By Rachel Barron and
Marisa Taylor
Troubled
depression device-maker Cyberonics appears to have dodged a bullet
after a key advisory panel at the U.S. Food and Drug Administration
determined that a rival company’s device was ineffective at treating
severe depression.
The FDA’s Neurological
Devices Panel decision on Monday dealt a severe blow to Neuronetics’
NeuroStar TMS
System, a non-invasive device that stimulates the brain to alleviate
severe depression. Panel chairman Thomas Brott said trial results for
the new device were “marginal, borderline, [and] questionable.”
Although
the FDA is not bound to follow the panel’s decision, the agency often
does, meaning it appears unlikely that privately-held Neuronetics would
receive approval to market its device. That cheered Cyberonics
investors, who worried that Neuronetics could have emerged as a
formidable competitor.
Houston-based
Cyberonics has developed pacemaker-like device that is implanted
in the chest and is believed to relieve depression by sending mild
electrical pulses to stimulate the vagus nerve in the neck. The company
has been beset by doubts about its products efficacy, as well as a
public boardroom battle.
After
the FDA panel scrutinized the NeuroStar, shares of Cyberonics shot up
more than three percent, closing at $20.93 on Monday.
Neuronetics
remained optimistic about its NeuroStar device, saying that it looks
forward to conducting further trials and answering any questions that
the FDA might have.
Cyberonics’
implant was granted FDA approval in July of 2005, but its effectiveness
has come under heavy scrutiny. Trial data has suggested the device
works for about 30 percent of patients who use it. The Cyberonics
device is the only implantable device on the U.S. market for people
whose depression has resisted typical treatments with anti-depressants.
With
Neuronetics making an attempt to enter the depression device space, and
with a non-invasive technology to boot, analysts speculated that the
FDA’s approval of
Some
analysts believed that Cyberonics entry into the depression device
market 18 months ago would have paved the way for Neuronetics to
follow, but Dr. Alexander Arrow, an analyst for Lazard Capital Markets,
says that the opposite occurred, and that many physicians now suggest
the Cyberonics approval was a mistake. “The panel has taken a
‘not-again’ attitude, a kind of indictment of both companies’ data
sets,” he wrote in a recent research note.
And
while Friday’s panel discussion might have eliminated Neuronetics from
serious competition with Cyberonics, the latter company has been facing
internal strife and management upheaval.
On Monday, Cyberonics
announced that three contested board members resigned from the helm of
the company. Hugh Morrison, a current board member, was appointed as
chairman, a change that observers said would enable the company to
start moving beyond its management troubles.
Alfred
Novak, Arthur Rosenthal, and Jeffrey Schwartz, all nominees from the
shareholder group led by Metropolitan Capital, have been appointed to
replace Tony Coelho, Kevin Moore, and Stanley Appel.
Up until now, the
company has struggled questions of inappropriate
backdating of stock options, the arrival of Carl Icahn as an investor
to shake up management, and the inevitable fallout that has included
the resignation of the company’s CEO (see Cyberonics
Denies Impropriety, Cyberonics
Board Fight Continues, Corporate
Raider Takes Cyberonics Stake, and Cyberonics
CEO Resigns).