Musculoskeletal News Roundup 17-Jan-07
BY LAUREN UZDIENSKI, JANUARY 17, 2008
Earnings
Biomet reported earnings for 2FQ:08 last week, with net sales up 11% to $578.1 million over the comparable quarter. Worldwide, knee sales were up 17%, and hip was up 12%. Extremity sales increased 11% and bone cements and accessories sales were up 8% worldwide. Dental sales increased 19% worldwide and arthroscopy sales increased 30%. Fixation sales decreased 4%, and spinal products were down 3% as well.
M&A
Lifecore Biomedical has entered into definitive documentation to be acquired by affiliates of the private equity firm Warburg Pincus for $239.0 million in cash, or $17.00 per share. This represents a 30% premium over Lifecore's volume-weighted average price for the last 30 trading days. LifeCore has 30 days to entertain a competing offer, but the transaction is expected to close by the end of 1Q:08.
Regeneration Technologies, Inc. and Tutogen Medical, Inc. will likely have a new name following their proposed merger - RTI Biologics, Inc. Shareholders will be asked to approve the new name at a meeting scheduled for February 27th. The stock will continue to trade on the Nasdaq Global Market under the symbol RTIX. “Our new company name is centered around ‘Biologics,’ which can include a wide array of biological solutions. These are areas that represent strong growth and great promise in healthcare,” said Brian K. Hutchison, RTI’s chairman, president and CEO.
Regulatory
Orthovita, Inc. filed a 510(k) to expand indications for its CORTOSS Bone Augmentation Material to include the product's use in vertebral augmentation. The company adds that three IDE and several European studies were designed to show that CORTOSS is substantially equivalent to PMMA, with results indicating the same degree of clinical improvement in pain and function with approximately 40% less material than PMMA. The company says CORTOSS' other benefits include consistent handling characteristics and viscosity.
Stryker received an FDA warning letter regarding reported flaws in certain devices, including the Trident hip system. Among other concerns, the letter states that patients have complained about squeaking hip components.
Funding
SpineSource Inc. raised $1.2 million to fund the launch of three new products. The names of the investors were not disclosed, but SpineSource president and chief executive Tom Mitchell said they were "[St. Louis-area] professionals who are friends with whom he attends church." The company is seeking an additional $1.5 million from angel investors or bank financing in 2008 to complete the product launches.
Product Introduction and Update
Alphatec Holdings, Inc. announced that its unique DYNAMO™ Semi-Rigid Spinal System has been successfully introduced. Alphatec's complete solution combines the DYNAMO Semi-Rigid Rod with the rigid stabilization of Alphatec's ZODIAC™ Spinal Fixation System to offer a new segmental solution for treating different stages of spinal degeneration at contiguous levels. The DYNAMO provides surgeons with the flexibility to address varying degenerative indications and patient needs by matching the magnitude of stabilization needed for each of the multiple levels of spinal degeneration. "The commercial introduction of the DYNAMO represents a significant milestone in Alphatec's commitment to product differentiation and innovation. DYNAMO is used in tandem with our ZODIAC products and is designed to allow for controlled compression, distraction, flexion and extension of vertebrae adjacent to a fusion location, which should enable the patient to have an additional range of motion during the initial healing phase following fusion surgery," stated Kathe Liljestrand, Vice President of Marketing of Alphatec.
RSB Spine announced the first implantation of its InterPlate™ L for use in the lumbar spine and that the InterPlate C device for use in the cervical spine is now being rolled out. Later this year the company plans to launch two new InterPlate products manufactured from PEEK.
Legal
A patient who received meniscal allograft processed by Cryolife is suing the company for $110.0 million, according to a press release distributed last Friday. In its rebuttal, the company said, "CryoLife believes that it handled the tissue in accordance with its procedures and in accordance with all applicable industry standards and regulatory requirements." The company added that the patient had severely compromised knee function prior to the surgery and it intends to "vigorously defend" itself against the lawsuit.
Orthofix revealed in a recent SEC filing that the company received federal grand jury subpoena from the U.S. State Attorney's Office for the District of Massachusetts. The company believes the subpoena relates to physician payments during the period from January 1, 2000 through July 15, 2007. There is an ongoing OIG investigation into payments made to surgeons by Orthofix subsidiary Blackstone Medical.
Collaborations
Pfizer signed a licensing deal with Scil Technology GmBH to exclusively develop and commercialize Scil's cartilage-specific growth factor CD-RAP. Pfizer will make up-front and milestone payments of about $250.0 million.
Appointment
Alphatec Holdings, Inc. announced that veteran biomechanics and clinical research practitioner Andrew Mahar has joined the company as Senior Director of Biomechanics and Clinical Research. Andrew's substantial product development and clinical research experience will be relied upon during the commercialization of Alphatec's significant product pipeline. "Andrew Mahar brings an extensive background in clinical research and product development to the Senior Director of Biomechanics and Clinical Research position at Alphatec. His leadership will help Alphatec bring to market many exciting and revolutionary new product candidates," said Dirk Kuyper, Alphatec's President and Chief Executive Officer.
Miscellaneous
DePuy Orthopaedics, Inc. announced that more than 700 of its sales representatives have completed a certified and accredited sales training program in orthopedics. According to the press release, "DePuy is the first orthopedic device manufacturer to require its sales representatives to earn continuing education credits in subject areas, including anatomy and biomechanics, orthopaedic products, HIPAA policies, patient rights, infectious disease prevention and operating room and hospital protocols."
