miraDry by Miramar Labs Receives FDA 510(k) Clearance

SUNNYVALE, Calif.--(BUSINESS WIRE)--Miramar Labs today announced that it has received FDA 510(k) clearance for the new miraDry System for the treatment of primary axillary hyperhidrosis, commonly known as excessive underarm sweat. miraDry is a non-invasive, quick, outpatient procedure that provides a lasting solution for this debilitating condition.

“Prior to the miraDry procedure, there were limited options available for treating axillary hyperhidrosis, none of which offered a lasting, non-invasive solution. While temporary, non-invasive solutions and surgery have been available, miraDry provides my patients with the opportunity for a truly lasting solution in a non-invasive office procedure”

Primary axillary hyperhidrosis is a medical condition in which more underarm sweat is produced than is needed to cool the body. Millions of Americans suffer from excessive underarm sweat, and many suffer silently—ashamed, frustrated and embarrassed because excessive underarm sweat can interfere with nearly every aspect of life.

The miraDry procedure takes approximately one hour per doctor’s office visit, and is typically conducted in two visits. It requires only a local anesthetic, causes little to no downtime, and provides a lasting solution. This is in stark contrast to previously available alternatives.

“Prior to the miraDry procedure, there were limited options available for treating axillary hyperhidrosis, none of which offered a lasting, non-invasive solution. While temporary, non-invasive solutions and surgery have been available, miraDry provides my patients with the opportunity for a truly lasting solution in a non-invasive office procedure,” said Dr. William P. Coleman, III, Clinical Professor of Dermatology and Adjunct Professor of Surgery at Tulane University Health Sciences Center, Founder of Coleman Cosmetic Dermatologic Surgery Center in Metairie, Louisiana, and Past-President of the American Society for Dermatologic Surgery.

A robust, randomized, blinded clinical study that involved 120 people across 7 sites and followed patients 12-months post treatment demonstrated the efficacy and safety of miraDry. “In this study, we saw compelling efficacy and safety data with the miraDry procedure. The efficacy rates were virtually stable from 3-months out to 12-months. This data, combined with the histology data on miraDry patients, is convincing,” said Dr. Michael S. Kaminer, a board certified dermatologist and Assistant Clinical Professor of Dermatology at Yale University Medical School and co-director of SkinCare Physicians in Boston.

The miraDry procedure is safe and straightforward. It entails delivering electromagnetic energy to the area beneath the underarm skin where the sweat glands reside, resulting in thermolysis of the sweat glands. The effect can be seen almost immediately. The miraDry procedure will be available later this year through miraDry-certified dermatologists.

“We are very excited to introduce a procedure for physicians that will help alleviate the suffering of millions of people, allowing them to lead better quality lives,” said Darrell J. Zoromski, President and Chief Executive Officer of Miramar Labs. “Axillary hyperhidrosis is a disease of silent sufferers, and we are thrilled to be able to offer a clinically proven, non-invasive, lasting solution to these patients.”

For more information, visit www.MiramarLabs.com.

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. Miramar Labs is excited to have developed a breakthrough technology platform using microwave energy. 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 procedure uses microwave energy to provide a non-invasive, lasting solution to axillary hyperhidrosis. 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.