Sofwave’s next-generation ultrasound device proves to be a true game changer in the aesthetic market 

wendy lewis is  President of
Wendy Lewis & Co Ltd, Global
Aesthetics Consultancy, author
of 12 books, and Founder/
Editor-in-Chief of www.
beautyinthebag.com. Her newest book is 
Aesthetic Clinic Marketing in the Digital Age 
(CRC Press 2018)
contact [email protected]

Ultrasound-based energy devices have long been a
staple in the popular minimally invasive skin rejuvenation vertical. Next-generation devices such as Sofwave maximise the aesthetic benefits and outcomes that can be achieved with ultrasound technology while minimising any potential downsides.

Driven by the desire for visible results with less downtime, this already-booming market is expected to grow by $996.64 million from 2020 to 2024, according to the latest report from ResearchAndMarkets.com1.

Sofwave employs Synchronous Ultrasound Parallel Beam SUPERB™ Technology, which is delivered via seven cooled transducers directly coupled to the epidermis, enabling full protection of the epidermal layer and precise targeting of mid-dermal tissue in a safe manner.

Innovated by globally-recognised experts, the Sofwave system scored 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2019 for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles. In September 2020, Sofwave secured a CE Mark (Conformité Européenne) for their technology, which was approved for use for the treatment of fine lines and wrinkles in the EU. 

According to New York City dermatologist Anne Chapas, M.D. of Union Square Laser Dermatology, ‘Sofwave is a new and comfortable ultrasound system for treating the face and neck. We can heat and tighten more of the tissue area quickly and we get results in only one session. Another plus is that it doesn’t require pain medication and there is no recovery time which our patients appreciate.’

Sofwave’s sweet spot

Using seven synchronous ultrasound transducers with no moving parts or optics to deliver high-frequency energy simultaneously, Sofwave creates a 3D-volumetric coagulation zone parallel to the direction of collagen fibres at the ideal depth of 1.5 mm (mid-dermis) to improve skin elastosis and wrinkling.

According to San Diego, CA dermatologist Arisa Ortiz. ‘The impacted treatment zones stimulate neo-collagenesis, which increases and regenerates the collagen in the skin, leading to the reduction in fine lines and wrinkles and improvements in tightening.’ 

In company-sponsored studies, fully 88% of patients who underwent one 30–45-minute Sofwave treatment on facial wrinkles and necklines were marked as improved or significantly improved at 12 weeks2.

First, do no harm

Sofwave comprises an integrated direct contact transducer cooling mechanism for optimal epidermal protection and accurate targeting of the thermal effect. 

Sofcool™ offers patients comfort and protects the epidermis. Patient comfort is a key factor in generating word-of-mouth referrals. ‘Most patients are comfortable during treatment simply by utilising a topical anaesthetic immediately prior to treatment,’ says Dr. Virginia Benitez Roig, an aesthetic doctor practising in Marbella, Spain. ‘Although visible results can be achieved with one Sofwave session, some patients may need additional treatments. The ability to manage patient discomfort with a topical anaesthetic as well as no downtime encourages patients to come back if needed’, she says.

Figure 1 (A) Before and (B) 3 month follow up from a single Sofwave treatment. Courtesy of Arielle Kauvar, MD
Figure 2 (A) Before and (B) follow up results from a single Sofwave treatment. Courtesy of
Dr. Virginia Benitez Roig

Rising above the competition

The synchronous parallel delivery of ultrasound beams and large contact area allows for fast treatment times (30–45 minutes full face and neck) and also ensures repeatable and controllable energy deposition in the skin. Sofwave’s unique technology generates heat at this exact depth in the mid-dermis, ensuring no damage to the underlying structures: bones, facial nerves, facial fat, and blood vessels. 

According to Professor Eyal Gur, MD, Director of the Department of Reconstructive and Aesthetic Surgery at the Tel Aviv Sourasky Medical Center, ‘The device meets an unmet need among patients looking for a non-invasive, fast procedure that addresses the face and neck ageing. The Sofwave treatment has shorter treatment sessions and the results I’ve observed are pretty impressive. I truly believe that we are introducing something that is effective for people that want to rejuvenate the skin.’ 

Sofwave offers some key advantages over other energy-based skin rejuvenation technologies. The gold standard for energy-based skin rejuvenation was ablative technology, but the downtime and risks associated with these laser technologies prevented widespread adoption and patient acceptance. Moreover, these technologies can be too aggressive for younger millennials or ‘prejuvenation’ patients who present with significantly less photodamage, a population that makes up a growing share of the aesthetic customer base. Fully 73% of American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) members believe that there will be an even greater emphasis on earlier maintenance for patients starting in their 20s and 30s who wish to forestall bigger procedures and surgery for longer3.

Sofwave fills this gap, and laser skin resurfacing is not safe for use on all skin types. By contrast, Sofwave can be used to treat all skin types. 

‘Ultrasound absorption is determined by the microscopic and bulk mechanical properties of tissue and is independent of skin colour or pigmentation,’ says Dr. Ruthie Amir, SofWave’s Chief Medical Officer. This means there are no limitations on skin type, gender or age for patients 22 and older with the technology.

Sofwave provides more consistent results due to the higher levels of delivered energy precisely to target independent of patient impedance variations, which radiofrequency devices must work around. Additionally, RF Microneedle devices also involve the use of needles which can cause significant injury to the epidermis, and adds post-procedural downtime, according to Dr. Amir.  

Sofwave is needle-free and requires no pre- or post-treatment care. 

The technology also confers substantial volumetric impact on collagen, creating a significant fractional Volumetric and Directional Thermal Impact (VDTITM). ‘The high-frequency ultrasound beams circulate through the tissue and create an array of volumetric cylindrical-shaped 3D thermal zones in the dermis separated by regions of undamaged tissue, thereby creating a fractional effect in the mid dermis’, explains Dr. Amir.

Maximum ROI

Sofwave empowers physicians to succeed through a high-touch approach, dedicated expert team, and innovative best-in-class technology. Sofwave eliminates the need for a practice to stock and maintain inventories of expensive disposables. An Advanced eStore allows physicians to buy pulses online and get the device up and running right away to treat patients. 

According to Facial Plastic Surgeon Jason Bloom, MD, FACS in Bryn Mawr, PA, ‘I added this device to my practice early on because it offers painless, non-invasive, skin tightening for my patients in a single 30–40 minute treatment that my extenders can safely perform. The financials behind this device also make sense for my practice. The average disposable costs are about $250–300 USD per treatment, which allows us to charge somewhere between $1,800–2,500 USD per treatment. That cost range is affordable for most patients, even if we repeat the treatment for maintenance every eight to 12 months. The device pays for itself in about 40 treatments.’

Aesthetic medicine in the era of Covid-19

The Covid-19 pandemic continues to upend everything about daily life, including aesthetics and the practice of medicine. Many practices were forced to shut their doors for weeks to months due to widespread shelter-in-place mandates. 

Because it is non-invasive with no epidermal disruption, no aerosol during treatment and no post-procedure wound treatment infection risks, Sofwave is a good fit for this period. In addition, the short treatment time allows patients to be in and out of the office quicker, which goes a long way toward assuaging anxiety and helps the practice follow social distancing guidelines.

To help providers get up and running quickly, Sofwave created the THRIVE programme which varies by country. This programme also gives new providers the ability to preserve cash while reopening their practice with leasing options available and payments starting in 2021 to restore cash flow for day-to-day business expenses, business expansions and growth.

According to Beverly Hills, CA plastic surgeon Gregory Mueller, ‘Adding Sofwave to your practice makes sense as a good investment that has been shown to add profitability. This technology can help you satisfy existing patients and attract new ones, even in the era of Covid-19.’

References

  1. Researchandmarket.com. Global Energy-Based Aesthetic Devices Market 2020-2024. July 2020. Available at: https://www.researchandmarkets.com/reports/5135067/global-energy-based-aesthetic-devices-market-2020?utm_source=BW&utm_medium=PressRelease&utm_code=w5tbv2&utm_campaign=1424421+-+Global+Energy-Based+Aesthetic+Devices+Market+Report+2020-2024&utm_exec=joca220prd [Last accessed 25 November 2020] 
  2. Amir R. A novel approach to treating wrinkles and laxity of the face and neck using Intense Ultrasound Beam. Sofwave white paper, 2020. Available at: https://dist.sofwave.com/2020/07/Sofwave-White-Paper_PB00030-3.pdf [Last accessed 25 November 2020]
  3. American Academy of Facial Plastic and Reconstructive Surgery. AAFPRS annual survey reveals face of plastic surgery goes younger. AAFPRS Press release, February 2020. Available at: https://www.aafprs.org/Media/Press_Releases/New%20Stats%20AAFPRS%20Annual%20Survey.aspx?WebsiteKey=5d3e122f-6cba-47ca-a903-c75cb1c94f61 [Last accessed 25 November 2020]