Novaestiq’s Partner Croma-Pharma Submits Final Application for Hyaluronic Acid Dermal Filler

Novaestiq Corp., an aesthetic company that focuses on delivering intelligent and innovative skin solutions to practices and patients, announced its partner Croma-Pharma GmbH finalized the submission of its premarket approval to the US Food and Drug Administration (FDA) for the saypha MagIQ hyaluronic acid dermal filler earlier this year. Novaestiq plans to commercialize saypha MagIQ in early 2025. 

“We are delighted that our partner Croma has submitted this first filler product to the FDA,” said Miles Harrison, CEO of 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 a study that evaluated the safety and effectiveness of the products in a multicenter, blinded, spilt face, controlled, non-inferiority designed trial. 

A total of 270 patients were follow for 12 months from the initial treatment. They 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. 

More information will be shared at upcoming medical conferences.