Musculoskeletal News Roundup 26-Aug-10
BY LAUREN UZDIENSKI, AUGUST 26, 2010
Earnings
Corin reported 1H:10 revenues of GBP 21.9 million ($33.0 million), up 6% over the year-ago period. The company attributed sales momentum to the Trinity hip system and the LARS ligament augmentation system in the Australian market. Growth rates exclude the effects of currency. EPS for 1H:10 was GBP 0.56 ($0.84), which compares to a loss per share of GBP 0.16 ($0.26) in 1H:09.
Medtronic reported F1Q:11 sales of $3.8 billion, down 2% over the year-ago period and missing estimates by $0.1 billion. Spinal sales declined by 5% to $829.0 million, with core spine down by 6% and biologics down by 1%. The company did not release sales figures for its balloon kyphoplasty segment and attributed the sales deceleration to "weaker procedure growth and increased pricing pressures." Growth rates exclude the effects of currency and adjust for an extra selling week in FY2010. Adjusted net income for the quarter was $868.0 million, or $0.80 per share. EPS increased by 1% over F1Q:10 and was in line with estimates.
TiGenix reported 1H:10 revenue of EUR 1 million ($1.22 million), which includes EUR 0.3 million ($0.4 million) in ChondroCelect sales. The company noted that their European ChondroCelect sales team is in place and that pricing and reimbursement applications are filed. The company also reports that their ChondroMimetic product is slated to launch in September of 2010. Net loss for the period was EUR 7.0 million ($8.5 million).
M&A
Stryker announced plans to acquire Gaymar Industries for $150.0 million in cash. According to the press release, Gaymar manufactures support surface and pressure ulcer management solutions as well as temperature management products. 2009 sales were $77.0 million. The transaction is expected to close by October 1, 2010.
Regulatory
DePuy received an FDA warning letter alleging that the company is marketing the TruMatch Personalized Solutions System and the Corail Hip System "without the required marketing clearance or approval." The TruMatch provides customized instrumentation for knee replacements; the Corail is a cementless THA system.
Medyssey received 510(k) clearance to market the Zenius Thoracolumbar Spinal System, which the South Korea-based company plans to launch in the U.S. in 4Q:10. The system is indicated for trauma, deformity and degenerative spinal pathologies.
Product Introduction and Update
Binder Biomedical launched the NEWTON Intervertebral Body Spacer System, which the company describes as a line of lumbar spinal spacers that enable anterior, posterior or lateral insertion angles to reach the intervertebral disc space.
CareFusion launched the AVAmax Vertebral Balloon for use during kyphoplasty. The company says that their vertebral balloon product and related components "cost up to 40% less than similar kyphoplasty products on the market today."
DePuy is voluntarily recalling the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System due to an unexpectedly high revision rate, as identified in U.K. registry data.
Xylos Corporation announced the first human implantation of Securian Tissue Reinforcement Matrix in a clinical study at the University of Mississippi Medical Center. The device is based on the company's biocellulose technology and is 510(k)-cleared for the repair of rotator cuff injuries.
Clinical
Benvenue Medical enrolled the first patient in its KAST (Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial) study, which compares the company's Kiva system for the treatment of VCFs to balloon kyphoplasty. The KAST study will be used to support 510(k) clearance of the device in the U.S.
Education
Integra LifeSciences opened its Center for Research, Education and Training in Irvine, California. The 2,800-square-foot center is designed to accommodate "hands-on simulated surgical training" as well as a lab for R&D in spine, orthopedics and neurosurgery. The company also hosted its first spine research lab in the new facility on August 21.
Appointment
MAKO Surgical announced that Richard R. Pettingill has been appointed to the company's Board of Directors. Prior to his retirement in 2009, Mr. Pettingill served as the President and Chief Executive Officer of Minnesota hospital system Allina Hospitals and Clinics.
