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This article was originally published in The Tan Sheet

Executive Summary

CNS ENTERS OTC MARKET WITH BREATHE RIGHT EXTERNAL NASAL DILATOR, a single-use disposable product shaped like an adhesive bandage that is "placed across the nose and exerts a gentle lifting force to instantly open the nasal passages," Minneapolis- based medical device firm CNS, Inc. said. CNS, which said it made a "conscious decision" to diversify the company and move into the OTC arena, began shipping Breathe Right to distributors on Oct. 13, shortly after receiving FDA marketing clearance on Oct. 7. CNS would not elaborate on future OTC products it is considering developing. Breathe Right, which does not contain a drug ingredient, will be sold in packages of 10 external dilators, each packaged in its own paper sleeve. The 10-dilator box is expected to carry a suggested retail price of $ 6. CNS is positioning the product as an "alternative to oral and nasal spray decongestants" and as "ideal for nighttime use." Although the firm said that it has not yet settled its advertising budget for Breathe Right, CNS plans to initially work with various health care professionals on a promotional campaign to position the product ethically. CNS also is working with Bloomington, Minn.-based public relations firm Media Relations to devise promotional activities highlighting the product's unique qualities, the company noted. CNS said that it expects a traditional advertising program to follow. In addition to marketing Breathe Right over-the-counter, CNS will sell the product to hospitals and home care providers for use on patients with respiratory ailments, particularly those on oxygen therapy. CNS pointed out that FDA clearance of the product was based on a clinical study showing a 31% average decrease in nasal airway resistance in 24 patients with a variety of conditions ranging from allergic rhinitis to chronic lung disease. All but one patient experienced some level of relief, the company asserted, adding in an Oct. 12 release that clinical trial participants "reported improved sleep and reduced snoring as a result of using the product." Breathe Right, CNS said, exerts about 25 grams of pressure on the nasal passages.

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