging Diagnostic Systems is now working on a neonatal unit to scan infants without harmful X rays and researchers hope CT Laser Mammography will not only detect breast cancer in the future but treat it as well."
First Business says to contact them if you have any questions or comments: Phone 1-800-521-3442 Fax 1-202-463-3186
IMDS lie about orders
Copyright 1995 Medical Data International, Inc. Medical Industry Today
August 23, 1995, Wednesday
SECTION: DEVICE & DIAGNOSTICS
LENGTH: 221 words
HEADLINE: Laser Mammography Breast-Imaging Units Sold to Asia
BODY: An initial order valued in excess of $1 million has been received by IMAGING DIAGNOSTIC SYSTEMS (IDSI; Fort Lauderdale, FL) for its CT Laser Mammography breast-imaging laser system. "We've been issued a PO for five systems, and we anticipate delivery in the first quarter of 1996." IDSI Executive Vice President Allen Schwartz told Medical Industry Today. Schwartz said the initial order was from Asia and that the order is in line with foreign demand for the system which detects breast abnormalities in the early stages. "We have so much demand for the machine in Europe and Asia, we are going to continue our sales efforts there." The firm began scanning patients with the system in February in the U.S. The laser system employs a cross-sectional imaging technique which does not use ionizing X-rays. Schwartz said clinical testing is now underway, but doesn't expect U.S. marketing to get underway in the immediate future. "We have six beta test sites right now, and it will take quite some time to collect all the clinical data, evaluate it and then initiate premarketing with the FDA," Schwartz said. The firm, in a press release, said it names Business Asia Consultants as its distributor for the Asia Pacific Rim. It is an export management company based in Miami. CONTACT: Allan Schwartz (305/746-0500)
IMDS Lie about Cycle of Life orders
Laser offers alternative to mammogram for detecting breast cancer Thu Jan 27 17:09:00 EST 2000
TORONTO, Jan 27, 2000 (The Canadian Press via COMTEX) -- Mammograms may soon be replaced by laser technology to detect breast cancer.
A Toronto company, Cycle of Life Technologies, has landed a distribution deal with the American developers of a new laser mammography system.
However, the technology, which takes mammograms without compression or radiation, still needs regulatory approval in the United States and Canada.
``The clarity is tenfold more (than traditional mammography),' said company president Lee-Anne Gibbs.
And where traditional mammography only reads the sections of the breast the machine can squeeze, the laser system reads the entire breast including the upper quadrant, which includes the lymph nodes, Gibbs said.
Cancer cells are highlighted on the screen, eliminating the need for a biopsy in almost all cases.
And results are available faster, since no radiologist is required to read results, which are stored on a CD-ROM and can go directly to the doctor, she said.
``You know instantaneously this way (if there are any cancer cells),' she added. ``There's no more discomfort (and) no more indignity.'
Women lie on a scanning bed and place a breast in a chamber. The laser rotates 360 degrees around the breast, collecting data until the entire breast is scanned.
Clinical trials are being conducted in Long Island, N.Y., and Virginia. The studies will look at patients with specific abnormalities and compare the laser results with current imaging methods, such as X-ray mammograms, ultrasound and magnetic resonance imaging.
For approval, results have to be the same as or better than traditional mammography.
``Ours will also read through cosmetic surgery if there's leakage traditional doesn't do it,' Gibbs said. And, if all goes as expected, the technology will also be used to detect prostate cancer.
Gibbs' company has sole distribution rights for Canada, the Middle East, South America, eastern Europe, South Africa and several western European countries.
A Florida-based company, Imaging Diagnostic Systems Inc., developed the technology. (Toronto Star)
Copyright (c) 1999 The Canadian Press (CP), All rights reserved.
Imaging Diagnostic Systems Reports Sales at RSNA Medical Conference For the Millennium FORT LAUDERDALE, Fla., Dec. 1 /PRNewswire/ -- Imaging Diagnostic Systems Inc. (OTC Bulletin Board: IMDS - news) announced today that it has received the first signed and funded orders for its CT Laser Mammography system. The corporation Cycle of Life Technologies, based in Toronto, Canada, has signed an agreement for two systems totaling $500,000 in revenues with the delivery of two additional systems immediately following.
The Cycle of Life Technologies has signed a three-year distribution agreement with a commitment of fifty systems to be delivered within two years. Their distribution channel encompasses an extensive network of international hospitals and physician practices. They are the primary suppliers for various medical services and equipment throughout Canada, Europe, South Africa and the Middle East. Cycle of Life Technologies is also involved in the development of DNA diagnostics and gene therapy with ACGT Corporation of Canada and Harvard Medical School.
Imaging Diagnostic Systems has committed to commence delivery of the first CTLM systems in the first quarter of the millennium. This will be the first revenues generated for Imaging Diagnostic Systems since the inception of the company.
Imaging Diagnostic Systems has developed the world's first patented laser-based mammography imaging system that utilizes state-of-the-art laser technology and proprietary computed algorithms to create contiguous cross sectional slice images of the breast without the use of compression or x-rays.
Safe Harbor statement under the Private Securities Litigation Reform Act of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including, but not limited to, risks associated with the uncertainties of future events and other uncertainties detailed in the Company's filings with the Security and Exchange Commission.
SOURCE: Imaging Diagnostic Systems Inc.
Two months later IMDS disclosed it was a loan
IMAGING DIAGNOSTIC RECEIVES ADDITIONAL FUNDING
FOR IMMEDIATE RELEASE Fort Lauderdale, Florida, February 22, 2000-Imaging Diagnostic Systems Inc., (OTC BB IMDS) announced today that the quarterly report for the period ending 12/31/99 was filed on February 18. Since December 31, 1999, the Company has received capital to fund its current working capital needs. The capital the Company has received includes $500,000.00 as a loan from its distributor Cycle of Life Technologies, Inc. (see "recent developments" on page 13 of the 12/31/99 quarterly report). In addition many warrant holders have exercised their outstanding warrants, resulting in the Company receiving an excess of $1 million. In addition to the loan, the Company is currently reviewing several term sheets from different investment bankers for additional equity funding for the Company's future needs
That's all for now folks. Soooooooooooooo much more it could fill a library.
Linda B. Grable Chair and Chief Executive Officer Imaging Diagnostic Systems, Inc. 6531 NW 18th Court Plantation, FL 33313
Dear Ms. Grable:
This Warning Letter informs you of objectionable conditions found during a Food and Drug Administration (FDA) inspection conducted at Imaging Diagnostics Systems Incorporated (IDSI). This letter also discusses your written response to the noted violations and requests that you implement prompt corrective actions. Mr. Victor Spagnoli, an investigator from FDA’s Florida District Office, conducted the inspection from August 5 through August 18, 2003. The purpose of the inspection was to determine if your activities as a sponsor for the [redacted] study complied with applicable FDA regulations. The [redacted] is a device defined in Section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321 (h)].
The FDA conducted the inspection under a program designed to ensure that data and information contained in requests for Investigational Device Exemptions (IDE), Premarket Approval Applications (PMA), and Premarket Notification [510(k)] submissions are scientifically valid and accurate. The program also ensures that human subjects are protected from undue hazard or risk during scientific investigations.
Our review of the inspection report prepared by the district office revealed serious violations of Title 21, Code of Federal Renulations (21 CFR), Part 812-Investigational Device Exemptions, Part 50-Protection of Human Subjects, and Section 520(g) of the Act [21 U.S.C. 360j(g)]. At the close of the inspection, Mr. Spagnoli presented a Form FDA 483 “Inspectional Observations” to you for review and discussed the listed deviations. The deviations noted on the FDA 483 and our subsequent inspection report review are discussed below:
1. Failure to ensure proper monitoring of the investigational study. [21 CFR 812.25(e) and 812.40]
Sponsors must monitor studies based on written procedures, and at adequate intervals, to assure that investigators are complying with the signed agreement, investigational plan, and all applicable FDA regulations. The inspection conducted in August 2003 revealed numerous monitoring violations, including the following:
A. Sponsors are required to include written procedures designed to ensure proper monitoring of the study as part of their investigational plan. You failed to establish adequate procedures for identifying and addressing discrepancies between the source data and the data submitted in the PMA. In some instances, the data submitted in the PMA did not match the source data. For example, the patient listing for[redacted] shows a right [redacted] score of 1 while the [redacted] shows a score of 4. In addition, the PMA reports the [redacted] for patient [redacted] while the source document lists the same patient's [redacted]. With regard to patient [redacted]; the initial and independant second [redacted] reading were positive and negative respectively. The reason for the difference is unclear and undocumented.
Monitors also failed to observe that the first enrolled patient’s [redacted] was assessed with an earlier software version. Because earlier software versions were not equivalent to later versions used in the study, the data should not have been included in the data analysis.
Although your response indicated that these were typographical or transcription errors occurring mainly at the [redacted] site, adequate monitoring procedures should detect such discrepancies.
B. You failed to adequately monitor the clinical investigators participating in this study to assure that they were following the protocol. For example, patient logs indicated that 50 of the patients enrolled from November 16, 2001, through June 18, 2002, at the [redacted] clinical site did not meet the protocol’s enrollment criteria. These patients had [redacted] scores of 1, 2, and 5 while the protocol required that only patients with scores of 3 or 4 be included in the study. The patient logs for the [redacted] and [redacted] sites also indicate that a total of 36 enrolled patients had [redacted] scores of 1, 2, or 5. Although the PMA data listings excluded most patients with [redacted] scores of 1 or 2, the listing included a total of 29 patients with scores of 5.
The protocol also required that enrolled patients already have scheduled biopsies. At the [redacted] sites, there were no biopsies indicated for four patients [redacted] and [redacted] with [redacted] scores of 4 who should have had scheduled biopsies.
We disagree with your response that the [redacted] site enrolled all patients with non-qualifying [redacted] scores within the first 2 months of the study (November and December, 2001). We note that the [redacted] site enrolled 10 patients with [redacted] scores of 1, 2, or 5 between January 9 and April 8, 2002. During the post-inspection discussion, IDSI staff informed the FDA investigator that [redacted] continued to enroll non-qualifying patients after IDSI informed her that this was a protocol deviation. Your response also does not account for the 36 non-qualifying patients enrolled at the other sites. The response is also unclear about the four patients at the [redacted] and [redacted] sites with [redacted] scores of 4 who did not have scheduled biopsies.
The protocol also required that abnormalities observed on the [redacted] be geographically located in the same place as lesions observed on [redacted] to permit increases in the [redacted] adjunctive scores, and there were specific criteria for determining geographic equivalence of lesions. There is no documentation or evidence that the physician determining geographic equivalence of lesions followed these criteria, and this physician failed to explain to the investigator why there were many unexpained discrepancies between the [redacted] and [redacted] results. The PMA Patient Listing included 45 subjects with abnormalities on [redacted] and increased [redacted] scores regardless of biopsy results or lesion location on the [redacted].
Your response describes how the investigators calculated the [redacted] score; however, the response does not account for the 45 discrepancies noted above. Although investigators did not document that they calculated scores according to the protocol, if they followed the protocol, [redacted] results and [redacted] scores should correlate with biopsy and lesion results.
The monitors failed to assure that the investigators signed and dated their [redacted] readings on the assessment sheets. additionally, the sheets contained alterations and inconsistent use of checkmarks to record data. According to IDSI’s monitoring procedures described in Standard Operating Procedure (SOP) 500007, investigators must “correct errors in logbooks by drawing a line through the entry, initialing/dating, and entering the correct information alongside.” The procedures also state that investigators should initial and date [redacted] entries. As the study sponsor, you had an obligation to monitor the investigators' activities under the study and assure their compliance with these requirements. Your response indicates that you are aware of this responsibility.
C. The monitors failed to assure that investigators maintained accurate, complete, current records as required in 21 CFR 812.140(a)(3). The monitors also failed to follow IDSI’s monitoring procedure to assure that monitoring reports documented efforts to obtain missing source records or document the reasons that these records were missing. Many records remained missing from several sites at the time of the inspection. Examples included missing [redacted] and pathology reports for biopsies at the [redacted] site and a missing pathology report for case [redacted] reported as positive and included in the PMA Patient Listing. There was no biopsy report for patient [redacted], also reported as positive in the PMA.
Your response indicates that monitors used spreadsheets to generate reports of missing items and followed up with calls/emails to obtain the missing information. However, there was no documentation available during the inspection to verify that you used these procedures. Not only must your SOPs clearly describe your monitoring procedures, you must also document that you carry them out and account for any missing records.
D. Monitors failed to assure that clinical investigators complied with the requirements for obtaining informed consent. Clinical investigators at the [redacted], and [redacted] sites used informed consent forms that did not contain all of the basic elements of informed consent as required by 21 CFR 50.25(a). Specifically, the informed consent forms used at these sites failed to mention that patients would be required to have a biopsy before undergoing a [redacted].
The monitoring report for the [redacted] site failed to address the absence of [redacted] measurements required in the informed consent form approved at this site. Furthermore, IDSI management was unaware that the consent form included the [redacted] measurement requirement.
We note that your corrective action plan includes revising your monitoring procedures to assure that all participating sites adhere to approved language in the informed consent documents. Your corrective action plan should also assure that sites use complete documents containing all required elements.
E. The monitor failed to verify that clinical investigators reviewed the seven adverse events reported in the PMA. The Adverse Event Reports collected by the monitors lacked clinical investigators’ signatures and dates indicating that investigators had reviewed the reports, evaluated the patients, and concurred with the assessment. Your response indicates that you recognize the need for investigators to document that they have reviewed all adverse events regardless of their significance and have evaluated the patients.
2. Failure to select qualified investigators [21 CFR 812.43]
Sponsors are also responsible for selecting investigators qualified by training and experience to investigate the device. The protocol required testing the clinical investigators’ proficiency in [redacted] interpretation prior to interpreting cases submitted in the IDE. No documentation is available to verify that investigators received adequate training and demonstrated [redacted] interpretation proficiency prior to study participation. Your response indicates that you agree that investigators’ training should have been documented in writing.
As part of their training, investigators received only small numbers of normal and abnormal scans to interpret. The adequacy of such a limited number of cases to develop proficiency is questionable. The number of discrepancies with a tendency toward high numbers of false positive [redacted] results is evident. For example, [redacted] received only four abnormal scans. Of these, both the first and second readings for cases [redacted] and [redacted] were positive whereas the biopsy result was negative. At the [redacted] site, there were nine cases of positive [redacted] readings with corresponding negative biopsies. There was no follow up to assess these results.
Additionally, agreement among investigators regarding the same [redacted] was poor, and in only five of the six cases did one or more investigator agree that there was an abnormality; in no instance did all of the investigators agree. There is no indication that there was follow up to determine if additional training was needed or to assess the quality of the scans. These observations failed to support the sponsor’s statement in the PMA that “post-market diagnostic accuracy will be consistent among different users.”
We note that you are investigating these observations and will respond later.
3. Failure to secure compliance from a non-compliant investigator [21 CFR 812.46 (a)]
When sponsors discover that investigators are not complying with the signed investigator agreement, the investigational plan, the requirements of applicable FDA regulations, or any conditions of approval imposed by FDA or the reviewing Institutional Review Board (IRB), the sponsor must promptly either secure compliance or discontinue shipments of the device to the investigator and terminate the investigator’s participation in the investigation. Both clinical monitoring visits and reports from your monitors indicated that several participating clinical investigators repeatedly failed to follow the protocol during the clinical investigation (examples noted above in section one). However, there was no indication that you obtained prompt correction and compliance or that you terminated these investigators’ participation in the study as required by regulation.
The above-described deviations are not intended to be an all-inclusive list of deficiencies that may exist in this clinical study. It is your responsibility as a sponsor to assure adherence to each requirement of the Act and all applicable federal regulations.
Within 15 working days after receiving this letter please provide written documentation of the additional, specific steps you have taken or will take to correct these violations and prevent the recurrence of similar violations in current and future studies. Any submitted corrective action plan must include projected completion dates for each action to be accomplished. Failure to respond to this letter and take appropriate corrective action could result in the FDA taking regulatory action without further notice to you. Send your response to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring, Program Enforcement Branch II (HFZ-312), 2098 Gaither Road, Rockville, Maryland 20850, Attention: Sybil Wellstood, Ph.D.
We are also sending a copy of this letter to FDA’s Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751, and request that you also send a copy of your response to that office. If you have any questions, please contact Dr.Wellstood by phone at (301) 594-4723, ext. 140, or by email at saw@cdrh.fda.gov.
Sincerely yours,
/S/
Timothy A. Ulatowski Director Office of Compliance Center for Devices and Radiological Health
Makers of the Lintro-scan And Lintronics' former owners Richard J. Grable and Linda Grable Now founding CEO and President of Imaging Diagnostic Systems, Inc.
Additional Public Records
SEC document describing the end of Lintronics in 1994 and the recall of all remaining "Lintro-Scan" breast imaging devices sold in the U.S.
FDA affidavit of Diane Strait, former employee of Imaging Diagnostic Systems, Inc.
From the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report: "Inappropriate Use of Transillumination for Breast Cancer Screening -- Wisconsin, 1990" MMWR. May 10, 1991; 40(18): 293-296
Journal of the National Cancer Institute, Nov. 21, 1990, V. 82: 1739-1740, "False Screening Claims Undermine Breast Cancer Detection Efforts," p. 1739, p. 1740 (.pdf files require Acrobat Reader).
U.S. Patent 5,692,511 for CTLM issued to Richard Grable.
Statement claiming CTLM patent issued to IMDS, Securities and Exchange Commission Form 10-QSB, filed Feb. 6, 1998
CTLM patent licensing agreement from IMDS' Securities and Exchange Commission Form S-2, filed July 21, 1998
FDA FOIA Documents Listed by Dates:
FDA FOIA letter, Aug. 10, 1998
April 1, 1983
June 12-13, 1983, p.1 (The year is probably a typo - it probably should be 1986)
June 12-13, 1986, p.2
June 12-13, 1986, p.3
June 12-14, 1986, p.4
Oct. 20-21, 1988, p.1
Oct. 20-21, 1988, p.2
Sept. 6-21, 1990, p.1
Sept. 6-21, 1990, p.2
Sept. 6-21, 1990, p.3
Sept. 6-21, 1990, p.4
Sept. 6-21, 1990, p.5
Sept. 6-21, 1990, p.6
Sept. 6-21, 1990, p.7
Sept. 6-21, 1990, p.8
Sept. 6-21, 1990, p.9
Sept. 6-21, 1990, p.10
Sept. 6-21, 1990, p.11
Sept. 6-21, 1990, p.12
Sept. 6-21, 1990, p.13
Sept. 6-21, 1990, p.14
Sept. 6-21, 1990, p.15
Oct. 11 & 14, 1992, p.1
Oct. 11 & 14, 1992, p.2
.
FDA Affidavit of Diane Strait, Former Employee of Imaging Diagnostic Systems, Inc. February 11, 1998
NCREDIBLY DAMAGING ARTICLE ABOUT IMDS: Published Monday, February 22, 1999, in the Miami Herald
Engineer's dream machine is a nightmare to shareholders
By JAMES McNAIR and NEIL REISNER
Dr. Stuart Kaplan said IDS was never ready to proceed full-speed, so he ended the relationship.
Diane Strait, in a statement given to the FDA, said Grable told her to modify images with a computer graphics program.
Richard Grable's dream machine is a narrow, thinly padded, fiberglass bed with a hole in it.
Grable's company, Imaging Diagnostic Systems in Plantation, touts it as a major breakthrough in the early detection of breast cancer with lasers. The National Cancer Institute and American Cancer Society estimate that 175,000 American women will be diagnosed with breast cancer in 1999. About 43,300 women will die.
At some point, Grable wants to substitute his computerized laser scanner for X-ray machines that require women's breasts to be clamped to the brink of pain. If he succeeds, he will have beaten the world's biggest medical equipment makers in the race to laser mammography.
``We're the closest to the finish line,' said Grable, who formed IDS in 1994 and serves as its chief executive officer. ``There's nobody else in the world who has done a study or who can show you images.' But there's plenty of reason to wonder if IDS will even finish the race.
Will they finish?
To date, IDS has burned through $28 million and hasn't yet obtained U.S. Food and Drug Administration approval for its device, let alone sold one. Since early 1996, when IDS' common stock topped $9 a share, U.S. investors have bailed out, driving down the share price to 51 cents as of Friday. To stay alive, IDS has relied increasingly on high-priced money from offshore financing havens like Liechtenstein and Tortola. Its auditors express having ``substantial doubts' about the company's chances of survival.
The company's own statements and history make it an easy target for skepticism. Consider:
In June 1996, Grable wrote that IDS should have FDA marketing approval by mid-1997 based on test results of 400 to 600 patients. But as of last week, only 37 patients have been tested on the optical scanner -- no more than two outside the company's own lab -- and IDS still doesn't have FDA permission to sell the machine in the United States.
On several occasions since 1997, IDS has said it would begin clinical testing of its machine on hospital patients -- a mandatory step in obtaining FDA marketing approval. But its machine still hasn't seen the inside of a hospital.
From time to time, IDS has announced the assignment of ``exclusive distribution agreements' to medical equipment dealers in countries like Italy and Turkey. No overseas orders have been booked.
In November 1997, a former IDS employee told the FDA that Grable had ordered her to enhance images taken by the machine to make a better impression at an annual radiology convention. Grable refused to talk about it, calling her a ``disgruntled employee who was fired.'
In April 1998, IDS said it expected $66 million in revenue and $32 million in pre-tax profit from the machine in the year ending June 30, 1999. Now the company says it will need $8 million in financing to get through the next two years ``to complete all necessary stages in order to enable it to market' the machine. Yet it insists it will still achieve the revenue and profit forecasts, this time by June 2000.
IDS never disclosed that, because of technology delays, its profit projection would be delayed a year. Grable couldn't remember making the projection. ``We'll have to find it and see what it says,' he said.
The steady flow of public statements that don't come true has evoked the ire of some IDS shareholders. Dan O'Leary, a Detroit accountant who has invested several thousand dollars in IDS since 1996, said he believes the company's fudging of facts warrants a federal investigation.
``Whether this company is a sham or not is up to the government or the courts to decide,' O'Leary said. ``What is clear is that management has placed their own interests above the interests of the shareholder, failed to properly protect shareholder interests and made misleading statements that were damaging to shareholders.'
People in the radiology industry, too, have learned to filter what IDS has to say.
``You can't really expect them to get into into the market in a year or two,' said Brian Casey, editor of Diagnostic Imaging Scan newsletter. ``On the other hand, they've discussed this as though it's on the cusp of commercialization.'
Man behind the machine
At 56, Richard Grable has spent nearly a third of his life pushing contraptions to make breast exams easier and more reliable for women. The first, a breast illuminator, got into his head through a magazine story from Sweden in the late 1970s.
``It sounded like a good concept,' said Grable, an engineer by trade. ``The more I looked at it, the more I liked it.'
Grable and his wife Linda Grable started Lintronics Industries in 1981 to develop a breast illuminator of their own. Their first machine, the Lintro-Scan, employed off-the-shelf parts and infrared light. The Grables opened the publicity spigots.
In trade magazine ads and product brochures, Lintronics promoted the device as an alternative to X-ray mammography. In a promotional videotape sent to TV stations and prospective investors and buyers, a narrator says, ``Malignant tumors typically show up very dramatically on the (Lintro-Scan) monitor. Extremely effective in detecting tumors in their earliest stages of development.'
The claims eventually reached the FDA. From 1986 to 1990, FDA investigators took issue with the Lintro-Scan campaign and reminded the Grables that light-scanning devices not approved by the FDA couldn't be used for diagnosing diseases.
But by then, the Grables had already sold some of their machines in the United States. One company in Wisconsin toted around a Lintro-Scan in a van, advertising mammography screens in shopping center parking lots. Federal marshals seized it.
Lintronics did a fade. The Grables told the FDA that the first incarnation of the company, Lintronics Industries, was taken over by a hostile raider and driven into insolvency. They said they sold the second, Lintronics International.
After a short hiatus, the Grables formed Imaging Diagnostic Systems in 1994. It went public by doing what is commonly called a reverse IPO -- merging with a publicly traded ``shell' company already registered with the Securities and Exchange Commission. Ever since, IDS's shares have traded on the Nasdaq Electronic Bulletin Board, the nation's haunt for ``penny' stocks trading for less than $5. Both reverse IPOs and penny stocks are frowned upon by all but the most speculative investors.
Hitting the trail
IDS planned to pick up where Lintronics left off, using laser technology developed by Richard Grable to detect abnormalities in women's breasts. Once again, he hit the publicity trail, telling The Miami Herald in 1995, ``We feel that over the next year, we'll make a real impact on the imaging of the breast.'
Not much happened during the next year, however. The FDA gave IDS the go-ahead to test its prototype machine on up to 50 women at the Strax Breast Diagnostic Institute in Lauderhill. The machine was installed at Strax, but in the 18 months it was there, only two women were tested. Grable cited technology delays and the landlord's unwillingness to let IDS install a five-ton laser cooler on the roof. Dr. Stuart Kaplan, the medical director at Strax, said IDS was never ready to proceed full-speed, so he ended the relationship.
``We were waiting so long for them to develop the technology for us to be able to do a clinical trial,' Kaplan said. ``We said we needed the space for other things.'
At IDS' 34-employee headquarters and lab in Plantation, there is ample evidence of a medical technology company in a pre-production stage. Employees are testing the laser-optic systems and wiring computer work stations. The company has five finished machines and several variations of its scanning bed.
Despite the fact that IDS can't sell its machine in the United States yet, its publicity machine has chugged along nonstop. Its public relations firms are more like partners. At least three of them have accepted IDS shares as payment, giving them an added monetary incentive to put a positive spin on the company's press releases.
The company cajoled its way into puff pieces on Good Morning America, The Phil Donahue Show, CBS This Morning and, last week, on NBC 6 in Miami. In September, U.S. News & World Report fawned over IDS in a full-page story entitled, ``No more slam-o-gram.' Irate members of the American College of Radiology's Task Force on Breast Cancer flogged the magazine for treating IDS' unproven machine as a viable alternative to X-ray mammography.
IDS was a regular guest on the news wires in 1998. It said clinical trials of its machine ``will commence in hospitals in Miami, Chicago, Los Angeles, Boston and New York.' It said the machine is in the ``last stages' of development and is anticipated to be ``ready for distribution' in the summer (of 1998). It projected sales of $66 million and pre-tax earnings of $32 million for the year ending June 30, 1999.
Statements unfulfilled
So far, none of those statements have come true. IDS has obtained FDA approval to test its laser mammographer on up to 275 patients with breast abnormalities or positive mammograms at the Nassau County Medical Center in New York, but nowhere else. Grable said talks are under way with hospitals in the other cities, making the company's original statement ``still true.' He wouldn't identify the other hospitals.
As for the machine's commercial availability and sales projections, IDS attorney Rebecca Del Medico said technological problems led to delays. She said the revenue and profit projections now apply to the year ending June 30, 2000.
``At the time it (the release) was put out, the company believed it was true and was going to happen,' Del Medico said.
Grable's most missionary endeavor, though, occurs in November, when he crates up his machine to show at the Radiological Society of North America convention and trade show in Chicago.
Because potential future customers are there in force, Grable has done the road trip to RSNA every year since 1995. The company buys a space on the trade show floor, displaying its laser mammography prototype and images taken from tested patients.
In 1997, Grable's preparation for that event turned into a scandal.
Diane Strait, who joined IDS as a technical writer and graphic designer in late 1996, said Grable declared breast images taken during clinical testing as unfit for use at RSNA. In a statement given to the FDA, Strait said Grable told her to modify the images with a computer graphics program called PhotoShop. On one image, she darkened two cysts. On another, she brightened an area of cancer and moved it elsewhere on the breast.
``The altered images were posted at the IDSI booth at the RSNA meeting,' Strait said in her FDA affidavit. ``None were identified with the statement, `images enhanced.' '
When she learned that the company planned to send the images to the FDA, Strait said she objected, saying she didn't want to take part in a fraud. The following Monday, she said she was fired.
Grable wouldn't talk about Strait, her allegations or why she was fired.
``She made a statement filled with half-truths, and I'm not going to say what was true or untrue,' he snapped. ``I will not get down in the dirt with a disgruntled employee who was fired.'
No action taken
The FDA has taken no action. A spokeswoman would not confirm or deny if the agency is investigating the claim. Strait, now a freelance technical writer, wasn't the only one at IDS who was disgruntled. Investors had complaints, too.
In an interview, O'Leary raised objections over the ownership of the laser mammography technology. In disclosures, the company treats it as its own. But the patent was issued to Grable, who then licensed it to IDS.
In return, Grable received 7 million shares of company stock and royalties of 6 percent to 10 percent of revenue from the machine. At present, the company has no revenue. Its stock, worth 51 cents a share Friday, makes Grable's 7 million shares worth about $3.6 million. Altogether, the Grables own 32.5 million shares.
Laurie Holtz, a forensic accountant in Miami, said the terms of the patent assignment sound stacked in Grable's favor.
``If he's getting shares and royalties for the patent, I don't quite get it. That sounds a little greedy,' Holtz said.
Considering that IDS has yet to sell a single machine, the Grables also draw lucrative salaries and stock options.
According to company documents filed with the SEC, Richard Grable received $286,000 in salary in 1998 and options to buy 500,000 shares of IDS stock for 31 cents a share, worth $100,000 as of Friday. The year before, Grable earned $673,000 in cash and stock. Linda Grable received $119,000 in 1998 and the same option package as her husband.
Grable said he, his wife and executives are, if anything, underpaid, given the amount of work they do.
``We did a survey of what executives of startup companies are paid and we're below the 50 percent mark,' he said.
CEOs of at least three startup medical companies in South Florida -- that have actual revenue -- take home less than Richard Grable. Alan Cohen of Andrx in Fort Lauderdale netted $257,000 in 1997. Paul Brown of HEARx in West Palm Beach earned $270,000. Jack Aronowitz of Technical Chemicals & Products in Pompano Beach earned $177,000. And none of the three received stock options in 1997.
Family spends millions
Further, while IDS is losing millions, the Grable family is spending millions on real estate and luxury cars -- nearly $4 million on real estate since October 1996. Public records show they took mortgages on several of the properties.
The Grables paid $732,000 in 1996 for their house in Plantation Acres, then added a $1.3 million unit in the Tony Portofino Tower in Miami -- $1 million of it borrowed -- and a $185,000 oceanfront condo in Fort Lauderdale's pricey Harbor Beach neighborhood off State Road A1A. In the past two years, Linda Grable has bought properties in Arizona and Ohio for sums totaling $483,000. Between them, they drive three Jaguars, two of them 1997 models.
Two Grable relations on the IDS payroll are living comfortably as well. Trishia Grable, an IDS marketing employee, bought a $400,000 house, also in Harbor Beach, in 1997 and drives a 1995 Jaguar. IDS spokeswoman Deborah O'Brien -- who says she is Linda Grable's niece, not her daughter, as Linda Grable told the FDA in 1990 -- paid $565,000 for a house a block away from Trishia and drives a 1994 Mercedes S320.
Grable made the topic of his and his family's outside investments off-limits. He did say, however, that he has driven Jaguars for 35 years. The Grables' lifestyles probably wouldn't bother IDS' shareholders and employees as much if the company were meeting its product release timetables and sales projections.
Since its inception, IDS has lost $28 million. It has no venture capital backing, no credibility in the U.S. stock market and no deep-pocketed partners. In the past three years, most of IDS' cash infusions have come from offshore stock offerings that give hefty discounts to foreign buyers of stock. For instance, last June the company netted $990,000 from the issuance of preferred stock to Austost Anstalt Schaan in Liechtenstein and Balmore Funds in Tortola, British Virgin Islands. The attraction to IDS was the infusion of cash for working capital. The attraction to the investment firms was the ability to convert the preferred stock to IDS common stock at a 75 percent discount to what U.S. shareholders are paying for it.
At about the same time, IDS announced a deal that would allow IDS to draw up to $15 million by selling stock to Austost and Balmore. Nine months later, IDS still hasn't tapped that source of money, saying its stock is too underpriced.
Officers chip in
On Feb. 3, IDS announced yet another method of raising money. It said its officers and directors have agreed to sell a ``portion' of their personal stock to help the company pay its bills.
O'Leary, the IDS stockholder, calls the latest move a publicity stunt.
``I see no mention of the amounts they are sacrificing,' he said. ``How does it compare to the excessive compensation they have received from us in the past? It does me no good for someone to take a billion dollars from me and then try to look generous by handing me a $10 bill.'
Richard Grable said raising money conventionally in the United States has not worked out.
``When you try to raise money for a company, everybody goes for the throat,' he said. ``We've had offers from United States investors asking for 65 percent of the bid (price). Venture capital people sometimes ask for 40 to 60 percent of the company.'
This far along, Grable isn't willing to sell out or give up control. With his machine due to make its hospital debut on Long Island, Grable believes momentum is on his side. No starting date has been set. If it takes place, the test should tell the world -- once and for all -- whether or not the IDS machine is the real deal.
But according to documents filed with the SEC, IDS doesn't expect to reach the marketing phase for its machine for two years -- and that's only if it obtains $8 million to stay afloat during the clinical testing period. If IDS lives up to that schedule, testing will have taken five years. That strikes Marc Watson, managing director of C/max Capital, a Coconut Grove venture capital firm, as a long time.
Once a company has gone through an adequate span of research and development, Watson said, ``The clinical program shouldn't take that long. You have to basically demonstrate that the machine is comparable to some gold standard. If you have your data together, it can be a short process.' A contrary view comes from Robert Wasserman, a stock analyst at Southeast Research Partners in Boca Raton. He said clinical trials can be quite involved.
``To some extent, it explains why a lot of the larger companies have done well this year, because it's increasingly expensive and difficult to get products approved by the FDA,' Wasserman said. ``It might have made sense for them (IDS) to do a joint venture with a Philips, Siemens or GE.' The big question is whether or not IDS deserves the benefit of the doubt. Kaplan, the mammography clinic director who worked as closely with IDS as anyone, remains skeptical.
``I certainly don't discount it as being a possible viable technology,' he said. ``Technology doesn't develop overnight. Sometimes it takes years and years and years of researching and developing and testing
``But I always had a problem with the impression they wanted to give, that this (laser mammography) was out there, ready to go and ready to replace the mammogram,' he said. ``That was ludicrous.'
I was recently employed by Imaging diagnostic Systems, Inc. (ISDI) 6531 NW 18th Ct., Plantation, Florida xxxxx in the position of Technical Writer and Graphic Designer. My address is xxx xx xth xxx, xxx, Florida xxxxx. My social Security number is xxx-xx-xxxx and my Florida Driver's license number is xxxx-xxx-xx-xxx.
On February 11, 1998, I met with investigator Michelle S. Dunaway and Supervisory investigator Keith S. Ehrlich at the office of the Food and Drug Administration, 1499 Palmetto Park Road, Suite 110, Boca Raton, Florida 33486 and provided information about certain operations and activities that I observed during my employment at IDSI.
I first started working for IDSI as a technical writer under contract with Academy Design, Margate, Florida. In this position I was responsible for designing and composing the User Manual for the Computed Tomography Laser Mammography (CTLM) breast imaging system. On February 24, 1997, I began working for IDSI as a full time employee with technical writer and graphic designer responsibilities. In this position, I continued to design and compose the User Manual and also designed brochures, CD Covers, magazine advertisements, company profiles, and press releases.
On an unknown date in September, 1997 I volunteered to be a test patient as part of the investigational study for the CTLM breast imaging system in addition to performing my normal duties described above.
During the period September 1997 through November 1997, images were taken of an unknown number of individuals as part of a twenty person clinical trial. Those individuals were scanned on a CTLM unit, connected to a network computer, in the showroom of the Plantation, Florida facility. Because none of the images from these individuals were deemed useful, two additional patients were referred to the study by Dr. Stuart Kaplan of Strax Breast Center Detection Institute. Lauderhill, Florida. Also during this period, images were taken of my breasts to function as a normal control for the study. The two individuals from which the cancer and cysts case studies were made and myself were scanned on a CTLM unit, connected to the network computer known as "Hydra", located in Bay 2 of the facility in Plantation, Florida. Of the number of images taken during this period, only the images from five cases were considered to be of use for public presentation purposes of the investigational device. These five cases were the cancer case and the cyst case that had been referred by Dr. Kaplan, two phantoms and my normal control.
On an unknown date in the middle of November 1997, Mr. Richard Grable, CEO called a small meeting that included the following individuals: Richard Grable, CEO; Sharon D. Jones, Director of Applications; Steven T. Gardner, Mechanical Engineer; Steve Ponder, Acting Head Software Engineer; Steven G. Ross, Software Engineer; William Dieckmann, Software Engineer, and Gary Becker, Software Engineer. During that meeting Mr. Grable said that the images that had been produced for the cancer and cyst case studies were not acceptable for presentation at the Radiological Society of North America (RSNA) Scientific Assembly and Annual Meeting in Chicago during the period of November 30, 1997 through December 6, 1997. He said that he did not want to waste the $350,000 that had been spent in preparation for the meeting by having these images presented "as they are now". He said they were going to "enhance" the images. Mr. Gardner suggested that the company would be protected if a statement such as "*images enhanced" was placed on each film. Mr. Grable said that was a good idea and everyone agreed to proceed with enhancing the images. Someone asked Mr. Grable how this was going to be accomplished and he stated that he was going to take care of the situation with Sharon Jones and myself "with PhotoShop".
On November 26, 1997 the following individuals agreed to meet at 6:30 pm on Thanksgiving Day, November 27, 1997 to make final preparations for the RSNA meeting: Richard Grable, Sharon Jones, Steve ponder, David Hall (title unknown) and myself. Steve Ponder selected the best images and placed copies of them in a software folder that had been labeled as RSNS97. I accessed these images and converted them to a .tif file so I could access them with the desktop publishing software PhotoShop. X-ray films were then made from the images, several of which had been modified from the original scanned images. A total of five case studies were made for presentation at the RSNA meeting.
I made several modifications, all of which I cannot remember, at my workstation as directed by Mr. Grable. These modifications included the following:
Cyst patient: Mr. Grable indicated that this CTLM image was not acceptable for the following reasons: the bright spot (artifact) in the center of the image, the scalloped edges of the image and the low resolution of the known (from mammogram and ultrasound) cysts. He directed me to darken the central artifact, to make a better defined contrast of the two known cyst areas at 2 o'clock and 6 o'clock and to flatten out the scalloped outside edges. These alterations made it appear as if the CTLM breast imaging system had produced better resolved images for the cysts in this case study that what had actually been produced. Mr. Grable also directed me to alter the mammogram by darkening a lighter area to emphasize the cyst.
Cancer patient: Mr. Grable indicated that this CTLM image was not acceptable because it looked too splotchy and had scalloped edges. He directed me to make the bright cancer area brighter and to smooth out the darker areas. These alterations made it appear as if the CTLM breast imaging system had produced better resolved images for the cancer in this case study than what had actually been produced. Mr. Grable and I also scanned a photograph of a breast with cancer from a medical book into the computer. Because the cancer in this photograph was not in the correct location, Mr. Grable directed me to cut and paste the cancer to a location that better matched the case history.
I believe that Sharon Jones, David Hall and Steve Ponder were aware that these images were being altered by me at the direction of Mr. Grable.
The above altered images were posted at the IDSI booth at the RSNA meeting. None were identified with the statement "*images enhanced". The following publications, which I composed, also included these altered images: The CD entitled "Imaging Diagnostic Systems, Inc. The Future of CT Laser Mammography" and the brochure with the same title. These publications have been sent out to prospective investors, shareholders and potential clinical sites.
On February 6, 1998, I overheard Sharon Jones, repeatedly mentioning my name. When I asked Ms. Jones what she was talking about, she told me that she was getting together a packet of information to send to the FDA. This packet of information contained the same images that had been altered by myself at the direction of Mr. Grable as well as images of myself that had been taken as a normal control. I informed Ms. Jones that I did not want my images to be included in the submission because I knew the collection had been altered and I did not want to be involved with fraud. Ms Jones said that she would tell Mr. Grable. I later observed Ms. Jones to enter and leave Mr. Grable's office. Immediately after Ms Jones left Mr. Grable's office, I observed the door to slam and I heard loud yelling voices whom I believe belonged to Mr. Grable and Mrs. Linda Grable, coming from the office. Ms. Jones later told me that Mr. Grable had said "don't use them then" in response to my wishes (meaning not to use my normal control images.) Prior to leaving work that day, I made copies of original scanned images for the cancer and cyst patients from the IDSI software onto a disk.
On February 9, 1998, I arrived at work and noticed that the hard drives from both of the computers in my workstation had been removed. I was then informed that I was fired. Later that day, I telephoned Michael E. Marcarelli FDA/CDRH after having been referred to him by Andrew Skolnick, Editor for the Journal of the American Medical Association (JAMA). I informed Mr. Marcarelli that I had just been fired from IDSI because I had stated on February 6, 1998 that I did not want hard copies of images that had been taken of me included with the packet of information, containing the altered images, that was going to be submitted to the FDA.
On February 10, 1998, I received a telephone call from Investigator Dunaway during which we agreed to meet at the offices of the Food and Drug Administration on February 11, 1998 to discuss my knowledge of certain operations and activities that I had observed during my employment at IDSI. In preparation of this meeting, I had hard copies of the original images for the cyst and cancer case studies, as described above, made and I also bought a zip disk for $18.95 upon which I copied the two above described original unaltered images and an unknown number of unidentified original unaltered CTLM slices for accessing in a PC format.
Yes. Many of the documents AS posted on his site are no longer available. It would be beneficial to see those posted here as Grable loves to cover her tracks.
The inerview AS did with Dickie and the IMDS corporate lawyer was classic, as well as the FDA inspection reports of both Linronics and IMDS.
Lucky had his own IMDS booard on MSN for a few years and finally slinkied away. Moon aka kgsimmons aka Kent aka 100 other aliases still posts on Yahoo, here, and other boards.
Linda has almost a million dollar IRS lien on her for stealing the employeed with holding for years.
You need to read her SEC deposition from 2013. It's as funny as ones you exposed them under back in the day. I cannot believe these people are still walking around and not in prison. Too bad the SEC didn't stop this scam back when they were caught altering images back in 1997.
Nice to speak with you. Been a long time since the SI and Raging Bull days. I used Kenita as I assumed only you and the Grable clan would know that. Anything you would like to share?
Thoughts on this latest scam of the Chinese angel investor money to bail out Linda?
The swirling noise has been going on with IMDS for 20 years. It is the sound of investors money being flushed down the toilet to support the Grable's lavish lifestyles.
Any mistake that was made was most likely by “the company”. A PMA is a more stringent requirement than the 510(k). The only mistake that FDA might have made is by indicating the reason as “No 510(k)” instead of “No PMA” but the bottom line is that “the company” did not complete the requirements to legally market the device in the USA and that is why the item was refused admission.
======================
Sincerely,
=|<:}Geoff Mr Geoffrey S Clark, ConsumerSafetyOfficer HHS/PHS/FDA/CDRH/OCER/DSMICA (HFZ-220) 240.276.3158x122 ====================== Wise men learn by others harms; fools scarcely by their own. - B.F. ===========================================================
From: xx] Sent: Friday, November 02, 2007 8:32 AM To: Clark, Geoffrey S. Subject: Re: 10-442 gsc - Imaging Diagnostic Systems
Thank you for looking into this Mr Clark
Please allow me to clarify. I am trying to understand what this all means myself.
Country of Origin Entry # DOC Line Suffix Manufacture Name City / ISO Country Code District Product Code Product Description Date Reason
United States KG2-0524008-1 1 1 Imaging Diagnostic Systems, Inc. Plantation, FL 33313-4520 FLA-DO 90K--PS COMPUTED TOMOGRAPHY LASER BREAST IMAGING SYSTEM MODEL 1020 S 20-SEP-2007 NON STD
NO 510(K)
####
To me this suggests a 510k application was rejected or denied, or at least the company was denied permission to market the device.
However, Deborah O'brien, an IDSI Vice President has distributed the following email claiming an FDA "mistake" was made. However I don't see any correction made by the FDA. So I''m trying to understand what this database entry really means and what "mistake" could have been made.
## From: WarrenTSI@aol. com [mailto:WarrenTSI@aol. com] Sent: Tuesday, October 16, 2007 3:56 PM To: obrien@imds. com Subject: 510(k) Deb: If the 510(k) was not approved, is it considered a serious setback to the company?
Thanks
Warren
It was a mistake made by FDA. The company has never filed for a 510K it does not meet the requirements for a 510K. This is why the company is seeking approval through a Pre-market Approval application as directed by the FDA. We are handling the matter at this point and trying to get the issue rectified. ####
Hologic Inc came up with one of the first 3-D breast imaging devices in 2001, which continues to dominate the market. Siemens AG submitted its application for the approval of its own 3-D breast imaging device in June.
Why is it GE, Hologic, and Siemens all can make successful FDA submissions while IMDS after taking 130 MILLION dollars, failed three times?
Could it be that Grable put in place her children with no medical education, job experience, or qualifications in charge of FDA submissions?
I encourage everyone to read the former IMDS CEO Linda Grable's sworn SEC deposition from 2013. You will see the arrogance and deceitfulness first hand. (jump to page 237)
I don't see why not. Look at all the positive things IMDS has going for it
SEC revocation order of the stock awaiting final notice SEC investigaion of the CEO and CFO resulting in fines, censures, and resigntion of them both Sale of company to unknown Chinese investors for reasons unknown No sales of CTLM in years No FDA submission Patents on CTLM expiring next year IRS lien on company for non payment of taxes Five million dollars in liabilities Company has stopped reporting to the SEC a year ago Stock delisted
I'd say this is the best investment opportunity since Apple went public. Of course you should have all of your family and friends invest their money as well.
Looks as if IMDS main toxic lender is under SEC investigation as well.
SEC And Manhattan DA Investigate Southridge Capital
Southridge Capital Management, a Ridgefield, Conn., hedge fund firm run by Stephen Hicks that primarily employs an investment strategy known as PIPEs, is under investigation by the Securities and Exchange Commission and Manhattan District Attorney Robert Morgenthau.
The SEC has opened an investigation into Southridge, according to two subpoenas the SEC sent in late July to companies that had received financing from the firm’s hedge funds.
In the five-page subpoenas, Vyta Corp. and Hyperdynamics Corp. , two micro-cap companies that have been fighting Southridge for years in court, were asked by the SEC to produce documents reflecting all transfers of cash between them and the Southridge hedge funds over a four-year period. The companies were also told to provide documents relating to securities they issued to Southridge and communications between the companies and Southridge.
Late last week, the Ridgefield Police Department searched Southridge’s offices, executing a search warrant on behalf of Morgenthau. The search was first reported by Bloomberg News.
“Our department assisted the Manhattan district attorney’s office,” said Ridgefield Police Captain Steven Brown. A Manhattan DA spokesperson declined to comment. An SEC spokesperson neither confirmed nor denied the existence of an investigation.
In an e-mailed statement, Southridge Capital Management says: “We are cooperating fully with authorities and cannot provide any further information at this time.”
Hyperdynamics and Vyta, formally known as Nanopierce Technologies, first sued Southridge back in 2001, alleging Southridge manipulated their stocks. In May 2009, Vyta announced it was ceasing its operations. Hyperdynamics is battling to keep its case in state court in Georgia.
“From the nature of the document requests, they are looking into trading patterns with respect to Southridge, and they are looking at what Southridge Capital promised companies with regard to certain financings versus what actually happened,” says James “Wes” Christian, an attorney who represents Vyta and Hyperdynamics. Christian says he represents LecStar Telecom, which has also sued Southridge. The suit of another Christian client against Southridge, Internet Law Library, has been tossed out of court.
Hicks’ main investment strategy has been to make private investments in public equities, known as PIPEs, in which Hicks invested in thinly traded stocks. In these deals, Hicks would get securities that were convertible into discounted common shares of the companies in which he invested.
Hicks and Southridge Capital were the subject of a 2002 Forbes article (see “Sinking Fund”) on death spiral preferred financings that also detailed the work of Mark Valentine, former chairman of Canadian brokerage Thomson Kernaghan. Southridge was a key client of the now defunct Thomson Kernaghan. Valentine pleaded guilty in March 2004 to U.S. federal charges of securities fraud, receiving nine months of house arrest and four years of probation. He was also banned from working as a stockbroker.
Hicks founded Southridge Capital in 1996 and also set up an affiliated brokerage, Southridge Group, which provides investment banking and financial advisory services. Southridge claims its funds have provided $1.3 billion in capital to over 250 issuers worldwide.
Over the last few years, hedge funds have made billions of dollars of investments in penny stocks using PIPE structures, often causing the underlying stocks to plummet. The practices of hedge funds that specialize in penny stock PIPE financings have recently come under renewed scrutiny by regulators and law enforcement agencies.
In July, the SEC subpoenaed documents from NIR Group, the Long Island hedge fund firm run by Corey Ribotsky that specializes in PIPEs, in an investigation focusing on the performance valuations of NIR’s family of hedge funds and communications NIR made to investors.
Prosecutors from the U.S. Attorney’s office in Brooklyn and investigators from the FBI are looking into whether Ribotsky defrauded investors as the stock market fell last year, The Wall Street Journal has reported. NIR has previously said that it’s fully cooperating with the SEC and is eager to provide to it any information or documents that it requests.
The efforts of hedge funds like NIR Group and Laurus Capital Management to turbocharge their returns by focusing on penny stocks and PIPEs have been the subject of several articles in Forbes over the last three years
Patience. The SEC has done everything possible to warn off any investor from this scam including the C&D order, the stock suspension, the investigation resulting in fines,censures and resignations of of the CEO and CFO, the skull and crossbone caveat emptor warning, the delisting of the stock and now the revocation.
The stock will be revoked soon enoigh. That is not how the rules work. The SEC did order the stock revoked. Every company is afforded the opportunity to provide their response and the SEC then makes a final determination.
Have you seen any significant stock trading since the revocation order on 8/1?
I believe there is a language barrier issue here. Nevertheless, I wonder what is taking so long for the final revocation decision from the SEC. More games being played by IMDS?
Second, that "distributor" is a beauty clinic that does massages and accupuncture, and had false and misleading information on their website.
IMDS- "distributor" - Hang Lekiu Medical Center-
Quote:www.hanglekiumed.com [translated] Modern lifestyle, especially diet, have contributed more or less contributed to the increase in attacks to degenerative diseases such as diabetes, heart disease, hypertension and obesity. For that, Hang Lekiu Medical Center offers solutions in the form of consulting services and medical therapy. Body Countouring, Skin Rejuvination, Beauty Dental, Sport Massage, Facial, Medical Check Up. Available packages include health care, Body Countouring, Skin Rejuvination, Beauty Dental, Sport Massage, Facial, Physiotherapy, Medical Check Up, Sports Clinic and Clinical Nutrition. The Nutrition Specialist, Sports Specialist, and Doctor Expert Beauty will give a program to suit the needs of visitors. Hang Lekiu Medical Center also comes with a personal touch and comfort are different. You can even save more time for consultation by telephone reservation schedule.
"FIRST and ONLY THERE IN INDONESIA IN HLMC! Tool for early detection of breast cancer, with the latest tekhonologi without RADIATION EFFECTS! CT Laser is the latest tool for early detection of breast cancer with the approach via a digital laser. With the detection accuracy rate of up to 90% of the CT Laser safe to use because it does not cause radiation effects. Inspection is more convenient and efficient because without pressing.
Enjoy 50% discount for each examination CTLM. Contact us immediately! ""
Last, you have not heard a word from this "distributor"in two years. Like every other shill distributor, it was all about selling stock.
Is the CTLM viable? The answer seems clear. Twenty years, 130 million dollars, three failed FDA submissions, and they have sold less than ONE machine per year when they claim to have been approved to sell the machines in dozens of countries. If the machine worked as claimed, every country would be beating on their door for them. Instead, not one reputable hospital has ever installed one, IMDS has never been able to give one away in Canada. Why is that?
I'd suggest you do some research on Grable and her medical device scams. Start with her former one, Lintronics.
Miami Herald report which provides a clear history of the scamming from Lintronics to IMDS.
Quote:February 22, 1999
Grable and his wife Linda Grable started Lintronics Industries in 1981 to develop a breast illuminator of their own. The first machine, the Lintro-Scan, employed off-the-shelf parts and infrared light. The Grables opened the publicity spigots. In trade magazine ads and product brochures, Lintronics promoted the device as an alternative to X-ray mammography. In a promotional videotape sent to TV stations and prospective investors and buyers, a narrator says, "Malignant tumors typically show up very dramatically on the (Lintro-Scan) monitor. Extremely effective in detecting tumors in their earliest stages of development. The claims eventually reached the FDA. From 1986 to 1990, FDA investigators took issue with the Lintro-Scan campaign and reminded the Grables that light-scanning devices not approved by the FDA coundn't be used for diagnosing diseases. But by then the Grables had already sold some of their machines in the United States.One company in Wisconsin toted around the Lintro-Scan in a van, advertising mammography screens in shopping center parking lots. Federal Marshals seized it. Lintronics did a fade. The Grables told the FDA that the first incarnation of the company Lintronics Industries, was taken over by a hostile raider and driven into solvency. They said they sold the second, International. After a short hiatus, The Grables formed Imaging Diagnostic Systems in 1993. It went public by doing what is commonly called a reverse IPO - merging with a publicly trading "shell" company already registered with the SEC. IDSI planned to pick up where Lintronics left off, using laser technology developed by Richard Grable to detect abnormalities in women's breasts.
Grable has been scamming people for over 30 years.
Spot on. Tbat is how the Grables have managed to become multi millionaires, by scamming people with fairy tales and broken promise of their sham medical devices for three decades. They have managed to swindle over 130 million dollars from the public in IMDS alone
Go back and do a search of the boards from 2012 and you will see the biggest promoters of IMDS on this board later state after claiming to have lost thousands of dollars that Linda Grable lied to them repeatedly.
This is a pattern that has been repeated over and over throughout the years. IMDS has been sued by their vendors, distribuors, board members, employees, stock promoters, the IRS, the State of Florida, and investigated by the SEC on many occasions.
Every company Grable has ran is no longer in business,with IMDS soon to follow.
IMDS was NEVER $34.5 a share. Again, that is another misrepresentation of facts. The stock has not been above a PENNY in years. IMDS did a reverse split and ADJUSTED for the reverse split the stock price RETROACTIVELY WOULD HAVE BEEN that price. BIG difference.
Just another reminder of how Grable screwed the investors.
And $100 lost is still $100 lost. Too bad investors have LOST over 140 MILLION dollars since inception in this scam.
The stock is on the verge of being revoked. That is all that is needed to know.
Long, he was already informed in April of 2014 the shares were aquired at $0 cost. 11/21/2013 Elizabeth J. Shotmeyer Director 100,000,000 Acquisition at $0 per share.
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