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July 29, 2013
19:53 EDTOFIXOrthofix delays Q2 earnings release
Orthofix International announced that it is postponing the release of its financial results for Q2 and its previously announced conference call to discuss such results, including managementís Business Analysis and Key Strategic Initiatives Update, originally scheduled for July 31. The company stated that the audit committee of its board, on the recommendation of management, and after discussion with the companyís independent auditors, concluded that additional time is needed to review matters relating to revenue recognition for prior periods. The audit committee has commenced an independent review into these matters, with the assistance of outside professionals. The audit committee cannot predict the length of time or outcome of its review. The company does not expect to file its quarterly report by the August 9 deadline. At this time, the company is not providing annual or quarterly guidance for FY13.
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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.

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