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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 20-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 20, 2011

Earnings
Kensey Nash reported F1Q:12 revenues of $20.0 million, up 18% over the year-ago quarter and beating estimates by $0.8 million. Orthopedic sales increased 140% to $12.7 million during the quarter; excluding sales from the company's May 2011 Norian acquisition, orthopedic sales increased by 53%. Sports medicine sales increased by 36%, which the company attributed to reductions in inventory in F1Q:11 and, to a lesser degree, recovery in the market. Spine sales of $5.4 million increased 113%, which was attributed to the Stryker's acquisition of Orthovita. Trauma and CMF products, which were comprised almost entirely of Norian sales, were $3.6 million. Adjusted EPS for the quarter were $0.32, beating estimates by a penny.

Johnson & Johnson reported 3Q:11 sales of $16.0 million, up 3% over the year-ago quarter and missing estimates by $12.6 million. DePuy sales totaled $1.4 billion, up 2% over 3Q:10, with hip up 1% and knee down 4%. Growth rates exclude the effects of currency. Excluding special items, net earnings for the quarter were $3.4 billion, or $1.24 per share, up 1% over the year-ago period and beating estimates by $0.04.

Medicrea reported 3Q:11 sales of EUR 4.0 million ($5.4 million), down 10% over the year-ago period. The company noted that they recently reorganized, strengthened the U.S. sales force and are expecting "renewed strong sales growth" in 2012. Medicrea also announced first half results, stating that for the first time since the company's IPO, they recorded an operating profit. EBIT was EUR 0.5 million ($0.7 million), compared to an operating loss of EUR 1.0 million in 1H:10 ($1.2 million).

Stryker reported 3Q:11 sales of $2.0 billion, up 12% over the year-ago period and missing estimates by $1.2 million. Recon sales were up 4% to $901.0 million, with hip up 5%, knee down 1% and trauma and extremity up 12%. Spine sales increased by 5% to $179.0 million. Growth rates exclude the effects of currency. Adjusted net earnings for the quarter were $352.0 million, or $0.91 per share, up 11% over the year-ago period. EPS beat estimates by $0.02.

Synthes reported 3Q:11 sales of $1.0 billion, up 7% over the year-ago period and beating estimates by $2.4 million. The company noted that it was their first quarter reaching billion-dollar sales. Synthes reported "mid single-digit growth" in North America improving sales outside North American with "strong double-digit growth" in CMF, Power Tools, Asia Pacific and Latin America and solid single-digit growth in Trauma and Spine when compared to 2Q:11.

Funding
Ranier Technology raised GBP 3.0 million ($4.5 million) from current investors First Ventures and Alliance Trust Equity Partners. The funding will support the European commercialization of Cadisc L, the company's CE-marked spinal lumbar disc, as well as clinical trials and the controlled launch of Cadisc C, its spinal cervical disc.

Regulatory
BioMimetic Therapeutics received regulatory approval to market Augment Bone Graft in Australia. The product has been approved for use as an alternative to autograft in hindfoot and ankle fusion procedures based on BMTI's U.S. pivotal study and Canadian registration data.

Medtronic received 510(k) clearance for its Aquamantys3 System as well as the new 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pieces. The device features Transcollation, which combines radio frequency energy with saline to provide hemostatic sealing of soft tissue and bone during surgery, and enables RF cutting functions. The technology was obtained through the acquisition of Salient Surgical earlier this year.

Spineology received 510(k) clearance for the Rampart line of Interbody fusion implants. The company says the Rampart line will include a variety of implant configurations, lengths and heights.

Product Introduction & Update
The HipSextant Navigation System, an image-guided system for hip replacement surgery, was used commercially for the first time this week. The system uses low-dose CT imaging to create a 3D model of a patient's hip; during surgery, the HipSextant is intended to aid surgeons in placing an acetabular cup.

joimax introduced several new products at Eurospine, including the Multiuse instruments for endoscopic facet joint denervation.

K2M launched the RAVINE Lateral Access System along with the ALEUTIAN Lateral Interbody System. The company says the RAVINE "provides a dual flat blade platform for a less invasive muscle splitting transpsoas approach." The system offers rigid fixation to the spine.

Medicrea introduced six new products at Eurospine: the LigaPASS, an implantable device for connecting an osteosynthesis rod to the spinal column via an artificial ligament; the PASS OCT for the treatment of occipito-cervical-thoracic pathologies; the PASS MIS, the company's first entry into the percutaneous osteosynthesis market, designed for use in traumatological spinal column pathologies and degenerative lumbar-region pathologies; the GRANVIA-L lumbar disc, available in the EU in mid-2012; the CARYATID radiolucent corporectomy implant; and the LaminoJAWS, a non-fusion implant allowing reconstruction of the posterior cervical arch under cervical laminoplasty.

Intellectual Property
ICAP Patent Brokerage, an intellectual property brokerage and patent auction firm, is offering for sale a medical device patent portfolio related to posterolateral lumbar disc arthroplasty. The press release states that patent portfolio covers both the device and methods of implantation.

Investigations
TranS1 announced that the company received a subpoena from the OIG relating to federal healthcare fraud and false claims statutes. The document was received on or around October 6th, and the company adds that "no claims have been made against the company at this time." No further details have been made public.

Clinical
Globus Medical will collaborate with the Society for Minimally Invasive Spine Surgery (SMISS) to fund a patient outcomes registry in the U.S. The registry will capture prospective clinical data from 10 to 15 clinical sites and enroll up to 250 patients treated with MIS techniques for degenerative lumbar spondylolisthesis, degenerative disc disease, stenosis and degenerative scoliosis. Patients will be followed for a minimum of 24 months, with outcomes measured by the Health Related Quality of Life (HRQOL) survey and by Quality Adjusted Life Years (QALY). The registry will also record the rate and incidence of peri-operative and post-operative adverse events, radiographic correction and fusion rates as well as cost of treatment with the MIS approach.

Distribution
Zimmer and Benvenue Medical have entered into a multi-year, exclusive agreement for Zimmer Spine to distribute Benvenue Medical's Kiva VCF Treatment System. The Kiva VCF Treatment System delivers a percutaneously-introduced, cylindrical PEEK-OPTIMA implant to stabilize and provide structural support to the vertebral body and serve as a conduit for bone cement placement. The system received CE mark certification in 2008 and has been used in over 500 VCFs globally. The Kiva System represents Zimmer Spine's first VCF product offering.

Collaborations
Scorpion Medical, a precision manufacturer of medical devices, and Monet Medical, a medical device development company formed a joint venture called Biologic Therapies. The new company is developing what they call "Autologous Orthobiologic Therapy" for the treatment of both soft and hard tissues.

Appointments
K2M announced the appointment of three new global team members: Larry W. Found as Senior Vice President, Global Human Resources; Gianluca Iasci as Senior Vice President of International; and Carol Pinto, Area Vice President, Latin America. The company said that the appointments were a "significant advancement towards the company's strategy of leadership in the global spine market" and credited the Welsh, Carson, Anderson & Stowe transaction last August for helping attract talent and enabling "rapid global expansion."

Lanx created a Surgeon Advisory Board chaired by orthopedic surgeon Andrew Cappuccino, MD. The company says the Board will "provide guidance to the company on product commercialization, clinical studies and surgeon training."

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