Musculoskeletal News Roundup 28-Aug-08
BY LAUREN UZDIENSKI, AUGUST 28, 2008
Earnings
AOI Medical Inc. reported a 1H:08 loss of $3.5 million, widening from a loss of $1.8 million in 1H:07. The company added in the press release that they're conducting a new clinical study for their Ascendex tools for the treatment of spinal fractures. The study was ordered by the FDA, and AOI expects to complete it before the end of the year. Following its completion, AOI will launch the product.
Corin reported 1H:08 revenues of GBP 22.9 million ($45.7 million), up 63% over 1H:07. Sales growth was attributed to the U.S. launch of the Cormet hip resurfacing system. Excluding exceptional items, underlying pre-tax profit was GBP 3.7 million ($7.4 million), up from GBP 1.2 million ($2.4 million) in 1H:07.
TiGenix reported a 1H:08 net loss of EUR 7.4 million ($11.7 million), up 34% from 1H:07, which the company attributed to "costs related to the strengthening of the team at all levels, the operational expansion in the manufacturing, the preclinical efforts for TGX002 and to the continuous efforts with respect to the MAA [Marketing Authorization Application] filing in Europe. " Highlights for 1H:08 include the release of three-year data from the ChondroCelect pivotal study, which showed "significantly better structural regeneration and clinical outcome for the ChondroCelect treated patients as compared to the control group that received microfracture treatment."
Regulatory
K2M, Inc. received CE Mark clearance for a number of its products, including the RANGE Spinal System, MESA Spinal System, DENALI Spinal System, PYRENEES Cervical Plate System and ALEUTIAN Spacer Systems.
Appointments
Orthofix International NV appointed Brad Mason president of Blackstone Medical Inc. Mr. Mason was previously president of the company's Breg unit, and he replaces Oliver Burckhardt, who is leaving to pursue other opportunities.
Effective September 1, Ronda Harris will take on the role of Chief Accounting Officer at Symmetry Medical Inc. Ms. Harris will assume responsibility for Symmetry's consolidated financials, external reporting and standardizing global accounting and provide direct controllership support. Previously, Ms. Harris served as Assistant Controller of General Electric's Consumer and Industrial Business.
