Zacks_Analysts' Blog : FDA Clears Integra's Spine Devices - Analyst Blog

In a major breakthrough, Integra LifeSciences Holdings Corporation’s (IART) three new spinal intervertebral body fusion devices (IBD) have been cleared by the US Food and Drug Administration (FDA). The devices have undergone a soft launch in the market. However, the company is aiming at full commercial release later in 2011. 

These three IBDs, namely Cervical Stand-alone IBD, Vu cPOD Non-Strut IBD and Steerable IBD are the new generation spinal fixation implants that help the physicians to simplify the surgical procedures as well as provide comfort to the patients by soothing their nerves and associated back pain. Additionally, their graft windows allow natural bone growth to occur.

Integra develops and markets surgical implants and medical instruments for orthopedics (spine, orthobiologics and reconstructive surgery), neurosurgery (including neurotrauma) extremity reconstruction and general surgery. Orthopedics, being one of its major as well as fastest growing segments witnessed strong sales growth (up 8.1% year over year) during the fourth quarter of fiscal 2010. Integra derived 38% of its total revenue from orthopedics during the quarter.

In a drive to boost sales further, the company has taken several strategic initiatives. Presently, Integra is dedicating more resources to support the new product development and expansion of 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. Also, Integra is attempting to pursue licensing deals, the recent being the exclusive licensing and development relationship with Stout Medical.

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).