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To: KAKALAK who wrote (1629)8/26/1998 9:18:00 PM
From: Dan O  Read Replies (1) | Respond to of 4122
 
Richard Grable (self proclaimed "pioneer") is apparently speaking out and making threats (if this is a legitimate quote). Here is a post from the AOL board. What do you fellas make of it?:

Subject: Re: Email from Richard Grable.
Date: Wed, Aug 26, 1998 12:26 EDT
From: DRJMF1
Message-id: <1998082616262300.MAA09042@ladder03.news.aol.com>

The following is an email from Richard Grable in response to my inquiry concerning his connection with Lintroscan. Please note that the posting on the SI board by this fellow Andrew listed old references to support the negative comments about transillumination mammography:

Subj: Letter from Richard Grable
Date: 8/25/98 3:46:03 PM Eastern Daylight Time
From: Feedback@IMDS.com (Robert V Smith)
To: drjmf1@aol.com

Dear Dr. Freedman:

Thank you for your interest in Imaging Diagnostic Systems, Inc. (IDSI). Ihave read your e-mail and I would like to comment on yourobservations.

The Internet is a powerful tool that has the potential for being of greatvalue to those who are able to use it. Unfortunately, the Internet also has the potential to allow unscrupulous individuals to act irresponsibly and anonymously through use of an alias. Persons using the Internet arenot regulated, and can and do say anything they desire, factual,fictional or contrived.

For these reasons, it is the policy of IDSI not to respond to anonymouspostings or postings without a verifiable identity of the individual making the posting. Anyone who asks a direct question of the company,verbally or in writing, and provides their name and address receives areply.

I am aware of at least one recent posting on Silicone Investor (SI) thatI believe was made with malicious intent. If you are referring to this recent posting concerning Lintronics Industries Inc. LINTRO-SCAN, and Mrs. Grable and me, your spin on LINTRO-SCAN, i.e. &quot;lintroscam&quot;, clearly supports my decision to not respond to trash on the Internet. You apparently may have made the decision to slur LINTRO-SCAN into &quot;lintroscam&quot; based
on the limited information you received from this posting. The posting failed to mention that a 15-month clinical evaluation of the LINTRO-SCAN was conducted at the University of Miami School of Medicine and a paper was published on the results. In this clinical trial involving over 700 women, the LINTRO-SCAN demonstrated a sensitivity of 96%, specificity of 74% and a false negative rate of 4%. The physicians concluded, in part in their abstract,
&quot; ... I.L.S. (LINTRO-SCAN) of the breast has proven effective in the hands of trained personnel and should be used with routine breast examination or mammography to increase yield of breastpathology.&quot;

The SI posting appears to be a collage with confused time-frames of selected excerpts from FDA supplied information. The complete history of breast transillumination for the entire period from about 1982 through 1994 would be a significant volume.&nbsp; The FDA did not classify breast transilluminators as Class III devices, thus requiring a pre-market approval (PMA), until 1994. I found it interesting that the posting focused on a comment that
referred to the &quot;...hypothetical patient who might receive Lintro-Scan and be informed that she is disease free when in fact, she has breast cancer ...&quot;. Interestingly, by replacing the name &quot;Lintro-Scan&quot; with word &quot;mammography&quot;, the statement meaning is identical. Why single out LINTRO-SCAN? Mammography has the highest number of malpractice suits of any radiographic procedure because of delayed and/or missed diagnosis.
As a physician, I am sure that you know there is no single test that will provide 100% sensitivity to a disease.

The LINTRO-SCAN was a device that was extremely operator dependent. When the examination was performed by the interpreting physician, the results were good. When the examination was performed by a technician and a video tape of the procedure interpreted later, the results were not as good. But, the idea of using near infrared light as an imaging modality was in fact demonstrated. The limitations of breast transillumination and the viability of near
infrared light for breast imaging were two of the motivations for building the MAMMO-SCAN, the first computed tomography scanner to use a laser diode and solid state-electronics to produce a cross-section image of the breast. The prototype was demonstrated at the Radiological Society of North America (RSNA) meeting in Chicago in 1989. The laser and computer technology of 1989/1990 prevented furtherrefinement of the prototype.

I am a pioneer in the field of medical optical imaging. I would be happy to show you the collection of proceedings that I have from conferences over the past several years. There is no shortage of research, but no one, except IDSI and perhaps Philips Medical of the Netherlands, has an operational in vivo scanner that has undergone clinical testing.

If you obtain the FDA documents yourself, you will see the selectivelifting of factual information and presentation of that information in a totally different light. THERE WAS NO FOOD and DRUG ADMINISTRATION (FDA) ACTION ever taken by the FDA against Lintronics Industries Inc., Mrs. Grable or myself in any of the companies we owned or managed. The documents referred to are routine FDA inspection reports. On those pages (forms) where FDA action could
be initiated, all of the blank lines for initiating action are empty, not one single notation. The Internet posting leads you to a totally different conclusion.

The FDA action taken in Wisconsin concerning the LINTRO-SCAN resulted because of the irresponsible action of the individual who owned the LINTRO-SCAN and personally chose to promote it improperly. The individual promoted the LINTRO-SCAN as a replacement for mammography, a claim never made by me or anyone directly associated with the company. Mrs. Grable nor I had any control over the device nor how it was promoted or used after it was sold. The
posting presents this fact in a totally differentmanner.

The subject of FDA inspections must be addressed. Every device manufacturer is inspected by the FDA. At the conclusion of an FDA inspection, the inspector prepares an affidavit of observations made. It is considered to be medical industry practice not to read or otherwise review or sign the affidavit, but, instead, to wait for an official FDA action, if any, to be taken. Discussions with the inspector are of little use because an inspector does not
make any decision on FDA action, their supervisor is the first level of decision making. The discussions noted in the posting represented to have occurred between the FDA inspector and me are inaccurate because the content is subject to the recall and interpretation of the inspector. For example, &quot;Mr. Grable was informed that (these) may be violations of the Federal Food, Drug, and Cosmetic Act. Mr. Grable stated the he agreed with my
observations and promised to respond to FDA in writing on each item that was listed.&quot; I have a different memory of this event.

This posting and other evidence points to the activities of a disgruntled employee who has publicly stated the intention to ruin the company. Many of the events alluded to could only have been known by someone working in the company. An outsider would not have had the opportunity to have any knowledge of some of them. The company is looking into legal remedies tolimit damage to the company and its reputation.

Please note, we believe that &quot;Andrew Abraham&quot; is most likely not the authors' real name. We have initiated an investigation to learn the real identity of &quot;Andrew Abraham&quot;. We believe the posting to be a libelous act and we will initiate appropriate legal action to protect the reputation and names of IDSI and the individualsaffected.

With respect to what you refer to as &quot;phase 2&quot;, the company's press release of March 23, 1998 informed shareholders that an FDA approved IDE had been obtained for continued in vivo testing. Our present web-page posting includes phantom images as well as a notice that in vivo images will be provided. As a physician with knowledge of science, I am sure you can appreciate that what IDSI is doing has not been done before and there is no roadmap
to show the way. Other researchers in the field have not advanced as far as we have and they have, in most cases, twicethe time and money invested.

IDSI is a development stage company in the public market place. We believe that certain market makers/brokers have acted for their personal profit at the expense of all other shareholders, including me. When the unusually high volume and small spread between bid-and-asked prices is reviewed over a considerable period of time, there appears to have been a consorted effort to short IMDS stock,. As would be expected, shorting of IMDS stock has resulted
in a significant depression of the price of the stock. The mis-information posted on the Internet serves only to further depress shareholder and investor confidence, and MORE IMPORTANTLY, the company is powerless to mount an effective counter-attack without aconsiderable expenditure in time and money.

The management of IDSI is regulated by Securities and Exchange Commission (SEC) law. Information released by IDSI management must be factual and accurate, and cannot be selectively disclosed. Information is released as it is available. Our press releases reflect what we are legally able to talk about. Since you have visited IDSI once before, now would be a good time for you to visit again and see for yourself the progress of our pioneering efforts.

Sincerely,

Richard J. Grable
Chief Executive Officer
<div>Regards</div>
<div>Robert V Smith</div>
<div>Imaging Diagnostic Systems, Inc</div><div>6531 NW 18th Court</div><div>Plantation, Fl 33313</div><div>1.954.581.9800&nbsp; voice</div><div>1.954.316.0006&nbsp; fax</div>http://www.IMDS.com

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To: KAKALAK who wrote (1629)8/27/1998 2:33:00 PM
From: Andrew Abraham  Read Replies (2) | Respond to of 4122
 
It appears that one of the IRB members, DR. LISA BANCHIK, is a bit too close to the company to make her an impartial review board member. She's married to IMDS' software designer!

If any one speaks with her, ask her how she can make impartial decisions about IMDS clinical studies if a major part of her household income depends on FDA approval of IMDS' mammography device.

Also, if anyone speaks with the FDA, ask the agency why it allows a company to put someone on its IRB with such an obvious conflict of interest.

Let me know the answers.

-A.A.