Medical Device Daily National Editor

GERD (gastoesophageal reflux disease) offers a range of not very nice symptoms. In its mildest forms, such as heart burn or acid reflux, it simply degrades quality of life. (A more hard-to-diagnose version is laryngopharyngeal reflux [LPR, sometimes called "silent reflux," because it may not be accompanied by heartburn], referring to the backflow of stomach contents up into the throat.)

In its most serious form, GERD destroys the mucosal lining of the esophagus and becomes Barrett's esophagus and, from there, can move on to cancer.

The therapies for GERD are likewise varied, but putting patients between the proverbial rocks and hard places of medical care, depending on symptoms severity: for those less severe, drugs, primarily antacids and proton pump inhibitors; for the more difficult types, a tricky surgical procedure, Nissen fundoplication, in which the esophageal valve controlling the acids moving upward is strengthened by wrapping a part of the stomach around the lower esophagus.

And a variety of endoscopic and laparoscopic procedures have been developed, including placing stitches in the esophagus to strengthen it. Most of these have shown little long-term efficacy and have been withdrawn.

The Stretta procedure, first developed by Curon (Fremont, California) and then sold to Barxx (Sunnyvale, California), is a treatment for Barrett's esophagus, using RF energy (Medical Device Daily, March 23, 2006).

Now comes a therapeutic strategy that takes a more or less middle path between extremes: somewhat invasive — but less invasive than Nissen fundoplication — more invasive than drugs — but with longer-lasting efficacy and fewer side effects, its developers hope.

The key to this middle way: a system called Magnetic Sphincter Augmentation (MSA). The product: a series of magnetic beads formed into a sort of bracelet, placed around the esophagus to strengthen the lower esophageal sphincter (LES) and prevent the corrosive back-flow of stomach acids.

The device, the LINX Reflux Management System, is being developed by clinical-stage firm Torax Medical (Shoreview, Minnesota), which says the technology is a platform system that could be applied to other parts of the body.

Key to the strategy is the attractive force of the miniature, rare earth magnetized beads, each encased in titanium, tightening the LES while still allowing the sphincter to open for food to pass downward. Thus, the strategy is not to provide an artificial intervention but to strengthen the body's natural function.

Todd Berg, founder and president/CEO of Torax, told Medical Device Daily that another key benefit of the LINX system is that the magnetic beads supply their own energy of action rather than requiring an outside battery source.

Berg spoke to MDD yesterday, just after deplaning from a trip to seek a C-round of funding, hopefully of $15 million to $20 million.

Interestingly, he said that the company, formed in 2002, raised the first tranche of an A-round funding of $3.5 million, from Sanderling Ventures (San Mateo, California) and Mayo Medical Ventures (Rochester, Minnesota), without knowing the particular technology the company would pursue in developing the treatment, only that GERD was the disease target.

He offered the view that it is better to start with a disease problem than a technology, rather than taking a technology "and trying to force it into" some therapy. "Our philosophy is that companies should be based on clinical problems, not technology. It's really hard to decide what the right solution is if you haven't identified the problem."

He said that company engineers had various ideas concerning possible technologies to pursue and "magnetism wasn't one of them, but the idea came up within the closing of initial financing."

The company then in 2005 completed a $10 million Series B round of financing, led by Thomas, McNerney & Partners (Minneapolis) and Sanderling, with participation also by Mayo Medical Ventures.

Berg said that early 2011 is the "best estimate" for filing a PMA for the LINX with the FDA, but he declined to offer a guess as to the timeline for a final agency decision.

The current multicenter trial will evaluate the safety and effectiveness of the device in up to 100 patients.

The LINX is currently being evaluated for GERD at UC San Diego Medical Center and other cites in the U.S. and Europe. Lead investigator at UC San Diego Medical Center is Santiago Horgan, MD, director of minimally invasive surgery and the first U.S. surgeon to use the procedure in the trial.

Horgan told MDD that the LINX "bracelets" come in four sizes to match the anatomy of the particular patient and that the placement procedure takes no more than 30 minutes.

Before speaking to MDD, Horgan recently had completed one of the LINX placements, for a woman whose primary symptom had been continual "burping," and that after placement, this had greatly subsided.

"With medical therapy alone, the production of acid in the stomach is suppressed, but the actual problem of reflux remains. The most appropriate long-term therapy for GERD is to restore the body's physiological barrier to correct the cause of reflux itself ... without pain or discomfort," said Horgan, who specializes in laparoscopic and scarless surgical techniques.

He noted another key advantage of LINX use, compared to the rather complicated Nissen funcoplication procedure: while the surgical procedure must be followed by a severely restrictive dietary regimen, the person implanted with the LINX can resume a normal diet immediately.
The current trial, testing safety and efficacy, will have an enrollment of 100 patients.

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