Miramar Labs® Announces Health Canada Regulatory Approval for the miraDry® System to Treat Excessive Underarm Sweat
Canadian Patients now have access to Innovative technology
SUNNYVALE, CA (November 7, 2012) – Miramar Labs announced today that the miraDry System has received Health Canada regulatory approval for the treatment of primary axillary hyperhidrosis, commonly known as excessive underarm sweat.
Health Canada joins the growing list of regulatory bodies who have granted approval for the miraDry System. U.S. Food and Drug Administration clearance was granted for miraDry in January 2011 following a robust, randomized, blinded clinical study that involved 120 patients at seven clinics followed for 12-months post-treatment. And just last month, two year data on the miraDry System was presented at the American Society for Dermatologic Surgery (ASDS) meeting in Atlanta. These impressive results from a Canadian study showed patients experienced sustained improvement in sweat reduction and quality of life at 24-months post treatment. 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. Since sweat glands do not regenerate, results are lasting.
After presenting the two year data to physicians at Dermatology Update 2012 in Vancouver, BC, Dr. Chih-ho Hong, Principal Investigator in the study and co-founder of SkinFitMD in Surrey, BC, felt that interest was high among physicians for this novel new technology but the real winners will be the patients. “The happiest are the patients in Canada who now have another option for treating hyperhidrosis.” Dr. Mark Lupin, director and founder of Cosmedica in Victoria, BC and co-Investigator, echoed his sentiments: “So soon after presenting the two-year miraDry results at ASDS, it’s exciting to hear that the device has now been granted a license by Health Canada. The non-invasive nature of the miraDry Procedure coupled with the long-term reduction in sweat is unparalleled.”
“We’re looking forward to giving Canadian patients the opportunity to receive the miraDry Procedure. As we bring more awareness to the condition of excessive underarm sweat, we hope that the tens of millions of people who silently suffer will now speak up and seek treatment,” said Darrell J. Zoromski, President and Chief Executive Officer of Miramar Labs. “After treating over 5,000 patients worldwide, miraDry’s track record speaks for itself in terms of providing lasting relief.”
Primary axillary hyperhidrosis is a medical condition in which more underarm sweat is produced than is needed to cool the body. People who suffer from excessive underarm sweat tend to feel frustrated and embarrassed because excessive underarm sweat can interfere with many aspects of everyday life.
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 effect 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.