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  • RMDC

    thought you might find this....interesting

    Rubicon Medical Corp. (OTCBB: RMDC.U), a Salt Lake
    City-based developer and manufacturer of medical devices, today
    announced that it has received a $15 million investment from Boston
    Scientific Corp (NYSE: BSX.N).
    In exchange for its $15 million investment, Boston Scientific
    received 1,090,147 shares of Rubicon's Series A Preferred Stock
    convertible into 10,901,470 shares of Rubicon common stock. Coupled
    with the common shares it received in its July 2003 investment of $2.0
    million, Boston Scientific now owns a total of 18 percent of Rubicon's
    fully diluted equity.
    In connection with the definitive agreements, Rubicon's two
    largest stockholders (previously holding more than 50 percent of
    Rubicon's issued and outstanding shares of common stock) have granted
    Boston Scientific the option to acquire all of their shares for an
    initial consideration of $2 per share payable, at the discretion of
    Boston Scientific, in cash or shares of Boston Scientific common stock
    plus additional "earn-out" amounts of up to $1.50 per share if certain
    performance milestones are achieved by Rubicon. Boston Scientific has
    agreed that if it exercises its option to acquire the shares of the
    two largest Rubicon stockholders, it will also make an offer to
    acquire all shares of common stock of Rubicon Medical held by all
    other stockholders on the same terms, including price and form of
    consideration.
    Boston Scientific's option will expire 90 days after Rubicon's
    receipt of FDA clearance for the Rubicon Filter. The earn-out amounts
    generally consist of an additional $0.50 per share if Rubicon develops
    a stroke therapy device that meets certain stringent independent
    testing requirements prior to Sept. 30, 2004, and an additional amount
    of $1.00 per share if net sales of Rubicon's embolic protection filter
    exceed $50 million in any 12-month period during the five years
    following its receipt of FDA marketing clearance for the Rubicon
    Filter.
    "This is a monumental day for Rubicon and its shareholders," said
    Richard J. Linder, president and chief executive officer of Rubicon
    Medical. "While no assurance can be given that Boston Scientific will
    exercise its option, in the event that it does, all Rubicon
    shareholders will be offered the same amount per share. In addition,
    Rubicon has established an important strategic relationship and has
    gained the financial wherewithal that should see us through European
    and U.S. clinical studies. Everything we have seen thus far supports
    our belief that our team has developed a highly advanced embolic
    filtration device."

    About Rubicon Medical

    Rubicon Medical Corp. (www.rubiconmed.com) is a Salt Lake
    City-based developer and manufacturer of interventional vascular
    medical devices and products. The company focuses on minimally
    invasive endovascular techniques and products that are safer and more
    cost effective than surgery.

  • #2
    The Guardian System

    The Guardian System is a balloon embolic protection system that was licensed by Abbott Laboratories in 2000. The Guardian utilizes a balloon that is inflated downstream of a total or partial occlusion (lesion) of a blood vessel and stops flow within the vessel. A stent is then advanced over the Guardian wire and placed at the site of the lesion. Another balloon is then inflated to permanently place the stent in the vessel. During this procedure, and while the flow within the blood vessel has been stopped by the Guardian, the small pieces of plaque (emboli) that have broken free into the blood stream, are then aspirated out of the vessel by a catheter which is another component of the Guardian System. Once the blood vessel has been cleaned out, the Guardian balloon is deflated, and the procedure is completed. The Guardian System is currently under clinical development by Abbott Vascular, a division of Abbott Laboratories.

    The Rubicon Filter

    Another type of embolic protection is filtration. This technique allows blood to flow continuously during a stent procedure while filtering out small pieces of plaque (emboli) that break free during the procedure. The Rubicon Filter is the smallest profile embolic filter in existence, and the easiest to use. The size (outside diameter) of the filter is important because the smaller the size, the less potential for adverse events. Because of the Rubicon Filter's size and ease of use, along with its steerability and flexibility, clinical results could be superior to other filter technologies on the market. The Rubicon Filter is currently in pre-clinical testing. Rubicon expects clinical development to begin in 2003 in this potential $1 billion per year annual worldwide market.

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    • #3
      10/22/2003 -- Rubicon Medical Initiates Second European Clinical Study with the Rubicon Filter;
      SALT LAKE CITY and HAMBURG, Germany – October 22, 2003 – Rubicon Medical Corp. (OTC BB: RMDC), a Salt Lake City-based developer and manufacturer of medical devices and products, today announced it has successfully completed the first human cases of its Rubicon Filter in the carotid arteries.

      Rubicon’s carotid studies are being conducted by Prof. Dr. Juachim Schofer, co-founder of the Center of Cardiology and Vascular Intervention in Hamburg, Germany and Rubicon’s principal investigator for its clinical studies seeking clearance for use of the Rubicon Filter in carotid arteries.

      “The Rubicon Filter performed superbly in the three initial carotid cases performed here in Hamburg. We were particularly impressed with the filter’s small profile, ease of use and simple retrieval mechanism,” Schofer said. “It is my opinion that the Rubicon Filter will play a key role in the field of embolic protection devices because of its unique features. Those features that will benefit patients undergoing carotid artery stenting.”

      The carotid arteries are found in the neck and feed blood directly to the brain. Carotid artery stenting is often performed on carotid arteries that have developed blockages as a result of plaque buildup on the artery walls. A stenting procedure involves deploying a small wire mesh tube known as a stent inside a partially blocked blood vessel to improve blood flow by propping open the blood vessel. Helping physicians prevent embolic events from occurring during and after carotid stenting is critical to maintaining blood flow through arteries in the brain and ensuring patient health.

      The Rubicon Filter is designed for use in medical procedures downstream from a blockage in a bloodstream to allow the capture and removal of dislodged embolic material. It is a guidewire-based filter that is deployed without the use of a catheter, making it smaller and easier to navigate through blood vessels than other embolic protection devices. Rubicon believes the Rubicon Filter is the world’s smallest-profile embolic filtration device. Rubicon also believes the filter’s small profile should considerably decrease trauma to the body and the risk of dislodging particles during passage of the filter through a blockage in a blood vessel.

      “First, we are honored to be working with Professor Schofer and Dr. Tubler, as well as with the cath lab personnel in Hamburg at one of the leading carotid centers in Germany,” said Richard Linder, president and chief executive officer of Rubicon Medical. “We are further grateful to Professor Schofer for his work as the principal investigator of the RULE-Carotid, Europe study using the Rubicon Filter in carotid artery stenting. We are also thrilled with the initial successful results of the Rubicon Filter in this indication and look forward to completing the carotid study in the coming months.

      “Additionally, with each new procedure, we grow more and more confident that the Rubicon Filter will revolutionize the field of embolic protection. We also see a growing number of potential applications for our technology.”

      Rubicon anticipates enrolling additional carotid patients for ongoing trials of the Rubicon Filter in Germany and Italy.

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