Musculoskeletal News Roundup 3-Feb-11
BY LAUREN UZDIENSKI, FEBRUARY 3, 2011
Earnings
CONMED reported 4Q:10 sales of $184.1 million, down 3% from the year-ago period and missing estimates by $5.0 million. Arthroscopy sales declined by 4% to $73.1 million. Non-GAAP diluted earnings per share were $0.36, in line with estimates and down from non-GAAP diluted earnings per share of $0.37 in 4Q:09.
Kensey Nash reported F2Q:10 revenues of $17.4 million, down 9% over the year-ago period and beating estimates by $0.1 million. Orthopedic sales declined by 20% to $4.8 million, with sports medicine down 14% and spine down 30%. Net profit fell from $3.8 million to $3.3 million, or $0.38 per share, missing estimates by $0.01.
RTI Biologics reported 4Q:10 revenues of $45.4 million, up 8% over the year-ago period and beating estimates by $0.1 million. Among segments, sports medicine sales increased by 19%: spine decreased by 1%; dental decreased by 9%; surgical specialties increased by 20%; and bone graft substitutes and general orthopedic sales decreased by 8%. Net income for the quarter was $2.8 million, or $0.05 per share, in line with estimates and up from net income of $1.5 million, or $0.03 per share, in 4Q:09.
M&A
Kensey Nash acquired Nerites Corporation, a developer of medical adhesives and anti-fouling coatings, for $20.0 million in cash. Nerites is developing a technology platform of adhesive-based biomaterials that Kensey says will help the company "further its penetration into the regenerative medicine markets" within soft tissue surgical repair, orthopedics, sports medicine, spine and neurosurgery. Additionally, Nerites' anti-fouling technology can be applied to prevent bacterial biofilm formation.
Stryker closed the sale of its OP-1 product family to Olympus. The divested assets include the OP-1 Implant, OP-1 Putty, Opgenra and Osigraft, all of which are indicated for use in orthopedic bone applications. The transaction also includes the sale of the manufacturing facility in Lebanon, NH. When the deal was announced in December, Olympus was said to be paying $60.0 million for the products.
Funding
Spine Wave closed $17.5 million round of financing led by existing investor New Enterprise Associates, who were joined by Morgenthaler Ventures, Compass Global Fund, New Leaf Venture Partners, Canaan Partners, Foundation Medical Partners and Memphis Implant Partners. Funds will be used to expand commercial operations and support additional clinical trials of the NuCore Injectable Nucleus.
On Wednesday, Tornier raised $166 million in an IPO, selling 8.75 million shares for $19 each. Tornier is using proceeds from the IPO to repay debt of about $115 million and for general purposes. The 70-year-old company, well-known to the industry, specializes in shoulders, elbows, wrists, ankles and feet and was bought by Warburg Pincus in 2006.
VertiFlex raised $14.0 million in equity placement, with a provision for an additional $14.0 million investment within twelve months. Current investors Aberdare Ventures, Alta Partners and New Enterprise Associates were joined in the financing by new investor Thomas, McNerney & Partners. Funds will be used to complete enrollment in the Superion Interspinous Spacer IDE study and to "advance global market development of the technology."
Regulatory
BioMimetic Therapeutics announced that the FDA has "tentatively scheduled" an Orthopedic and Rehabilitation Devices Panel meeting on May 12, 2011 to review the company's PMA application for Augment Bone Graft for the treatment of foot and ankle fusions. Assuming a positive panel hearing, BioMimetic expects approval of Augment within three to six months after the panel date.
ConforMIS received 510(k) clearance to market its iTotal CR Knee Replacement System, which the company says is the first truly patient-specific system on the market. The iTotal CR uses the company's iFit technology to create patient-specific implants and individualized jigs.
Product Introduction and Update
SpineGuard expanded its PediGuard platform to include the PediGuard Curv, which is in limited release and offers a curved-tip alternative to the company's PediGuard technology. PediGuard is a handheld, wireless device that can detect possible vertebral cortex perforation during pedicle preparation for screw placement.
Legislation
A Florida judge has declared President Obama's healthcare reform legislation unconstitutional. The particular issue at hand was the constitutionality of a mandate that would require all Americans to purchase insurance. The case is now expected to be taken up by the Supreme Court.
Distribution
Sonoma Orthopedic Products signed a licensing and distribution agreement with Ai-Medic, a subsidiary of Olympus Business Creation Corporation, for the supply of Sonoma's products to the Japanese market. The agreement includes "significant license fee and revenue commitments" and relates specifically to the company's WaviBody clavicle fixation device.
Wright Medical extended their supply agreement with LifeCell for the supply of GraftJacket Regenerative Tissue Matrix through December 2018 for orthopedic markets. Financial terms were not disclosed.
Education
Biomet donated $1.3 million to the Orthopaedic Research and Education Foundation (OREF), which will be used to fund orthopedic fellowship and resident enhancement programs. Fellowship funding will underwrite advanced education in the sub-specialties of adult reconstruction, upper extremity, sports medicine, oncology, trauma and spine.
Appointments
CareFusion announced that Kieran T. Gallahue will assume the role of Chairman and Chief Executive Officer, succeeding David L. Schlotterbeck, who announced plans to retire last year. Prior to accepting the post at CareFusion, Mr. Gallahue served as Resmed's President and Chief Executive Officer.
Interventional Spine appointed Brit DuBois Vice President, Distributor Relations. Mr. DuBois joins Interventional Spine from Lanx, where he served as Vice President of Business Development and Surgeon Relations. He has also held positions at Zimmer Orthopedics, Medtronic Sofamor Danek, Aesculap and Macropore.
