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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 31-July-08 BY LAUREN UZDIENSKI, JULY 31, 2008

Earnings
Cryolife reported 2Q:08 revenues of $27.2 million, up 18% over the year-ago period and beating estimates by $1.4 million. Orthopedic tissue processing revenues declined 76% to $0.3 million, as the company has discontinued that segment of the business. Net income was $3.9 million, or $0.14 per basic and fully diluted common share, missing estimates by $0.04.

Exactech reported 2Q:08 revenues of $43.7 million, a 38% increase over the year-ago period. Organic growth, excluding acquisitions and distribution terminations, was 28%. Revenues beat estimates by $2.8 million. Net income for the quarter was $3.0 million, or $0.24 per share, beating estimates by a penny. Among segments, knee was up 21% to $20.5 million in sales; hip was up 4% to $5.7 million; biologics were up 21% to $4.7 million; shoulder was up 69% to $3.9 million; and spine sales stemming from the Altiva acquisition were $1.9 million.

MAKO Surgical reported 2Q:08 revenue of $0.7 million, up from $0.1 million in 2Q:07 and beating estimates by $0.4 million. Sales growth was attributed primarily to procedure volume; there were 140 MAKOplasty procedures performed in 2Q:08, up 37% sequentially. The company reported a loss of $7.6 million, or $0.42 per share, beating estimates by $0.03.

Osteotech reported 2Q:08 revenues of $27.6 million, up 4% from the year-ago period but missing estimates by $0.8 million. DBM revenue contributed $16.58 million in revenue; hybrid/synthetic products contributed $0.73 million; and spinal allografts contributed $2.29 million. Net income for the quarter was $1.7 million, or $0.10 per share, beating estimates of $0.03.

Synthes reported 2Q:08 sales of $792.5 million, up 18% (12% in local currencies) over the year ago-period. Among regions, North America contributed $471.7 million in revenue, up 11% over 2Q:07; growth was attributed to new product introductions and accelerated sales force expansion. Europe contributed $196.1 million, up 27% (12% local currency). Asia Pacific contributed $74.4 million, up 29% (16% local currency), with sales growth supported by the Asia-specific PFNA (Proximal Femoral Nail) and LCP (Locking Compression Plate) product lines; and ROW contributed $50.3 million, up 34% (19% local currency), with sales supported by the first shipments of a tender order to the Middle East as well as double-digit growth in Latin America. Net income for 1H:08 was $348.8 million, or $2.94 per share, up 24% over the year-ago period.

Trans1 reported 2Q:08 revenues of $6.0 million, beating estimates by $0.1 million and representing a 46% increase over 2Q:07. The company reported a net loss of $5.3 million, or $0.26 per share, missing estimates by $0.03. The company adds that there were 703 TranS1 procedures performed during 2Q:08.

Wright Medical Group reported revenues of $118.5 million, representing a 21% increase over the year-ago period and beating estimates by $3.1 million. Among segments, hip sales increased 20%; knee increased 21%; extremity increased 49%; and biologics increased 4%. The company reported adjusted net income increased 18% to $7.2 million, or $0.19 per share. Analysts were expecting adjusted earnings of $0.11 per share.

Funding
ReGen Biologics completed a $2.5 million private placement of convertible notes, which the company says will help it to fund operations through 4Q:08. Additionally, ReGen has submitted a new 510(k) for its Menaflex collagen meniscus implant, which was shown in a recent study published in JBJS to improve outcomes for some patients.

Vertiflex has raised around $28.3M in venture funding. Names of the investors participating in the round have not been released, though current investors include Aberdare Ventures, Alta Partners and Morgenthaler Ventures.

Legal
Two former Medtronic employees have filed a qui tam lawsuit in a Boston federal court against more than 100 orthopedic and neurosurgeons and several distributors alleging violations of the False Claims Act as well as accusations of kickbacks. Among other claims, the suit alleges that the defendants colluded with Medtronic to file claims for reimbursement that the defendants knew to be "false, exaggerated or ineligible."

Regulatory
Osteotech announced that FDA 510(k) clearance for Plexur M Biocomposite has been expanded to include use in spinal applications, in conjunction with autograft, as a bone void filler. Previously, Plexur M had been cleared for filling bony voids or gaps in the pelvis and extremities.

Titan Spine has received expanded FDA 510(k) clearance for the Endoskeleton TA vertebral body replacement device to include an interbody fusion device indication. The Endoskeleton is now indicated for use in skeletally mature patients with DDD at one or two contiguous levels from L2-S1.

The FDA cleared Xylos' Surgical Mesh under a Special 510(k), adding additional processing methods to the company’s previous Surgical Mesh 510(k) for soft tissue reinforcement.

Product Introduction and Update
ApaTech launched Actifuse MIS, a new applicator that can offer "unprecedented access" to a graft site during MIS and open procedures. The company says the product can be used in spine and orthopedic procedures including posterolateral fusion, tumor and bone void filling and acetabular cysts.

Pioneer Surgical Technology launched the SlimFuse anterior cervical plate system. According to the company, the SlimFuse offers narrow plate width, and scalloped cutouts "provide improved interoperative visualization" compared to traditional systems. The system also allows the surgeon to choose between a rigid, semi-rigid or translationally dynamic system without additional instrumentation.

Distribution
Exactech Inc. received a national purchasing contract from HealthTrust Purchasing Group that will cover the Equinoxe Shoulder product line. Exactech already has contracts with HealthTrust for several of its hip and knee products. The three-year agreement for the Equinoxe is effective August 1st.

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