1st submission in the United States for saypha® line of dermal fillers represents a key Novaestiq milestone
The submission is a foundational milestone for Novaestiq and supports our effort to create the next great aesthetic company— Miles Harrison, CEO
SOUTHLAKE, TX, UNITED STATES, August 21, 2024 /
EINPresswire.com/ -- Novaestiq Corp., a growth-oriented aesthetic company that focuses on delivering intelligent and innovative skin solutions to practices and patients announced today 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.
About Novaestiq
Novaestiq is a private, growth-oriented company that boasts a broad range of aesthetic and dermatology products that are both practice and patient/consumer focused. Novaestiq is poised to bring a variety of intelligent and innovative skin solutions to the market in the coming months and years. With a strong emphasis on driving practice success, Novaestiq is set to redefine industry standards.
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Drew Fine, Chief Commercial Officer. Email: drew@novaestiq.com
Media Relations Novaestiq Corp. Email: inquiries@novaestiq.com
Drew Fine
Novaestiq
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