Coherex Medical Successfully Completes First Human Cases with Its Coherex FlatStent PFO Closure System as Company Begins COHEREX-EU Study to Seek CE Mark Clearance



    Coherex Medical, Inc., a privately held medical device company,
    today announced it has successfully completed the first human cases of
    its Coherex FlatStent(TM) PFO Closure System.

    Under the direction of Professor Horst Sievert, M.D. (an
    internationally renowned interventional cardiologist and Principal
    Investigator for the COHEREX-EU Study), Coherex(TM) successfully
    conducted procedures in Frankfurt, Germany yesterday to close the
    common heart defect known as a Patent Foramen Ovale (PFO). Joining Dr.
    Sievert in these cases were:

    -- Brian Whisenant, M.D., Coherex founder and chairman, and
    Interventional Cardiologist with the Utah Heart Clinic at LDS
    Hospital in Salt Lake City;

    -- Robert Sommer, M.D., Director of the Adult Invasive Congenital
    Heart Services Center at New York-Presbyterian
    Hospital/Columbia University Medical Center and Associate
    Professor of Clinical Medicine and Pediatrics at Columbia
    University; and

    -- Jonathan M. Tobis, M.D., Professor of Medicine and Director,
    Interventional Cardiology at the David Geffen School of
    Medicine at UCLA.

    "The Coherex FlatStent PFO Closure System worked flawlessly during
    each of our procedures, just as we expected," Dr. Sievert said. "The
    device was extremely easy to use and there have been no complications
    from its use in any of the cases. The Coherex FlatStent marks the
    beginning of a new era of medical device technology and significantly
    raises the bar by providing a simple and safe alternative in PFO
    closure for physicians and their patients."

    "These fantastic results are the product of many years of research
    and hard work by Coherex' employees," said Richard J. Linder, Coherex
    president and CEO. "Our assertion that the Coherex FlatStent is a new
    breed of stent to treat heart defects has now been successfully
    validated in patients and confirms the confidence our investors have
    had in our vision. We look forward to additional clinical research in
    Europe as part of the COHEREX-EU Study."

    These initial procedures were performed at Sankt Katharinen
    Hospital in Frankfurt as part of the company's COHEREX-EU Study.
    Coherex expects to include data from these cases in its application
    for CE Mark clearance.

    "The FlatStent technology was straightforward and extremely easy
    to use and was successfully implanted in all of the patients today,"
    Dr. Sommer said. "The device is unique in its construction and is
    designed to sit almost entirely within the PFO tunnel, with minimal
    mass and minimal left atrial exposure."

    "The FlatStent technology is an exciting new advance in PFO
    closure since nearly the entire device is embedded within the
    inter-atrial tunnel," Dr. Tobis said. "My expectation is that the scar
    tissue will remain within the tunnel and effectively close the right
    to left shunt. This should have a significant effect in preventing
    paradoxical emboli in stroke patients, and hopefully we can
    demonstrate in future clinical trials that migraine headaches will
    also be reduced with the Coherex FlatStent."

    "We are thrilled to have the world's leading interventional
    cardiologists participating in the COHEREX-EU Study with the Coherex
    FlatStent," Dr. Whisenant said. "I found the device to be intuitive
    and simple to use, and believe it may well indeed be one of the most
    important advancements in the treatment of structural heart disease.
    Yesterday's successful procedures reflect the incredible ingenuity and
    commitment of the entire Coherex team."

    About Patent Foramen Ovale (PFO) Heart Defects

    A foramen ovale is a tunnel-like opening between the upper
    chambers of the heart that allows blood to bypass the lungs and is
    present in all fetuses. Normally, the foramen ovale closes soon after
    an infant is born. However, if this opening fails to close naturally
    after birth the opening is said to remain patent and the condition is
    called a patent foramen ovale (PFO).

    A common heart defect that occurs in roughly 25 percent of the
    population, PFOs allow blood to bypass the lungs and shunt directly
    from the right side of the heart to the left, thus

    -- increasing the likelihood that blood clots in the heart flow
    directly to the brain; and

    -- preventing the filtration of chemicals out of the blood that
    occurs in the lungs.

    There are at least two medical conditions that may benefit from
    PFO closure: stroke and migraine. According to the Stroke Council of
    the American Heart Association, approximately 500,000 strokes each
    year worldwide may be attributable to the presence of a PFO, which
    represents a potential annual market size of close to USD 2 billion.

    Migraine affects approximately 12 percent of adults. Multiple
    retrospective studies have demonstrated a marked reduction in migraine
    symptoms following PFO closure. As such, the worldwide market
    potential for PFO closure to treat migraine patients has been
    estimated to be more than USD 15 billion per year.

    About the Coherex FlatStent PFO Closure System

    The Coherex FlatStent PFO Closure System is similar in use and
    function to self-expanding vascular stents which are widely used by
    Interventional Cardiologists. However, Coherex' patent-pending
    FlatStent Closure System incorporates a unique fusion of PFO closure
    mechanisms and accepted medical practices in a design expected to
    naturally seal a PFO tunnel.

    About Coherex Medical

    Formed in 2003 by Brian Whisenant, M.D., Coherex Medical is
    focused on addressing structural heart disease and conditions through
    medical devices. For more information, please visit www.coherex.com or
    call 801-433-9900.

    Coherex and FlatStent are trademarks of Coherex Medical, Inc. All
    other trademarks are the properties of their respective owners.