Musculoskeletal News Roundup 26-Jan-12
BY LAUREN UZDIENSKI, JANUARY 26, 2012
Earnings
DJO announced preliminary 4Q:11 sales of $284.1 million, up 14% over the year-ago period. The company said this was "driven by a combination of new product launches, improved sales force execution and improved quality and customer service." Excluding the impact of acquisitions, pro forma sales increased by 3%. Among segments, Bracing and Vascular sales increased by 4%; Recovery Sciences declined by 1%; International increased by 6%; and Surgical Implant sales increased by 5%. Growth rates exclude the effects of currency.
Johnson & Johnson reported 4Q:11 sales of $16.3 billion, up 4% over the year-ago period and missing estimates by $24.7 million. DePuy sales were flat at $1.5 billion, with the company adding that "strong sales in sports medicine were partially offset by lower sales for knee and spine products." Hip sales were up 1%; knee declined by 3%; and spine was down 3%. Adjusted net earnings for 4Q:11 were $3.1 billion, or $1.13 per share, up 9% over the year-ago period and beating estimates by $0.04.
Life Spine announced record revenues in 2011 and 29% sales growth over 2010. The company launched 14 new products over the past year.
Medicrea reported 4Q:11 sales of EUR 4.1 million ($5.3 million). The company calls full-year sales "disappointing," attributing the slower sales growth partially to changes in the U.S. sales structure.
Stryker announced 4Q:11 sales of $2.2 billion, up 11% over the year-ago period and in line with a pre-announcement. Reconstructive sales increased by 1%, with hip flat, knee down by 2% and trauma and extremities up by 8%. Sales in the Neurotechnology and Spine division increased 47% as reported and 2% in constant currency after adjusting for acquisitions; spine sales alone increased by 6%. Growth rates exclude the effects of currency, unless otherwise noted. Adjusted net earnings for 4Q:11 were $390.0 million, or $1.02 per share. EPS increased by 10% over the year-ago period and was in line with estimates.
Zimmer reported 4Q:11 sales of $1.2 billion, up 2% over the year-ago period and beating estimates by $6.0 million. Among segments, recon sales increased by 2%, with knee flat, hip up by 4% and extremity up by 9%. Dental sales increased by 2%; trauma increased by 11%; and spine declined by 6%. Growth rates exclude the effects of currency. Net earnings declined by 2% during 4Q:11 to $245.0 million, or $1.36 per share. EPS beat estimates by $0.02.
Regulatory
Interventional Spine received 510(k) clearance of its Opticage Expandable Intervertebral Body Fusion Device. The device is part of the PerX360 System, which the company says enables a surgeon to perform a complete percutaneous lumbar interbody fusion via two 15mm incisions for the treatment of lumbar discogenic pain.
Medtronic received 510(k) clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer, which provides hemostatic sealing capabilities for both incised soft tissue and epidural veins with a single device.
Suspension Orthopaedic Solutions received 510(k) clearance for two new products, the Distal Clavicle Fracture Fixation System and a plate designed to address repair of mid-shaft clavicle fractures. The company says the Distal Clavicle Fracture Fixation System features Suspension's patent-pending T-Loc Technology, which "enables knotless, protected and precisely controlled tension" for fixation of multiple soft-tissue injuries, and the Mid-Shaft Clavicle Plate "creates a complete clavicle system".
Product Introduction and Update
Choice Spine launched the Starfire Pedicle Screw System, which the company says features top-loading polyaxial screw implants that "can address a variety of patient anatomies, including small and large-sized patients."
Intellectual Property
KFx Medical was granted U.S. Patent No. 8,100,942, covering knotless double row rotator cuff repair. They added that the new patent follows an anonymous request that the USPTO re-examine the company's first patent, also covering knotless double row rotator cuff repair. The patent office rejected the arguments from the anonymous party and upheld the patent.
Legal
A federal court denied motions from Medtronic and NuVasive ahead of a Thursday hearing on an ongoing patent infringement case. Medtronic asked for an injunction that would prevent NuVasive from selling products that infringed its patents, and NuVasive requested a dismissal of $101.2 million in damages stemming from a jury decision in September. Today's hearing will go on as scheduled.
Operations
Pioneer Surgical Technology announced the grand opening of its newly-expanded Greenville, North Carolina manufacturing facility, which houses the primary manufacturing operations for Pioneer Surgical's biologic products sold in the United States and Europe.
Appointments
DJO announced that on January 5, 2012 its Board of Directors elected Mike S. Zafirovski as a member of the DJO Global Board and as non-executive Chairman of the Board. Mr. Zafirovski will succeed Les Cross as Chairman, though Mr. Cross will remain a member of the Board of Directors.
