Musculoskeletal News Roundup 30-Oct-08
BY LAUREN UZDIENSKI, OCTOBER 30, 2008
Earnings
Exactech reported 3Q:08 revenues of $37.9 million, missing revenues by $0.9 million and representing an increase of 27% over the year-ago period. Among segments, knee revenue increased 16%; organic hip implant revenue increased 8%; biologic services revenue increased 12%; and shoulder revenue increased 73%. Sales of spine products contributed $1.4 million to "other revenue" of $6.9 million, which also included sales from the company's recently-acquired French distributor. Net income was $2.1 million, or $0.16 per share, beating estimates by a penny. Adjusted for expenses related to a DOJ inquiry, net income was up 15% to $2.9 million.
RTI Biologics, Inc. reported 3Q:08 revenues of $38.5 million, missing estimates by $5.2 million and representing a 62% increase over the year-ago period. Among segments, spinal constructs revenue was up 1%; sports medicine was up 29%; dental was down 6%; surgical specialties (including orthopedic and trauma implants, breast reconstruction and urological repair) was up 79%; bone graft substitute sales were down 32% due to decreased revenues from the company's largest spine distributor; and general orthopedic revenues were up 533% due to the inclusion of Tutogen revenue. Net income was $0.38 million, and adjusted earnings per share was $0.02, missing estimates by $0.02.
Straumann pre-announced 3Q:08 revenues of CHF 176.4 million ($160.8 million), up 11% over the year-ago period. The company attributed performance to "sustained growth in North America and contributions from Straumann’s new generation Bone Level implant, the SLActive surface technology and the CAD/CAM prosthetics business."
TranS1 reported 3Q:08 revenues of $6.0 million, missing estimates by $0.19 million and representing an increase of 39% over the year-ago period. 671 TranS1 procedures were performed during the quarter. Net loss was $4.8 million for the quarter, and adjusted EPS was ($0.20), beating estimates of a loss of $0.25 per share.
M&A
The MEDICREA Group acquired all patents and intellectual property rights pertaining to C-JAWS, a cervical fixation system cleared in the U.S. as an interbody cage buttress. The transaction was valued at EUR 1.0 million ($1.28 million) in cash.
Funding
As a result of a settlement with Deutsche Bank, BioMimetic Therapeutics has received a $39 million line of credit with the bank. The settlement concerned BMTI's holdings of auction-rate securities (ARS).
DFine, Inc., a developer of minimally-invasive VCF treatments, raised $30 million in its Series D round. The funding was led by BBT Fund LP and Highland Capital Management, who were joined by Prospect Venture Partners and Vanguard Ventures. Proceeds will be used to commercialize the StabiliT Vertebral Augmentation System.
MAKO Surgical entered into a definitive agreement for an equity financing of up to $60 million, consisting of initial gross proceeds of $40 million and conditional access to an additional $20 million. The $40 million tranche is scheduled to close on October 31. The financing was led by Montreux Equity Partners and Skyline Ventures and included Alta Partners and certain existing MAKO shareholders. Per the company, proceeds will support the commercialization of version 2.0 of the Tactile Guidance System and its MAKO-branded bi-compartmental implant and disposable products, continuing R&D for MAKO's future products and expansion of operations and working capital.
Salient Surgical Technologies, Inc. raised $17.9 million in a Series F round that included Piper Jaffray, Arnerich Massena & Associates, Medtronic, Inc., RiverVest Venture Partners and others. Salient plans to use the proceeds to expand its sales and marketing organization and develop new products based on its Transcollation technology. The company says that its Transcollation products utilize saline and RF energy to remodel and seal collagen and are currently used in orthopedic, spine and surgical oncology procedures.
Regulatory
Imaging Therapeutics received FDA clearance to market the OsDx Hip Bone Mineral Density system, an x-ray image-processing software system designed to estimate BMD of the proximal femur using antero-posterior hip or pelvis images.
MEDICREA announced CE marking certification for K-JAWS, a combination of the C-JAWS and the IMPIX-C cervical cage. The FDA is currently reviewing the company's 510(k) application for U.S. market clearance. MEDICREA expects to launch K-JAWS in the U.S. by the end of 2008.
Osteotech, Inc. received 510(k) clearance for its next-generation grafting material for use as a bone graft substitute and bone void filler in the spine, pelvis and extremities.
Legal
Smith & Nephew announced that a U.S. District Court judge in Oregon will grant the company's request for an injunction against Arthrex that will prohibit the company from manufacturing or selling devices infringing a SNN patent. The affected devices include the Bio-SutureTak, PEEK SutureTak, Bio-PushLock and PEEK PushLock suture anchors. Additionally, SNN was awarded $14.7 million for past infringement through 2005.
Clinical
BioMimetic Therapeutics, Inc. announced results from its North American pilot study evaluating the safety and clinical utility of Augment Injectable Bone Graft for the treatment of closed distal radius fractures. Among the results: patients treated with AIBG demonstrated earlier bone formation as measured by CT scans and all AIBG patients had a 100% bone fill at six months compared to 82% of the control patients. So far, 314 patients have been enrolled in the study in the U.S. and Canada; the company plans to enroll 396 patients.
Centinel Spine initiated a U.S. Alpha Site evaluation to determine when in 2009 the company will launch the STALIF C NO PROFILE Stand Alone Cervical IBF Device. The evaluation is expected to take one to two months.
Appointment
Alphatec Holdings, Inc. announced the addition of Siri S. Marshall, Esq. 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. Ms. Marshall is the former Senior Vice President, General Counsel and Secretary and Chief Governance and Compliance Officer at General Mills, Inc., having retired from those positions in January 2008.
