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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 19-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 20, 2009

Earnings
Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04. By segment, knee sales increased 3%; organic hip was up 17%; upper extremity was up 57%; and biologics/spine increased 13%, excluding the impact of the Altiva acquisition.

Medicrea reported 2008 revenues of EUR 9.0 million ($12.7 million), a 32% increase over 2007. The company attributed sales growth to strength in the U.S. division of the business, strong performance by the Medicrea Europe Francophone distribution subsidiary and demand for the Pass LP thoracolumbar stabilization and fixation system.

Medtronic reported FQ3:09 revenues of $3.49 billion, in line with analysts' estimates and up 3% over FQ3:08. Adjusted net income was $795.0 million, with adjusted EPS of $0.71 per share, representing 12% and 13% increases, respectively, over FQ3:08. Adjusted EPS beat estimates by a penny. Sales in the company's spine division were up 3% to $832.0 million, with core spinal sales up 5% to $479.0 million, biologics down 1% to $205.0 million and Kyphon flat at $148.0 million.

Synthes reported 4Q:08 revenues of $811.2 million, a 14% (constant currency) increase over 4Q:07. Though the company does not break out segment revenue, Synthes did disclose that double-digit sales growth occurred in all regions and product segments, noting "accelerated sales growth and market share gains in spine." 2008 net income was $735.0 million, a 16% (constant currency) increase over 2007.

Wright Medical Group, Inc. reported 4Q:08 revenue of $120.1 million, representing a 16% increase over 4Q:07 and beating estimates by $0.4 million. Extremity sales increased 31%, hip by 22%, knee by 9% and and biologics by 5%. Adjusted net income for the quarter was $12.6 million, an increase of 25% over 4Q:07, with adjusted EPS of $0.31.

Regulatory
Small Bone Innovations, Inc. received the CE Mark for its PRECISE SD Distal Volar Radius Plating System, indicated for a number of wrist trauma repair and reconstruction procedures.

Funding
Orthox Limited received a GBP 1.6 million ($2.3 million) Wellcome Trust Translational Award. The company is developing cartilage repair technology based on silk. Their core technology is a biomaterial called Spidrex, described as "combining the resilience, high strength and bioresorption found in spider silk."

ReGen Biologics completed a $1.7 million funding round, the second of a two-stage private placement. Combined gross proceeds, which will support the U.S. Menaflex launch, are $9.0 million.

Intellectual Property
Brookhaven Science Associates and BioSurface Engineering Technologies, Inc. (BioSET) have been issued a U.S. patent covering their B2A synthetic peptide. The peptide is utilized in BioSET's AMPLEX combination product for lumbar fusion, which consists of the B2A growth factor and an ultra-high grade ceramic bone substitute.

Product Introduction and Update
Ascension Orthopedics, Inc. will launch the Ascension Silicone PIP System at the AAOS annual meeting next week. The company says the system features the "smallest pre-flexed silicone proximal interphalangeal (PIP) implant offered in the orthopedic market today."

Cardo Medical announced modifications to its Align 360 Uni-Compartmental Knee System. Design enhancements address a femur-first approach and include novel femoral tibial alignment instruments with dedicated alignment and resection guides.

IlluminOss Medical announced the completion of the first procedure with the company's Photodynamic Bone Stabilization System. The system utilizes a 4.5mm pathway into the bone to stabilize it without traditional metal instrumentation; a balloon catheter and light fiber are inserted into the intramedullary canal of the bone, and the balloon is filled with a photo-sensitive, liquid monomer that hardens in 90 seconds when the light source is activated.

Pegasus Biologics, Inc. announced the first implantation of its OrthADAPT PR Bioimplant in a rotator cuff repair procedure. The company says the device is designed for arthroscopic delivery and consists of a collagen matrix combined with a polymer mesh. The procedure was performed in Caracas, Venezuela last week by U.S.-based surgeon Luis Vargas.

ReGen Biologics initiated the first surgeon training course for the company's Menaflex implant in Europe, where four U.S. surgeons met with European surgeons who have been actively using the Menaflex device. The course format included reviewing cases and clinical data, and discussing patient selection, surgical technique and rehabilitation protocol.

Spinal Kinetics announced the launch and first implantation of the company's M6-L artificial lumbar disc in Europe. The procedure was performed at Sana Clinic Sommerfeld in Sommerfeld, Germany by Karsten Ritter-Lang, M.D.

Investigations
The SEC initiated a formal investigation into ArthroCare's accounting practices, following a previous informal inquiry and an internal audit committee's findings of "improper practices" in the spine business unit relating to reimbursement for the company's coblation technology. The U.S. Attorney's offices in Florida and North Carolina are also conducting separate, but related, investigations into the company.

Appointments
David Fitzgerald has been named ArthroCare's Acting President and Chief Executive Officer following the resignation of Michael A. Baker. Mr. Fitzgerald has been on the Board at ArthroCare since 2003 and served as President and Chief Executive Officer of Howmedica prior to his retirement in 1996. He also serves on the Board of Directors of Orthovita, Inc.

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