A Breakthrough in Non-Surgical Skin Tightening: The Sofwave System
A groundbreaking skin-tightening device has recently been granted approval by the Food and Drug Administration (FDA), sparking significant optimism among medical professionals about its potential to transform the aesthetic industry. Sofwave Medical Ltd., an Israeli company specializing in aesthetic devices, announced this major advancement in a recent press release regarding their innovative Sofwave System.
This advanced device is engineered to combat facial lines and wrinkles by employing ultrasound technology to firm the underlying skin tissue. The FDA's approval of the device was bolstered by a blinded study involving 59 participants, which effectively demonstrated its safety and efficacy. The study results showed that 86% of the participants experienced an improvement in the appearance of wrinkles, with at least a one elastosis score (~1ES) increase. The elastosis score is a critical measure of physiological changes in the skin, making it essential for verifying actual improvements within the dermis. Furthermore, blinded reviewers accurately matched pre- and post-treatment photos for 78% of the treated subjects, reinforcing the device's effectiveness.
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Dr. Roy Geronemus, a prominent New York City dermatologist from the Skin & Laser Surgery Center of New York and a key investigator in the trial, believes that the study holds immense promise for the device's future success. "Many of our patients experienced moderate to significant tightening of the jawline and neck, and their satisfaction levels were high," he notes.
Dr. Jason Pozner, a dermatologist based in Boca Raton, Florida, who presented on the device at the American Society of Plastic Surgeons (ASPS) 2019 meeting, agrees: "The trial's outcomes are remarkable for non-surgical skin tightening, but like any new technology, it needs real-world validation."
This is not the first non-surgical skin-tightening device to hit the market. Ultherapy, an FDA-approved, non-invasive procedure for lifting and firming the neck, chin, and brow, also employs ultrasound technology to enhance skin appearance. Ultherapy's ultrasound technology penetrates three distinct depths: 1.5 mm, 3 mm, and 4.5 mm, addressing both the skin and deeper tissue layers. According to the brand, Ultherapy is the only technology capable of non-invasive treatment at 4.5 mm, a depth previously attainable only through surgery.
While there are no direct comparative studies between the two devices, doctors highlight several significant differences between the Sofwave System, which treats the entire face and neck, and Ultherapy. Dr. Pozner explains that the device "differs from Ultherapy in that the energy is focused on the mid-dermal layer rather than the deeper layers targeted by Ultherapy." Although the company remains somewhat reserved about the technology, Dr. Pozner speculates that Sofwave's focus on the mid-dermal layer could potentially reduce the incidence of certain side effects associated with ultrasound skin tightening. Some patients have reported fat loss following their Ultherapy treatments, and a recent study linked the treatment to "subcutaneous tissue edema with resulting atrophy," which refers to swelling and subsequent shrinkage of soft tissue. Given its recent introduction to the market, potential side effects of Sofwave have not yet been extensively documented or studied.
Dr. Pozner also emphasizes that Sofwave utilizes multiple focus points, allowing it to cover a larger area simultaneously, whereas Ultherapy creates a single focal point to direct its energy to one specific area.
Louis Scafuri, the CEO of Sofwave Medical, views the FDA clearance for Sofwave technology as "a pivotal milestone for the company," adding that the new technology "targets a growing demographic of patients looking to reduce their wrinkles and facial lines without resorting to surgery." Sofwave Medical Ltd., which recently secured $8.4 million in funding, plans to use the proceeds to commercialize its proprietary skin-tightening technology in the coming months. The device is expected to be available in the United States by the end of 2024.
