Cure is on the way!!!

Tommy123

Member
Please email the company & encourage them to develop something to cure palmar hyperhidorsis.

miraDry by Miramar Labs Receives FDA 510(k) Clearance
Novel technology treats axillary hyperhidrosis

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.

“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”
.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 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. 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 Miramar Labs for additional information about Miramar Labs.
 

cm123

Well-known member
This news is amazing. Would it be possible to be a subject for one of their clinical studies?
 

woofytalk

Well-known member
Is this a similar theory of treatment to that of Iontophoresis? Does the effect of the treatment create thicker top layers of skin, consequently reducing perspiration?
 

landon

Member
I called the company and it seems like palmar hyperhidrosis is not something that they are concerned with right now. The guy I spoke with seemed a little confused regarding my query and said that maybe in the future it might be something that they will look at. I encourage everyone to be proactive and write or call them.
 

landon

Member
I spoke with the vice president of Miramar and she basically said that the technology is only to be used for the underarm. Due to the complexities of the hand, with many nerves and tendons located in the palm, using the Miradry system to treat palmar HH is not considered safe by Miramar or the FDA. So right now and in the near future they will just focus on armpit hh.
 

Felipe

Member
I sent Miramar Labs an e-mail yesterday.

They answered me today, and were very clear: miraDry treats only axillary hiperidrosis.

Here's the answer I got:


Thank you for your interest in the miraDry System for the treatment of axillary hyperhidrosis (excessive underarm sweating).

The miraDry System has been designed to treat only underarm (axillary) hyperhidrosis. All of the clinical testing has been for excessive underarm sweating and the FDA approval specifically states it is not to be used elsewhere.


Kind Regards,
Hyoung "HP" Park
Director, Marketing

Miramar Labs
445 Indio Way
Sunnyvale, CA 94085
phone: 408.940.8700
fax: 408.940.8795
Miramar Labs
 

scruffpot

Well-known member
I sent Miramar Labs an e-mail yesterday.

They answered me today, and were very clear: miraDry treats only axillary hiperidrosis.

Here's the answer I got:


Thank you for your interest in the miraDry System for the treatment of axillary hyperhidrosis (excessive underarm sweating).

The miraDry System has been designed to treat only underarm (axillary) hyperhidrosis. All of the clinical testing has been for excessive underarm sweating and the FDA approval specifically states it is not to be used elsewhere.


Kind Regards,
Hyoung "HP" Park
Director, Marketing

Miramar Labs
445 Indio Way
Sunnyvale, CA 94085
phone: 408.940.8700
fax: 408.940.8795
Miramar Labs

so how does it all work...?
what does it do, how does it combat etc/ what changes? does it grow extra skin etcetc?
I looked online but got confused
 
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