Musculoskeletal News Roundup 7-Oct-10
BY LAUREN UZDIENSKI, OCTOBER 7, 2010
Earnings
Medyssey announced that 3Q:10 sales increased by 112% over 3Q:09. Additionally, year-to-date sales increased by 73% over the same period in 2009. The company attributed sales growth to new regulatory clearances, the addition of several key distributors in emerging markets and the launch of its U.S. sales initiative.
RSB Spine announced that 3Q:10 sales increased by 229% compared to 3Q:09 and 46% compared to 2Q:10. The company also closed a $1.5 million private offering to expand U.S. operations.
Funding
DJO Inc. announced plans to undertake a $300.0 million senior subordinated note offering. The company plans to use the funds to refinance and repay existing debt.
Wright Medical Group received a $2.4 million grant from the U.S. Department of Defense to fund a clinical study of OSTEOSET T bone graft substitute pellets in combat-related open fracture wounds. OSTEOSET T is a surgical-grade calcium sulfate bone graft substitute impregnated with 4% tobramycin sulfate.
Regulatory
Advanced Vertebral Solutions received 510(k) clearance for its Steerable TLIF spinal fusion implant. The device is made from Zeniva PEEK resin, which is manufactured by Solvay Advanced Polymers, LLC. Advanced Vertebral Solutions says Zeniva PEEK has "a modulus very close to that of bone plus excellent toughness and fatigue resistance."
Alphatec Spine received CE mark approval for commercial sale in the European Union and other jurisdictions for its HeliFix Interspinous Spacer System and Solus ALIF System. The HeliFix Interspinous Spacer System is a minimally invasive non-fusion solution for lumbar spinal stenosis (LSS). The Solus ALIF System is a zero-profile, single-action locking implant that is used in anterior lumbar interbody fusion (ALIF) procedures.
Centinel Spine received 510(k) clearance to market the new STALIF MIDLINE system for anterior lumbar interbody fusion. The system features the company's Lumen Locking and ABO (Anti Back-Out) technology, which protect against screw back-out.
DFine received 510(k) clearance for a platform extension for its percutaneous radiofrequency ablation (RFA) device. The device is indicated for the palliative treatment of cancer patients and provides localized tumor necrosis of vertebral body lesions where metastatic disease has spread to the spine.
DiFUSION Technologies received 510(k) clearance for the Xiphos line of posterior interbody devices, indicated for intervertebral body fusion of the lumbar spine from L2 to SI. The company is also developing CleanFUZE anti-microbial technology for orthopedic implants.
Integra LifeSciences received 510(k) clearance for the Vu aPOD Prime ALIF device, which allows two fixation options: two self-tapping bone screws, which the company says require no additional fixation and reduce the number of operative steps compared to other ALIF devices, or the SpinPlate internal buttress plate technology, which also require no additional fixation.
NovaBone received 510(k) clearance for the NovaBone Putty MIS Delivery System, which consists of a syringe pre-loaded with NovaBone Putty and 6mm cannulas of varying lengths.
Product Introduction and Update
Alphatec Spine announced two new product releases in the U.S. market, the Aspida Anterior Lumbar Plating System and the PureGen Osteoprogenitor Cell Allograft. The Aspida System has 510(k) clearance and features a slim profile, a single-action self-locking mechanism and a dual-lead threaded screw, all of which are designed to minimize the disruption of tissue near the implant and reduce operating time for the surgeon. PureGen is a highly concentrated, pure population of adult stem cells that originates in bone marrow and is collected from live, healthy donors for optimal cell functionality.
DePuy Spine launched the MIS Lateral Platform, which consists of the COUGAR LS Cage System, the PIPELINE LS Lateral Access System and the VIPER2 System of rods and screws. Additionally, the company introduced the EXPEDIUM Offset System, which they say can be used in a range of procedures and offers polyaxial and fixed bolts, angulating and slotted connectors and single and multi-level plating options.
K2M launched its first spinal biologic, the VIKOS Cervical Allograft System. K2M is collaborating with LifeNet Health to supply the allograft. The company also introduced the RAVINE Lateral Access System, which represents their first entry into the far lateral market and an expansion of their MIS portfolio.
LDR announced the expansion of its lumbar VerteBRIDGE portfolio to include new direct lateral and oblique lumbar systems. The company says that systems designed for this approach have been used successfully in Europe in more than 100 cases.
Materialise launched the SurgiCase Orthopedics service, which uses CT and MRI images to aid in virtual surgical planning and construction of customized cutting and drill guides and physical patient models.
Medtronic announced the U.S. launch of the VERTEX SELECT Reconstruction System Posted Screw Module, which is designed for use in the upper-thoracic spine, as well as the KYPHON Express Curette, indicated for scraping or scoring bone in the spine.
Orthofix initiated a limited release of a new spinal deformity correction module based on the company's Firebird pedicle screw. The system features the new Direct Vertebral Rotation (DVR) device, which allows surgeons to "combine rod reduction and direct vertebral rotation in one low- profile instrument." The company adds that the device offers faster assembly and disassembly when compared to competitive systems. Full market launch will take place in 1Q:11.
OrthoPathways Group announced that they are in the "final development stages" for the Bio-Aug FX, an instrument for extracting and re-delivering autologous stem cells. The press release says the system can be used to help orthopedic injuries heal.
Osseon Therapeutics introduced the Osseoflex DR Steerable Bone Drill for use in the treatment of VCFs that may contain sclerotic bone resulting from osteoporosis or fibrotic metastases. The company says the device allows for unipedicular access to fractures previously considered inaccessible due to dense, sclerotic bone or malignant bone tissue.
Pioneer Surgical Technology launched the Pioneer Advantage, an allograft portfolio that includes a large ALIF interbody called Bigfoot as well as machined allografts for cervical and anterior lumbar procedures and demineralized strips and cubes for use in various spinal and general orthopaedic surgeries.
TiGenix announced the European launch of ChondroMimetic at the 9th World Congress of the International Cartilage Repair Society in Barcelona, Spain. ChondroMimetic is an off-the-shelf, bi-layer collagen implant for the treatment of small osteochondral lesions.
Titan Spine will launch its Endoskeleton TC, an interbody fusion device for the cervical spine, in 1Q:11. The device received 510(k) clearance in July and has been in limited release since August. The company says the product has an acid etched titanium surface and is "biomechanically designed to promote spinal fusion."
Intellectual Property
Osseon Therapeutics received its second patent Notice of Allowance for its VCF technology. The company notes that they now have two allowed and twelve additional patent applications pending in the U.S. as well as additional applications throughout the world.
Pioneer Surgical Technology announced that the U.S. Patent Office has reissued a patent covering nanOss, the company's nanocrystalline calcium phosphate technology.
Legal
NuVasive initiated a patent infringement lawsuit against Globus Medical. NuVasive contends that Globus' LLIF lateral fusion portfolio, including instruments, implants and techniques sold under the trademarks TransContinental, MARS 3V and LLIF, infringes XLIF's IP.
Synthes and Norian settled a federal investigation into allegations that they facilitated unauthorized clinical studies of bone graft substitute Norian XR for use in VCF cases. Per the terms of the settlement, Norian and Synthes will pay fines of $22.5 million and $0.7 million, respectively, and Synthes will sell the Norian unit by May of 2011 or face exclusion from federal payment programs.
Clinical
ISTO Technologies completed enrollment in its Phase I study of NuQu, an injectable formulation of juvenile chondrocytes designed for the treatment of persistent discogenic back pain. The study enrolled 15 patients at two sites. According to the company, preclinical studies have shown that NuQu's juvenile chondrocytes have "far greater regenerative potential than adult cartilage cells" both in vitro and in vivo.
SpinalMotion completed enrollment in an international study evaluating the Kineflex lumbar artificial disc, data from which will support future international regulatory submissions. The company has already submitted PMAs to the FDA for its lumbar and cervical discs.
Orthopedic surgeons in Ireland recommended that the Health Service Executive, the country's national health service, establish a registry to track the safety and efficacy of joint replacements.
Distribution
Creaspine and Scient'x have entered into a five-year exclusive worldwide distribution and licensing agreement. Under the terms of the agreement, Creaspine will manufacture and provide to Scient'x and its affiliates an innovative interbody fusion device marketed under the name ISOFORM. ISOFORM has received CE mark approval.
Osseon Therapeutics entered into an agreement with DePuy Spine for the distribution of its Osseoflex steerable spine augmentation needle throughout the U.S. The Osseoflex product is an MIS option for use in VCF treatments.
Licensing
Captiva Spine announced that it has signed a license agreement with Dr. Kamaljit Paul of Oshkosh, WI regarding a cervical plate system designed and patented by Dr. Paul. The company says the device features a proprietary nitinol locking mechanism will be marketed under the trade name SmartLox.
Collaborations
DePuy Spine signed a preferred partnership agreement with BrainLAB, whereby the two companies will co-develop and market image-guided navigation tools for use in minimally invasive spine surgery.
Operations
BioMimetic Therapeutics will spend $20.0 million to expand its Tennessee headquarters to include manufacturing capabilities for Augment. The company expects to launch the product in 2011.
Education
Integra LifeSciences announced that almost 400 surgeons have signed up for a series of workshops the company is hosting at the 65th Annual Meeting of the American Society for Surgery of the Hand (ASSH) on October 7-9 in Boston, Massachusetts. The workshops will focus on wrist arthritis, nerve repair, ulnar nerve decompression and radial head fractures.
Appointments
DiFUSION Technologies announced new appointments to its management team, including John Kaelblein as President. Mr. Kaelblein was previously the CEO and Founder of Nutek Orthopaedics, Inc. Chris DeNicola, was named Senior Vice President of Sales. Prior to joining DiFUSION, he was Vice President of Sales for Scient'x USA. Jami Hafiz, Ph.D. was appointed Vice President of Product Development after serving as a Senior Staff Scientist at Chameleon Scientific. Finally, Joseph Crudden, Ph.D. joined the company as Vice President of Research and Development. He was previously an R&D chemist at AW Chesterton.
