Musculoskeletal News Roundup 12-Mar-09
BY LAUREN UZDIENSKI, MARCH 12, 2009
Earnings
BioMimetic Therapeutics reported a net loss in 4Q:08 of $12.2 million, or $0.65 per share, widening from a net loss of $6.9 million, or $0.37 per share, in 4Q:07. Analysts had forecast a net loss of $0.53 per share. Revenues for the quarter were $1.8 million, including $1.6 million of royalty income and $0.2 million of sublicense fee income. Among the highlights for the quarter were the completion of enrollment in the U.S. foot and ankle pivotal trial and the EU foot and ankle clinical trial.
MAKO Surgical reported 4Q:08 revenue of $1.0 million, representing an increase of 150% over 4Q:07 and beating estimates by $0.1 million, which the company attributed to primarily to the 200 MAKOplasty procedures performed during the quarter. Deferred revenue increased to $11.6 million as of December 31, 2008, of which $2.7 million was generated during 4Q:08, primarily due to the sale and customer acceptance of four TGS units. Net loss for 4Q:08 was $10.8 million, or $0.48 per share, missing estimates by $0.04.
Orthovita reported 4Q:08 revenues of $20.8 million, representing a 34% increase over 4Q:07 and beating estimates by $0.4 million. The company attributed revenue growth to U.S. sales of VITOSS FOAM and VITAGEL products. The net loss for 4Q:08 was $1.2 million, or $0.02 per share, down from $4.9 million, or $0.06 per share, and beating estimates by a penny.
Funding
SpineForm, the developer of a staple to correct scoliosis, received $0.3 million from the non-profit group CincyTech as well as $0.95 million in a funding round from Queen City Angels, Cincinnati Children's Hospital Medical Center Tomorrow Fund and other investors.
Regulatory
Inion received 510(k) clearance for its BioRestore Sahara, a synthetic bioactive and biodegradable bone graft substitute that can be cut or shaped to fit and fill voids in the spine or skeleton. The product consists of a porous scaffold of bioactive glass that eventually degrades to allow new bone to fill the void. Inion BioRestore was first cleared in 2007.
Product Introduction and Update
K2M launched the CASPIAN Spinal System for rigid posterior fixation of the cervico-thoracic spine after receiving 510(k) clearance and the CE mark for the device. The system features two polyaxial screw options, the Mini MESA and Mini DENALI, as well as Mini Hooks and 3.5 mm Rods.
Osseon launched the Osseoflex and Osseoperm systems for the minimally invasive treatment of VCFs. The company describes Osseoflex as a "steerable and curvable needle that can access the majority of the vertebral body from a single percutaneous access point." The Osseoperm is a closed cement delivery system. The company says its procedure, called the Osseoplasty, results in the "rapid stabilization of vertebral fractures and significant pain relief in most patients within the same day."
Investigations
Stryker announced in an 8-K filing that the company is currently being investigated by a federal grand jury regarding the illegal promotion of OP-1, the sale of misbranded medical devices and the submission of false reports to the FDA regarding the number of patients treated with OP-1 under the company's HDE.
Clinical
Orthomimetics announced the enrollment of the first patient in its single-center, Budapest-based clinical trial for Chondromimetic, an organic, resorbable device for articular cartilage and bone repair that "supports the body's natural repair mechanisms." Outcome targets for the study are safety and efficacy. The company has already received the CE mark for the product.
