Novaestiq Corp., a growth-oriented aesthetic company that focuses on delivering intelligent and innovative skin solutions to practices and patients announced that earlier this year its partner Croma-Pharma GmbH finalized submission of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the saypha® MagIQ™ hyaluronic acid dermal filler. Novaestiq plans to commercialize saypha® MagIQ™ beginning in early 2025.
“We are delighted that our partner Croma has submitted this first filler product to the FDA,” said Miles Harrison, Chief Executive Officer, Novaestiq. “The submission is a foundational milestone for Novaestiq and supports our effort to create the next great aesthetic company. We look forward to continued collaboration with our partners at Croma as we drive our “Aesthetics for All™” ethos.”
The PMA application includes results from the U.S. pivotal study, which evaluated the safety and effectiveness of the products in a multicenter, blinded, split face, controlled, non-inferiority designed trial. Patients were followed for 12 months from initial treatment. A total of 270 patients were enrolled and received saypha® MagIQ™ in one NLF and Juvederm® Ultra XC in the contralateral NLF. saypha® MagIQ™ met the primary endpoint at 24 weeks. Additional information will be shared at upcoming medical conferences.
saypha® MagIQ™ has 8+ years of global experience and is manufactured by Croma in Leobendorf, Austria. More than 22 million syringes have been manufactured from the saypha® product line demonstrating high quality, a proven safety profile, and consistent performance in over 80 markets around the world. Novaestiq anticipates that their partner Croma will be submitting a second filler product for approval early in 2025.
