Breathe Right nasal strips stage "three-peat" as FDA clears product for deviated-septum sufferers; More than 12 million Americans could benefit, but 80 percent can't identify condition.

MINNEAPOLIS--(HealthWire)--June 11, 1996--Americans with deviated septums no longer need to curse their condition when congestion causes nasal nightmares. It's official -- those "nose bandages" can help.

Breathe Right(R) nasal strips can now be marketed as a temporary treatment for deviated-septum sufferers, says the Food and Drug Administration (FDA). This announcement marks the product's third FDA clearance in eight months, joining previous clearances for snoring and nasal congestion.

According to research published by the New England Society of Allergy, approximately 12 million Americans suffer symptoms regularly because of a deviation, or bending, in their septum -- the cartilage and bone that separates the nostrils. Countless others are affected when their deviated septums are complicated by colds, sinusitis, or allergies. In fact, only 20 percent of the population have perfectly straight septums.

Because the curvature blocks airflow through the nose, people with deviated septums can suffer from congestion, breathing difficulties, headaches, runny or bloody noses, sleeplessness and snoring.

"Thirty percent of the population has a deviated septum," according to Dr. Craig Nystrom, an ear, nose and throat specialist at Fairview Southdale Medical Center in Minneapolis. "Of those, approximately one third suffer symptoms regularly."

"For me," said Bruce Johnson, the inventor of the nasal strips, "this new FDA clearance is great because my own deviated septum problems led me to develop Breathe Right, before Breathe Right I would modify paper clips to hold open my nose -- just to get enough air to sleep."

For people with extreme breathing difficulties stemming from their deviated septums, a surgical procedure -- often confused with a "nose job" -- can improve nasal breathing by up to 33 percent. For those who suffer minor or occasional nasal problems related to a deviated septum, Breathe Right strips can provide temporary relief.

Ignorance is not bliss

According to the Breathe Right, survey, 80 percent of Americans questioned couldn't accurately define a deviated septum. Some incorrect responses included "something to do with your intestine," and "a split in the mouth."

"By not being able to recognize the condition, these people may suffer unnecessarily from symptoms associated with it," said Daniel E. Cohen, an M.D. and the CEO of CNS. "Rarely can it be seen from the outside, which makes a deviated septum hard to detect."

Knowledge is relief

People can self-test their nasal breathing to discover if their septums are deviated. By blocking each nostril with a finger, consumers can compare airflow from side to side. Restricted breathing consistently on one side can mean that the septum is bent.

While many people are born with them, deviated septums also are often the result of trauma to the nose, especially if the nose is broken. (In the Breathe Right survey, 15 percent of respondents said they had broken their noses at some point.) In a study of 2,380 infants, 27 percent were born with deviated septums, a result of molding pressures during pregnancy and birth.

Breathe Right nasal strips provide relief by gently pulling the nostrils open, which decreases airflow resistance by 31 percent. The strips feature an adhesive pad with two thin plastic strips running the pad's length. When placed across the bridge of the nose, the parallel strips attempt to straighten. As they gently "spring back," they lift and open the nasal passages.

In November 1995, Breathe Right nasal strips made headlines when the FDA cleared the way for the product to be sold as a way to reduce or eliminate snoring by improving nasal breathing. In March 1996, CNS received FDA approval to market the strips as a temporary relief for nasal congestion.

Invented by Johnson in 1987, Breathe Right nasal strips were first cleared to market by the FDA in October 1993. The strips are available across North America in the cough/cold section of drug, grocery and discount stores, and in sporting-goods stores. They are produced by CNS, Inc., a publicly traded company located in the Minneapolis suburb of Bloomington, and distributed internationally by 3M.

CONTACT: Dianne Boyer or Joe McGrath

Shandwick USA

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