Musculoskeletal News Roundup 24-Feb-11
BY LAUREN UZDIENSKI, FEBRUARY 24, 2011
Earnings
Alphatec Spine reported 4Q:10 consolidated revenues of $46.0 million, an increase of 38% from the $33.3 million reported in 4Q:09. U.S. revenues for the fourth quarter 2010 were $32.1 million, an increase of 14% from the $28.3 million reported for 4Q:09. International revenues (including Europe, Asia and Rest of World) for 4Q:10 were $13.9 million, an increase of $8.9 million from the $5.0 million reported for 4Q:09. Among the highlights for the year were the acquisition of Scient'x S.A., which created global scale with sales in over 50 countries in all major markets and became the third-largest global pure-play spinal implant company, and the launch of Alphatec Spine products in all major European markets and several other major international markets. Net loss for 4Q:10 was $2.9 million, or $0.03 per share, compared with a net loss of $1.3 million, or $0.03 per share for 4Q:09.
Integra LifeSciences reported 4Q:10 revenues of $194.1 million, up 6% over 4Q:09 and beating estimates by $0.5 million. Orthopedics sales increased by 8% to $74.1 million. The cmopany reported 4Q:10 net income of $24.0 million, or $0.80 per diluted share, beating estimates by $0.06 and up from $21.0 million, or $0.71 per diluted share, in 4Q:09.
LDR announced that 2010 revenues increased by 77% in the U.S. and 45% overall when compared to 2009. The company attributed the increase to strong demand for its VerteBRIDGE Plating Technology, global presence and pipeline of innovative products, including the Mobi-C Cervical Artificial Disc.
Medtronic reported F3Q:11 revenues of $4.0 billion, up 3% over the year-ago period and missing estimates by $100.0 million. Spinal revenue increased 2% to $861.0 million, with core spinal down 1% and biologics up 10%. According to the press release, biologics growth was driven by the acquisition of Osteotech, stabilizing InFuse sales and performance in Other Biologics. Compared to the prior quarter, the company believes global spine market growth has remained stable. F3Q:11 net income was $922.0 million, or $0.86 per share, up 8% over the year-ago period and beating estimates by $0.02.
NuVasive reported 4Q:10 revenues of $129.3 million, up 21% over 4Q:09 and in line with a pre-announcement. Among the highlights for 2010, he company noted that they achieved sales growth "despite challenging spine market dynamics" and continued to build their body of evidence supporting the XLIF technology. Net income for the quarter was $61.9 million, or $1.39 per share, beating estimates by $0.15.
Symmetry Medical reported 4Q:10 revenues of $ 96.0 million, up 26% over the year-ago period and in line with a pre-announcement. The company said the sales growth reflected "improved customer demand in the Company's orthopedic and other medical device businesses." Net income for the quarter was $4.3 million, or $0.12 per diluted share, missing estimates by $0.03 and up from $0.6 million, or $0.02 per diluted share, in 4Q:09.
TranS1 reported 4Q:10 revenues of $5.9 million, down 6% over the year-ago period and beating estimates by $0.5 million. The company said that they continued to be "adversely affected by insurance denials for lumbar fusion surgery due to medical necessity and ongoing AxiaLIF physician reimbursement pressures." Net loss for both 4Q:10 and 4Q:09 was $5.7 million. Net loss per share of $0.27 missed estimates by $0.05.
Funding
Mazor Robotics closed a PIPE funding round of $6.3 million, led by the Phoenix Holdings Company. Phoenix is joined by additional Israeli financial institutions. Mazor will use the capital to expand its worldwide sales and marketing operations.
Regulatory
Anulex received an FDA warning letter relating to a 750-patient study of its Xclose device for anular repair. The device has been cleared for use in "soft tissue approximation for procedures such as general and orthopedic surgery." The FDA determined that Anulex would need an IDE approval to conduct an Xclose annular repair study. The company has 15 days to respond to the letter, which is dated February 11.
ArthroCare received 510(k) clearance to market its second-generation Parallax Contour -enhanced Vertebral Augmentation Device specifically for void creation in a vertebral body followed by injection of bone cement. The new device is lower-profile, which the company says "makes it easier for surgeons to operate in tight spaces and to provide additional tactile and audible feedback to improve ease of use during the void creation process."
Zimmer received 510(k) clearance to market the TM-S Trabecular Metal Cervical Interbody Fusion Device, which the company describes as the industry's first cervical interbody device incorporating porous metal technology. It is also the first Zimmer Trabecular Metal device for cervical interbody fusion in the United States.
Reimbursement
Smith & Nephew has been awarded a C1 premium reimbursement from Japan for its OXINIUM Oxidized Zirconium for use in hip replacement surgery. The company also has the premium designation for its OXINIUM knee replacement products.
Product Introduction and Update
Smith & Nephew launched the Short Modular Femoral (SMF) Hip, a modular total hip replacement stem system. The SMF Hip is 20% shorter than conventional hip stem, allowing the surgeon to preserve bone in the femoral neck.
Clinical
Intrinsic Therapeutics enrolled the first patient in a randomized study of its Barricaid device for lumbar anular closure. The device is designed to prevent reherniations following lumbar discectomy while "allowing the surgeon to retain as much of the native nucleus as possible [and] preserving normal disc height and biomechanics." The study will enroll up to 800 patients who will receive wither the Barricaid or traditional limited discectomy.
Zimmer announced results from a peer-reviewed publication on the first surgery performed using the DeNovo NT Graft, which consists of juvenile cartilage allograft tissue for the repair of cartilage lesions. The case study reports improvements in both pain and function through two years as demonstrated by improvements in the IKDC Subjective and Knee Injury and Osteoarthritis Outcomes Scores; additionally, MRI data demonstrated that the treated defect was filled with repair tissue.
Zimmer also reported that early clinical results of the first patients treated with Zimmer MotionLoc Screws were "free of complications." The Zimmer MotionLoc Screw features a locking plate technology and is intended for use in conjunction with the Zimmer NCB Polyaxial Locking Plate System in the treatment of complex long bone fractures.
