Musculoskeletal News Roundup 13-Jan-11
BY LAUREN UZDIENSKI, JANUARY 13, 2011
Earnings
aap Implantate announced preliminary 4Q:10 sales of EUR 7.5 million ($9.9 million), flat over the prior year but up 14% after adjusting for project sales, the divestiture of the Analytics segment and other one-time effects. The company also noted that they missed sales goals on account of a decision to postpone the launch of a new product and breach of patent accusations over an allograft product that forced the company to halt sales in certain geographies.
MAKO Surgical released selected 4Q:10 operating results this week. They placed 13 new RIO systems in commercial sites during the quarter, bringing their total domestic base of systems to 67. Utilization rates increased 12% over 4Q:09, with the company reporting an average of 6.7 procedures per system in 4Q:10.
NuVasive pre-announced full-year 2010 revenues of $478.0 million, above guidance of $470-$475 million and topping analyst estimates of $473.7 million. The company also said they expected adjusted earnings per share to exceed guidance of $1.42-$1.45. Analysts had forecast adjusted EPS of $1.45.
Stryker pre-announced 4Q:10 net sales of $2.0 billion, up 9% over the year-ago period and in line with analysts' estimates. Full-year sales increased by 8% to $6.7 billion. Orthopedic sales increased by 4% to $1.2 billion for 4Q:10 and 3% to $4.3 billion for 2010. The company also expects adjusted diluted net earnings per share for 2010 to be in the range of $3.31 to $3.33, above prior guidance of $3.27 to $3.30.
M&A
Globus Medical acquired the assets of Facet Solutions, Inc. The company did not disclose terms of the acquisition. Facet Solutions is developing the ACADIA, an unconstrained pedicle-screw-based total facet replacement system, which is currently in a phase III IDE study for symptomatic spinal stenosis compared to a posterior spinal fusion control.
Smith & Nephew has rejected a $10.9 billion takeover bid from Johnson & Johnson, reportedly deciding that the offer undervalued the company. The offer represented a 15% premium over the stock's closing price on January 7th and about a 2.8x revenue multiple. The stock price has increased about 19% over the past three months, driven by acquisition rumors.
Funding
Doctors Research Group raised $7.7 million of a potential $15.0 million offering, according to a regulatory filing. The company manufactures KRYPTONITE bone cement, a resinous material indicated for use in cranial defects
Product Introduction and Update
Wright Medical Group launched the DARCO Foot & Ankle Plating System in Japan. The system, which consists of over 40 locked plates, has been available in the U.S. and other global markets since 2007.
Zimmer launched their NexGen LPS-Flex Mobile Bearing Knee with Prolong Highly Crosslinked Polyethylene in the U.S. The company says the LPS-Flex Mobile Bearing knee "provides a revolutionary anteriorly-positioned pivot near the entry point of the ACL, replicating the anatomic center of knee rotation."
Intellectual Property
Ascension Orthopedics received a European patent for a PyroCarbon humeral head design, which the company is developing as a component of their TITAN Modular Shoulder System. The company says that PyroCarbon "has been shown to cause much less damage to cartilage and bone joint tissues than the Co-Cr metal alloy currently used for shoulder joint hemi-arthroplasty."
Sonoma Orthopedics received its first patent for its flexible fixation technology. The company currently markets the Sonoma WRx distal radius fracture fixation system and the Sonoma CRx for intramedullary clavicle fixation.
Clinical
Wright Medical Group received FDA approval to conduct an IDE study to investigate the INBONE Total Ankle Replacement with Calcaneal Stem for treatment of end stage ankle arthritis or revision of a failed ankle replacement with subtalar joint insufficiency.
Collaborations
China Kanghui Holdings and Consensus Orthopedics announced an exclusive partnership whereby Kanghui was granted the exclusive right to manufacture and market Consensus’ joint implant products under both the Kanghui and Consensus brands in China and other select international territories. The firms will also explore OEM opportunities, shared purchasing and manufacturing collaborations. Under the terms of the agreement, Consensus will receive an equity investment from Kanghui and also will be eligible for royalties on commercial sales in the licensed territories.
License Agreements
TriMed, Inc. has reached an agreement to license its "pin plate" device to Stryker, Inc. The licensing agreement covers U.S. Patent No. 5,931,839 and ends a four-year patent infringement suit. The agreement was reached in October 2010. The device is used for treating distal radius fractures without the need for a post-surgical cast.
Supply and Distribution Agreements
Wright Medical Group announced a supply and distribution agreement with AlloSource for FUSIONFLEX Bone Matrix, a flexible cancellous scaffold intended for use in primary fusion procedures of the foot and ankle and other orthopedic bone grafting applications.
