KISSIMMEE, Fla., April 20, 2012 /PRNewswire/ -- Miramar Labs announced today 18 months of follow-up data to a study which assessed the efficacy and safety of the miraDry System, a non-invasive technology that was cleared by the U.S. Food & Drug Administration (FDA) to treat primary axillary hyperhidrosis (excessive underarm sweat). The data showed patients treated with the miraDry System experienced, on average, 82 percent sweat reduction at 18-months post procedure, consistent with the results seen at the 12 months check-in date. The study also demonstrated patient satisfaction and efficacy of more than 90 percent. The data was presented today at the American Society of Laser Medicine & Surgery Annual Conference in Kissimmee, Fla. A more detailed description of the study's 12-month results will be published in the May issue of Dermatologic Surgery.
"The recent data is exciting because it shows that the improvements made to the miraDry System and protocol over the earlier FDA approval study have increased patient satisfaction and efficacy while maintaining an excellent safety record," said Dr. Mark Lupin, director and founder of Cosmedica in Victoria, B.C. and co-author of the Dermatologic Surgery journal article. "Additionally, histology shows that the device's mechanism of action does in fact destroy sweat cells; once destroyed, sweat glands do not regenerate. The miraDry Procedure provides a lasting option for sweat sufferers enduring an often embarrassing condition."
In the U.S., 1 in 5 adults suffer from bothersome underarm sweat. The miraDry Procedure delivers energy non-invasively to the underarm area where the sweat glands reside, creating localized heat to eliminate the glands.
Thirty-one adults with excessive underarm sweat were enrolled in the study at two centers in Canada. The study participants had follow-up office visits for 12 months after all procedure sessions were complete. Patients' level of underarm sweat was evaluated by Hyperhidrosis Disease Severity Scale (HDSS) scores, gravimetric weight of sweat and the 10-question, validated Dermatology Life Quality Index (DLQI), a dermatology-specific quality-of-life scale.
In addition to the 12-month data presented by Dr. Lupin, he also shared preliminary results from ongoing patient follow-up. The data collected 18 months post-treatment demonstrated stable results in sweat reduction, with HDSS efficacy and patient satisfaction still above 90%.
"We are very pleased about the growing body of data and peer-reviewed journal articles that demonstrate the efficacy, safety and high-patient satisfaction in patients who have had the miraDry Procedure," said Darrell J. Zoromski, president and chief executive officer of Miramar Labs. "This recent data further validates the lasting nature of the benefits of the miraDry Procedure for those who are bothered by underarm sweat."
The FDA granted clearance for the miraDry System in 2011 following a robust, randomized, blinded clinical study that involved 120 patients at seven clinics who were followed 12-months post treatment. The full treatment plan requires two procedures to maximize results and each miraDry Procedure takes approximately one hour in the doctor's office. Since the procedure is non-invasive, there is little to no downtime, so patients can go about their normal routines after treatment.
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.
SOURCE Miramar Labs