Torax Medical wins CE Mark for GERD device

April 7, 2010 by MedCity News

Torax Medical Inc. wins CE Mark approval in the European Union for its Linx device, which is designed to treat gastro-esophageal reflux disease.

By Brandon Glenn

Torax Medical Inc. won CE Mark approval in the European Union for an implantable device that treats patients suffering from acid-reflux disease.

The company’s Linx device is intended for patients with gastro-esophageal reflux disease, which occurs when stomach juices flowing upward into the esophagus. The disease is caused by defects in the esophageal sphincter muscle, which typically prevents acid and bile from entering the esophagus.

The device has been implanted in more than 150 patients in the U.S. and Europe in clinical trials, according to a press release. The Linx consists of a ring of interlinked, miniature titanium beads with magnetic cores. It’s placed around the esophagus just above the stomach and is designed to help the esophageal sphincter muscle prevent the reflux of digestive juices. When a patient swallows, the beads momentarily separate to allow food to pass into the stomach.

The device has not yet been cleared for sale in the U.S. In September, Torax completed patient enrollment in a pivotal clinical trial that could be the springboard for approval by the Food & Drug Administration, according to Torax senior vice president of market development Mark Stultz. Assuming all goes well with the trial, the company could seek FDA approval by the end of the year, Stultz said.

Torax’s website lists only one press release from the company, a 2005 announcement that it raised a $10 million Series B round (PDF). That financing was led by Thomas, McNerney & Partners of Minneapolis and Sanderling Ventures of San Mateo, Calif. Torax raised a $3.5 million Series A round from Sanderling and Mayo Medical Ventures.

Last year, the company raised a Series C round of $18 million, bringing its total funding since inception to $31.5 million in equity, Stultz said. Kaiser Permanente Ventures contributed $3 million to the Series C round.

Todd Berg, Torax’s co-founder and CEO, was previously St. Jude Medical’s (NYSE:STJ) vice president of emerging technology.

Torax was founded in 2002 and has about 20 employees, Stultz said.

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