Commercial Device Study Of The miraDry® Procedure Demonstrates Lasting Sweat Reduction Sustained For Two Years in Patients With Axillary Hyperhidrosis
ATLANTA – October 12, 2012 –Miramar Labs announced today ground-breaking two-year results from their commercial device study which showed patients treated with the miraDry System — a noninvasive technology that was cleared by the U.S. Food & Drug Administration (FDA) to treat primary axillary hyperhidrosis — experienced sustained improvement in sweat reduction and quality of life at 24-months post treatment. This is follow-up data to a study that assessed the efficacy and safety of the miraDry Procedure, which previously reported an average of 82 percent sweat reduction at 12- months post procedure. The data was presented today at the American Society for Dermatologic Surgery Annual Meeting in Atlanta.
“This new data adds to the growing evidence that validates the efficacy of the miraDry Procedure to provide significant and lasting reduction in underarm sweat. The substantial improvement in quality of life and long-term reduction in sweat in patients who had the procedure have been maintained for two years and further supports that the procedure eliminates sweat glands,” said Dr. Mark Lupin, director and founder of Cosmedica in Victoria, B.C. who presented the data today. “Aside from surgery, which is invasive and contains inherent risks, there are no other options that can provide results confirmed by multi-year follow-up data.”
Highlights of the 24 month data:
- All of the participating patients have HDSS (Hyperhidrosis Disease Severity Scale) scores of 1 or 2 which indicate that underarm sweating no longer substantially impacts their daily lives
- 1.3 average DLQI (Dermatology Life Quality Index) which indicates long-term stability, compared to average baseline score of 11.8
The study enrolled 31 adults with excessive underarm sweat at two centers in Canada. Participants had follow-up office visits within the first year and completed a survey every three months after the first year. Patients’ level of underarm sweat was evaluated by HDSS scores, gravimetric weight of sweat (up to 12 months) and the multi-question, validated DLQI, a dermatology-specific quality-of-life scale.
“We are delighted to see consecutive studies that support the efficacy, safety and improved quality of life in patients who have had the miraDry Procedure,” said Darrell J. Zoromski, president and chief executive officer of Miramar Labs. “Given that other primary therapies currently available provide only short-term relief or are ineffective, we are seeing a growing demand for a lasting treatment option to address this embarrassing condition.”
In the U.S., 1 in 5 adults suffer from bothersome underarm sweat. The miraDry Procedure is the only FDA-cleared device that delivers energy non-invasively to the underarm area where the sweat glands reside, creating localized heat to eliminate the glands. Since the sweat glands do not grow back once they have been eliminated, the results are lasting.
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.