New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
December 16, 2012
17:43 EDTOFIXOrthofix concludes bone growth stimulator investigation
Orthofix International announced that it has resolved all matters related to the investigation of its bone growth stimulation business. Consistent with the agreement in principle that the Company previously announced in May 2011, the Company will pay approximately $43 million to resolve all civil and criminal matters, which included a plea to obstruction of a June 2008 federal audit. These charges were previously recorded in the first quarter of 2011. As part of the resolution, the Court imposed a five-year term of probation, during which the Company must continue to comply with the terms of its previously-executed Corporate Integrity Agreement. This final settlement also includes the resolution of a related qui tam complaint filed against the Company, which remains pending against several of its competitors.
News For OFIX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
September 23, 2015
08:02 EDTOFIXOrthofix: Trinity Evolution showed per joint fusion rates at 86.8% at 12 months
Orthofix International announced results from the largest study conducted to date evaluating the safety and effectiveness of their cellular bone allograft, Trinity Evolution, in foot and ankle arthrodesis procedures. Published online in Foot & Ankle International, patients treated with Trinity Evolution demonstrated per joint fusion rates of 86.8 percent at 12 months follow-up. Additionally, successful fusion significantly correlated with improvements in pain, function, and Quality Of Life, even in patients with comorbidities such as obesity, diabetes and smoking. In this prospective, multicenter, open-label clinical study, Trinity Evolution was evaluated in 92 patients undergoing 153 foot and ankle fusion procedures. Compared with previous studies, this trial used prospective enrollment and included patients who were at high risk for bone fusion failure due to age, diabetes or obesity. The primary endpoint was successful fusion based on high resolution CT scans and radiographs assessed by an independent lab. Based on radiographic effectiveness, the study demonstrated a per joint fusion rate of 81.1 percent at six months, which increased to 86.8 percent at 12 months. Additionally, comorbid factors known to be associated with fusion failure, such as diabetes, age and obesity, did not have a negative effect in this study. There were no serious adverse events attributable to Trinity Evolution as determined by an independent consultant.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the disclaimer & terms of use