Regulatory
Interventional Spine announced that the FDA has conditionally approved its IDE application for the PercuDyn System, pending the company providing some additional information to the FDA. CEO Walter Cuevas commented that the company will now begin collecting data to support its PMA application.
Funding
Core Essence Orthopedics, which is developing "a variety of minimally invasive products for soft tissue repair in the upper and lower extremities," received a $5 million equity investment led by NewSpring Capital of Radnor, Pa. The funds will help the company "complete product development and launch commercialization programs for its product line" by year end.
Product Introduction and Update
Anika Therapeutics, Inc. has begun shipping MONOVISC, its single-injection HA, to Europe. The company is currently conducting a clinical study to support the product's U.S. market clearance.
Off-label use of rhBMP (the active protein in InFuse and OP-1) in cervical fusions has been correlated with serious complications, according to a public health notification released by the FDA. Adverse effects reported over the past four years include difficulty swallowing, breathing or speaking within two to 14 days following surgery.
Distribution
Trans1 lowered 2Q:08 revenue guidance from $6.3-$6.5 million to $5.9-$6.0 million, based on "sales force turnover and personnel issues," including the promotion of several high-performing salespeople into regional management roles. President and CEO Rick Randall added, "Approximately 50 percent of our direct sales personnel have been on the job for six months or less and thus are not seasoned in their territories."
Appointments
Scient'x S.A. appointed Mr. Robert Brosnahan VP of Product Development. He will be in charge of product development worldwide. He will work with the product development teams in both the US and France as the company executes a series of strategic product development initiatives including new technology platforms, expanded custom and prototype capacity as well as implementing a streamlined product development process. Mr. Brosnahan brings with him over 26 years of experience in the medical device industry. Most of his career was spent with Smith & Nephew where he held various positions such as Group Director, Product Development and Regulatory Affairs, Group Director Product Development Implants, and VP Technology Licensing.
Scient'x also appointed Mr. Emmanuel Zylber to the role of R&D Director. Mr. Zylber will be responsible for the development and execution of the R&D strategy, participating in the development of the company's product portfolio and project pipeline. He will work to maintain and optimize the global product development process. Zylber brings with him over nine years of R&D experience, of which, eight years was spent in the spinal implant business. In his most recent position, Mr Zylber served as Principal Engineer at Zimmer Spine where he was responsible for the development of dynamic stabilization implants.
Orthofix International N.V. has appointed Brad Mason to the newly created role of group president for North America. He was formerly president of Breg Inc. Brad Lee has been promoted to president of Breg after previously serving as vice president and general manager of the division.
