The only filler utilizing Cold-X technology is looking to add another member to its roster of treatments. Hoping to join the hyaluronic acid fillers Evolysse Form and Evolysse Smooth, Evolus has submitted its latest innovation, Evolysse Sculpt for Food and Drug Administration approval.
You may be familiar with Evolus, or at least its popular neurotoxin, Jeuveau, which received FDA approval in 2019 for the temporary treatment of moderate to severe glabellar lines. In February, Form and Smooth received FDA approval for treatment of nasolabial folds. Both use near-freezing temperatures to preserve the structure of hyaluronic acid, an approach that allows for more natural and longer-lasting results.
Its latest innovation, Sculpt, also utilizes Cold-X, and is designed to treat volume loss.
“This submission represents an important milestone in expanding our Evolysse collection of injectable HA gels,” said Rui Avelar, MD, chief medical officer and head of research and development at Evolus. “Sculpt is our most structured product, manufactured using a novel technology and designed to address midface volume loss, a high-value segment in facial aesthetics.”
The application for FDA approval is supported by a study comparing Sculpt to Restylane Lyft, with results evaluated at 24 months. With approval expected in the second half of 2026, Sculpt would join a small collection of products indicated for volume loss in the midface.
