Sofwave is a highly effective treatment that delivers visible results without the pain and recovery (downtime) of more invasive treatments.
We’ve put together some commonly asked questions to give you more information about Sofwave technology. If you have a question that you can’t find the answer to, please contact us, and we will answer you shortly.
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- How does Sofwave fit into my practice?Your patients want the best treatments to address their needs and help them look and feel their best at all times. As we age, we all experience wrinkles, sagging, and poor-quality skin especially on the face and neck. In fact, to reverse the effects of aging is the most desired aesthetic treatment after hair removal. No previous technology has fixed in a satisfactory way the sagging and crepiness that patients hate, especially in the neck. Sofwave is the solution your patients are seeking.
- How is Sofwave better than other existing modalities?Sofwave differs in many ways in comparison to existing solutions:The problem with all technologies that try to tighten skin is the epidermis gets in the way. Whether it is lasers that directly injure the skin, microneedling and RF microneedling that puncture the epidermis, or bulk heating technologies that overheat the epidermis, they just cannot get enough heat into the mid-dermis to make a difference without damaging the epidermis.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.
- Every company says their technology tightens skin. Why should I believe Sofwave will be different?It’s all in the numbers. Sofwave can heat up to 14 % of dermal volume in one single pass. It’s well known that at least 25% of the tissue must be regenerated to result in a real change in skin elasticity. In a single, double pass treatment, or in a series of 2 Sofwave treatments, that threshold is easily reached.
- How does Sofwave technology differ from existing Ultrasound technologies?It’s faster and more effective. Sofwave’s proprietary Intense Ultrasound Beam coagulates more tissue, more quickly and at the ideal depth to create a significant clinical effect in half the time. A quicker treatment is more comfortable for the patient, easier and more cost-effective for the practice. And while depositing more energy faster, the epidermis is completely protected with cooling.The first-generation Ultrasound device, HIFU (High Intensity Focused Ultrasound) which has captured momentum over the past few years, has shown medium efficacy, requires a long learning curve for administering treatment and has produced inconsistent results. In addition, HIFU has been associated with multiple drawbacks, among them, limited treatment areas, a complex treatment protocol, excessive pain and additional adverse effects, such as burns and injury to nerves.
- How can it work so quickly?Sofwave’s unique technology uses a broad beam of ultrasound to heat a significant amount of tissue quickly.Sofwave incorporates 7 transducers which operate simultaneously, 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.
- How does Sofwave work?Sofwave is a next generation ultrasound device intended to treat fine lines and wrinkles. Using a breakthrough patented technology that generates an Intense Ultrasound Beam™ (IUB), the device emits a high intensity, high frequency, parallel ultrasound beam array through seven ultrasound transducers which 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 the majority 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.The parallel delivery of Sofwave ultrasound beams and the large contact area allow for low sensitivity to tissue inhomogeneity. This ensures a uniform effect in the tissue and a repeatable, controllable energy deposition in the skin.Competing Ultrasound technologies run the risk of causing significant skin laxity due to targeting depth well below the dermis and damage in the sub-cutaneous fat layers (fat atrophy).
- What are the exact feedback mechanisms controlling consistent energy delivery and deposition and ensuring reliable thermal effects?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. This cannot be done with HIFU because you cannot contact the skin directly and there is a need for intermediate area to create the focusing effect. Accordingly, measuring the injected energy when using HIFU is not accurate since this is energy injected to the coupling fluid in the transducer which is not the same as the energy injected into the skin
- Is there any risk of epidermal injury?No, Sofwave is a non-invasive, no down time treatment. Patient comfort is simply controlled by the application of high percentage topical anesthetic just prior to the treatment. Further, there is no pain or recovery period post treatment after treatment.The device incorporates integrated cooling within the transducers. This cooling mechanism not only protects the epidermis and provides optimal pain management, it also ensures accurate targeting of the thermal effect.Sofwave also incorporates a real time skin temperature monitoring mechanism which measures skin temperature, ultrasound coupling efficiency and energy deposition into the skin.
- Is the treatment safe for all skin types?YES. Ultrasound absorption is determined by the microscopic and bulk mechanical properties of tissue and is independent of skin color or pigmentation.
- What is the Sofwave’s FDA clearance?The Sofwave device is indicated for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles
- From a business perspective, how does Sofwave compare to other existing modalities?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 consumables involved.Sofwave delivers a fast treatment because there are multiple transducers and the spot size is large - 35mm2. A full face and neck take approximately 30-40 minutes to treat.In addition, Sofwave can treat all skin types and clinical trials have shown high patient satisfaction (data on file).Competing technologies have a longer and complicated treatment protocol (prep time and treatment time); and the complex protocol usually requires a physician to perform the procedure.
- What is Sofwave’s unique Mode of Action?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, an ideal depth for the treatment of fine lines and wrinkles. 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 (elastogenesis), thereby improving skin laxity and reducing facial lines and wrinkles.
- What proof do you have that it works?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 ultrasound technology on facial wrinkles and neck lines. Patients with mild to moderate facial wrinkles were enrolled in the study and overall, 295 areas were treated. At 3 months, physicians rated 88% of the patients to be improved to very much improved on the Global Aesthetic Improvement Scale (GAIS). 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 excellent with no adverse events reported.
- Is the Sofwave treatment painful?Based on the clinical data gathered thus far, it is clear that the Sofwave treatment is comfortable when applying a high percentage topical anesthetic prior to the treatment. There is no pain following the treatment and patients can resume their daily facial care regimen immediately post treatment.
- What is the treatment protocol?Clinical data supports the efficacy of a single treatment session. Ongoing studies are investigating the need of more than one treatment session in different patients based on their degree of wrinkling and laxity.During a single treatment, it is recommended to perform a double pass, using approximately 200-300 pulses. The treatment time may vary, depending on the needed treatment areas but a full face will typically take around 30-40 minutes.
- How do you ensure that Sofwave is properly calibrated for power deposition?Regarding sensitivity to skin inhomogeneity unlike HIFU we don’t need to focus the energy 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 compared to a beam that needs to be focused.
- How are pulses recharged and what does each pulse cost?Pulses can be recharged via our eStore on our website. This eStore provides an easy, straightforward way to download and recharge pulses to ensure treatment continuity. All that’s needed is a PC connected to the internet, the Sofwave device’ hand-piece serial numbers and a credit card. Once connected to our estore, you or your staff simply complete the order form, complete the transaction, download the pulses to a memory stick and insert the memory stick into the Sofwave console.
- What is the Service policy?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
- Can fillers be used with a Sofwave treatment?Yes, a filler can be applied up to 48 hours before or 48 hours after treatment.