Integra LifeSciences Holdings Corporation (IART) has added another feather to its cap with the latest 510k clearance by the US Food and Drug Administration (FDA) for its new Accell Evo3 Demineralized Bone Matrix. Earlier this week, the company received FDA approval for three spinal intervertebral body fusion devices.
This approval is based on a pivotal animal trial as well as radiographic, histologic and biomechanical analyses. This new generation Demineralized Bone Matrix works as a bone graft extender in the spine, extremities and pelvis and helps fill the voids and gaps in the bone resulting from surgical defects or the traumatic injury to the skeletal system. Additionally this device is expected to provide relief by avoiding additional surgeries as well as post operative pain.
Integra currently provides a full array of bone graft substitutes to orthopedic surgeons and neurosurgeons, which includes Accell TBM, Accell Evo3, Accell Evo3c, Accell Connexus, DynaGraft, and OrthoBlast demineralized bone matrices and the Integra Mozaik product line.
Integra develops and markets surgical implants and medical instruments for orthopedics (spine, orthobiologics and reconstructive surgery), neurosurgery (including neurotrauma) extremity reconstruction and general surgery. The company derived 38% of its total revenue from orthopedics and 38.2% from neurosurgery during the fourth quarter of fiscal 2010. Integra witnessed strong internal growth primarily in these two major segments, the Orthopedic (up 8.1% year-over-year), and Neurosurgery (up 8.8%).
Additionally, the company has taken several strategic initiatives to boost its sales further. Presently Integra is splurging all resources to support the new product development and sales distribution. During the last quarter, the company reported a 12.9% rise in research and development cost and an 8% hike in selling, general and administrative expenses.
However, a weaker economy and tighter capital spending continues to challenge the surgical instruments market. Moreover, Integra faces direct competition in the Medical Instruments & Supplies industry from major players like Medtronic (MDT) and Stryker Corp. (SYK).
INTEGRA LIFESCI (IART): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
STRYKER CORP (SYK): Free Stock Analysis Report
Zacks Investment Research
Be the first to comment