EndyMed Medical is Proud to Announce That Its Newa™ Skin Care System Has Received the World’s First FDA Clearance for a Home Use, Energy Based, Wrinkle Reduction Device

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The Newa Skin Care System, based on EndyMed's patented 3DEEP® radiofrequency technology, will now be available in The United States, in addition to the Newa's current worldwide distribution channels.

We see this world’s first FDA approval as a major competitive advantage for EndyMed. Our management is now directing our activities in order to maximize our business potential in North America.

EndyMed Medical Ltd., a pioneer and world leader in the use of multi-source radiofrequency for professional aesthetic treatments, is proud to announce that it received FDA clearance for the Newa, its energy based skin care device designed for the aesthetic home use market.

Based on EndyMed's patented 3DEEP® radiofrequency (RF) technology, the Newa home use device is clinically proven to reduce mild to moderate facial wrinkles. This revolutionary 3DEEP RF technology incorporated into the Newa delivers controlled energy deep into the skin, allowing for new collagen regeneration. 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.

EndyMed's CEO, Mr. Uzi Blumensohn, stated: "We are very proud and pleased to receive FDA 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. We see this world’s first FDA approval as a major competitive advantage for EndyMed. Our recent FDA clearance is an exciting development in our home use marketing strategy, and our management is now directing our activities in order to maximize our business potential in North America and use it to solidify our leading technological position in the world’s RF based home use skin care devices market."

Scientific studies have shown that after the age of 30, the skin loses 1-2% of its collagen each year. Loss of collagen results in the creation of wrinkles and saggy, older looking skin. The controlled heat produced by the Newa triggers the skin fibroblasts to produce new, more active collagen and elastic fibers, reducing wrinkles and promoting healthier, tighter and rejuvenated looking skin. The unique, sophisticated technology incorporated in the Newa treatment system allows, for the first time, the use of the highly effective, painless and safe 3DEEP treatment 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 device triggers the body's natural healing process to eliminate damaged tissue and rebuild the skin's natural support structure.

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 described their skin as firmer, rejuvenated and radiant. Clinical studies using the Newa have shown an average wrinkle score reduction of 44.5%, as assessed by independent dermatologists three months after the initial one month treatment schedule.

What is 3DEEP® Technology?
Radiofrequency 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, it 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 production of new collagen.

About EndyMed Medical
EndyMed Medical ltd., established in 2007, is a cutting-edge 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, skin tightening and body 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 Rejuvenation System, please see our websites at http://www.mynewa.com, and http://www.endymed.com.

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Tammy Weisman Maman

Amy Kamin
since: 06/2011
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