TranS1 gets FDA nod for new spine surgery device

TranS1 gets FDA nod for new spine surgery device

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March 24 – Medical device maker TranS1 Inc  TSON.O said U.S. health regulators approved a new version of its minimally invasive device for spine surgery, sending its shares up 33 percent on Thursday.

TranS1 said it will start selling the device immediately, and that it expects a full commercial launch in the second half of 2011.

“It is a product update, and the new version should slowly replace the original product,” said First Analysis Securities analyst Greg Chodaczek. The device, AxiaLIF 1L+, is an upgraded version of a device that was launched in 2005. It provides a biomechanically stable implant at the base of the spine, the company said.

The new version should help in better bone fusion, but it likely will not produce immediate changes in the company's product revenue, Chodaczek said.

The company said on March 21 that it expects total revenue of $4.8 million to $5.2 million for the first quarter of 2011.

TranS1 competes with larger device makers such as Medtronic Inc  MDT.N , NuVasive Inc  NUVA.O , Stryker Corp  SYK.N and privately held companies such as Globus Medical and DePuy Spine in the spine surgery market.

TranS1 shares were up 29 percent at $4.20 in Thursday morning trading on the Nasdaq stock market. They touched a high of $4.35 earlier in the session.

 

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