Musculoskeletal News Roundup 28-Jul-11
BY LAUREN UZDIENSKI, JULY 28, 2011
Earnings
CONMED reported 2Q:11 sales of $183.2 million, flat over the year-ago period and missing estimates by $2.3 million. Sales of arthroscopy products decreased by 8% to $74.9 million. Growth rates exclude the effects of currency. Non-GAAP diluted earnings per share for the quarter were $0.35, up from $0.32 in 2Q:10 and in line with estimates.
Integra reported 2Q:11 revenues of $193.3 million, up 6% over the year-ago period and beating estimates by $4.3 million. Orthopedics sales increased by 11% to $80.6 million, with the company noting that the SeaSpine acquisition "brought both new products and excellent management to our spine business". Growth rates exclude the effects of currency. Adjusted net income for 2Q:11 was $21.2 million, or $0.70 per diluted share, which compares to $20.9 million, or $0.68 per diluted share, in 2Q:10. EPS beat estimates by a penny.
MiMedx Group reported 2Q:11 sales of $1.9 million, a six-fold increase over 2Q:10 and an 85% increase over 1Q:11. The company said their amniotic membrane tissue revenue "exceeded our expectations," while their HydroFix products "fell short of expectations," though the company received an additional FDA clearance during the quarter that will broaden the product's indications for use. The company recorded a net loss of $2.5 million, or $0.03 per diluted common share, in 2Q:11, which compares to a net loss of $2.7 million, or $0.04 per diluted common share, in 2Q:10.
NuVasive reported 2Q:11 revenues of $133.0 million, up 11% over the year-ago period and beating estimates by $1.1 million. Non-GAAP earnings were $12.4 million in 2Q:11, or $0.30 per share, beating estimates by $0.02. The company said they "made progress against our profitability goals in spite of challenging spine market growth dynamics."
Orthofix reported 2Q:11 sales of $143.6 million, down 2% over the year-ago period and missing estimates by $2.7 million. Spine sales were down 3% overall, though implants and biologics sales increased by 9%. Additionally, orthopedics sales were flat and sports medicine sales increased by 8%. Adjusted net income for 2Q:11 was $12.8 million, or $0.69 per diluted share, up 32% over the year-ago period. Adjusted EPS beat estimates by $0.06.
RTI Biologics reported 2Q:11 sales of f $43.5 million, up 6% over the year-ago period and beating estimates by $3.0 million. The company said that growth was driven primarily by growth in the surgical specialties and direct sports medicine businesses. The company reported net income of $2.0 million, or $0.04 per share, which compares to net income of $0.9million, or $0.02 per fully diluted share, in 2Q:10. EPS beat estimates by a penny.
Wright Medical reported 2Q:11 revenues of $132.5 million, flat over the year-ago period and beating estimates by $0.2 million. Among segments, hips were down 3%; knee was up 2%; extremity was up 9%; and biologics were down 11%. Growth rates exclude the effects of currency. Net income was $6.1 million, or $0.16 per diluted share, during the quarter, which compares to net income of $4.8 million, or $0.13 per diluted share, in 2Q:10. Analysts had forecast EPS of $0.17.
Zimmer reported 2Q:11 revenues of $1.1 billion, up 2% over the year-ago period and beating estimates by $7.7 million. Among segments, recon sales were flat, with knee declining by 1%; hip increasing by 2% and extremity increasing by 4%. Additionally, dental was up 16%, trauma was up 14% and spine decreased by 6%. Growth rates exclude the effects of currency. As adjusted, net income for the quarter was $232.5 million. Adjusted net earnings per share increased by 11% to $1.21, beating estimates by $0.02.
Regulatory
ArthroCare received 510(k) clearance for its SpeedFix Suture System, a push-in anchor made of PEEK that is designed for the repair of tears of the labrum in a shoulder.
The FDA has issued draft guidance intended to clarify when changes or modifications to a previously cleared 510(k) device require a new premarket submission. These changes may include specific kinds of labeling changes, changes to the technology used in the device, changes in performance specifications, manufacturing changes and changes in the materials used in the manufacture of the device.
Product Introduction and Update
Osseon Therapeutics announced that the first Osseoplasty cases were performed in India this month. Osseoplasty is a percutaneous vertebral augmentation system that uses a steerable, unipedicular system of vertebral body access and cement delivery.
Legal
Synthes has filed a patent infringement lawsuit against Globus over its spacer technology. Named in the suit are Globus' Independence, Coalition and InterContinental systems
Clinical
Carbylan BioSurgery announced results from a double-blind, multi-center study evaluating the safety and efficacy of Hydros-TA Joint Therapy, a single-injection viscosupplement consisting of bacterially-derived hyaluronic acid and a corticosteroid, compared to Synvisc-One for the treatment of knee OA. A total of 98 patients were treated and followed for six months post injection, and the company said that Hydros-TA "demonstrated the potential to provide greater pain relief with faster onset than Synvisc-One." The company added that Hydros-TA also appeared to be associated with a lower rate of product-related adverse events, including post-injection pain.
Histogenics Corporation announced results from phase II data for the NeoCart Autologous Cartilage Tissue Implant. According to outcomes from a prospective, randomized, controlled study comparing NeoCart to microfracture for the treatment of knee cartilage injury, NeoCart was associated with statistically significant improvements in knee and general health outcomes scores at six months and the primary endpoint of twelve months. Results were sustained for at least two years, and NeoCart had a higher proportion of therapeutic responders in comparison to microfracture at one and two years.
Lanx commented on two poster presentations on their Aspen Spinous Process Fixation System given last week at the International Meeting on Advanced Spine Techniques (IMAST). One study evaluated the Aspen compared to pedicle screw fixation in 24 sheep that underwent a posterolateral fusion procedure at L5-L6. Within six months, 12 of 12 sheep in the Aspen device group showed "robust bridging bone" on at least one side, whereas only 7 of 12 in the pedicle screw group showed the same degree of bridging bone on at least one side. A biomechanics study demonstrated that both the Aspen device with bilateral facet screws and bilateral pedicle screws provided "statistically superior stability" compared to five different constructs combining facet screws, pedicle screws and the Aspen device on the basis of flexion-extension, lateral bending and axial rotation.
Operations
Smith & Nephew announced that the company is reorganizing the former orthopedic reconstruction and endoscopy segments into one unit, which will be named Advanced Surgical Devices. Former president of endoscopy Mike Frazzette will lead the new unit, and recon president Joe DeVivo will resign his post effective August 5.
