SANTA ROSA, CA – September 15, 2009 – Osseon Therapeutics, Inc. 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 commercial release 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 Asia, 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 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 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 Therapeutics, Inc. was incubated at the University of Northern California’s Science and Technology Innovation Center in Santa Rosa. Its first-generation products are currently released in the United Stated and have recently received CE Mark for product distribution in the European Union.
Osseon Therapeutics, Inc. focuses on bringing to market alternative minimally invasive treatments for degenerative bone and joint disease. Headquartered in Santa Rosa, CA, the company's groundbreaking technology and delivery system provides comparable or better efficacy and safety than other commercial solutions while offering significant advantages in efficiency and cost. By improving the treatment of compression fractures within the lower portion of the thoracic and the entire lumbar vertebral spine, Osseon offers alternative solutions to patients suffering from these maladies, as well as the physicians and medical facilities that treat them. Its first-generation products have received both FDA clearance and the CE Mark for product distribution in the United States and European Union. For more information, visit our web site at www.osseon.com.
Osseon® is a registered trademark of Osseon Therapeutics, Inc.
CONTACT: Michael Bivens, Director of Business Development, Osseon Therapeutics, 707.636.5953