BENEV Launches Sylfirm X Ultimate Edition, a Novel Radiofrequency Micro-needling Device, in the U.S. as the Exclusive Distributor

MISSION VIEJO, Calif., April 26, 2021 /PRNewswire/ -- BENEV Company Inc., an FDA registered manufacturer with global presence, is proud to announce the launching of a novel RF micro-needling device, Sylfirm X, in the U.S. as the exclusive distributor.

The company established in 2001 is a leader in regenerative aesthetics,  offering the best-in-class medically developed cosmeceutical line distributed through their global medical network and partners. Currently the brand is sold in over 28 countries around the world and counting, not to mention the other countless other brands they both private label and contract manufacture. As leading experts and pioneers in the market, the brand has redefined the regenerative sector, having released a line of growth factor products for skin rejuvenation 20 years before its time, now widely known, and in 2019 & 2021, unveiling Exosome Regenerative Complex for skin rejuvenation & Exosome Regenerative Complex + for skin and scalp which harnesses exosome technology the most cutting edge biotech breakthrough, and now in 2021 the brand brings the World's First and Only FDA Registered Dual Wave RF Micro Needling System featuring both PW [Pulsed Wave], and CW [Continuous Wave] Modes with New 300 Micron Depth …Sylfirm X Ultimate Edition.

"With the rapid growth in regenerative aesthetics driven by scientific and technological advancement on one side, and increasing patient demand on the other, aesthetic practitioners are making pivotal decisions on how to integrate new treatment approaches into their practice and we are proud to be their solution provider, and a provider that they can trust to be in alignment with their practice to offer only the most safe & effective offerings," says Ethan Min, CEO of BENEV Company Inc.

Next-Generation Treatments
Increased demand for minimally invasive and non-invasive procedures has practitioners seeking a multi-layer approach to rejuvenative and regenerative treatments. "For the first time in aesthetics, there is finally a multidisciplinary approach to bring skin rejuvenation to the next level," said Diane Duncan, MD, director of Plastic Surgical Associates (Fort Collins, Colo.). "The go-to regenerative approach in my practice involves my trusted and true trifecta from BENEV Company; Sylfirm X Ultimate Edition, which offers the next generation of a radiofrequency (RF) micro-needling device; Exosome Regenerative Complex + powered by ExoSCRT, providing me with the premiere post-treatment solution utilizing exosome technology; and MIRACU PDO threads, superior threads for full face and body treatments." 

Sylfirm X Ultimate Edition, manufactured by Viol Co., Ltd (Gyeonggi-do, South Korea) and. distributed in the U.S. by BENEV Company, boasts eight different continuous and pulse wave bipolar RF delivery modes. It uses bipolar non-insulated microneedle RF electrodes to uniformly treat the entire skin layer, maximizing treatment results and providing global skin improvements, specifically redness and vascularity with PW modes; and skin laxity with the CW modes.

JongJu Na, MD, PhD, of South Korea worked to develop a device that targeted pigmentation and skin rejuvenation for all skin types, with reduced treatment time and little to no pain or downtime. Sylfirm was the result, featuring not only traditional adjustable-depth CW delivery but his patented PW modes as well, treating both the face and body. The safety, versatility, and the subsequent outcomes, are supported by 25+ publications.

"Out with the old and in with new," said Richard Goldfarb, MD, director of the Center for Smart Lipo in Philadelphia, Pa. "Patients do not want downtime. My patient demographic is anywhere from 21 to 70 years of age, and the needs of each are different and sometimes unexpected. The versatility of Sylfirm X Ultimate Edition improves my ability to treat a wider range of patients."

Undoubtedly the most profound advantage seen with Sylfirm X Ultimate Edition is the 'Na Effect,' named for its inventor and detailed in a 2015 study1 of tissue reactions to bipolar RF micro-needling. Na and colleagues performed in vivo treatment of micropig skin and ex  vivo treatment of bovine liver tissue with RF micro-needling,  varying needle insertion depth and conduction time in both cases. Tissue reactions in and around thermally induced coagulation columns were carefully noted via histologic examination. 

Overall, Na and colleagues found that by using uninsulated needles and two-second conduction times with minimal surface penetration, individual regions of thermal coagulation around each pointed needle tip converged with nearby coagulation zones. This rapidly produced a pronounced effect at the surface, limiting depth of coagulation to 300 microns and reducing treatment time to less than 20 minutes. Damage but not destruction of vascular tissue in the treatment area was noted, while preserving the surrounding skin. Furthermore, Sylfirm X can penetrate from 300 microns to 4 mm, thus enabling treatment of all skin layers – the epidermis, basal membrane and papillary dermis – as well as superficial blemishes to deeper structures, promoting color correction and collagen remodeling while utilizing a single tip.

Supported by six published clinical trials, stable RF delivery using CW modes will create wide, independent coagulation around each electrode, harnessing the Na Effect for overall dermal rejuvenation and regeneration. For pigmentation and vascularity, Sylfirm X's unique PW modes provide softer, more selective coagulation in the basal membrane and vascular structures, targeting abnormal, small blood vessels while leaving surrounding tissue virtually unaffected. Recovery after this selective coagulation and dermal remodeling is rapid. The efficacy and mechanism of action are currently confirmed by ten studies.

"I didn't want an ordinary RF device," said Richard Jin, MD, PhD, director of RJ Clinical Institute and Cellum BioMedical (Mission Viejo and Temecula, Calif.). "I needed a device that could allow me to do more, and better control the outcome." 

My problem has been patients that need both pigmentation and skin laxity addressed, and we see all different Fitzpatrick skin types in my clinics, so I needed a device that could cater to that," Dr. Jin continued. "The Sylfirm X Ultimate Edition does more by providing me with a 300-micron depth for pain-free, no downtime treatments, which encourage patient compliance. My patients now come in consistently, allowing us to give them results in less time. Patients trust me with their treatment and it is my responsibility to offer them the best option available."

"The ability to tailor treatments based on what the patient wants and what their skin needs, using just one device, is the definition of 'advancement' in the regenerative space. With this device I target skin pigmentation as well as aging on the face and body. The technology, pulse wave and continuous wave delivery options, plus pain free treatment at the optimal depth of 300 microns, is all I need in a device," Dr. Goldfarb expressed. "This is my go-to device, it has replaced all other micro-needling and RF devices in my practice," said Dr. Duncan. "Patients report feeling no pain, and love the fact that their treatments do not involve down-time. For what this device does and for what it replaces, the price is a steal."

Syflirm X Ultimate Edition FDA # K200185
SYLFIRM X Ultimate Edition™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. (K200185)

About the Manufacturer of Sylfirm X
Viol Co Ltd is a leading research and development medical device manufacturer. With Viol's bio-electro technologies and products, you can enjoy the beauty of a healthier and richer life

Reference
1.  Na, J; Zheng, Z; Dannaker, C; et al. Electromagnetic initiation and propagation of bipolar radiofrequency tissue reactions via invasive non-insulated microneedle electrodes. Sci Rep 2015;5:16735.

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SOURCE BENEV Company Inc.