Orthopedic News Roundup 16-Nov-2006
BY LAUREN UZDIENSKI, NOVEMBER 16, 2006
Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a fully diluted basis. Langer attributed the loss to a decline in sales: net sales for 3Q:06 were approximately $9.0 million, compared to approximately $10.5 million in 3Q:05, a decrease of 13.9%.
Financing: Andover Medical announced completion of a bridge financing for $673,000. The funds will to be used for working capital, including expenses incurred in connection with proposed acquisitions. One area of focus is orthopedic durable medical equipment. Additionally, Robert A. Baron has also been named to Andover’s board of directors. He served in executive business roles for 45 years, with successful exits to public companies.
Clinical: BMC Musculoskeletal Disorders published the study protocol for the prospective, randomized multi-center PROCON trial, which will evaluate the clinical outcome, development of adjacent disc disease and costs of cervical anterior discectomy without fusion, with fusion using a stand alone cage and implantation of a Bryans disc prosthesis. According to the abstract, "The results of this study will contribute to the discussion whether additional fusion or arthroplasty is needed and cost effective.:
Regulatory: The FDA announced last week a series of recommendations for stricter post-market surveillance of medical devices. The proposal includes, among other changes, creating a cross-cutting organizational structure within CDRH to better integrate premarket, postmarket and enforcement efforts; developing internal performance measurements to track the center's handling of postmarket issues, such as recalls; pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime; and proposing mandatory use of electronic reporting for adverse event reports and revising the current system that records reported adverse events.
ReGen Biologics announced that it has received a letter in which the FDA provided that ReGen may submit a new 510(k) for clearance of its collagen scaffold (CS) device with modified indications for use in the meniscus. These modifications were suggested to the FDA by ReGen during the appeal process, and they are consistent with the current indications for use of the device in Europe and its use in the multicenter clinical trial in the United States. The CS device is intended to be used as a surgical mesh for soft tissue reinforcement, with one of the designs developed for repair of meniscus defects.
Medtronic's INFUSE Bone Graft has been recommended for approval by the FDA for certain oral and maxillofacial indications. Traditionally, dental specialists have had to harvest bone from other portions of the patient's body, including the iliac crest, for transplantion to the mouth. This causes unnecessary pain due to donor site morbidity and dramatically increases both the surgical time and infection risk. The use of INFUSE has the potential to reduce surgical time and infection risk while eliminating donor-site pain.
Appointment: NuVasive President Keith Valentine has been named Chief Operating Officer in addition to his current post. As President, Valentine is responsible for product development, marketing, regulatory, distribution and customer service functions. In his expanded role, he will be responsible for customer service, distribution, inventory planning, manufacturing and vendor relationships. Alexis Lukianov will continue to serve as chairman and chief executive officer.
Bone Solutions Inc. announced that its board of directors has elected Stephen A. Schendel, M.D., D.D.S. as BSI's first Chief Medical Officer (CMO.) The new post is effective immediately. Schendel is former Chief of the Division of Plastic and Reconstructive Surgery at Stanford University Medical Center.
Larry Dorr, M.D., has been elected to Amedica's board of directors. Dr. Dorr is an orthopedic surgeon and clinical professor at the University of Southern California, and he was the recipient of the 2005 Humanitarian Award from the American Academy of Orthopedic Surgeons for his international charitable surgical work.
Miscellaneous: On Thursday, November 16, at 6:00 p.m. (MT), LDS Hospital in Salt Lake City, UT will broadcast a live Zimmer MIS Total Knee replacement procedure featuring the Zimmer® Gender Solutions™ High-Flex Knee™, the first knee replacement shaped to fit a woman's anatomy. The broadcast can be viewed live at OR-Live.
