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Consumer Reports

Nights on the sofa prompted creation of new snore-reducing device | (KRT) Using a tiny wind tunnel, a leather tongue and a Shop-Vac, Tim Conrad helped invent a medical device that's the centerpiece for a Roseville, Minn., company with some 50 employees and prospects of $8 million in sales next year.

But Conrad's biggest payoff from the invention may be peace and harmony in his own bedroom.

"I used to get jabbed and told to go and sleep on the sofa," Conrad says.

Not any more. "The other night, she kicked the dog out and I got to stay."

Restore Medical's new device is an implant to treat snoring, and Conrad not only helped invent it, but he was also one of the first patients to receive it.

The whistles, wheezes and snorts of snoring are always good for a laugh - anyone who has seen a Three Stooges movie can attest to that. But it's not so funny when it's 2 a.m. and you can't sleep - either because of the racket or because you're getting poked in the ribs.

Getting a good night's sleep is becoming a big industry. Another Minnesota company, Eden Prairie-based CNS Inc., sells Breathe Right nasal strips and throat spray aimed at the snoring market, and the products accounted for most of its $79 million in sales last year. Research firm Frost & Sullivan's said treating snoring and related sleep disorders is growing at an annual clip of about 15 percent to 20 percent. The firm projects it could become a $1 billion industry in four years.

"As far as we're concerned, CNS has barely scratched the surface of their potential customer base," said Chris Krueger, a securities analyst with Miller, Johnson, Steichen & Kinnard in Minneapolis.

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Snoring isn't just about sleep, however. Sometimes heavy snoring can be a sign of sleep apnea or other maladies.

"Some of the symptoms are elevated blood pressure, hypertension, excessive drowsiness and poor daytime performance," said Thomas Okner, an ear, nose and throat physician in St. Paul, Minn.

And there are the social consequences of snoring. Snorers often get complaints and ridicule from those they disturb, and sometimes are banished to the couch at home or forced to get a separate hotel room on the road.

Sue Critzer, the chief executive of Restore Medical, offers one rather extreme example. "I was on an airplane once, and after I told one woman what I did for a living, she said to me, `I wish you'd come up with that seven years ago - I might not be divorced now,' " she said.

Snoring is prevalent among adults, and is increasingly common among children as well. Nearly half of all American adults snore occasionally, and half of those - 40 million or so - are habitual snorers. Of those, about 27 million heavy snorers disturb their bed partners and about 12 million are diagnosed with sleep apnea.

"It's becoming a very big problem, especially as the population is aging and weighing more," said Dr. Philip Rapport, an Edina, Minn., ear, nose and throat physician. Age and obesity, along with genetics, are key factors in snoring, he said. Other factors are smoking, drinking and sedatives.

As a result, the market is growing and is wide open for new competitors since no one has come up with a surefire cure. Over-the-counter treatments such as nasal strips, splints, oral appliances, throat sprays, ergonomic pillows, wrist alarms that vibrate in response to snoring, and pills all claim to help reduce snoring.

A recent study looked at the most popular over-the-counter remedies and cast doubt on their effectiveness.

Medical procedures to treat snoring - they include scarring or cutting away soft palate tissue or amputating the uvula - are invasive, can be painful and are often not enough.

Another new approach is to inject a hardening agent into the soft palate, a procedure called injection snoreplasty. The procedures typically range in cost from $1,000 to $2,000 and are not covered by health insurance. The Restore implant and radiofrequency (also called somnoplasty) procedures cost in the middle of the range, Restore CEO Critzer said.

"There is nothing that can eliminate snoring," says ear, nose and throat specialist Thomas Okner, who has used all of the above procedures and has implanted the Restore device as well.

Those with obstructive sleep apnea are sometimes prescribed a breathing machine that uses air pressure and a mask to create continuous air pressure, preventing airway blockage that causes snoring and apnea. Although effective, the machines are intrusive and noisy and patient compliance is not high.

The lack of a cure intrigued Conrad, a patent attorney, and his partner, Mark Knudson, a physiologist who works for a venture capital firm. They were looking for a medical market with unmet needs and found the snoring and sleep disorder market as ripe territory.

Conrad knew from experience that surgical approaches to treat snoring seemed too painful and drastic, while the over-the-counter ones were ineffective.

"The only thing that worked was my sleeping on the couch," Conrad said.

So they set out to invent a less invasive, more effective treatment for snoring. They started by studying the aerodynamics of snoring using a small wind tunnel, a leather "tongue," and a ShopVac to simulate breathing.

"We found that if we put a piece of tape on the leather to stiffen it, it stopped fluttering," Conrad said.

The implant consists of three pieces of polyester yarn less than an inch long that are each inserted into the soft palate on the roof of the mouth. The implants prompt the tissue to stiffen and that in turn reduces the "flutter" that is a main culprit in the snore.

After refining some of their ideas, they incorporated the company, then called Pi Medical, in 1999. They quickly filed patents and were able to raise $12 million in venture financing in 2000.

The product won marketing approval from the Food and Drug Administration (FDA) late last year, was launched this spring and was an attention-getter at a national convention of ear, nose and throat doctors in Orlando in September.

As Restore has built up its marketing force to train doctors to perform the implant_it takes a few minutes using a pre-loaded insertion device - the company expects that the number of patients getting the implant will hit 800 this year and climb to 11,000 next year. Restore Medical plans to see if its implant can help those suffering from sleep apnea as well.

Okner says it's too soon to say if Restore's implant can treat sleep apnea. He suspects that it may be effective in cases of mild sleep apnea, but the studies are not far enough along to make any conclusions.

While Restore does not claim its implant cures snoring, it does say it reduces it significantly in most patients.

"A reduction to the point where the spouse can sleep in the same bedroom is a reasonable outcome," Okner said. In nearly four of five patients in whom he's inserted the Restore implant, that has been the outcome, which reflects the results of studies of the device, he said.

The implants have the added advantage of being a quick, one-time procedure in the doctor's office that is relatively painless and is reversible, he says. And doctors like the procedure because it's quick, efficient and standardized, and doesn't require any capital equipment. None of the other procedures can offer all of those benefits, he says.

"It's still early, but I would say this is one of the most promising methods that has come along," said Rapport.

Take the example of one of his patients - Pat DeNucci, a pilot who lives with his wife, Judy, and their two children in Eden Prairie.

"I would get an elbow or a slap on the pillow - she would do anything to get away from the freight train," DeNucci said.

Even on his annual golf trips to northern Minnesota with his dad and brothers, DeNucci's snoring was so loud that that brothers "drew straws to see who had to sleep with me."

DeNucci had undergone a procedure called somnoplasty, in which the soft palate is zapped with a radio frequency that kind of microwaves the tissue from the inside out to stiffen it. There was some improvement, but even after the maximum four treatments, he was still keeping Judy awake.

But since the Restore implant, things are far quieter in the DeNucci bedroom.

"It's not totally gone, but it's not keeping me awake at night," said Judy DeNucci.

Only if he has a cold or a few too many glasses of wine will the freight train start chugging again, he said.

Todd Sharratt, who is building a house in Stillwater, reports similar luck with the Restore implant. Before the procedure, his snoring was enough to draw a midnight nudge from his wife and even banishment to the couch.

"Now some nights she shakes me to see if I'm alive," Sharratt said.

While Breathe Right strips made center stage a few years back as an athletic performance enhancer (Remember all the professional football players who wore them?), that's the last reason most people buy them these days. The strips are aimed at helping people breathe through their nose better.

A recent buyer survey showed that 44 percent bought the strips to reduce snoring, 30 percent to treat nasal congestion resulting from allergies or colds, and only a few percent used them in exercising, said Leah Stevenson, director of marketing services at CNS, which has 55 workers here. Manufacturing is outsourced to a vendor that CNS declined to identify.

A recent study presented at the Orlando convention cast doubt on the effectiveness of three over-the-counter remedies for snoring - the Breathe Right nasal dilator strips, a lubricating mouth spray called Snorenz and the ergonomic pillow "Snore-No-More."

In late September, CNS issued a statement saying the study was "seriously flawed" because it did not use the product correctly.

"The study was a little unfortunate because it only tested the product for one night," said Andy Anderson, head of research and development for CNS. "The user isn't going to clamp his mouth shut after one night. Had they given it a week or so, they might have made a different conclusion."

The company points out that the FDA has approved its Breathe Right strips for use in relieving snoring, and that it has several other studies to bear out that claim.

A year ago, CNS introduced its own throat spray that not only lubricates the throat, but also carries an astringent that tightens up the soft palate tissue. Sales of the spray hit $7.5 million last year, well exceeding the company's expectations, said Dennis Nielsen, a securities analyst with Feltl & Co. in Minneapolis.

Anderson said that five out of six people will get some benefit from using the strips or the spray or both products.

"We have done assessments with snorers and their partners, and it does work enough to be noticeable," Anderson said.

As for Tim Conrad, the co-inventor of the Restore implant, the payoff has been significant - if you talk to Sarah Conrad, Tim's wife of 18 years.

"He's been pretty much silent at night since the procedure - and I'm sleeping a lot better."

She calls his willingness to get the implant "an act of love."

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© 2003, Saint Paul Pioneer Press Distributed by Knight Ridder/Tribune Information Services