Musculoskeletal News Roundup 31-Mar-11
BY LAUREN UZDIENSKI, MARCH 31, 2011
Earnings
Bacterin reported 4Q:10 revenues of $5.3 million, up 141% over 4Q:09. The company reported a net loss for the quarter of $5.5 million, or $0.15 per basic share, widening from a net loss of $1.6 million, or $0.06 per basic share, in 4Q:09. The company said that among their highlights from 2010 securing $15.0 million in funding, increasing its direct and indirect biologics sales force by over 150% and launching OsteoSelect DBM Putty, Osteosponge SC and hMatrix.
Regen Biologics disclosed in a regulatory filing that they will not be able to file their 10-K on time due to "an inability to obtain adequate external financing." The company does not know when they will be able to file.
Regulatory
Artimplant received CE mark clearance for the Artelon CMC Soft, which differs from the Artelon CMC Spacer in that its size can be adjusted to the patient. The company expects that Artelon CMC Soft, which was co-developed with SBi, "will gradually replace existing Spacer products for thumb base osteoarthritis in the CMC-joint."
curasan received CE mark clearance for Osseolive, which the company describes as a "bioactive", poly-crystalline calcium-alkali-phosphate ceramic. curasan adds that the material has a "stimulating effect on bone formation as well as on bone mineralization."
DePuy received 510(k) clearance for the A.L.P.S. Total Foot System and the AFFIXUS Hip Fracture Nail System. The company says the A.L.P.S. Total Foot System is a next-generation system of anatomic plates designed specifically for foot surgery and the AFFIXUS Nail System is a set of short and long nail and screw options and instrumentation for the treatment of proximal femoral fractures. DePuy adds that "Both systems are designed to help surgeons accommodate individual anatomic variation in patients."
Ortho Development Corporation received 510(k) clearance for the Escalade Acetabular System, which is indicated for use with the company's Ovation Hip Stem in total hip procedures. The company says the Escalade system allows for "larger femoral heads in smaller, extensively- crosslinked liners."
Seikagaku withdrew its PMA for a shoulder osteoarthritis indication for SUPARTZ, its hyaluronic acid-based agent, after discussions with the FDA indicated that further clinical studies would be necessary for approval. SUPARTZ is currently marketed in the U.S. as treatment for knee osteoarthritis.
Product Introduction and Update
Ascension Orthopedics launched the TITAN Modular Shoulder Fracture Prosthesis, which features a modular design that allows the surgeon to "independently adjust the height of the body and stem without need for jigs or use of cement."
CareFusion launched an 11-gauge vertebral balloon for use in the spinal fracture treatment market. The company says this small-sized vertebral balloon physicians to "repair vertebral compression fractures that have been historically more difficult to treat due to their size and location in the spinal column, including smaller vertebra."
DePuy launched the GLOBAL ADVANTAGE+, a new instrumentation system for shoulder replacement surgery for use with the company's GLOBAL ADVANTAGE shoulder replacement implant.
MAKO Surgical announced a binding commitment for the establishment of 11 new MAKOplasty sites from Health Management Associates, Inc., an operator of acute care hospitals primarily in the southeast and southwest areas of non-urban America. The company expects these MAKOplasty sites to be established in 2011.
Reimbursement
Small Bone Innovations announced that the U.S. Department of Defense's TRICARE health care program, which covers armed forces personnel, retirees and their families, will now provide its 9.6 million beneficiaries access to the STAR Total Ankle Replacement system.
Legal
A federal judge in California tentatively denied Medtronic's motion for summary judgment in an ongoing patent suit against NuVasive. The judge also denied NuVasive's motion to "rule one of the [Medtronic] patents invalid, that the company didn't infringe two others and that one co-plaintiff isn't entitled to lost profit damages."
Collaborations
Synthes and Materialise announced an exclusive partnership for the development and distribution of Materialise's solutions for CMF surgery. Under the partnership, Materialise will provide pre-operative planning services directly to the surgeon via interactive, web-based collaboration tools, and will fabricate intra-operative guides and anatomical models. Synthes will distribute these intra-operative guides and models and continue to deliver patient specific surgical implants.
Appointments
Alphatec announced the addition of Leslie H. Cross to its Board of Directors. This appointment increases Alphatec Spine's Board of Directors in size from nine directors to ten, and increases the number of independent directors from five to six. Leslie H. Cross is currently the President, Chief Executive Officer and a Director of DJO Global, Inc. Mr. Cross has held principal executive roles at DJO Global and its predecessors since 1995.
