Next-Gen Ultrasound Technology

When high intensity focused ultrasound energy (Ultherapy, Merz) was first FDA approved for skin lifting and tightening, it was hailed for the nonsurgical facelifting results it can deliver. But it also likely had your patients silently chanting, ‘no pain, no gain’ throughout the course of treatment.

Today, there’s a new kid on the block with similar ultrasound technology that delivers something patients appreciate: Comfort. Intense Ultrasound Beam (IUB) technology (Sofwave, Sofwave Medical) puts energy into the mid dermis using seven high-power transducers at a 1.5-mm depth. And that’s the key difference, according to Jason Pozner, M.D., a plastic surgeon in Boca Raton, Fla.

“Because all the energy is put down to 1.5 mm… it's a very comfortable procedure for the patient. There's no epidermal injury and there's zero downtime,” says Dr. Pozner.

Additionally, he points out that it has active cooling in the handpiece and does not require visualization as Ulthera has, which Dr. Pozner says they have never used in his practice.

Notably, the Sofwave device has FDA 510(k) clearance as a non-invasive aesthetic treatment to improve facial lines and wrinkles. Ultherapy, however, is FDA-cleared for skin lifting and tightening.

A Question of Skin Thickness

According to Dr. Pozner, who was involved in developing some of the initial Ultherapy protocols, the procedural-related pain is the result of the HIFU energy going too deeply below the skin.

“That was a high-intensity focal point focused to 1.53 or 4.5 mm… If your skin is 2 mm and you put down a pulse that's 4.5 mm, you're through the skin and into the fat, fascia and potentially muscle,” he says.

With the IUB device, energy ranges from 3 J to 5 J at a depth of 1.5 mm.

“That is it,” says Dr. Pozner. “Five is a little spicy. Three, you can’t feel at all. So this is a very different procedure than previous microfocus ultrasound devices because this is a very tolerable procedure.”

How It Works

IUB technology is an ultrasound beam that creates injury, or burn zones in dermis, without epidermal injury or going into the fat. The result, says Dr. Pozner, is volumetric and directional thermal coagulation.

“By heating the collagen to 60 to 70 degrees — and this is optimal, 1.5-mm depth and multiple passes that give you this high coverage range. That's the secret to success.”

And it’s because of the 1.5-mm depth that there's no damage to fat or underlying structures such as nerves because most of these are located below 2 mm.

The Treatment Process

Dr. Pozner’s current pretreatment approach includes removing the patient’s makeup and applying a long-acting numbing cream. Next, he sets the device parameters and applies the ultrasound gel.

Despite the benefits offered by additional cooling with his Zimmer Cooler, Dr. Pozner says he is currently opting for the numbing cream as part of his plans to conduct future studies to evaluate outcome and burn zone effects.

The procedure takes Dr. Pozner 25 to 30 minutes for full face, neck and forehead.

“Certainly, if you add more passes, it's going to take a little bit longer, but like I like the 30-minute procedure.”

Dr. Pozner’s current regimen is a total of 80 pulses to the cheek (2 passes per cheek, 20 in two different directions) and neck and between 30 and 40 on the forehead.

“We're trying to see what that does before we proceed to different settings,” he says.

With other devices, it’s important to avoid treating the thyroid area, but that’s not the case with IUB technology.

“I've never seen anyone whose skin is thinner than 1.5 mm, so all the [IUB] energy is in the skin. You're not worried about thyroid placement or nerve injury with this device.”

Furthermore, “There’s no post-treatment care, as it doesn’t break the skin. You can work out the same day. You can take a shower. You can resume normal activities immediately after the treatment,” he says.

Patient and Practice Considerations

Dr. Pozner says, in general, the Sofwave device is for those patients in their fourth to sixth decades, though there are exceptions.

“You can have older patients who are good candidates. I think of this as [for] your 35 to 55 [year old patients], who have pretty good skin who just want some tightening,” he says. “…there are certainly some older patients who are good candidates for this, but those are patients who are in pretty good shape.”

Dr. Pozer’s suggested protocol is 1 to 2 treatments with 30 days between treatment. He says the ROI is good at a little over 10%, and that more than 2 treatments in a series isn’t practical. 

“For $2,000 a pop they're probably not going to do series of threes. I think that's going to be cost prohibitive,” he says.