Sponsored by Sofwave Medical Ltd.
Whether it manifests from old age, rapid weight loss or some other cause, tissue laxity is a top aesthetic concern. With the rise of weight loss drugs like glucagon-like peptide 1 agonists (GLP-1)1, and the resultant media hype surrounding the tissue laxity issues that stem from rapid fat loss, the call for non-invasive tissue laxity therapies is skyrocketing.
“There is no question about increasing demand, and there is a large void in this space,” said Roy Geronemus, MD, director of the Laser & Skin Surgery Center of New York (New York City, 
N.Y.). “The demand is increasing because the number of people that have lost weight has increased dramatically with the GLP-1 drugs. Most current alternatives that provide meaningful improvement are surgical, which leave unsightly scars in almost all patients. So, many people refuse to consider those options, especially in the upper arm.”
Sofwave™ from Sofwave Medical Ltd. (San Clemente, Calif.) is a novel non-invasive ultrasound (US)-based modality designed specifically for tissue contraction. It boasts a growing list of FDA clearances including wrinkle improvement, eyebrow lifting, lax submental and neck lifting, short-term improvement in the appearance of cellulite, improvement in the appearance of acne scars, and most recently, improvement in upper arm skin laxity.2 Sofwave’s synchronous ultrasound parallel beam (SUPERB™) technology features an innovative and patented approach to induce collagen denaturation, which in turn promotes new collagen, elastin and hyaluronic acid (HA) production without compromising the epidermal barrier.
“For skin tightening, surgery obviously provides the best results,” mentioned Eric Bernstein, MD, founder of Main Line Center for Laser Surgery (Ardmore, Pa.). “However, for every patient willing to undergo the costs, risks and downtime, there are thousands who would pursue a nonsurgical option. And the kind of laxity examined in this study, especially in a challenging-to-treat region such as the upper arm, is very difficult to treat and surgery in this area leaves significant scars. So, for every person that chooses surgery, there are thousands that will readily try a non-invasive treatment.”
SUPERB technology features multiple synchronous US transducers to deliver a fractional and controlled thermal effect, targeting 1 mm to 2 mm (centered at 1.5 mm) into the dermis. It delivers high volumetric tissue coverage, raising target tissue to scientifically-determined levels (60° C to 70° C) for a therapeutically relevant length of time, using four to five second pulses. Effects are achievable in a single treatment lasting 30 to 45 minutes, with minimal downtime.
To maximize both safety and optimal energy delivery, Sofwave includes integrated epidermal cooling and real-time skin temperature feedback. Parallel US beams delivered from multiple synchronous transducers causes directional thermal coagulation parallel to the surface of the skin, with a large contact area. This results in low incidence of tissue inhomogeneity and reproducible, controllable energy deposition for all skin types with rapid treatment time. As stated in a 2024 study of Sofwave by Michael Gold, MD and Julie Biron, BSc: “Highintensity, high-frequency, non-focused, parallel ultrasonic waves are generated by seven transducers which propagate into the dermis layer to depths of 0.5 mm to 2 mm and create controlled thermal injury zones at the mid-dermis while preserving and avoiding damage to the epidermis and other skin layers.”3
“Unlike previous US devices, which were associated with significant pain, Sofwave found the sweet spot for thermal injury and depth for ideal tightening with minimal discomfort,” Dr. Geronemus explained. “On the upper arm there is thin, sensitive skin so this is paramount. With the areas where you have more laxity, you are much more likely to get a preferential outcome hitting that sweet spot.” Patients can be treated regardless of age or skin type.
Suzanne Kilmer, MD, founder of the Laser & Skin Surgery Center of Northern California (Sacramento, Calif.), has three devices in her practice and they are always in use. “Patients are always looking for a no-downtime tightening device that works, and if you have that, they are willing to pay for it,” she said. “We have a large practice with at least a few physicians and RNs working at any given time doing different treatments, and Sofwave runs almost all day. It is a robust workhorse platform with no moving parts, it is easy to learn and use, and designed to be safe for delegation to ancillary staff. Demand is high because it is safe and effective non-invasive technology, which any aesthetic practice can use.”
An FDA trial2 that led to Sofwave’s clearance for improvement of the appearance of upper arm laxity was recently completed by dermatologists Amy Forman Taub, MD, founder of Advanced Dermatology and Skincare Boutique (Lincolnshire, Ill.), Dr. Bernstein, Dr. Geronemus and Dr. Kilmer. According to the abstract, the multicenter, prospective, self-controlled clinical study included subjects (n=46) presenting with upper arm laxity of both arms (totaling 92 treated areas). Of these, 45 completed the two-session protocol (one month between visits); 44 completed follow-ups out to three months. Pre- and post-treatment images were randomized for evaluation by three independent masked reviewers not affiliated with the trial. Each was asked to rank the upper inner arm skin using a five-point crepiness/ laxity grading scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=extreme). Objective measurement of circumference and diameter at the maximal skin laxity point were taken for each subject at each visit. Subjects were also asked to rank both their improvement and their perceived discomfort during treatment sessions. Throughout the study, anticipated tissue responses and safety aspects were recorded.
“There are a variety of ways people describe the condition, but the bas
ic setup is that for older women, upper arm skin laxity is a strong concern, especially when they may be going out with short sleeves or no sleeves,” Dr. Taub shared. “That need has been there for quite some time, but whatever we had was very painful and not very effective – hovering around 50% efficacy, at best. With the rise of GLP-1 we have a growing number of people who are experiencing laxity resulting from rapid weight loss, expanding demand considerably. We did two treatments a month apart, with follow-up at three months after the final treatment.”
Results showed that 93% of treated arms exhibited improvement in the appearance of upper arm skin laxity, as per the correct identification of the post-treatment photograph by at least two of the three blinded evaluators. The mean improvement level was 0.98±0.59 units, based on the skin crepiness/laxity grading scale, reflecting an improvement of 31% of t
he grading. Measurements of upper arms’ circumference and diameter at follow-up (three months) demonstrated significant reduction. Circumference of upper arms was significantly improved (mean reduction -7.5±14.2 mm); diameter was significantly improved as well (-4.5±7.4 mm). In subjective assessment, 72% of the subjects reported improvement. No device related adverse events were noted. The most common anticipated tissue responses were erythema and edema, which resolved spontaneously after treatment. Most of the subjects reported levels of pain as ‘none’ to ‘mild’ (mean of 3.6±1.5 on zero to ten subjective pain scale) during treatment and no post-treatment discomfort. Thus, the overall conclusion was that Sofwave SUPERB treatment was demonstrated to safely improve the appearance of lax skin of the upper arms. “Just to avoid confusion – this study was not performed specifically on patients after rapid weight loss with GLP-1,” Dr. Taub added. “That would be a potential avenue for further study.
“On top of the efficacy data, what stands out is the tolerability of Sofwave,” Dr. Taub continued. “I was involved with research using an older technology for upper arms and the difference is profound. You have to understand that what patients want in a non-invasi
ve treatment are safety, results and convenience, but if it is hard to tolerate we will have compliance issues. That means they will not come back, will not get the full result, will not be happy and will not be referring their friends.”
Jordan Wang, MD, medical director of Laser & Skin Surgery Center of Pennsylvania (Devon, Pa.) and medical research director for Laser & Skin Surgery Center of New York (New York, N.Y.), has served as lead author of three published clinical trials4-6 leading to Sofwave clearances. “Sofwave SUPERB energy causes the coagulation, or the heating, of the dermis, with the effect centered at 1.5 mm,” he explained. “So, you are not going too deep and you are not going too superficial. You can get a lot more pain and swelling, as well as tissue necrosis, by going too superficial. Built-in computer algorithms control the heating with real-time temperature feedback. This assures heating to, and maintaining, a set temperature because ‘too high’ will cause more pain, and ‘too low’ lowers the ceiling for outcomes. Also, older treatments were very technique intensive, meaning they were very hard to reproduce. With all the technology incorporated into Sofwave, it is very easy to reproduce and know what you will be getting.”
Another key part of the continuing Sofwave story, according to Dr. Taub, is the proven increase in elastin associated with treatment, especially when considering the issue of laxity due to rapid weight loss. “This device is one of the very few, if not only, tissue tightening devices on the market that have been shown to improve elastin. That is critical because what happens when your skin sags and does not snap back? When you are young you have a lot of elastin, but as we age and elastin (as well as elastin production) decreases, even if you increase collagen you do not restore youthful elasticity. As a result, when my patients come to me and say, ‘Should I wait until I am finished losing weight to seek treatment for laxity?’ I suggest that no, come around the halfway point so that we can start the process of making new collagen and elastin to keep pace with the changes. The farther down the road you go before we begin to address laxity, the harder it will be to try to firm up the area, whatever the area is.”
Return on investment is also a major advantage with Sofwave, according to Dr. Kilmer, for three specific reasons. “At the top, the ‘no downtime’ factor is a huge selling point because if it is safe, effective and has no downtime, patients will si
gn right up. Second, it is an easy procedure to perform and integrate into your office. It is designed to be safe and easy to use. Third, in my opinion, is the high safety profile. We have not had a problem with it, and we are using these all day, every day. Sofwave is always paying for itself.
“What brings things full circle is when patients see their before-and-after pictures,” Dr. Kilmer added. “We are a clinical trial site, so we take top quality pictures, and when patients see them they say, ‘Oh my God, I had no idea,’ because they either forget how they used to look or they do not have a good view of the treated area. It is always good to manage expectations with any treatment, but good pictures will help you harness patient satisfaction.”
Also of high importance, the Company has earned a reputation for integrity and transparency through its commitment to strong science. Physicians are listening and benefiting. “It is exciting to be working with a company that really cares about science and works with you,” Dr. Bernstein said. “They have an incredibly seasoned team behind the device, and a lot of engineering went into it. Sofwave developed a protocol that enables you to deliver energy into the dermis with a reasonably large surface area without a lot of discomfort. That translates into compliance. With older US devices, the pain involved meant that patients might not come back for enough sessions, which is a problem we do not have with Sofwave. In my experience patient satisfaction is very high with proper patient selection, which is important for any therapy. But this is more difficult to achieve with non-invasive technologies, and we will certainly need a device to meet the growing demand we are seeing with the proliferating use of GLP-1 for weight loss.”
“Bear in mind that this is not an anticipated need,” Dr. Wang explained. “We are already seeing this leap in demand within aesthetic medicine. They are getting these weight loss medications from a doctor or medspa, using them successfully, and looking to us for solutions after the fact. This rapidly growing demand is only going to increase.”
References:
- Sauer N, Reining F, Schulze Zur Wiesch C, Burkhardt T, Aberle J. Off-label antiobesity treatment in patients without diabetes with GLP-1 agonists in clinical practice. Horm Metab Res 2015;47(8):560-564.
- Data on file, Sofwave Medical Ltd.
- Gold MH, Biron J. Efficacy and safety of high-intensity, highfrequency, non-focused ultrasound parallel beams for facial skin laxity. J Cosmet Dermatol. 2024 Jan;23(1):117-123.
- Wang JV, Ferzli G, Jeon H, Geronemus RG, Kauvar A. Efficacy and safety of high-intensity, high-frequency, parallel ultrasound beams for fine lines and wrinkles. Dermatol Surg 2021 Dec 1;47(12):1585-1589.
- Wang JV, Bajaj S, Geronemus RG, Kauvar A. High-intensity, high-frequency, parallel ultrasound beams for submental lifting. Dermatol Surg 2023 May 1;49(5):532-534.
- Wang JV, Bajaj S, Kauvar A, Geronemus RG. Eyebrow lifting from high-intensity, high-frequency, parallel ultrasound beams. Dermatol Surg 2023 Jul 1;49(7):718-720.
