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News Breaks
February 6, 2014
05:27 EDTOFIXOrthofix not in compliance with NASDAQ listing rule
Orthofix International provided an update on issues relating to its listing status with the NASDAQ Stock Market. As previously announced, the company intends to restate its financial statements for the 2011 and 2012 calendar years, as well as for 1Q13. As a result, the company has not yet filed its quarterly reports on Form 10-Q for the fiscal quarters ended June 30, 2013 and September 30, 2013, and therefore, also as previously announced, the company is not in compliance with NASDAQ Listing Rule 5250(c)(1). The company, in coordination with the Audit Committee of the company’s board, is currently preparing the financial restatement and the Delinquent Reports, and substantial progress has been made in that regard. The company intends to complete the restatement and file the Delinquent Reports as promptly as practicable, and is currently proceeding with the objective of completing this by the end of 1Q14.
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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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