June 18 EnteroMedics Inc's shares
jumped about 37 percent in premarket trading on Wednesday, a day
after an advisory panel to the U.S. Food and Drug Administration
voted in favor of the company's device to treat obesity.
The independent panel voted 8 to 1 in favor of the device's
safety and 6 to 2, with one abstention, that the device's
benefits outweighed its risks.
"The panel reaffirmed our thesis that (the device) offers a
less invasive and safer, yet effective, treatment for the large
and under-treated obese population," Roth Capital Partners
analyst Chris Lewis wrote in a note.
The pacemaker-like device, called Maestro Rechargeable
System, blocks certain nerves that regulate digestion and
stomach activities using electrical impulses. This neuroblocking
technology, called Vbloc, helps to control both hunger and
Lewis said he expected the FDA to accept the panel's
recommendations and approve the use of Maestro in treating
morbid obesity in the second half of the year.
EnteroMedics' device could help morbidly obese patients, who
have few options other than surgery as drugs are of little help
However, the advisory panel voted against the device's
effectiveness, saying 12-month data from a trial did not support
Lewis said the negative efficacy vote was not representative
of the panel consensus that Vbloc therapy showed the necessary
clinical benefit, but was based on the data from one trial.
"Ultimately, the panel determined that 24 percent and 25
percent excess weight loss in the treatment arm at 12 and 18
months ... was clinically significant and effective enough to
recommend for approval, regardless of the fact that the ReCharge
trial did not meet its arguably flawed co-primary efficacy
endpoints," he said.
Obesity has started assuming epidemic proportions in the
United States, with more than a third of Americans reported to
be obese. The condition is a serious concern for regulators and
With related complications such as diabetes and heart
problems, obesity cost the U.S. healthcare system up to $210
billion a year, according to a report by lobby group Trust for
America's Health published in 2012.
EnteroMedics' shares closed at $1.52 on Tuesday on the
(Reporting by Esha Dey in Bangalore; Editing by Kirti Pandey)