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 the Sofwave™ 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.

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.