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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 18-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 18, 2008

In addition to its regularly scheduled payments, Orthofix International will make a $10 million debt prepayment on December 29th in advance of the scheduled maturity. According to Executive Vice President and CFO Bob Vaters, "This is a good time to begin deleveraging our balance sheet. The improving outlook at Blackstone along with more normalized capital expenditures and the completion of purchases of Trinity . . . contributed to our decision to make a prepayment."

Pioneer Surgical Technology closed a Series B financing totaling $15 million. Investors included InvestMichigan! Growth Capital Fund, who was joined by previous investors Pharos Capital Group, LLC, Highlander Partners, LP, Hopewell Ventures and River Cities Capital Funds. The funds will be used to conduct a pivotal study for the NuBac nucleus replacement device.

TiGenix received a EUR 1.81 million ($2.41 million) grant from the Flemish government to support its meniscus repair program. Goals of the two-year program are the further development and application of allogenic stem cells in combination with a biocompatible scaffold, the identification of biomarkers predictive of the quality of meniscus-like tissue and establishing preclinical proof-of-principle for cellular repair of meniscus lesions. TiGenix will collaborate with the Biomedical Research Institute of the University of Hasselt and the University of Leuven.

ApaTech received 510(k) clearance for Actifuse, an osteoconductive bone void filler indicated for filling for gaps and voids in the extremities, pelvis and spine, including use in posterolateral fusion procedures in combination with stabilizing hardware.

PEAK Surgical received 510(k) clearance for its PlasmaBlade Tissue Dissection Device for use in orthopedic, arthroscopic, spinal and neurological procedures, among other indications. The system utilizes radiofrequency energy to incise tissue and control bleeding.

Preclinical Development
Orthofix International announced a milestone in its collaboration with the Musculoskeletal Transplant Foundation to develop a next-generation stem cell allograft. MTF recently provided Orthofix with "a conclusive data package" the company says meets the terms of the companies' development agreement. The next-gen product will be called Trinity Evolution, and it is now expected to be ready for market launch by June 2009.

Centinel Spine has retained exclusive U.S. distribution rights to the Stalif TT stand-alone lumbar interbody fusion device developed by Surgicraft. Centinel Spine now has exclusive global distribution rights for the product and expects to see increased revenue from this technology as early as 1Q:09.

LDR announced the expansion of its South American and Latin American distribution network, with an Brazil office opening earlier this year and the addition of exclusive distributor networks in Argentina, Peru and Venezuela Additionally, the company expects to add new distributors in Chile and Colombia in Q1:09. The company also launched the Mobi-C in Mexico and will launch of the ROI, MC+ and Easyspine fusion lines in Argentina in Q1:09.

The Wall Street Journal reports that Medtronic plans to inform the FDA of a death related to the off-label use of Infuse. The company says they were unaware of the death until the family filed suit against the company.

Alphatec Spine, Inc. held its first medical training for commercial use of the OsseoFix Spinal Fracture Reduction System, the Company's innovative product for the treatment of vertebral compression fractures. Over 30 participants including physicians and selected distributors were in attendance at the University of Vienna in Austria where they received hands-on cadaver lab training on the safe and effective use of the OsseoFix system. These physicians and distributors represented several countries in Europe, including The Benelux, Denmark, Greece, Italy and Turkey.

BioMimetic Therapeutics completed enrollment of 396 patients for its North American pivotal clinical study evaluating Augment Bone Graft for the treatment of hindfoot and ankle fusions. The randomized study will compare Augment to autograft. The company plans to file a modular PMA, where the submission will occur in sections, with the preclinical and the quality and manufacturing modules to be submitted to the FDA next spring, and the clinical data to be submitted in 4Q:09.

Exactech reported that surgeons are "experiencing excellent early results" with the Optetrak CR Slope knee system, which was launched in 4Q:08. The company says that the Optetrak CR Slope knee features varying posterior tibial slopes, which differentiate it from other posterior cruciate-preserving knee replacements. The system also offers choices in size and thickness.

Globus Medical, Inc. appointed Wendy DiCicco, CPA, as Chief Financial Officer. Previously, Ms. DiCicco was the CFO for Kensey Nash Corporation, a role she held for 10 years. Globus President and COO Dave Demski says, "Her financial knowledge and experience will be instrumental in helping us build upon our success as a leader in the spine industry."

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