CE Mark Approval for miraDry®
Miramar Labs Announces CE Mark Approval for the miraDry® System to Treat Bothersome Underarm Sweat
Patients & leading physicians across Europe will now have access to this innovative technology
SUNNYVALE, CA (January 6, 2013) – Miramar Labs®, Inc. announced today that the miraDry® System received Conformité Européenne (CE) Mark approval for the treatment of primary axillary hyperhidrosis, commonly known as bothersome underarm sweat.
People who are bothered by their underarm sweat tend to feel frustrated and embarrassed because their sweating can interfere with many aspects of everyday life, such as clothing choices, social activities and, in some cases, career decisions.
Clearance for miraDry was granted by the U.S. Food and Drug Administration in January 2011 following a robust, randomized, blinded clinical study that involved 120 patients at seven clinics followed for 12 months post-treatment. A follow up study was conducted in Canada that showed patients experienced sustained improvement in sweat reduction and quality of life 24-months post treatment. miraDry is now offered in cities across the US as well as in Asia Pacific, Canada, and Mexico. On average patients see more than 80 percent reduction in underarm sweat and report more than 90 percent satisfaction with the procedure results.
“The physician and patient interest in Europe is arguably the strongest we’ve seen,” said Steve Okland, Vice President of Sales and Marketing, Americas and Europe. “And through our early successes and experience in North America and Asia the past two years, we are confident we will establish a strong foundation for Europe in 2014, with sustained growth for years to come.”
The miraDry System delivers energy non-invasively to the area under the arm where the sweat glands reside, creating localized heat to destroy and eliminate the glands, which are not necessary to cool the body. Since sweat glands do not regenerate, results are lasting. “As our treated patient base has increased to over 20,000 we’re very pleased that miraDry’s safety record, efficacy and patient satisfaction numbers remain strong,” said Steve Kim, Co-Founder and Chief Technology Officer.
Each miraDry procedure takes approximately one hour in the doctor’s office. The full treatment plan requires two procedures to maximize results. The procedure is safe and the results can be seen almost immediately. Since the procedure is non-invasive, there is little to no downtime, so patients can go about their normal routine after treatment. The lasting result miraDry provides coupled with minimal downtime provides a significant improvement from previously available alternatives which require toxins or surgical incisions.
For more information, visit the miraDry website at www.miraDry.com, or follow miraDry on Facebook/miraDry and Twitter @miraDry.
About Miramar Labs:
Founded in 2006, Miramar Labs is a privately owned medical device company dedicated to bringing the next generation energy modality to the field of dermatology. Miramar Labs is the tenth company created by The Foundry, a leading medical device incubator based in Menlo Park, California. Supported by rigorous clinical research, Miramar Labs is focused on addressing medical conditions for which there are significant unmet clinical needs. Their first priority is the treatment of excessive underarm sweat, a medical condition that significantly affects the quality of life of millions of people. The miraDry System is cleared in the United States for the treatment of primary axillary hyperhidrosis. Physicians and patients are encouraged to visit www.miradry.com for additional information about Miramar Labs.