June 2010 – Circadiance® Becomes ISO 13485 Certified; Launches Products in Europe
EXPORT, Pa June 21, 2010 — Circadiance®, the world leader in soft cloth nasal CPAP masks, has launched the SleepWeaver® in the European Union and will launch in Canada soon. The company has secured the right to apply the CE Mark after becoming ISO 13485 certified.
“Sleep Apnea affects tens of millions of people around the world,” said David Groll, Circadiance’s CEO. “We have already established distributors in several European countries in preparation for this launch, and we anticipate the same enthusiastic reception in these new markets that we have enjoyed in the U.S. Our soft cloth mask is the answer to uncomfortable hard plastic masks that foster noncompliance. This milestone is just another step in our effort to establish global distribution for our superior cloth CPAP mask technology.”
More than 40 million American adults (and a similar number outside the U.S.) have Obstructive Sleep Apnea — a common breathing disorder in which the airway collapses or is blocked during sleep. It is most often diagnosed in men (twice as many men suffer than women,) and in older people — at least 1 out of 10 Americans over the age of 65 have sleep apnea.
Untreated, sleep apnea can cause a host of medical concerns, including high blood pressure, memory problems, diabetes, impotency, and headaches. Thankfully, patients who follow treatment orders greatly reduce their risk for heart disease and other major medical problems.
Circadiance® is the world leader in designing, developing and manufacturing soft cloth nasal CPAP Masks. Their innovative lightweight designs — including the patent-pending SleepWeaver® mask — have transformed the sleep apnea market by conforming to patient’s faces and creating better-fitting seals, so they’re more comfortable, don’t irritate the skin, and don’t allow air to escape where hard plastic parts don’t fit perfectly. They are quiet and come in a variety of colors. The company is IS013485 certified and the products carry the CE mark allowing them to be sold in Europe and soon Canada. The company, based in Export, Pennsylvania, offers its products online and through home care companies domestically and internationally.
David Groll, CEO