Musculoskeletal News Roundup 28-Jan-10
BY LAUREN UZDIENSKI, JANUARY 29, 2010
Earnings
Johnson & Johnson reported 4Q:09 revenues of $16.5 billion, representing a 9% increase over the year-ago period and beating estimates by $0.8 billion. DePuy reported $1.5 billion in sales, up 10% over the year-ago period, with hip up 12%, knee up 9%, spine up 9% and sports medicine up by 15%. EPS of $1.02 beat estimates by $0.05.
Kensey Nash reported FQ2:10 revenue of $19.1 million, representing an 8% decrease from the year-ago period and missing estimates by $1.0 million. $6.0 million in sales was derived from orthopedic products, sales of which declined by 18% compared to FQ2:09. Among segments, spine decreased by 14%; sports medicine decreased by 16% and "other orthopedic" decreased by 30%. Regarding the decline, the company said only that orthopedics sales have been "negatively affected in the short-term." Royalty income included $1.5 million from Orthovita. Net income was $3.7 million, or $0.32 per share, down from $5.2 million, or $0.44 per share, in the year-ago period. All growth rates exclude the effects of currency. EPS missed estimates by $0.09.
Stryker reported 4Q:09 sales of $1.8 billion, up 3% over the year-ago period and in line with estimates. Orthopedic sales were $1.1 billion, up 5% over 4Q:08 with hip up 4%, knee up 7%, spine up 6% and trauma up 6%. All growth rates exclude the effects of currency. Adjusted net income increased 10% to $299.0 million, or $0.82 per share, in line with estimates.
Zimmer reported 4Q:09 sales of $1.11 billion, up 3% over the year-ago period and in line with estimates. Among segments, hip was flat, knee was up 6%, dental was down 5%, extremity was up 16%, trauma was up 3% and spine was down 15%. All growth rates exclude the effects of currency. Adjusted EPS was $1.12 for 4Q:09, beating estimates by $0.04.
Funding
Neomend closed a $30.0 million Series D round led by Clarus Ventures, who invested $17.0 million. Other participants in the round included Sanderling Ventures, Novo Ventures, Vivo Ventures and Prospect Venture Partners. The company says the funding will help them attain cash flow break-even as they pursue other applications, including musculoskeletal, for ProGEL, a hydrogel polymer sealant currently indicated for thoracic surgery.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases has awarded a five-year, $3.8 million grant to support a partnership between the University of Cincinnati and Cincinnati Children's Hospital Medical Center. The funding will help develop applications for adult stem cells in the repair of musculoskeletal soft tissue injuries.
Regulatory
The FDA will hold a public meeting February 18, 2010 to discuss the 510(k) process. Topics will include issues related to "predicate devices"; "new technologies and scientific evidence"; "practices the FDA has adopted in response to a high volume of submissions"; and "postmarket surveillance and new information about marketed devices."
Life Spine received 510(k) clearance for the DYNA-LINK Spinal System and the PRESIDIO Spinal Plating System. The DYNA-LINK "features a next-generation stand-alone device that accommodates both fixed and variable angle screws"; and the PRESIDIO is a "thoracolumbar plating system that features multiple types of low-profile implants." The company adds that both include a zero-step locking mechanism and that instrumentation is designed to "reduce surgical steps and intra-operative complexity."
Product Introduction and Update
Integra LifeSciences announced that the Coral Spinal System for minimally invasive spine surgery was put into clinical use for the first time by Dr. Morteza Farr in Santa Cruz, California. The system is designed for the lumbar spine and features a new percutaneous tube-based instrument set. Additionally, Integra LifeSciences announced the completion of the first two-level surgery using the Paramount Pedicle Screw System since Integra acquired the device from IST. The procedure was performed by one of the designers of the system, Dr. Ali Araghi of the Texas Back Institute in Phoenix, Arizona.
Small Bone Innovations (SBi) announced the first surgeries in Malaysia using SBi's Surface Replacement Proximal Inter Phalangeal (SR PIP) replacement finger joints. SBi recently formed a joint venture with Khazanah Nasional Berhad and Malaysian Technology Development Corporation Sdn. Bhd. that is based in Kuala Lumpur.
Intellectual Property
Xylos received U.S. Patent No. 7,645,874, covering "Cellulose Oxidation by Nitrogen Dioxide in a Perfluorinated Tertiary Amine Solvent." The company says the patent "is another milestone in the expansion of our patent portfolio and directly addresses our ability to protect novel, resorbable forms of our biomaterial," which is used in soft-tissue repair.
Clinical
Tornier and LifeCell enrolled the first 13 patients in a multi-center study to evaluate the porcine-based Conexa Reconstructive Tissue Matrix in the surgical repair of large rotator cuff tears. Total enrollment is targeted at 65 patients.
Supply and Distribution Agreements
ETEX signed a non-exclusive distribution agreement with OrthoPediatrics Corp. whereby OrthoPediatrics will market and sell ETEX's nanocrystalline calcium phosphate in the U.S. and Canada. ETEX notes, "The ETEX bone graft portfolio complements pediatric orthopedic and spine surgery as illustrated in the recent publication of positive pediatric outcomes using ETEX nanocrystalline calcium phosphate in the treatment of unicamaral bone cysts."
Symmetry signed an exclusive five-year supply agreement with OrthoPediatrics Corp., which manufactures orthopedic devices for pediatric and small-stature patients. Per the agreement, Symmetry will manufacture implants, instruments and cases for OrthoPediatrics as well as provide engineering resources, inventory management, warehousing and supply-chain-management services. Symmetry is anticipating revenues from the deal to total $3.0 million in 2010.
Collaborations
Biomet, DePuy and Exactech all announced that they would provide funding to OREF's Clinician Development Program in 2010.
Don't forget to check out our new Dental News Roundup.
