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By Linda W. Lewis

In September 2011 the United States Food and Drug Administration cleared ZELTIQ’s CoolSculpting (www.coolsculpting.com) cryolipolysis device for fat reduction. Now another device using cryo energy is awaiting FDA approval—cold-induced neuromodulation. Billed as a toxin-free alternative to botulinum toxin injections, it is used to treat unwanted dynamic lines and wrinkles in the face. The technology employed in cryoneuromodulation was developed at Massachusetts General Hospital and Harvard Medical School before being purchased by Boston Scientific in 2005. A new company, MyoScience (www.myoscience.com), was formed to develop the technology for the aesthetic market.
Cold has been used for decades to safely deaden nerves for pain relief and more recently to treat heart arrhythmias. This self-contained technology employs a hand-held cryoprobe needle that produces controlled subcutaneous cooling. The probe freezes the nerve, interrupting neural signals and allowing the facial muscles that cause dynamic wrinkles to relax. Patients require local anesthesia for the 15-minute procedure. The single-use probes are then discarded.
In April, Vic Narurkar, MD, founder of the Bay Area Laser Institute in San Francisco, and Francis Palmer, MD, founder of the Beverly Hills International Center for Aesthetic Surgery and consulting medical director of MyoScience, presented a pilot study of the new technology at the 31st Annual Conference of the American Society for Laser Medicine and Surgery (ASLMS). All 31 of the patients in the study were treated for forehead lines and all experienced dynamic line reduction after two to eight cryoprobe insertions. Although this study was restricted to forehead wrinkles, the technology is expected to be equally effective on other dynamic lines and wrinkles—future studies will test other areas.
“The cold interrupts the nerve signal, immediately relaxing the muscle that is responsible for vertical and horizontal forehead lines,” says Dr. Narurkar. The immediate action means the doctor can see how well the treatment is working during the procedure and patients can see effects even before they leave the office.
Side effects include minor headaches and small focal areas of minor epidermal cold injury, as well as redness at the injection site. The pilot study indicated that cryoneuromodulation has the same clinical efficacy and safety as existing neuromodulators, such as Botox Cosmetic and Dysport. More studies are needed to determine how long the effects will last and to ascertain continued safety.
This new technology comes on the heels of GFX Notox (BioForm Medical, bioform.com), which uses radiofrequency energy to ablate the nerve governing glabellar furrowing. Unlike the Notox procedure—which permanently damages the nerve—cryotherapy merely injures the nerve, producing only a temporary cessation in neural signals. “Current studies indicate that the nerve returns to baseline in three to four months—about the same time it takes for botulinum toxins to wear off,” says Dr. Narurkar.
Once cryoneuromodulation clears the regulatory hurdle, how will it affect aesthetic practices? “It’s too early to speculate,” says Dr. Narurkar, “but my sense is that it will simply expand the market rather than being competitive with Botox and other existing neuromodulators. Some women are reluctant to inject a toxin into their bodies. They are likely to see cryoneuromodulation as a more natural approach.”

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