For those of you who like electrical devices, here's a new idea. I am
wondering if a microelectricity generator might be helpful somehow. -
Kathryn
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http://www.startribune.com/business/41244307.html
DAWNING DEVICES
Two medical device companies aim to use electrical stimulation of
nerves to deliver a good night's sleep to apnea sufferers.
By THOMAS LEE, Star Tribune
Last update: March 15, 2009 - 1:07 PM
Inspire Medical Systems Inc. has begun a human clinical trial of an
implantable device that uses low levels of electricity to treat
obstructive sleep apnea (OSA), a serious breathing disorder that
prevents a patient from sleeping. The Brooklyn Park-based start-up, a
spin off from Medtronic Inc., is developing a system (Inspire II) that
continuously monitors a patient's breathing during sleep and then sends
regular bursts of electricity to open up restricted airways.
Apnex Medical Inc. of St. Paul is also conducting a clinical trial of a
similar therapy. The company claims its technology is easier to implant
and more reliable than Inspire II.
Both devices use neurostimulation -- electrical stimulation of the
nerves -- to achieve the desired effect. Neurostimulation is a
relatively new method to treat OSA, a condition that affects an
estimated 30 million to 40 million people in the United States. OSA
sufferers can't get enough oxygen during sleep, causing them to
frequently wake up. Studies show that severe cases of OSA can even
cause obesity, high blood pressure and cardiac arrest.
Investors say OSA is a vastly underserved market. For one thing, many
people don't necessarily know they have it because the symptoms are
seemingly harmless: snoring, daytime drowsiness. In 2006, only 17.4
percent of patients with moderate to severe cases of OSA received
treatment, according to Canaccord Adams Investment Research. The group
estimates the global sales of sleep-therapy devices will hit $3 billion
in 2010 compared with $1.5 billion in 2006.
However, one medical expert says that the neurostimulation technology
still needs additional testing and that some existing therapies are
cheaper and probably more effective.
The most common and effective treatment for OSA is Continuous Positive
Airway Pressure (CPAP), a mask-like device that keeps airways open by
blowing air into a patient's nose and mouth during sleep. But many
patients don't like the masks because they're bulky and unappealing,
said Dr. John Trusheim, a neurologist and co-director of the sleep lab
at Abbott Northwestern Hospital.
A 2005 study published in the New England Journal of Medicine
"demonstrated an increased risk of stroke and death from any cause
among [OSA] patients despite the administration of various therapies,"
including CPAP.
Part of the reason, the study says, is patients don't use CPAP properly
and other treatments don't work.
Born-again device
Inspire II's clinical trial represents a turning point for the company
given its history, said CEO Tim Herbert.
"This is a real significant milestone," Herbert said. "It's really the
restart of the project."
Medtronic, best known for its heart pacemakers, first started
developing the technology in the early 1990s. But the original Inspire
device had design problems: The leads (insulated wires) were not
reliable. The system's sensor, which monitors breathing by measuring
lung pressure, was located too close to the heart; signals from the
heart were interfering with the sensor.
Researchers designed a more robust lead and moved the sensor to the
side of the body. Acting on data from the sensor, an impulse generator
stimulates the hypoglossal nerve, which instructs the tongue to move
forward. The movement opens up the airway.
But Medtronic eventually shelved the project and in 2006 spun off the
business as Inspire.
At the time it lost interest in Inspire, "Medtronic didn't have a
presence in the sleep market," Herbert said. But Medtronic now
"recognizes the value of the technology and the necessity for the
continued development of the therapy. It was aggressive in identifying
an alternative approach resulting in the spinning off of Inspire."
(Last year Medtronic purchased Restore Medical Inc., another local
start-up that is also developing devices to treat snoring and OSA.)
Medtronic kept a minority stake in Inspire and also does some contract
manufacturing for the start-up. Dr. Glen Nelson, a former Medtronic
vice chairman, joined Inspire as its chairman. Those factors helped
Inspire raise around $6.2 million in venture capital from firms such as
Kleiner Perkins Caufield & Byers and U.S. Venture Partners, both based
in Menlo Park, Calif.
"With Medtronic as an investor, we felt comfortable" with the
technology, said Dana Mead, a Kleiner partner. Medtronic's involvement
"would give me more confidence." Mead also said he liked the design
changes and the Medtronic talent now working at Inspire.
Eventually, 30 patients around the world will be implanted with Inspire
II, including at the Minnesota Regional Sleep Disorders Center at
Hennepin County Medical Center. Herbert said he hopes to start a
large-scale pivotal trial in the United States in 2010, the last step
before the company seeks approval from the Food and Drug
Administration.
Crosstown competition
But Inspire has competition. Apnex is developing a similar device to
stimulate the hypoglossal nerve. The company recently raised $16
million from New Enterprise Associates, Polaris Venture Partners, and
Mike Berman, a prominent local medical device entrepreneur.
Apnex CEO Bob Atkinson said they had been watching Medtronic's work for
years. The company decided to develop its own system in response to the
design flaws that plagued the original Inspire device.
In addition to sturdier leads, Atkinson said Apnex's breathing sensor
is more reliable because it uses a technique called "bio-impedance,''
which measures the lung's resistance to an electrical current. When a
person inhales, the lungs fill with air, making it harder for an
electrical current to pass through. Insight II, by contrast, monitors
lung pressure.
Stimulating the hypoglossal nerve makes sense, said Trusheim of Abbott
Northwestern, although "it would be hard for neurostimulation to
supplant CPAP in terms of cost and effectiveness." Trusheim is not
connected to either company.
A CPAP mask costs about $1,000. Inspire's Herbert says he does not yet
have enough information but estimates the entire cost of the therapy,
including the device and surgery, would approach $30,000.
And like any pacemaker, the device might interfere with MRI scans,
Trusheim said.
Still, even 10 percent of OSA patients using neurostimulation would be
an impressive number, he said.
"It's a big market," Trusheim said.
Thomas Lee • 612-673-7744
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