Novaestiq Announces Positive Data from Pivotal Trial for saypha® MagIQ™ Injectable Hyaluronic Acid (HA) Gel

saypha MagIQ is currently in the FDA approval process

SOUTHLAKE, TX, UNITED STATES, May 16, 2025 /EINPresswire.com/ -- • saypha^® MagIQ™ met the primary and key secondary endpoints of non-inferiority to Juvéderm^® Ultra XC at 24 weeks, with slightly higher responder rates observed through 48 weeks for secondary endpoints.
• With 270 subjects, the study is more than double the size of typical NLF studies and includes the largest number of subjects in Fitzpatrick I, V, and VI skin types for a pivotal NLF study, demonstrating broad utility across all skin types.
• The safety profiles were similar between saypha MagIQ and Juvéderm Ultra XC

Novaestiq Corp., a growth-oriented aesthetic company that focuses on delivering intelligent and innovative skin solutions to practices and patients, announced today positive topline results from a U.S. pivotal nasolabial fold (NLF) study of saypha MagIQ injectable HA gel. Data will be presented at the 2025 SCALE Meeting on May 16, 2025, in Nashville.

“New products with proven quality, a well-established safety profile, and high patient satisfaction are critical to expanding the aesthetic injectable market,” said Drew Fine, Chief Commercial Officer at Novaestiq. “The results from the largest pivotal NLF study, including the highest number of subjects in Fitzpatrick I, V, and VI categories, underscore the broad potential benefits that saypha MagIQ could deliver to U.S. practices and patients.”

saypha MagIQ, manufactured by Croma-Pharma in Leobendorf, Austria, utilizes proprietary MACRO Core Technology to create a stable 3D hyaluronic acid (HA) matrix. This differentiated injectable HA gel offers category-leading consistency and amount of HA delivered per syringe.

“These data reinforce our ‘Aesthetics for All™’ ethos,” said Miles Harrison, Chief Executive Officer of Novaestiq. “This robust clinical trial instills confidence in the safety and efficacy of saypha MagIQ across all skin types and supports our efforts to advance our commercialization strategy.”

saypha MagIQ is available in over 80 countries, and Croma-Pharma has manufactured more than 110 million HA syringes in Austria. saypha MagIQ was the first dermal filler approved for aesthetic use under European MDR regulations.

“As an investigator in this pivotal trial, I had firsthand experience in treating patients with the proven saypha MagIQ that is manufactured using Croma’s MACRO Core Technology process,” said Dr. Ava Shamban, MD. “Clinically, I found the product to be smooth and consistent upon injection while providing high levels of patient satisfaction similar to other published data from non-US trials. I look forward to offering it to my patients after FDA approval.”

Study Design
The U.S. NLF pivotal study was a randomized, subject- and evaluating investigator-blinded, active treatment controlled, non-inferiority, multicenter, paired (split-face) study. Patients were followed for 48 weeks from initial treatment. A total of 270 patients were enrolled and randomized to receive saypha™ MagIQ in one NLF and Juvéderm^® Ultra XC in the contralateral NLF.

The 24-week primary endpoint measured the change in NLF severity from baseline and was assessed through a live evaluation by a blinded independent investigator using a validated 5-point nasolabial scale.

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. www.novaestiq.com

For media inquiries or further information, please contact:
Drew Fine, Chief Commercial Officer. Email: drew@novaestiq.com
Media Relations Novaestiq Corp. Email: inquiries@novaestiq.com

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