A new skin-tightening device has just been cleared by the Food and Drug Administration (FDA), and doctors already feel that it has major potential to be an industry gamechanger. Sofwave Medical Ltd., an Israeli-based aesthetic device company, announced the big news regarding its new Sofwave System in a press release last week.
The device, which is intended to treat facial lines and wrinkles using ultrasound to tighten the tissue below the skin, was backed for FDA clearance by a blinded study that used 59 subjects to prove its safety and effectiveness. According to the study, 86% of the subjects revealed an improvement in the appearance of wrinkles by a minimum of one elastosis score (~1ES). An elastosis score is a measurement of physiological changes in the skin, so this assessment was vital in proving actual changes within the dermis. Also, blinded reviewers correctly recognized pre- and post-treatment photographs for 78% of the treated subjects, further verifying the device’s effectiveness.
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New York City dermatologist with Skin & Laser Surgery Center of New York, Dr. Roy Geronemus, who was an investigator for the trial, claims that the study showed a lot of promise in regards to the device’s future success. “Many of our patients achieved modest to moderate tightening of the jawline and neck, and patient satisfaction was good,” he says.
Boca Raton, Florida, dermatologist, Dr. Jason Pozner—who presented on the device at the American Society of Plastic Surgeons (ASPS) 2019 meeting—agrees: “[The] trial’s [results] are excellent for nonsurgical skin tightening, but as with any technology, [it] needs the real-world test.”
This isn’t the first nonsurgical skin-tightening device to hit the market. Ultherapy, which is an FDA-cleared, noninvasive procedure to lift and tighten the neck, chin and brow, also uses ultrasound technology to improve the skin’s appearance. Ultherapy’s ultrasound technology reaches three different depths: 1.5 mm, 3 mm and 4.5 mm, to treat both the skin and deeper tissue layers. According to the brand, Ultherapy is the only technology that can noninvasively treat at 4.5 mm, which is a depth previously accessible only through surgery.
Although there are no studies directly comparing the two devices, doctors say there are a few notable differences between the Sofwave System—which treats the full face and neck—and Ultherapy. According to Dr. Pozner, the device “differs from Ultherapy in that the energy is [directed to] the mid-dermal [versus] the deeper layers [that Ultherapy reaches].” While the company remains pretty tight-lipped about the technology, Dr. Pozner theorizes that Sofwave’s focus on targeting the mid-dermal layer might help lower the chance of experiencing certain side effects reported after ultrasound skin tightening. Some patients have associated fat loss to their Ultherapy treatments, and a recent study linked the treatment to “subcutaneous tissue edema with resulting atrophy,” the swelling and subsequent shrinking of soft tissue. Due to its new entrance onto the market, potential side effects of Sofwave have not yet been widely reported or studied.
Dr. Pozner also points out that Sofwave uses multiple focus points, therefore covering a larger area at one time, while Ultherapy creates a singular focal point to direct its energy to one area.
Louis Scafuri, Sofwave Medical’s CEO, calls the FDA clearance for Sofwave technology “an important milestone for the company,” adding that the new technology “targets a growing customer base of patients who are looking to reduce their wrinkles and facial lines [without surgery].” Sofwave Medical Ltd., which raised $8.4 million in funding last month, is planning to use the proceeds to commercialize its proprietary skin-tightening technology over the coming months. The device is expected to be available in the United States by the end of the year.
