The NEWA™ Skin Care System Has Received the World’s First FDA Clearance for an Energy Based, Over the Counter Home Use Wrinkle Reduction Device

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The NEWA Skin Care System, based on EndyMed's patented 3DEEP® radiofrequency (RF) technology, will now be available for sale over the counter in the United States, in addition to the NEWA's current worldwide distribution channels.

The NEWA is the world’s first RF based energy device cleared by the FDA for over the counter home use wrinkle reduction

EndyMed Medical Ltd., a pioneer and world leader in the use of multi-source radiofreqency for professional aesthetic treatments, is proud to announce that it received over the counter home use FDA clearance for the NEWA, its energy based skin care device designed for the aesthetic home use market. The NEWA is the world’s first device of its kind to be cleared by the FDA for over the counter home use for mild to moderate wrinkle reduction.

Based on EndyMed's patented 3DEEP® radiofreqency (RF) technology, the NEWA home use device is clinically proven to reduce mild to moderate facial wrinkles. EndyMed's unique 3DEEP RF technology incorporated into the NEWA delivers focused, controlled energy deep into the skin, promoting natural new collagen regeneration, which results in lifted, tightened skin. Developed by an internationally renowned dermatologist, the NEWA enables the home user to safely use the most advanced professional wrinkle reduction technology in the comfort and convenience of the home.

RF energy based systems are one of the most effective technologies used by dermatologists, plastic surgeons and aesthetic doctors worldwide for face and body skin tightening and lifting, says Dr Yoram Harth, Board Certified Dermatologist and Endymed ’s co-founder and Chief Medical Officer. The NEWA is the world’s first home device that uses the same medical grade RF technology used in high end professional clinics. The controlled heat produced by the NEWA triggers the skin fibroblasts to naturally produce new, more active collagen and elastic fibers, tightening and lifting the skin and reducing wrinkles and promoting healthier, rejuvenated skin. EndyMed's clinical studies have shown significant wrinkle reduction after as little as 4 weeks of NEWA use.

The skin loses 1-2% of its collagen each year. Loss of collagen results in the creation of wrinkles and saggy, older looking skin. A recent study performed in an internationally renowned research lab in New York confirmed a significant increase in dermal collagen level, an increase of as much as 3.8% of collagen generation starting after just one month of NEWA treatments, with a continued increase in collagen at the 12 week follow up.

EndyMed's CEO, Mr. Elad Magal, stated: "We are very proud and pleased to receive FDA over the counter approval for our new home use product. To our knowledge it is the first time that the FDA has cleared a home use device using RF technology for wrinkle reduction. The NEWA is already sold successfully in selected high end markets such as Japan. We see this world’s first FDA over the counter home use approval as a major competitive advantage for EndyMed in the North American market, and we are very optimistic regarding its potential."

The unique, sophisticated technology incorporated in the NEWA allows, for the first time, the use of the highly effective, painless and safe 3DEEP treatments in the home setting. While lotions and creams treat the appearance of wrinkles on the skins surface, RF energy-based devices like the NEWA work deep under the skin's surface where wrinkles begin to form, to stimulate the body's production of new collagen and elastin. Optimal safe heating by the NEWA triggers the body's natural healing process to eliminate damaged tissue and rebuild the skin's natural support structure that lifts and tightens the skin.

The NEWA provides both immediate and long term results. After the first treatment with the NEWA, the face looks and feels tighter, smoother and lifted. With continuous treatment, NEWA users have described their skin as firmer, rejuvenated and radiant. Clinical studies using the NEWA have shown an average wrinkle reduction of 36%, as assessed by independent dermatologists three months after the initial one month treatment schedule.

What is 3DEEP® Technology?

Radiofrequency (RF) is viewed by most Dermatologists and Plastic Surgeons to be the preferred technology for clinic-based, non invasive wrinkle reduction and skin tightening. In contrast to lasers and other light based treatments that are limited by skin color, RF allows for optimal safe heating of the deeper layers of the skin in any skin type. Used by some of the world's top Dermatologists and Plastic Surgeons, EndyMed's patented 3DEEP radiofrequency technology is the safest and most effective technology available today for highly effective and painless wrinkle reduction and skin tightening. Using multiple positive and negative energy sources that work together in a highly controlled way, 3DEEP technology enables precisely targeted energy delivery. The energy is directed into the deep dermal tissue, so that very little energy flows along the skin's surface. This keeps the skin relatively cool during treatments, while achieving the deep-skin heating necessary to optimize the natural production of new collagen.

About EndyMed Medical

EndyMed Medical ltd., established in 2007, is a medical device company that develops and commercializes energy based aesthetic treatment systems for the professional and home use markets. EndyMed's proprietary 3DEEP radiofrequency technology is a unique solution for wrinkle reduction, fractional skin resurfacing, microneedle RF collagen remodeling, face and neck and body skin tightening and contouring.

The NEWA home use wrinkle reduction device was a winner in the Medical Scientific Category of the prestigious Edison Innovation Award for 2013. For more information about the NEWA Skin Care System, please see our websites at, and

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Tammy Weisman Maman

Tammy Maman
since: 06/2011
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