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Hansen Medical hits new high on FDA nod

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Hansen Medical Inc.’s (Nasdaq: HNSN) stock hit a new 52-week-high this morning after the Mountain View, Calif.-based company announced it had received FDA clearance for commercialization of the Sensei Robotic Catheter System and Artisan Control Catheter.

Dr. Frederic Moll, founder and CEO of Hansen, said the news is particularly exciting considering that the firm didn’t expect FDA approval until the second half of the year.

Hansen, which was founded in 2002 and went public in 2006, sells medical robots used to move and control catheters.

Its stock shot up by $4.26, or 22.6%, to $23.15 this morning on the news after having traded as high as $26.69 earlier in the day. Previously, shares had traded between $10.02 (on Dec. 13, 2006) and $22.67 (on March 20) in the past year.

Volume was exceptionally heavy – by 11:18 am ET, more than 2.4 million shares had changed hands, compared with a three-month average daily volume of 221,177 shares.

The clearance, said Hansen, will allow physicians to use the company’s robotic platform to place mapping catheters in hard-to-reach anatomical locations within the heart and maintain catheter stability during the diagnostic phase of complex cardiac arrhythmia treatment.

Basically, the robotically controlled catheter is designed to help doctors better perform complex catheter procedures and contribute to the successful diagnosis of life threatening cardiac diseases. Currently, such procedures are done using a manual technique.

The company expects the device will help doctors perform procedures that historically have been too difficult or time consuming to accomplish routinely with the existing manual technique.