Miramar Labs® Announces South Korean Regulatory Approval for the miraDry® System to Treat Excessive Underarm Sweat
Innovative technology now available to patients in South Korea
SUNNYVALE, CA (September 12, 2012) – Miramar Labs announced today that the miraDry System has received regulatory approval in the Democratic Republic of Korea for the treatment of primary axillary hyperhidrosis, commonly known as excessive underarm sweat.
The South Korean regulatory approval clears the way for the company to begin selling the miraDry System to physicians in the country. KFDA is the latest regulatory body to grant approval for the miraDry System, which is also available in the U.S. and Japan. U.S. Food and Drug Administration clearance was granted for miraDry following a robust, randomized, blinded clinical study that involved 120 patients at seven clinics followed for 12-months post-treatment. The miraDry System delivers energy noninvasively 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.
“The growing number of patients successfully treated in the U.S. and Japan continues to prove the efficacy and safety seen in the company’s multiple clinical studies,” said Dr. William Coleman, III, Director of the Coleman Cosmetic Dermatologic Surgery Center, Metairie, LA and one of first physicians participating in the miraDry clinical trials. “Data presented earlier this year showed 90 percent efficacy and 90 percent patient satisfaction, and we’re continuing to see this trend in patients treated in a commercial setting.”
“We are excited to continue to expand patients’ access to the miraDry Procedure. There are tens of millions of people who silently suffer from the embarrassment and burden of excessive underarm sweat,” said Darrell J. Zoromski, President and Chief Executive Officer of Miramar Labs. “The results from the miraDry procedure can truly affect a person’s life for the better in a lasting, non-invasive way.”
To further support miraDry’s commercial efforts, the company has recently appointed James Lam as Managing Director for Asia Pacific and Steve Okland as Vice President, Americas and European Sales.
Mr. Lam joins Miramar Labs with over 30 years of experience in the technical and medical device spaces, hailing most recently from St. Jude Medical’s Asia Pacific division. Mr. Lam joined St. Jude through its acquisition of AGA Medical Corporation. As General Manager of Asia Pacific for AGA Medical, Mr. Lam was responsible for developing and overseeing the region which resulted in exceeding sales plan. “James has a proven track record creating value in an organization by driving business growth and sales across Asia Pacific,” said Mr. Zoromoski.
Mr. Okland has over 20 years of experience in the medical device industry and most recently led the field sales, clinical, and marketing organizations at Medivance, Inc., resulting in its successful acquisition by C.R. Bard, Inc. “Steve’s experience in leading and expanding sales forces will prove invaluable as we grow our business,” said Mr. Zoromski.
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.