Musculoskeletal News Roundup 4-Mar-10
BY LAUREN UZDIENSKI, MARCH 4, 2010
Earnings
Corin reported full-year 2009 revenue of GBP 40.6 million ($64.7 million), down 10% over the year-ago period. Among segments, OUS hip increased 2%; U.S. hip decreased 83%; and knee increased by 1%. All growth rates exclude the effects of currency. Group operating profit before exceptional items was GBP 1.8 million ($2.9 million), down from GBP 3.4 million ($4.9 million) in 2008. Corin attributed the decline to lower sales to Stryker, which the company added were partially offset by manufacturing efficiencies.
Integra LifeSciences reported 4Q:09 sales of $183.5 million, up 5% over the year-ago period and beating estimates by $1.2 million. Orthopedic sales increased 9% to $68.5. Adjusted net income for 4Q:09 was $17.8 million, or $0.60 per diluted share, up from $15.5 million, or $0.53 per diluted share, in 4Q:08. Analysts had forecast EPS of $0.58.
Osteotech reported 4Q:09 revenue of $26.3 million, up 7% over the year-ago period and in line with a pre-announcement. New products, including MagniFuse Bone Graft and Plexur M, contributed $1.0 million in revenue during the quarter. Net income for quarter was $0.9 million, or $0.05 per diluted share, improved from a net loss of $0.4 million, or $0.02 per share, in 4Q:08. Analysts had forecast EPS of $0.06.
M&A
Baxter announced plans to acquire ApaTech for up to $330.0 million, with $240.0 million in cash up front (a 4x revenue multiple) and additional milestone payments of up to $90.0 million. ApaTech manufactures ActiFuse, a silicated calcium phosphate bone graft substitute. The transaction is expected to close in 1Q:10.
Funding
Intrinsic Therapeutics closed on $18.0 million of a $20.0 million round consisting of equity, warrants and options. Returning investors included New Enterprise Associates, Spray Ventures and New Leaf Venture Partners. Last year, the company received CE mark clearance for the Barricaid, an anulus replacement implanted during discectomies.
Regulatory
Exactech received 510(k) clearance for the Equinoxe Platform Fracture Stem, which is designed to treat fractures of the proximal humerus or a deficient, irreparable rotator cuff. The company says the device is compatible with the Equinoxe Reverse shoulder components, "giving orthopaedic surgeons the intra-operative flexibility to decide whether to perform a hemiarthroplasty or a reverse total shoulder."
MiMedx Group received CE mark clearance for the HydroFix Spine Shield, a PVA membrane intended for use during anterior spinal surgeries as an adhesion-inhibiting barrier. The device is sutured into place to provide a "plane of dissection" during a revision surgery.
OrthoDynamix received 510(k) clearance for the ArthroSteer 3.5mm Ablator, an electrosurgical device designed for the resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in a number of orthopedic procedures.
The FDA has scheduled a Orthopaedic and Rehabilitation Devices Panel meeting for March 23, where the panel will discuss the re-evaluation of ReGen Biologics' Menaflex. The product was first cleared in December 2008, though concerns from FDA scientists about the rigor of ReGen's review quickly surfaced. A subsequent FDA investigation described the ReGen case as "deterioration" of the 510(k) process.
Product Introduction and Update
OrthoView will launch the latest version of their procedure-planning software at AAOS next week. The company says the new SmartHip automatic templating feature allows a surgeon to "plan a total hip procedure in less than 60 seconds."
Stryker Interventional Spine launched VertaPlex HV, a high-viscosity bone cement for use in treating vertebral compression fractures.
Stryker launched the ADM X3 Mobile Bearing Acetabular System, a "next-generation technology for hip replacement" that the company says reduces volumetric wear by 97% when compared to conventional polyethylene.
Intellectual Property
Amedica received U.S. Patent No. 7,666,229, which covers its ceramic-on-ceramic bearings for articulating joints. This technology will be used in "ultra-low-wear bearing components for motion-preserving implants" for large joints and the spine.
Reimbursement
Aetna and United Healthcare reversed prior policies and announced that they will cover NuVasive's XLIF, allowing the procedure to shed its "investigational" status.
Congress passed a bill to delay a 21% Medicare pay cut scheduled for March 1. The cut will now take effect April 1 if no other legislation is passed.
Clinical
ProChon Biotech is nearing the halfway point in patient enrollment for the company’s Phase II study of the BioCart Autologous Cartilage System. Enrollment in the randomized, double-arm, open-label, multicenter study should be completed within three months. The study will compare the safety and efficacy of the BioCart System to microfracture for the treatment of symptomatic cartilage defects.
Distribution
Spineology will distribute Captiva's capLOX Pedicle Screw System on a non-exclusive basis in the U.S.
