Musculoskeletal News Roundup 12-May-11
BY LAUREN UZDIENSKI, MAY 12, 2011
Earnings
aap Implantate reported 1Q:11 sales of EUR 6.5 million ($9.2 million), up 13% over the year-ago period. EBITDA increased from EUR 0.2 million ($0.3 million) in 1Q:10 to EUR 0.8 million ($1.1 million) in 1Q:11. The company says that "the main focal points of the corporate strategy in 2011 are the trauma and cement & cementing techniques product groups . . . as well as the continued focus on customers, costs and cash."
BioMimetic Therapeutics reported 1Q:11 revenues $0.4 million, flat over the year-ago period and beating estimates by $0.2 million. The company reported a net loss for the quarter of $8.0 million, or $0.28 per diluted share, which compares to a net loss of $8.5 million, or $0.39 per diluted share, in 1Q:10. Analysts had forecast a net loss of $0.38 per share.
DJO announced 1Q:11 sales of $249.7 million, which compares to sales of $240.1 million in 1Q:11; after adjusting for fewer shipping days in 1Q:11 and excluding changes in currency, daily sales increased by 5% in 1Q:11 compared to the year-ago period. Among segments, Recovery Sciences sales increased by 3%; Bracing and Vascular sales increased by 1%; International increased by 6%; and Surgical Implant declined by 1%. The company reported a net loss for the quarter of $21.2 million, narrowing from $33.7 million in 1Q:10.
Tornier reported 1Q:11 sales of $69.4 million, up 12% over the year-ago period and beating estimates by $3.6 million. Extremity sales, which comprise 76% of the company's revenues, increased by 14%, driven by the upper extremity product category. The company reported a net loss of $24.0 million, or $0.68 per share, widening from a net loss of $10.0 million, or $0.41 per share, in 1Q:10. Analysts had forecast EPS of $0.80.
TranS1 reported 1Q:11 sales of $5.1 million. down 24% over the year-ago period and beating estimates by $0.1 million. The company said that procedure volumes and revenues "continue to be adversely affected by ongoing AxiaLIF physician reimbursement pressures." Net loss for the quarter was $5.5 million, or $0.26 per common share, widening from a net loss of $5.1 million, or $0.25 per common share, in 1Q:10. Analysts had forecast a net loss of $0.23 per share.
Funding
OsteoGeneX received $0.5 million in matching grant funds from the Kansas Bioscience Authority. The company, which has also received funding from the Israel-U.S. Bi-national Industrial Research and Development Foundation, will use the grants to support a spinal fusion and fracture repair medical device program.
Regulatory
The FDA has ordered all manufacturers of metal-on-metal hip implants to conduct studies of the devices. Metal-on-metal hips, once accounting for one-third of all artificial hips implanted annually in the United States, have come under fire recently following reports on high failure rates and increased wear debris.
Product Introduction and Update
BioMimetic Therapeutics launched a new Augment Bone Graft product kit size in Canada. The standard 3cc kit will be complemented with a new 1.5cc kit and a 6cc size kit. All three sizes will be available at launch in the U.S. The company says the range of sizes will "provide surgeons with the flexibility to utilize the amount of material they feel is most appropriate . . . [and] help hospitals eliminate excess waste."
Wright Medical announced the full commercial launch of the INBONE II Total Ankle Replacement System, which the company says offers a "broader implant offering and further improves the system's highly precise surgical instrumentation." Features of the INBONE portfolio include implant modularity and intramedullary-guided instrumentation for "surgical accuracy and reproducibility."
Reimbursement
Orthovita announced that insurer Noridian published a Part B Future Local Coverage Determination offering continued reimbursement for percutaneous vertebroplasty and percutaneous vertebral augmentation, the procedure for which the company's Cortoss Bone Augmentation Material is indicated for use. Prior draft LCDs had considered not covering vertebral augmentation procedures.
License and Distribution Agreements
IFGL Bioceramics entered into a license agreement with Sree Chitra Tirunal Institute for Medical Sciences and Technology for the manufacture of calcium phosphate cement and bioactive ceramic composite granules for dental and orthopaedic applications. Both companies are based in India.
Novation is offering a rebate program to increase utilization of DePuy implant products whereby members that sign a new enrollment form by June 15 can receive rebates of up to 10% of their incremental purchases in the form of a credit memo.
Appointments
Medtronic appointed Omar Ishrak chairman and chief executive officer. Mr. Ishrak formerly served as president and CEO of GE Healthcare Systems. He will assume his new post on June 13, 2011.
RTI Biologics announced that the company has split the roles of chairman of the board and chief executive officer. Dean H. Bergy assumed the role of chairman of the board of directors effective May 5, 2011, while Brian K. Hutchison remained CEO and a member of the board of directors. Mr. Bergy currently serves as advisor to the chief financial officer at Stryker, and prior to that, he served as Stryker’s vice president and chief financial officer. He joined RTI’s Board of Directors in July 2010.
