Musculoskeletal News Roundup 11-Aug-11
BY SANDER DUNCAN, AUGUST 11, 2011
Earnings
In 1H:11, aap Implantate reported revenue of EUR 14.1 million ($20.2 million), up 10% over the year-ago period. The company raised approximately EUR 3.0 million in equity ($4.3 million) in April to strengthen its financial base and fund further growth.
MAKO Surgical announced 2Q:11 sales of $18.6 million, which represented growth of 81% versus 2Q:10 and beat analyst consensus of $16.1 million. The company noted that 1,557 MAKOplasty procedures were performed during the quarter, driving $7.7 million in implants and disposables revenue. MAKO also generated $9.5 million from the sale of 12 RIO Systems, and $1.4 million from general services. Net loss for the quarter was $9.9 million, or $(0.24) per diluted share, which was in line with analyst estimates.
Synthes posted 2Q:11 consolidated revenue of $992.0 million, a 5.4% increase over 2Q:10 when accounting for the effect of currency. North American revenues totaled $557.4 million, up 4.7%, while Europe posted sales of $236.9 million, up 6.2%. Asia Pacific generated revenue of $128.2 million, showing the company's highest regional year-over-year growth of 13.1%. Rest of World, dragged down by the Middle East, had sales of $69.5 million, down 2.8% versus 2Q:10. Synthes' net income year-to-date totaled $454.4 million, or $3.83 per diluted share, an increase of 7.0% over the year-ago period. In April, Synthes announced its $21.3 billion sale to Johnson & Johnson.
Tornier reported $65.2 million in revenue in 2Q:11, beating Wall Street estimates of $64.8 million and increasing 12.2% constant currency over the year-ago period. Among segments, total extremities generated sales of $50.8 million, up 14.4%. To this total, upper extremities contributed $40.7 million, up 15.1%, and lower extremities added $6.4 million, up 11.2%. Tornier's sports medicine and biologics division posted $3.5 million in revenue, an increase of 11.8% over 2Q:10. Large joints and other segments rounded out Tornier's 2Q:11 earnings with $14.3 million in sales, up 4.5%. The company recorded a net loss of $2.9 million for the quarter, or $(0.07) per diluted share, compared to a loss of $8.6 million in 2Q:10, or $(0.31) per diluted share. EPS was in line with estimates.
TranS1 announced 2Q:11 revenue of $5.3 million, down 26% from 2Q:10 but beating analyst projections of $5.1 million. U.S. sales totaled $4.9 million, representing a decrease of 27% over the year-ago period. 449 TranS1 procedures were performed globally in the quarter. Net loss in 2Q:11 was in line with analyst estimates at $4.2 million, or $(0.20) per diluted share, down from a loss of $3.3 million or $(0.16) per diluted share in the year-ago period.
M&A
Symmetry Medical, the publicly-traded orthopedic OEM, announced last week that it agreed to acquire Olsen Medical for an undisclosed amount in an all-cash transaction. Olsen manufactures electrosurgical instruments and accessories. Symmetry expects to close the acquisition by August 15.
Funding
On Monday, Ascendx Spine announced $4.8 million in financing, which included $3.1 million in debt converted to common stock and $1.7 million in cash. The new funds will allow Ascendx, formerly known as AOI Medical, to strengthen its balance sheet and pursue commercialization of its Ascendx VCF Repair System. The company expects the system, indicated for treating VCFs caused by osteoporosis, to receive FDA clearance and the CE mark later this year.
Regulatory
MedShape Solutions, which designs shape memory implants for soft tissue repair and joint fixation, received 510(k) clearance for its first ankle fusion product, DynaNail Intramedullary Ankle Fusion Nail. The device, indicated for tibiotalocalcaneal arthrodesis procedures, employs MedShape's proprietary shape memory material to dynamically maintain close apposition in the target bones.
Product Introduction and Update
Integra expanded its spine offerings this week with the global introduction of the Zuma-C Anterior Cervical Fixation System. The company's first interbody cervical device is based on the Zuma platform, which to date has focused on the anterior lumbar spine.
Clinical
Relievant Medsystems received FDA approval of an IDE to commence level 1 clinical trials evaluating the safety and effectiveness of their Intracept System, a probe that employs radiofrequency ablation to treat chronic axial lower back pain. The study, which begins this summer, will treat 200 patients in the U.S. in a prospective, randomized, double-blind trial. This investigation follows a smaller pilot study conducted in 2008, which reported positive results in treated patients.
SI-BONE is collecting additional data to support the validation of results from its recently-filed IDE for the iFuse Implant System, which allows for sacroiliac joint fusion via an MIS approach. The IDE study will be a U.S.-based prospective trial to examine safety and efficacy in the short- and long-term, as well as the device's economic effectiveness, when used "according to the current product label for [sacroiliac] joint fusion." The retrospective study will collect similar safety and economic data on previous iFuse procedures, which total over 1,500 to date since the product received FDA clearance in 2008.
Seikagaku, a Japanese specialty pharmaceutical company with a legacy of offering hyaluronic acid products, announced its intention to conduct an additional Phase III trial for SI-6603, its injectable treatment for lumbar disc herniation. After completing Phase II/III clinical trials in December, 2010, and following discussions with Japan's regulatory body, the company decided more clinical data was necessary to file a new drug application. SI-6603 is an enzyme that relieves pressure on the nerves while avoiding damage to surrounding tissues. Seikagaku is also pursuing device approval for SI-6603 in the U.S., and is currently in Phase II trials.
Distribution
Corin renewed its agreement with LARS to distribute LARS' ligament augmentation system through 2013. The agreement allows Corin exclusive rights to distribute LARS ligaments in countries such as Australia and the U.K., where Corin is based, as well as non-exclusive rights in other regions.
