Orthopedic News Roundup 22-Feb-07
BY LAUREN UZDIENSKI, FEBRUARY 22, 2007
Earnings
Medtronic reported 3Q:07 (ended 1/26/07) Spinal and Navigation revenue of US $629.0 million, and the Spinal segment increased 12% over 3Q:06. Growth was attributed to the Biologics product line and the CD HORIZON® LEGACY™ family of products, which includes the new PEEK ROD as well as the CRESCENT™ Vertebral Body Spacer and the VENTURE™ Cervical System. Overall, Medtronic recorded 3Q:07 revenue of $3.05 billion and a 10% increase over the $2.77 billion reported in the comparable quarter. Currency translation had a positive impact of $55 million in the quarter. As reported, 3Q:07 net earnings were $710.0 million, or $0.61 per diluted share, representing an increase of 11% over the same quarter last year.
NuVasive reported 4Q:06 revenues of $30.5 million, marking a 62% increase over 4Q:05's $18.8 million. Gross profit increased to $25.3 million, up 63% from the comparable quarter. Gross margin was 83%, up from 82.5% in 4Q:05. GAAP loss per share for the quarter was $(0.08).
CryoLife announced 4Q:06 revenues of $21.1 million, compared to $18.0 million in the fourth quarter of 2005, an increase of 17%. 4Q:06 net loss was ($50,000), and ($0.01) per basic and fully diluted common share, compared to a net loss of ($681,000), and ($0.04) per basic and fully diluted common share, in 4Q:05. BioGlue(R) revenues were $10.5 million for the fourth quarter of 2006 compared to $9.6 million in the fourth quarter of 2005, a 9% increase. Tissue processing revenues in the fourth quarter of 2006 increased 27% to $10.2 million from $8.1 million in 4Q:05. In addition to increases in tissue prices, the growth in tissue processing revenues was primarily due to an increase in unit shipments resulting from an increase in tissue procurement and an improvement in processing yields.
Osiris reported a net loss of $12.7 million for the fourth quarter of 2006 compared to a net loss of $8.1 million for the fourth quarter of 2005. The 2006 fourth quarter loss was largely driven by the advancement of the company's clinical trials. Osteocel sales for 4Q:06 were $3.0 million compared to $0.7 million in 4Q:05. Other revenues were $0.3 million for both the 4Q:06 and 4Q:05.
Henry Schein Inc.'s 4Q:06 profit rose 30%, attributable to a rise in dental equipment sales. Net income grew to $63.0 million, or $0.70 per share from $48.6 million, or $0.55 per share in 4Q:05. Revenue rose nearly 12% to $1.5 billion from $1.34 billion. Just over 2% of the growth came from foreign currency exchanges.
Alphatec Holdings, Inc.'s 4Q:06 revenue increased 23% to $19.2 million compared to $15.6 million in 4Q:05. Gross profit for 4Q:06 was $13.1 million with a gross margin of 68.1%, compared with a gross profit of $8.6 million with a gross margin of 55.5% in 4Q:05. The improved margins were primarily due to the increased sales volume and lower inventory provisions. The net loss for 4Q:06 was $11.3 million, or $(0.34) loss per share, compared to $8.4 million, or $(0.45) loss per share, in 4Q:05.
M&A
The U.S. Federal Trade Commission granted early termination of the waiting period for the proposed acquisition of Biomet by an entity currently controlled by private equity funds sponsored by each of The Blackstone Group, Goldman, Sachs & Co., Kohlberg Kravis Roberts and Texas Pacific Group. The granting of early termination of the waiting period means the proposed acquisition has cleared U.S. antitrust review, but remains subject to satisfaction of several other conditions, including approval of the transaction by Biomet's shareholders.
Regulatory
Inion received FDA 510(k) approval for the Inion CPS/OTPS FreedomPlate™ biodegradable device for surgical application in fixation of fractures and osteotomies in the entire skeleton, but excluding the spine. This clearance allows Inion to sell its biodegradable implant offering for all orthopaedic trauma indications, making it the first complete biodegradable plating system.
BioMimetic Therapeutics received orphan drug designation from the FDA for its protein therapeutic, recombinant human platelet derived growth factor (rhPDGF-BB) for the treatment of Osteonecrosis of the Jaw (ONJ). ONJ can be a side effect of high doses of bisphosphonates for the treatment of severe osteoporosis and other diseases. Orphan drug status, designated to drugs that have the potential to treat rare diseases, provides an accelerated path to FDA approval and seven years of market exclusivity.
An FDA panel convened on Thursday to consider and vote on a PMA application for Corin USA's Cormet 2000 Hip Resurfacing System. Among specific points, the panel will determine whether the Company's changes to the design and goals of a clinical study affected the Company's findings on the device.
Product Introduction and Update
Medtronic, Inc. launched the Direct Lateral Access Instrument Set to be used in lumbar direct lateral interbody fusion procedures. The instrument set is designed to help surgeons prepare a vertebral disc space for fusion procedures in the lower spine. Using the set, physicians may realize quicker procedure times, smaller incisions, less blood loss and a faster return to normal activities for their patients.
Globus Medical launched the GATEWAY™ Thoracolumbar System for the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis or failed previous spine surgery.
Small Bone Innovations debuted 17 new products at AAOS last week, targeting bones "finger to shoulder" and "toe to below the knee." Among the launches were the STABILITY Sigmoid Notch Total DRUJ System™, which replaces the sigmoid notch and ulna head; the UNI-Elbow™ Radio Capitellum System is designed to be used with SBi's rHead™ radial head prosthesis and is indicated for treatment of arthritic and traumatic conditions of the radio-capitellum joint; and the The Lateral rHead™ for treating radial head fractures and disease.
Service Agreements
Southwest Transplant Alliance, the federally-designated organ procurement organization (OPO) serving more than 200 hospitals in 90 counties throughout Texas, and RTI Donor Services have entered into a collaborative arrangement to "maximize the gift of donated tissue" in Texas.
Clinical
12- and 18-month clinical trials results show that Tigenix met structural and clinical primary endpoints in a Phase III trial of ChondroCelect cell-based therapy. The product is designed to treat knee cartilage defects.
Orthovita completed patient enrollment for its pivotal, prospective, randomized study for CORTOSS® Bone Augmentation Material in development for the treatment of vertebral compression fractures. The study is being conducted under an IDE and is designed to assess the safety and efficacy of CORTOSS for the treatment of osteoporotic vertebral compression fractures as compared to commercially available polymethylmethacrylate (PMMA) bone cement. A total of 256 patients are enrolled in the pivotal study with a randomization of approximately 2:1 (162 patients treated using CORTOSS and 94 patients treated using a PMMA bone cement) at 22 sites.
Operations
SpineVision announced today that it has established a wholly-owned direct sales subsidiary near London. The operation is led by Raymond Thomasen, who was previously Vice President Europe, MEA, for Wright Medical Technology for three years, and has held various positions during eight years with Stryker in the Middle East, Africa and the United Kingdom. SpineVision sells its motion preservation and fusion products directly in France, the United States, Italy and Belgium, and expects to add additional market coverage in the coming years.
