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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 18, 2007

Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss to "significant special charges" including expenses relating to the company's merger with LVB Acquisition, Inc. as well as the recent DOJ settlement. The company reported 13% worldwide sales growth (9% U.S.) in reconstructive devices, led by demand for knee products including the Vanguard™ Complete Knee System, the Vanguard™ SSK Revision Knee System and the Oxford® Partial Knee System. Hip sales increased 8% worldwide and 7% in the U.S. over the comparable quarter. Additionally, in comparison with FQ1:07, extremity sales increased 17%; dental sales increased 20%; bone cements and accessories increased 6%; fixation sales decreased 3%; and spinal sales increased 3%.

Johnson & Johnson reported 3Q:07 revenues of $15.0 billion, up 12.7% from 3Q:06 and beating estimates of $14.8 billion. Excluding certain charges, net earnings and diluted earnings per share in 3Q:07 were $3.1 billion and $1.06, representing increases of 7.0% and 8.2%, respectively, over 3Q:06. Earnings beat analysts' estimates by $0.07. Depuy reported worldwide sales of $1.09 billion, up 12% over the comparable quarter and led by sales of orthopedic joint reconstruction and sports medicine products. In the U.S., Depuy sales were $636.0 million, up 5.2% over 3Q:06.

Stryker reported 3Q:07 net revenues of $1.45 billion, beating estimates of $1.40 billion and representing an 18% increase over 3Q:06. Worldwide orthopedic sales were $855.9 million, up 15.4% over the comparable quarter, which the company attributed to higher shipments of reconstructive, trauma, spinal and craniomaxillofacial implant systems; bone cement; and the bone growth factor OP-1. Diluted net earnings per share increased by 19.6% to $0.55, in line with estimates.

Synthes reported consolidated sales of $689.2 million, an increase of 15.8% over the comparable quarter. The company reported double-digit sales growth in all its geographic regions, with revenues increasing 23.5% in Europe, 12.8% in North America, 20.6% in Asia Pacific and 13.9% ROW. Revenue growth in Trauma was attributed to demand for the company's TFN and PFNA femoral nails, the RAFN nail and the LCP Small Fragment system. In spine, the SynFix-LR, a cage with screws to replace and fuse a diseased intervertebral disc, helped drive growth in the quarter.

Lifecore Biomedical reported net sales of $15.7 million in FQ1:08, an increase of 5% over the comparable quarter. Revenues missed analysts' estimates by $0.3 million. The company reported net income of $1.26 million, or $0.09 per diluted share, beating estimates of $0.08. The Dental division reported net sales of $10.8 million, an increase of 6% over the comparable quarter, which the company attributed to increased sales of the Prima™ Implant System.

At a meeting on Tuesday, Kyphon stockholders approved the company's plans to merge with Medtronic. Earlier this week, Kyphon announced that the deal was approved by antitrust authorities in Spain, Austria and Cyprus.

Zimmer announced this week that the company was successful in its bid to acquire ORTHOsoft. At the expiry time of Zimmer's bid for the company, more than 90% of ORTHOsoft's common stock was held by Zimmer or its affiliates. Zimmer expects to close the transaction by early November.

Wilmington, N.C.-based spine company TranS1 began trading on the NASDAQ this week following an IPO on Tuesday. The stock debuted at $15 per share, above the $12-$14 per share forecasted by underwriters Lehman Brothers Holdings Inc. and Piper Jaffray, and raised a total of $82.5 million for the company.

CeraPedics, Inc. closed a $14.45 million private equity financing from OrbiMed Advisors, LLC, with Medical Capital Advisors serving as investment banking advisor for CeraPedics. The company is developing bone graft substitutes based on its proprietary small peptide technology.

Innovative Spinal Technologies received 510(k) approval for its Paramount™ IBF System for minimally invasive spine surgery. The product is available now and, according to the company, features a unique inserter design and may be implanted in either a direct posterior or transforaminal approach.

Inion Oy received the CE mark for its Inion S-2™ Anterior Lumbar Fusion System, a graft containment device that can be used in lumbar and thoracic spinal fusion procedures. The device is biodegradable and features the company's radiographic tracer technology, which allows surgeons to evaluate post-op device placement in an x-ray without hiding anatomy.

X-spine received the CE mark for its Capless™ and Spider Cervical™ spinal implants. The company concurrently announced an agreement whereby Highland Medical Ltd. would distribute X-spine products in the U.K.

Biomet, Medtronic, Smith & Nephew, Stryker and Zimmer are the subjects of an informal SEC investigation into possible violations of the Foreign Corrupt Practices Act. No details have been released on the nature of the investigation, but the the Act primarily seeks to prevent U.S. companies from making payments to foreign officials to obtain or maintain business.

Product Introduction
TEI Biosciences Inc. launched its SurgiMend™ Collagen Matrix for Soft Tissue Reconstruction this week, after receiving 510(k) approval for additional indications. SurgiMend can now be marketed for use in plastic and reconstructive surgery, including tendon augmentation. The device was previously cleared for hernia repair and muscle flap reinforcement indications.

Effective September 1, 2007, Osteotech entered into a tissue supply agreement with LifeNet Health, Inc. whereby LifeNet Health will provide Osteotech with tissue to be utilized by Osteotech for its core DBM, Biocomposite and Collagen Technologies. The agreement has an initial five-year term which will be renewed automatically at the term's end. Osteotech currently has an agreement with LifeNet Health and its distribution partner, Depuy Spine, for the processing and distribution of a private label DBM.

Symmetry Medical Inc. received ISO 13485 certification in Malaysia. The press release describes ISO 13485 as an international standard that assists medical device manufacturers in bringing safe, effective products into the international market. Symmetry believes the certification will allow the company to fully implement its Total Solutions® model and address the needs of the Asian market.

Facet Solutions, Inc. announced one-year follow-up outcomes for the first cohort of patients to receive its Anatomic Facet Replacement System (AFRS). According to the press release, results include a significant decline in leg and back pain, improved motion and function and no post-operative complications. The company adds that the first patient in the AFRS study has completed the two-year follow-up evaluation and shows similar positive outcomes.

Pioneer Surgical presented two-year clinical results of its NUBAC™ Disc Arthroplasty System at the recent Europe Spine Society meeting in Brussels, Belgium. The NUBAC is a motion preservation device that may be a tissue-preserving and less invasive surgical option for the treatment of DDD. According to the company, results in over 100 patients showed significantly fewer pain symptoms and lower levels of disability compared to pre-operative measurements. Additionally, radiographic examination showed that the index height and range of motion were maintained compared to pre-operative measurements.

Nobel Biocare announced the appointment of Petra Rumpf to the position of Head of Business Development and Strategic Planning, effective December 1. She formerly served as Vice President and member of the Central European management team at CapGemini.

Pioneer Surgical Technology appointed Terri Wells Vice President and General Manager of the company's spinal franchise. Previously, Wells was vice president of corporate solutions at Smith & Nephew Orthopaedics.

Effective November 1, John Hynes will assume the post of Chief Operating Officer, Europe at Symmetry Medical. Mr. Hynes will assume responsibility for Symmetry's medical implant, instrument and case facilities across Europe, including the UK, Ireland, France and Switzerland. Mr. Hynes' 20 years of operational management experience includes strategic management of Rolls-Royce PLC's operational supply chain.

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