Musculoskeletal News Roundup 22-Dec-11
BY LAUREN UZDIENSKI, DECEMBER 22, 2011
Earnings
Biomet pre-announced F2Q:12 this week, reporting that sales increased by 3% to $725.0 million compared to the prior-year period. Reconstructive sales increased by 3% during the quarter, with knee up 1% and hip up 6%. Further, sports medicine sales increased by 19%; extremity increased by 14%; trauma declined by 1%; spine declined by 6%; bone healing (non-invasive) declined by 4%; and dental increased by 1%. Growth rates exclude the effects of currency.
Legal
A U.S. judge in Oregon threw out an $85.0 million patent ruling that found Arthrex in violation of a Smith & Nephew patent for a suture anchor. Smith & Nephew plans to appeal.
Intellectual Property
SpinalCyte received a Notice Of Acceptance from the Australian Patent Office regarding its patent application for "Methods and Compositions For Repair Of Cartilage Using An In Vivo Bioreactor" to regrow the spinal disc using human dermal fibroblasts. The patent covers the use of autologous human dermal fibroblasts to regrow the nucleus of the spinal disc in vivo.
Clinical
Exactech initiated a prospective, randomized, multi-center clinical trial to evaluate the safety and effectiveness of a cartilage repair technology. The treatment uses autologous cells to treat cartilage defects in a single-stage procedure. The study will include one-year follow-up of patients treated for focal chondral or osteochondral lesions of the knee, and data will be used to support a PMA. The first of 92 procedures to be evaluated in the study has been completed Taiwan.
Blindness after spine surgery, a rare adverse event that occurs in roughly one out of every thousand patients, was found to be associated with six factors: 1) male sex, 2) obesity, 3) use of a surgical frame that places the head lower than the heart, 4) length of the surgery, 5) amount of blood loss and 6) use of certain fluids that replace lost blood. This is the largest study to date to evaluate the risk factors for this complication.
The FDA issued draft guidelines on increasing participation by female patients in device studies. Though many studies typically do not report outcomes by sex, a 2009 report on cardio devices estimated in studies that did report demographics, women made up 34% of participants in pivotal studies. The FDA says that genetics, hormones, body size and diseases with varied prevalence based on sex, diet and sociocultural issues can affect the safety and efficacy of a device, underscoring the need for more women to enroll in studies.
Collaborations
Spine Wave entered into an agreement with MB Innovations, which they call a newly-formed product development company based in Memphis, TN. MBI will initially develop products exclusively for Spine Wave while they expand their infrastructure in anticipation of taking on additional medical device clients. Spine Wave currently develops and markets a family of PEEK spacers. In conjunction with this collaboration, MB Venture Partners will be investing in Spine Wave.
Appointments
Integra LifeSciences appointed Peter Arduini as President and Chief Executive Officer as well as to a newly-created position on the Board. Since Mr. Arduini joined Integra in November 2010 as President and Chief Operating Officer. Current CEO Stuart Essig has been appointed as Executive Chairman of the Board. Richard Caruso, founder of Integra LifeSciences and its Chairman of the Board since its inception, will remain as a director of the company. All leadership changes are effective January 3, 2012.
