Sofwave™ FAQs

Sofwave™ – the next-generation ultrasound technology from Sofwave™ Medical, an emerging leader in energy-based aesthetic devices, will revolutionize how you think about noninvasive devices. Inconsistent results are a thing of the past with Sofwave™.

What Sets Sofwave™ Apart:
• Simple intuitive treatment protocol with a short learning curve
• Zero downtime and control of treatment comfort with topical only, no post treatment care
• Easy to delegate procedure
• Favorable safety profile – no epidermal damage, nor potential injury to nerves, bones, vessels and fat tissue
• Short treatment visit at the clinic (COVID-19)

Sofwave™ differs in many ways to existing solutions:

Sofwave™ generates fractionated high-intensity, high-frequency ultrasonic pulses which causes controlled thermal damage, by elevating the temperature to 60-70°C in the dermis. Direct contact cooling is used to cool the skin’s surface while sparing the epidermal layer. Sofwave is easy to use, can be used on any skin type and performed any time of the year.

It is all in the numbers. It is well known that at least 25% of the tissue (fractional coagulation coverage) must be regenerated to result in a real change in skin elasticity. In a single, double pass treatment, or in a series of 2 (two) Sofwave™ treatments, that threshold is easily reached.

Sofwave’s™ Synchronous Ultrasound Parallel Beam Technology SUPERB™ uses 7 synchronous beams of ultrasound to heat a significant amount of tissue quickly. Sofwave incorporates 7 transducers which operate simultaneously to deliver high energy, enabling a large fractional coverage effect in the mid dermis. These transducers create a volumetric directional thermal impact in the mid-dermis parallel to the skin and to the inherent vectors of skin elasticity. The direct coupling of the transducers to the skin enables precise energy delivery into the dermis with no epidermal damage.

Sofwave™ Synchronous Ultrasound Parallel Beam Technology SUPERB™ is a next generation ultrasound device intended to treat fine lines and wrinkles. Using a breakthrough patented technology that generates a Synchronous Ultrasound Parallel Beams, the device emits a high intensity, high frequency, parallel ultrasound beam array through seven ultrasound transducers that are in direct contact with the skin.

Treatment of sagging skin is optimized when the thermal effect is localized in the mid-dermis. The high frequency, parallel beams of Sofwave, enable most of the thermal effect to remain localized between 0.5 and 2mm within the dermis, with the center of the treatment effect in the depth of 1.5mm. The unique low divergence, high intensity beam eliminates the need for the beam to be focused, and the ultrasonic energy dissipates rapidly beyond a depth of 2mm, thus leaving the underlying deep dermal, hypodermal, nerve and bony structures unaffected. Another unique feature of Sofwave is the unique SofCool™ technology.

Each transducer is individually cooled and in direct contact with the epidermis during treatment. This ensures a uniform effect in the tissue and repeatable, controllable energy deposition in the skin without damaging the epidermal (outer) skin.

Control on power and energy delivery with Sofwave™ transducers is achieved since the transducer is in direct contact with the skin which enables us to measure the energy delivered to the skin by measuring the incident, reflected and absorbed energy in the dermis. This feature ensures full energy delivery into the dermis.

Sofwave™ presents a strong business opportunity. The system is simple to operate and extremely intuitive which makes it completely delegate-able to the staff. There are no disposable transducers involved. Sofwave delivers a fast treatment because there are multiple transducers simultaneously delivering energy and the spot size is large – 35mm2. A full face takes approximately 30-45 minutes to treat. In addition, Sofwave™ can treat all skin types and Sofwave™ clinical trial has shown high patient response (data on file).

As the Sofwave™ parallel beams propagate through the tissue, an array of volumetric cylindrical shaped (3D) thermal zones are created, thereby creating a fractional Volumetric and Directional (parallel to the skin) Thermal Impact (VDTI) in the mid dermis. The controlled thermal impact is created at a depth of 1.5mm in the mid-dermis. The maximal thermal effect achieved in the dermis is between 60-70˚C which is the optimal temperature range for the breakdown of collagen and elastin fibers. This thermal process stimulates an inflammatory wound healing response contraction and subsequent remodeling of the collagen (neocollagenesis) and elastin (elastinogenesis), thereby reducing facial lines and wrinkles.

Sofwave™ has an FDA clearance for treating fine lines and wrinkles and has been proven to be effective and safe in a blinded-controlled clinical study by leading US dermatologists. A 60 patient multi-center clinical study evaluated the clinical effects of Sofwave’s™ Synchronous Ultrasound Parallel Beam Technology SUPERB™ on facial wrinkles. Patients with mild to moderate facial wrinkles were enrolled in the study and overall, 295 areas were treated. At 3 months, most patients were marked as improved to very much improved per the Global Aesthetic Improvement Scale (GAIS following a single treatment session only.). 72% of the subjects were satisfied with their results and rated them as improved to very much improved on the GAIS.

The safety profile was strong:

• No bruising, ulceration, or skin pigmentation were reported in clinical testing.
• No device-related adverse events were observed in the clinical study.
• No penetration of the skin is required.
• None of the patients experienced persistent pain or tenderness that would delay a return to normal activities.

As the ultrasound energy is delivered, patients may feel the warmness of the skin. Patient discomfort can be usually managed by applying a topical anesthetic cream just before the treatment. Following treatment, there are no sensations and there is no need to apply special care to the skin. A patient may resume their daily care quickly post treatment.

Clinical data supports the efficacy of a single treatment session. Ongoing studies are investigating the need for more than one treatment session in different patients based on their degree of wrinkling. During a single treatment, it is recommended to perform a double pass, using approximately 180-220 pulses. The treatment time may vary, depending on the needed treatment areas but a full face will typically take around 30-40 minutes.

Regarding sensitivity to skin inhomogeneity unlike other energy-based devices we do not need to focus the energy or adjust to skin impedance variability to create the high-power density. The high-power density is created on the transducer plane and there is no need to focus it since our beam is a parallel beam which is much less sensitive to scattering by skin inhomogeneity.

Sofwave™ Medical provides depot and loaner service support for its products.  A toll-free technical support phone line is provided to directly assist and facilitate customer support.

Sofwave™ devices employ proprietary design and components. To ensure the functionality of
our devices within the manufacturer’s specifications and to resume the proprietary pulse
program e-store access, we reserve the right of reinspection for any used device resold by the
original purchaser.
The fee schedule for this reinspection and certification is as follows:

1. Console inspection and assessment: $2995
2. Applicator inspection and assessment: $750
3. Shipping and handling: $1,500 each way
4. Extended Warranty: $11,995. Please note that the purchase of an Extended Warranty is
   required in the case of the resale of the unit from the original owner to the new purchaser to
   enable the pulse purchase license.