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Osseon Receives CE Mark

SANTA ROSA, Calif., Sept. 21 /PRNewswire/ -- Osseon Therapeutics announced today that its Osseoflex (steerable and curvable bone cement delivery needle) and Osseoflex DR (steerable and curvable bone drill) systems for percutaneous vertebral augmentation received CE Mark approval for marketing and clinical use in the European Union.

CE Mark approval roughly corresponds to FDA approval in the United States, and allows for the Osseon systems to be used by surgeons and interventional radiologists for treatment of symptomatic vertebral fractures throughout Europe. Countries in numerous other regions including India, South America, and the Middle East also accept CE Mark approval as proof of clinical suitability, allowing for Osseon's steerable and curvable systems to be used in markets comprising nearly two billion people.

The Osseoflex systems employ a proprietary steerable access device to symptomatically correct acute fractures of the spinal vertebrae. These are seen in hundreds of thousands of patients annually, most commonly due to osteoporosis but also resulting from trauma or malignancy. The ability to access the entire vertebra through a single point of access reduces procedure time and decreases risk compared to systems requiring multiple points of access. This advantage, in turn, provides not only reliable clinical benefit, but reduces costs to hospitals, payors and ultimately patients. The Osseoflex systems, in conjunction with the proprietary Osseoperm biocompatible cement system have been in clinical use in the United States since December 2008. Data from nearly 400 patients at multiple centers in thirty states confirm the efficiency and efficacy of the Osseon system, with most patients treated as an outpatient with excellent pain relief.

"This is a great milestone for our company and our Osseoplasty System," said John Stalcup Ph.D., CEO of Osseon. "We knew that osseoplasty represented advancement for patient care, and we've seen it in the level of satisfaction from both physicians and patients. Now, we can bring that same advancement to a much broader market and patient population literally around the world."

Osseon website:

    Contact: Michael Bivens
             Marketing Director

SOURCE Osseon Therapeutics, Inc.
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