Santa Rosa, CA – December 1, 2009 – 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 Canadian Medical Device Licenses from Health Canada for marketing and clinical use in Canada.
Canadian Medical Device Licenses 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 Canada.
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 450 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 another 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 in Canada."
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.
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CONTACT: Michael Bivens, Director of Business Development, Osseon Therapeutics, 707.636.5953