Torax Medical Inc. has received regulatory approval from the European Union to sell an implantable device that treats patients suffering from acid reflux disease.
The company’s Linx device is intended for patients with gastroesophageal reflux disease, which involves stomach juices flowing upward into the esophagus. The disease is caused by defects to 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 statement from the company. The Linx consists of a ring of interlinked, miniature titanium beads with magnetic cores. It’s placed around the esophagus just under 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.
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The device has not yet been cleared for U.S. sales. In September, Torax completed patient enrollment in a “pivotal” clinical trial that could be the springboard for approval by the Food and Drug Administration, according to Mark Stultz, senior vice president of market development. Assuming all goes well with the trial, the company plans to submit 12-month data to the FDA by the end of the year, Stultz said.
Torax’s Web site lists only one press release from the company, a 2005 announcement that it raised a $10 million Series B round of financing. That round 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 chief executive and co-founder, was previously St. Jude Medical‘s vice president of emerging technology.
Torax was founded in 2002 and has about 20 employees, Stultz said.
