Musculoskeletal News Roundup 13-Dec-07
BY LAUREN UZDIENSKI, DECEMBER 13, 2007
Earnings
Tutogen reported FY07 revenues of $53.8 million, an increase of 42% over FY06. The Company reported net income of $6.8 million, or $0.36 per fully diluted share in fiscal year 2007 compared to a net loss of $0.6 million, or $(0.04) per fully diluted share, in the previous fiscal year. In FQ4:07, Tutogen reported sales of $15.2 million, up 41% over the year-ago period. In U.S. sales were up 38% for FQ4:07, and international sales were up 47% over FQ4:06. Among product segments, dental was up 34%; spine increased 23%; and surgical specialties product sales increased 69% over the year-ago period.
M&A
Exactech announced plans to acquire all outstanding shares of Altiva for a payment of $7.0 million in cash and Exactech common stock. The company previously announced a purchase valuation of Altiva totaling $25.0 million. Prior to the news of the acquisition, Exactech was a minority shareholder in Altiva.
Regulatory
Zimmer received FDA clearance for its Zimmer® NexGen® LPS-Flex Mobile Knee. Zimmer says the device, which required a PMA application, can be used with minimally invasive techniques and will be launched in limited release in January.
Cytori Therapeutics received 510(k) clearance for the Cytori Autologous Fat Transfer (AFT) System. This system may be used to harvest, filter and transfer a patient’s adipose tissue from one part of a patient’s body to another in the same surgical procedure. The system has applications in a number of surgical specialties, including orthopedic.
Amedica received Special 510(k) marketing clearance for the company's Valeo™ ceramic VBR spinal implant. According to the press release, the Valeo VBR utilizes a novel silicon nitride ceramic and is "designed to restore the biomechanical integrity of the anterior, middle and posterior spine, even in the absence of fusion."
Funding
aap Implantate announced that its bioimplants group received EUR 1.0 million in development funding from the European Union's Euro-Transbio program. The company plans to use this funding to produce of ultra-clean, detoxicated biopolymers at its Dutch location in Nijmegen. These biopolymers will be used for adhesion barriers for spine and other surgical applications.
Biomet has invested $15.0 million in the Changzhou Export Processing Zone in China and plans to use Changzhou as the company's export-oriented production base in the Asia-Pacific Region.
Mesoblast Ltd, an Australian stem cell company, has completed a $13.4 million capital raise. The company plans to use the funds to begin phase II clinical trials in Australia and the United States to evaluate Mesoblast's adult stem cells in bone and cartilage repair and regeneration.
Investigations
Wright Medical and Exactech received subpoenas this week for documents related to surgeon consulting and other professional service agreements dating from 1998 to the present. Both companies say they plan to cooperate fully with the investigation.
Legal
Acumed announced that a federal court issued a permanent injunction against Stryker that prohibits Stryker from further sales of its T2 Proximal Humeral Nail. In 2005, Acumed won a patent infringement suit with Stryker over the nail, and this ruling follows Stryker's appeal in that case.
A federal court upheld a patent infringement verdict against Medtronic regarding the company's Vertex line of spinal screws. Medtronic was ordered to pay $226.3 million to Depuy Spine, and Depuy plans to ask the judge in the case for an injuction against Medtronic's sale of the screws.
Product Introduction
Biomet launched two hip stems, the Taperloc® Microplasty™ Stem and the Balance® Microplasty™ Stem, describing the products as minimally invasive bone-conserving total hip implants. The company adds that the stems are an alternative to resurfacing technologies, which are not typically implanted with minimally invasive techniques.
Appointment
Smith & Nephew appointed Dwayne Montgomery Vice President & General Manager of Trauma Fixation and the promoted Bill Shopoff to Senior Vice President of International Business. Dwayne Montgomery was previously senior vice president of sales & sales operations for Trauma Fixation. Bill Shopoff was previously vice president for Medical Education and Professional Affairs for the business unit.
Scient'x announced today that Bryce T. IntVeld has joined the Company as Vice President of Sales. In this position, Mr. IntVeld will provide leadership and oversee the establishment and expansion of sales activities in the in U.S. market. Prior to joining Scient’x USA, Mr. IntVeld held several key positions for NuVasive, Inc. Previously, Mr. IntVeld also served as President of MedTech, Inc. and Director of Sales and Marketing for Shevlin Medical, Inc. In addition, Mr. IntVeld has also served as a sales representative for Danek Medical, and has held various other sales management positions within the orthopedic industry.
