A minimally invasive acid reflux treatment may be on its way to the market.
Torax Medical, a Minnesota company announced Friday that a U.S. Food and Drug Administration advisory panel has unanimously recommended the approval of its implantable reflux device to the agency. The FDA had asked the panel to review the so-called LINX device for its efficacy, safety and risk-benefit ratio.
The device uses a small, flexible band of interlinked titanium beads wrapped around magnetic cores, which is laparoscopically implanted around the esophageal sphincter. The magnetic attraction between is designed to resist the opening of the sphincter to gastric pressure, thereby preventing the entry of stomach acids into the esophagus. At the same time, much higher pressures from swallowing can overcome the magnetic pull and allow food and liquid to pass normally into the stomach.
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A spokeswoman with Torax declined to say when the company expects a premarket approval from the agency. She also declined to comment on how much money the company has raised.
In July, Torax was seeking $8 million and a regulatory filing shows the company was successful in raising at least $4 million. Earlier filings with the U.S. Securities and Exchange Commission show that the medical device company raised $18 million in 2009, $10 million in 2005 and another $3.5 million in 2004.
While the company has been awaiting U.S. approval, the LINX anti-reflux treatment has been available in Europe since 2010. Investors in the company include Sanderling Ventures, Thomas McNerney & Partners, Accuitive Medical Ventures and Kaiser Permanente Ventures.
