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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 16-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 16, 2010

Earnings
NuVasive lowered the top end of its 2010 guidance range, adjusting 3Q:10 revenue to $120.0-$123.0 million and full-year revenue to $485.0-$495.0 million, compared to previous guidance of $485.0-$500.0 million. Non-GAAP EPS for 2010 was adjusted to $1.50-$1.60 from $1.50-$1.64.

M&A
HydroCision announced that the majority of the company has been acquired by three venture capital firms, Volcano Capital, Bioventures and Omega Funds. In conjunction with the acquisition, Howard Donnelly, whom the press release described as having "20 years of executive-level experience in the medical device industry," was appointed President and CEO of the company. HydroCision manufactures SpineJet, which the company says enables discectomy and interbody fusion procedures "to be performed faster, less invasively, and with a higher degree of precision than traditional surgical modalities."

Funding
Orthopaedic Synergy raised $3.6 million of a planned $4.0 million offering, according to an SEC filing. No other information was available.

TiGenix announced the closing of a EUR 4.1 million ($5.2 million) seed-financing round for Acarios, a spinout established jointly with Therosteon and dedicated to developing drugs for bone and joint diseases. TiGenix retained a significant equity stake in Acarios and the rights to certain drug candidates developed by the company for the treatment of arthritis. The round was led by BioGeneration Ventures, who were joined by Erasmus MC Biomedical Fund, Gemma Frisius Fund, CD3, Baekeland Fund II, Credit Agricole, VINNOF and LRM.

Regulatory
Creaspine received CE mark clearance for Kira, a cervical fusion spacer designed for an "enhanced fit" between endplates. Per the press release, the device features an "anchor-like" shape to optimize load-bearing and is made from PEEK.

Ranier Technology received CE mark clearance for its Cadisc-L, which the company describes as an "elasto-mimetic" lumbar disc replacement. The device is made from polyurethane. Ranier added that initial outcomes in from the company's multi-center European study are "very pleasing," with patients reporting "significant reductions in average leg and back pain and overall disability" as well as an "increase in quality of life."

RSB Spine announced that 510(k) clearances for the InterPlate L-Ti have been expanded to include the KWQ product code, which covers anterior lumbar plating systems. The L-Ti was previously cleared as an interbody fusion device.

Product Introduction and Update
Integra LifeSciences introduced a new line of extended length and detachable Ruggles kerrison rongeurs for use in a variety of neuro and spine surgeries. The company says the extended length is intended to address patients with a larger body mass index, and the detachable feature allows for easier cleaning. The instruments also feature a coating designed to help preserve sharpness.

joimax launched the "Shrill" drill and resection system, designed to removes both soft and solid tissue. The drill is part of the TESSYS system for the endoscopic treatment of spinal stenosis.

Medtronic announced the European launch of the Kyphon Cement Delivery System, which is designed for use during balloon kyphoplasty. The company notes that the system allows more distance between the physician and the radiation source as well as one-handed operation during cement delivery.

SI-BONE initiated European training for its iFuse Implant System, an MIS system designed to treat the SI joint. The company says it consists of titanium implants coated with a porous plasma spray that "acts as an interference surface fit, which helps decrease implant motion." The company is expecting CE mark clearance for the system "at any time."

Intellectual Property
Amedica received U.S. patents No. 7,758,646 B2 and No. 7,771,481 B2, which cover its total disc replacement (TDR) technology, namely the disc's design and the use of the company's silicon nitride ceramic materials in its construction.

Clinical
SpineAlign Medical enrolled its first patient in the European Observational Registry for the company's VerteLift System, which is CE marked for the treatment of VCFs. The technology is a "transpedicular, minimally invasive approach to reduction, stabilization and pain relief associated with vertebral compression fractures" that offers "clinically measurable height restoration."

License Agreements
Geron entered into a collaboration with University Campus Suffolk in the U.K. to develop human embryonic stem cell-derived chondrocytes for the treatment of cartilage damage and joint disease. The project will be based within the new biotechnology unit at UCS and be jointly funded by Geron and UCS. UCS will provide facilities and equipment for the project, and Geron will fund the direct costs of the development work at UCS.

RTI Biologics announced a collaboration with Athersys, whereby RTI will have access to Athersys' Multipotent Adult Progenitor Cell (MAPC) technology. RTI plans on developing the cells for orthopedic applications, noting that MPAC will help them to differentiate their orthobiologics portfolio.

Collaborations
DSM Biomedical has extended their partnership with Spinelab Ltd. Spinelab is developing the Elaspine Implant System, a pedicle-screw based posterior motion preservation system for the lumbar spine, which is comprised of a DSM polymer called Bionate PCU. DSM describes the material has having "optional built-in surface modification" and "tough, load-bearing qualities."

Legal
A federal appeals court overturned certain rulings from a lower court in Synthes' ongoing patent infringement suit against Medtronic over the Maverick family of artificial discs. The court found that one disc, the O-Maverick, did not infringe Synthes patents, vacating $5.7 million in damages and additional legal costs and remanding the case to a lower court for a new determination of damages.

Synthes sued Biomet and a former Synthes sales rep for allegedly colluding to improperly convert Synthes customers to Biomet.

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