Musculoskeletal News Roundup 6-Jan-11
BY LAUREN UZDIENSKI, JANUARY 6, 2011
Earnings
Biomet reported FQ2:11 (ended November 30, 2010) sales of $698.3 million, up 2% over the year-ago period. Recon sales increased by 3%, with hip flat, knee up 3%, extremity up 23% and dental up 3%. The company said that while recon sales continued to be "depressed" during the quarter, the "improving economy, favorable demographics and product innovation" would drive long-term growth. Additionally, trauma and spine sales decreased by 2% and 3%, respectively. Adjusted net income for the quarter was $66.0 million, down from $74.8 million in FQ2:10.
RSB Spine announced that 2010 sales increased by 97% over 2009, with 4Q:10 sales up 184% over the prior-year period.
M&A
DJO acquired Elastic Therapy, Inc., a manufacturer of compression therapy products. The press release noted that in 2010, Elastic Therapy, Inc. recorded approximately $26.0 million in revenues.
MiMedx Group completed their acquisition of Surgical Biologics. The target company processes biomaterials from amnion membranes for a variety of surgical indications. No financial details were released.
Funding
Bonovo closed a $10.0 million Series C Preferred Stock financing led by OrbiMed Asia Partners, who were joined by Legend Capital and Bonovo's existing shareholders. Funds will be used to "further [expand] Bonovo's Chinese sales platform" and "[accelerate] the company's robust product development programs."
Graftys raised EUR 4.0 million ($5.3 million) in a round of funding led by Ventech, who were joined by prior investors. The company is developing a calcium phosphate cement designed to treat osteoporosis, and they will use proceeds from the round to "complete clinical validation" of the product.
Kensey Nash made a minority equity investment of approximately $4.0 million in Orteq Sports Medicine, the developer of Actifit, a biocompatible synthetic meniscal scaffold that is currently marketed in Europe. Orteq expects to receive FDA approval to start its Actifit clinical trial in the U.S. in 2011, which will trigger an additional $1.0 million investment in Orteq. Kensey will receive exclusive worldwide manufacturing rights to Actifit and an approximate 10% ownership in Orteq. Additionally, under the terms of the manufacturing agreement, Kensey will receive a transfer price and royalties.
Regulatory
Graftys received a determination from the FDA that their calcium phospohate bone cement with alendronic acid will be classified as a medical device. Applications for the material include orthopedic and trauma surgery for osteoporotic patients.
MiMedx received expanded CE certification for their HydroFix technology. The HydroFix Spine Shield is currently approved for use in certain locations along the anterior spine as a plane of dissection during revision surgery, and the new Class III certification is for use during posterior and anterior vertebral surgeries as a cover for the spine, including contact with the central nervous system and central circulatory system, to provide a plane of dissection during revision surgery.
Smith & Nephew received an FDA warning letter on December 21 based on alleged violations at a manufacturing plant in Tuttlingen, Germany that makes the R3 Ceramic Acetabular System. The letter said certain required tests weren't performed and that the company failed to establish and maintain procedures to correct problems.
SyncMedical received clearance from the Brazilian National Health Surveillance Agency to market the Ethos Spine Pedicle Screw System in Brazil. The system is part of the company's minimally invasive Ethos portfolio, which also includes the Ethos C-Spacer and the Ethos PEEK VBR System.
Product Introduction and Update
Alphatec Spine announced the first ever three-level Guided Lumbar Interbody Fusion (GLIF) procedure performed by Morgan Lorio, MD FACS of Bristol, TN. GLIF is the only lateral approach on the market today that provides the surgeon the ability to perform a 360-degree correction without repositioning the patient.
Medtronic launched the PEEK PREVAIL cervical interbody device in Europe. The product is zero-profile, does not require a plate and attaches to the spine using only two screws.
Clinical
Carbylan BioSurgery completed enrollment in their double-blinded, multicenter COR1.0 feasibility trial to evaluate the safety and effectiveness of their Hydros and Hydros TA Joint Therapies in patients with osteoarthritis of the knee. Hydros and Hydros TA are next-generation viscosupplement and viscosupplement/steroid combination products. The study compares the products to market leader Synvisc-One.
Graftys initiated a prospective, comparative, blinded study to evaluate the safety and efficacy of a minimally invasive femoroplasty using an injectable and resorbable bisphosphonate-loaded synthetic bone substitute to prevent contralateral hip fracture after osteoporotic fracture. The lead investigator is Professor J.N. Argenson of the University Hospital Sainte Marguerite in Marseille, France.
Appointment
TranS1 appointed current President and COO Ken Reali as Chief Executive Officer of the company. He will also be elected to the Board. Mr. Reali was hired in January 2010 from Smith & Nephew, where he held the post of as Senior Vice President and General Manager of the Biologics and Clinical Therapies Business. Current CEO Rick Randall will assume the newly-created position of Executive Chairman of the Board.
