miraDry®

Until now, treatment options have been limited to prescription-strength antiperspirants, oral medications, botulinum toxin A injections, and surgery. These options are either designed to temporarily disable the sweat glands, or involve surgery which contains inherent risks. There are other therapies that utilize energy in treating hyperhidrosis, however there is limited data, both in number of patients and amount of follow-up and they are not FDA approved. Only miraDry provides a lasting solution with a non-invasive procedure.

A Proven, Lasting Treatment Alternative:
The miraDry® Procedure – a lasting solution for excessive underarm sweat

• The miraDry System is the only medical device cleared by the FDA which dramatically reduces underarm sweating and provides lasting results
• A non-invasive, in-office procedure
• Eliminates sweat glands in the underarm without surgical incisions or cuts
• Other treatments are temporary or involve surgery which contains inherent risks
• Over 6,000 procedures successfully completed to date
• The miraDry® system is the result of more than 5 years of research and development, including a major long-term clinical study conducted by leading dermatologists across the United States

• The procedure delivers precisely controlled electromagnetic energy to the region where the sweat glands reside, and heats and eliminates the sweat gland
• Two procedures are required, spaced 3 months apart, to obtain the best results

miraDry is clinically proven to dramatically reduce axillary sweating and provide lasting results.In the most recent clinical study with the commercial system:

• Efficacy rate was 90%; post-procedure sweating became tolerable or was gone compared to intolerable or barely tolerable
• Average sweat reduction was 82% (measured weight of sweat)
• High patient satisfaction (>90%) with the results
• Because the sweat glands do not regenerate after treatment, results are lasting
• Published scientific research demonstrates that sweat glands do not come back or regenerate once they have been eliminated.
• Results are immediate – patients can expect to see a reduction in sweat immediately after treatment
• Strong safety profile

Miramar Labs has conducted a series of clinical studies to demonstrate the efficacy and safety of the miraDry procedure.

Pivotal study conducted with non-commercial system
• Randomized, blinded, sham-controlled study
• 120 patients total: 81 received miraDry treatment; 39 received sham
• Multi-center study at 7 sites across US with leading dermatologists
• Patients were followed for 12 months post final procedure and stable
• Efficacy was observed from 3 months onward
• Statistically significant difference between treatment and sham

Subsequent study conducted in Canada with optimized, commercial system and optimized procedure
• 31 patients at 2 sites
• Patients were followed for 24 months post final treatment
• >90% patient satisfaction
• >90% efficacy
• Histology collected confirms the elimination of the sweat glands
• Upon request, abstracts and scientific posters on the studies can be provided as well as a white paper on the histology results