Osseon Therapeutics' Osseoflex and Osseoflex DR systems receive Canadian Medical Device Licenses

Dec 4 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."