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  • TELEPHONICS TELEPHONICS May 21, 2006 11:08 AM Flag

    News Release Part I

    Given Imaging Announces PillCam� Capsule Endoscopy Studies To Be Presented At Digestive Disease Week 2006



    YOQNEAM, Israel - May 18, 2006 - Given Imaging (NASDAQ: GIVN) announced today that 86 abstracts on PillCam capsule endoscopy will be presented at this year's Digestive Disease Week� 2006 (DDW�) medical meeting from May 20 to 25 in Los Angeles. Given Imaging will host several educational "Meet the Experts" sessions throughout the week at booth number 644.



    Among the clinical data to be presented on PillCam capsule endoscopy are:




    Iron Deficiency Anemia


    "Comparison of Wireless Video Small Bowel Capsule Endoscopy (CE) and Upper Endoscopy (EGD) in Evaluation of Iron-deficiency Anemia (IDA) in Patients with Negative Colonoscopy," (Abstract M1301) Monday, May 22, 2006, 8:00 a.m. West Hall A (Los Angeles Convention Center)





    Clinical Practice/Outcomes


    "Capsule Endoscopy Findings and Clinical Outcomes in Patients with Obscure Gastrointestinal Bleeding," (Abstract S1463) Sunday, May 21, 2006, 8:00 a.m. West Hall A (Los Angeles Convention Center)

    "Capsule Endoscopy: Benefit in Evaluation of 'Missed' Endoscopic Lesions in Obscure GI bleeding," (Abstract M1247) Monday, May 22, 2006, 8:00 a.m. West Hall A (Los Angeles Convention Center)

    "Impact of Capsule Endoscopy on Clinical Outcomes," (Abstract M1323); Monday, May 22, 2006, 8:00 a.m. West Hall A (Los Angeles Convention Center)

    "Capsule Endoscopy for Obscure Gastrointestinal Bleeding: A Report of 100 Consecutive Cases to Investigate Long Term Clinical Outcomes," (Abstract M1259); Monday, May 22, 2006, 8:00 a.m. West Hall A (Los Angeles Convention Center)

    "Long Term Follow-up of Patients with Obscure Gastrointestinal Bleeding after Negative Endoscopy," (Presentation # 500) Tuesday, May 23, 2006, 9:30 a.m. 511 A/B/C (Los Angeles Convention Center)




    Crohn's Disease


    "Mucosal Healing in the Small Intestine Detected by Wireless Capsule Endoscopy," (Abstract S1407) Sunday, May 21, 2006, 8:00 a.m. West Hall A; (Los Angeles Convention Center)


    "Usefulness of the Capsule Endoscopy in the Study of Inflammatory Bowel Disease: Preliminary results," (Abstract T1122) Tuesday, May 23, 2006, 8:30 a.m. West Hall A (Los Angeles Convention Center)




    Given Imaging will also host teleconference on Friday, May 26th at 10:30 am ET to summarize the key abstracts presented at this year's DDW. To participate in the teleconference, please dial 800-289-0572 fifteen minutes before the conference begins. International callers should dial 913-981-5543. The call will also be webcast live at www.givenimaging.com. A replay of the call will be available on the company's website by dialing 888-203-1112. International callers should dial 719-457-0820. The replay participant code is 8747793.






    About Digestive Disease Week

    Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 20 - 25, 2006 in Los Angeles, at the Los Angeles Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

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    • Darbyred or Ed Shenkan of Needham,
      You both have provided useful clues--Darbyred on Olympus lawsuit date/details and Ed Shenkan on webcasts questions on 5/26/06 on Olympus.
      I reread 5604531--original patent of Iddan assigned to Given for 30 mil.$in 1998 by Rafeal.I reread USPTO rulings on 4/3/06 in details rejecting claims 1,2,3 and 11.These are the most important claims for Ingestible Capsule.Rest of the claims are not broad enough.I also reread 7039453 and find its claims very broad.My question to you,Ed Snenkan and Homi Shamir?
      Would you please address the risk to Given Imaging if Olympus prevails in its lawsuit--on the weakened aspects of "531".I think that a charge of one million$ in legal fees in 2006 and perhaps another one million$ in 2007 is to be expected.Am I correct in these estimates?
      To Ed Shenkan: How can you project 61 cents/share for 2007 with extra legal costs?Have you revised 2006/2007 EPS for GIVN?
      To Darbyred:What is your projection for EPS for 2006/2007?
      To Ed Shenkan and Darbyred?What happens to Given Imaging if Olympus gets Exclusive to 7039453?What will be the impact on GIVN EPS for 2007?
      Ed shenkan is unlikely to respond to the message board,but will Ed address some of these questions on 14th June at 9.00AM?
      If Ed does not change his rating from Hold--at least he should change his EPS forecasts?
      Hope Homi Shamir will be candid and develop credibilty--key to Stock's performance?I think if he plays games,he can quickly hurt his credibility and stock price could suffer as a result.

    • DD provides the answers to your question. Yes-Yes and Yes.

    • Making predictions about what or when FDA will act is akin to going long on penny stocks on the OTC market.Totally unpredictable what will happen in either case.

    • Nath12nath,
      You are a doctor and I am an investor only.You have very good points.But Dr.Fleischer of Mayo clinic and Dr.Van Dam of Stanford probably know the problems with Remote Control Capsule.All these problems will have to be handled before any company will take the lead in introducing such a (liabelous)product.Remote control(robotic)surgery was unthinkable a few years ago.
      As far as Olympus images,you may wish to read the transcript of DDW2006 webcast--Investor--SEC Filing 6K on June 5,2006 on www.givenimaging.com Dr.Faigel was asked about Olympus Capsule.
      All these enhancements can be changed with computer programs to meet doctors/medical/FDA requirements.
      As far as colonscopy with Capsule--first battery life has to be 24 hours or battery power has to be provided externally and then cleaniness issue has to be handled as you as a GI have so well explained.Capsule may not totally replace current equipment clonoscopy,but may help in situations where people avoid being scoped at all.
      I would appreciate your comment on Dr.Faigel's remarks on webcast.

    • CHipGWuy,
      Great example!Thanks.That is why GIVN with NIH thinking is likely to be in trouble against Olympus unless Homi Shamir realizes that" he cannot win the battle and lose the War".He needs to strengthen GIVN against attacks from different directions,by joint ventures on technology/marketing/patents.Olympus is well known in this market and when it comes out with full force,GIVN will find itself overwhelmed.GIVN must give up NIH thinking and acquire other patents and join hands with RFSystemlabs.With the help from J&J,strengthened technology/new products with Norika4 and other patents,GIVN will be able to defend itself better and not meet NEC's fate against Intel cited by you.

    • I don't know whether or not he is wasting his time but I know the risks. Major benefits of CE are being friendly and safe and device which is not controlled manually is not safe.. GIVN will have lot of troubles with the Pillcam colon because it will not be friendly; patients will be enforced to use the lousy cleaning material like in traditional colonoscopy and perhaps extra quantity (because Pillcam colon will probably not have the internal water splashing).
      Regarding Olympus images, I have looked at Olympus Europe web and to say the truth I did not like the images. Olympus enhance the images too much (you may see the enhanced points and edges.
      Everybody who wants to get the FDA approval knows that it is not aloud to add artifacts because docs may think that these artifacts are pathologies

    • Thanks for your comment.Do you think Stanford Univ.researchers--especially Van Dam--head of GI is wasting his time?

      I appreciate your GI speciality opinion? What is your opinion on Olympus capsule?

    • Thanks for your input.I read GIVN--SEC filing 6K on June5,2006 on DDW webcast.
      Darbyred and you all please read:
      Ed Shenkan's question/answer to Dr.Faigel on Comparison between Olympus and Given Capsules.
      Olympus product could end up better . Given must give up Not invented here-NIH/internal reliance and seek others for partnership(RFsystemlab)and acquire rights to 7039453.Getting bogged down in patent lawsuits/inferior product could hurt GIVN.
      Please let me know your views on Olympus CCD images after reading Dr.Faigel's reply.You can see Images on Olympus Europa website.

    • Many examples, but big one that stands out to me is intel vs. NEC on 8080 and 8086....NEC won the lawsuit that they did not infringe on patents, but lost marketing war at time when intel was $300M year in sales with no stock splits....NEC part was faster, used much less power (nmos v cmos), drop in plug replacement for a no engineering change and 75% less expensive...go figure...IBM stayed with intel vs having to do field replacements, whcih in the end they would not have had to do....great point, I agree GIVN shyould get this stuff out of the way fast!

    • Forget about remote control capsule. It is too risky � FDA will never approve it. You may control electronics and electro-optical features like power management, light intensity, type of light, data rate respond to more sensors etc, but that's all. No mechanics.
      Every GI Doc encountered colon perforation and knows that in the best case it causes serious infection but sometimes it causes death

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