Earnings
Biomet reported FQ4:08 revenues of $635.6 million, an increase of 16% (10% constant currency) over the year-ago period. Sales increased 10% in the U.S and 24% (11% constant currency) OUS. Recon sales increased 17% worldwide (12% constant currency) to $473.4 million. Among segments, knee increased 17% worldwide (12% constant currency) and 13% in the U.S., with sales drivers including the Oxford Partial Knee System and the Vanguard Complete Knee System. Hip sales increased 15% worldwide (8% constant currency) and 3% in the U.S., driven by the M2a-Magnum Acetabular System and the Taperloc Hip Stem, as well as sales of the ReCap Total Resurfacing System and the Exceed ABT Acetabular System in Europe. Fixation sales increased 12% worldwide (9% constant currency) and 8% in the U.S. Spinal product sales increased 3% worldwide (1% constant currency) and 9% in the U.S., which the company attributed to spinal stimulation sales growth. Dental sales increased 23% (16% constant currency).
Johnson & Johnson reported 2Q:08 revenues of $16.5 billion, beating estimates of $16.0 billion and representing a 9% increase over the year-ago period. Net earnings were $3.3 billion, or $1.17 per share, in 2Q:08, beating estimates of $1.12. DePuy reported $1.29 billion in sales, up 9% operationally over 2Q:07. On the conference call, the division reported the following growth rates among segments (all operational growth): hips increased 14% worldwide, 4% in the U.S. and 14% OUS. Knees increased 6%, 4% in the U.S. and 8% OUS. Spine increased 4% worldwide, was flat in the U.S. and up 14% OUS. Mitek, the sports medicine divison, reported 15% operational growth over the year-ago period.
Medicrea reported 1H:08 revenue of EUR 4.6 million ($7.3 million), an increase of 48% (55% constant currency) over the year-ago period. U.S. revenues increased 110% for the period.
Stryker reported 2Q:08 revenue of $1.71 billion, in line with estimates and representing a 17% increase (13% constant currency) over 2Q:07. Net earnings were up 27% to $305.8 million, or $0.73 per share, beating estimates by a penny. Sales of orthopedic implants were up 15% (9% constant currency) to $1.02 billion in 2Q:08. Among segments, hip was up 7% (2% constant currency); knee was up 18% (13% constant currency); trauma was up 22% (13% constant currency) and spine was up 21% (17% constant currency.)
Funding
Spineology Inc. closed on $7.5 million financing led by Oakridge Financial, among other investors. Proceeds will be used to fund additional commercialization, product development and clinical research.
Vertos Medical, Inc. has closed a $12.0 million Series C round led by CHL Medical Partners and Foundation Medical Partners, who were joined by previous investors Aweida Venture Partners and DFJ Mercury. Funds will be used to "expand the Vertos product portfolio" and support the launch of the Minimally Invasive Lumbar Decompression (MILD) system. The company describes the MILD procedure, as "a simple, percutaneous, fluoroscopically guided treatment" for lumbar stenosis.
Regulatory
Fziomed received a 5-2 "not approvable" decision from an FDA panel regarding its Oxiplex S/P PMA application. The panel found that the company's data did not definitively show product efficacy. The Oxiplex/SP Gel is an adhesion barrier designed to reduce pain following lumbar spinal surgery.
Zimmer is recalling an instrument used in the implantation of its NexGen Knee System. The company says alternative instrumentation is available, and sales should not be materially impacted.
Product Introduction and Update
Interventional Spine has trained more than 400 physicians on its PERCUTANEOUS spine therapy technologies since the line's launch in 2006. 150 physicians have completed the training in the past six months.
NovaBone Products released NovaBone Putty, a new formulation of the calcium-phosphate silicate bone graft substitute. CEO Art Wotiz says the putty "handles more easily" than earlier formulations and "is the only bone graft substitute that has been proven to signal, recruit, proliferate and differentiate osteoblasts."
Tornier has announced that 100,000 Aequalis Shoulders have now been implanted around the world. First launched in Europe in 1994, the Aequalis Shoulder is a complete shoulder arthroplasty system indicated for use in patients with severe osteoarthritis or who have experienced severe trauma.
VG Innovations, LLC launched VerteLoc, its minimally invasive spine stabilization system. The company says the system is "designed to address minor spinal instabilities by effectively stabilizing the spinal facets." The first Verteloc procedure was performed in May.
Reimbursement
Congress this week passed legislation blocking the 10.6% cut to physician Medicare payments, overriding a presidential veto of the bill.
Miscellaneous
U.S. News and World Report named the top ortho hospitals in the country, placing New York's Hospital for Special Surgery, which has the most discharges of any orthopedic hospital, a large nursing staff and advanced technologies, at the top. Other criteria included mortality rate, the extent of patient services and whether the facility had a trauma center. In addition to HSS, the Mayo Clinic, the Cleveland Clinic and Massachusetts General Hospital were among the top 10.