miraDry® Achieves EU MDR Certification, Expands Treatment Options for Sweat, Odor, and Hair Removal

miraDry® Expands Its Reach with EU MDR Certification

miraDry®, Inc., a trailblazer in the field of underarm sweat and odor treatments, has reached a significant milestone by acquiring the CE marking under the European Union's Medical Device Regulation (EU MDR 2017/745). This approval enables the company to broaden its treatment options for underarm sweat, odor, and hair reduction across Europe.

Based in Newport Beach, California, miraDry has become synonymous with innovative solutions in managing common underarm concerns. The recent CE certification not only validates miraDry's commitment to quality and innovation but also signifies an enhanced patient experience due to the approval of new software that decreases treatment time by up to 30%. Such efficiency improvements ensure that patients can benefit from a more comfortable and expedited service, which boosts overall clinic productivity.

With miraDry now available in over 14 European countries and having served more than 500,000 patients worldwide, the demand for its unique treatment approach is growing rapidly. The newly expanded indications for miraDry provide a comprehensive solution encompassing sweat, odor, and hair reduction—all achievable through a single non-surgical procedure. This streamlined treatment addresses three prevalent concerns effectively and conveniently.

Robert Catlin, the CEO of miraDry, expressed pride in achieving CE marking under the rigorous new MDR guidelines. He stated, "Securing this certification reflects not just our technological advancements but also our resolve to cater to the increasing demand for effective underarm solutions in Europe. We aim to deliver proven and sustainable solutions for sweat, odor, and hair reduction, offering genuine value to our providers and patients alike."

The growing consumer market for deodorants in Europe, projected to reach an astounding $16.15 billion by 2031, highlights the urgent need for effective treatments targeting underarm issues. With over 50 million consumers in the UK alone purchasing deodorants regularly, the scalability of miraDry's services aligns perfectly with market needs. Additionally, the laser hair removal segment is expected to experience significant growth, projected to hit $1.22 billion by 2032, further solidifying miraDry's place as a leader in this burgeoning industry.

Irene Mo, Vice President of Quality and Regulatory at miraDry, emphasized the clinical effectiveness and reliability of their technology: "Achieving this certification underscores our system's ability to comply with stringent international standards while safely providing lasting relief from sweat, odor, and hair concerns."

miraDry has maintained its status as the only FDA-cleared and now CE-marked system designed for the permanent reduction of underarm sweat, odor, and hair. Backed by the EU MDR certification, the system showcases an unmatched delivery mechanism and operational efficacy. Clinical data suggests that miraDry has proven successful in reducing underarm odor in 97% of cases, with 89% of patients reporting they no longer experience bothersome odors.

The miraDry treatment is particularly advantageous due to its unique action mechanism, which is effective across various skin and hair colors, unlike traditional laser hair removal technologies. Studies indicate that miraDry can achieve a substantial 70% reduction in hair for Fitzpatrick skin types I-V.

About miraDry®

Founded on the mission to provide effective, long-lasting solutions for excessive underarm sweat, odor, and hair, miraDry remains a pioneering force in medical aesthetics. The procedure is a safe, non-surgical option that not only targets sweat glands but also diminishes hair follicles, ensuring patient satisfaction rates hover around an impressive 90%. This innovative approach continues to gain traction globally, with more patients than ever experiencing the benefits of miraDry's technology.

To learn more about this groundbreaking treatment, visit miraDry.com.