A new line of underarm hair removal products by Miramar Labs, the creators of miraDry and the proprietary miraWave technology, has been cleared for distribution by the FDA. The new product line, known as miraSmooth, uses precisely-directed microwave energy to remove underarm hair of all colors. The FDA’s decision marks Miramar Labs as the sole distributor of a product that is licensed to treat both unwanted underarm hair and overactive sweat glands, positioning the miraDry/Smooth product line for aggressive growth in 2016.
The FDA approval comes in the wake of a study conducted at three private dermatology clinics in the United States. According to New York-based study co-author Jeremy Brauer, M.D., eligible patients were selected from a large group of individuals seeking treatment for underarm hair reduction. Brauer’s study group consisted of 56 people – 80 percent female and 88 percent Caucasian. Participants were given two sessions – each about three months apart - with overwhelmingly positive results.
“Using this technology we've seen stable axillary hair reduction of approximately 70% regardless of color, and these results were based on a non-optimized treatment protocol,” stated Brauer.
“It will be exciting to see the increase in results given the protocol improvements we've made since then," he added.
The miraDry/Smooth product line uses Miramar’s proprietary miraWave technology to send hyper-focused beams of microwave energy deep into the skin, where both sweat glands and hair follicles reside. Carefully-calibrated doses of microwave energy are used to scorch the glands and hair follicles, resulting in a permanent reduction of both. Hair reduction may take multiple sessions, but once sweat glands are treated they are unable to grow back.
One competitive advantage of miraSmooth’s hair removal technology: it does not require a chromophore to be effective, unlike laser hair removal. A chromophore is the part of the molecule that is responsible for dictating its color. The color is apparent when the molecule absorbs certain wavelengths of light and transmits or reflects others.
MiraSmooth’s successful testing marks a significant technological advance in hair removal; unlike laser hair removal systems, miraSmooth is not limited to certain hair types or colors. The introduction of the miraSmooth line has dermatologists and doctors nationwide ready to implement the groundbreaking treatment option into their practice.
"I'm extremely excited about this significant advancement in hair removal and am just as pleased to announce that our center will begin to offer miraSmooth to patients," stated Dr. Grant Stevens, Medical Director of Marina Plastic Surgery in Marina Del Rey, California.
"With miraSmooth, I can offer hair removal to patients that could not be treated with lasers before or for those that desire elimination of sweat along with their axillary hair,” added Stevens.
Founded in 2006, Miramar Labs is a privately owned medical device company dedicated to sourcing alternative energy solutions in the dermatology and cosmetic surgery industries. According to a Miramar spokesperson, miraSmooth is currently only offered in the United States. The list price of miraDry is $84,450.
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