FDA Nod for Integra's Extremity Offer - Analyst Blog

Medical products company - Integra LifeSciences ( IART ) recently received 510k clearance from the U.S. Food and Drug Administration (FDA) for its Proximal Humeral Fracture Plate System. The company believes that this achievement will act as a major impetus for growth of its Extremity Reconstruction business. With the FDA approval, Integra is planning for the controlled market release in 2013.

Integra believes that this product, with its treatment options for proximal humeral fractures, will be an apt fit for its Titan Shoulder portfolio. In addition, this plate system with its unique design will provide better fixation option for calcar neck with humeral head support.

According to Integra, proximal humeral fracture is the third most common fracture reported. The company claims that more than half of all kind of humeral fractures, which are surgically treated, was corrected using humeral plating systems. Accordingly, Integra foresees a huge demand for this new plate in the market based on the estimated 108,000 shoulder fixation procedures to be performed on older patients (65 years and more) in the U.S. this year.

Despite a challenging macroeconomic environment, we are encouraged by Integra's solid performance in U.S. Extremities, which grew 8.6% to $31.3 million at constant exchange rates or CER. The company's focus on strategic initiatives to drive growth and profitability in the orthopedic and Neurosurgery market is also quite encouraging. Several initiatives on the company's part such as planned product launches and acquisitions are expected to accelerate sales growth for the next several quarters.

However, tighter capital spending continues to challenge the surgical instruments market. Moreover, the company believes that the medical device excise tax and new depreciation on its ERP system will temper its 2013 margin growth.

Integra currently carries a Zacks Rank #3 (Hold). However, other medical device stocks worth a look are Given Imaging ( GIVN ), Cyberonics Inc. ( CYBX ) and Cytokinetics Incorporated ( CYTK ). All these stocks carry a Zacks Rank #1 (Strong Buy).

CYBERONICS INC (CYBX): Free Stock Analysis Report

CYTOKINETCS INC (CYTK): Free Stock Analysis Report

GIVEN IMAGING (GIVN): Free Stock Analysis Report

INTEGRA LIFESCI (IART): Free Stock Analysis Report

To read this article on click here.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story


Other Topics


Latest Markets Videos


Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at

Learn More