Croma-Pharma GmbH Celebrates FDA Approval of Obagi saypha® MagIQ™ for Aesthetic Use in the US
Croma-Pharma GmbH, a prominent global player in minimally invasive aesthetic medicine, has recently announced an exciting milestone: the Food and Drug Administration (FDA) in the United States has granted approval for Obagi saypha® MagIQ™, an innovative hyaluronic acid (HA) injectable gel. This groundbreaking product is notable for being the first intradermal filler available in the Obagi saypha® collection in the American market.
Developed by Croma-Pharma, the product will be imported into the United States by its strategic partner, Waldencast plc, under the Obagi Medical brand. This FDA approval signifies a remarkable achievement in Croma's strategy for global expansion, paving the way for new opportunities in the aesthetic medicine landscape. The commercial launch is anticipated for 2026, marking just the beginning of a broader multi-product rollout in the US market, including other promising innovations like saypha® ChIQ™ and more, pending additional regulatory approvals.
CEO Andreas Prinz expressed immense pride in being able to introduce their HA technology to the US market, emphasizing the collaborative efforts with Waldencast and Obagi Medical. He stated, "This approval fortifies our tradition of scientific excellence and innovation in aesthetic medicine." With over 110 million syringes produced and distribution across more than 80 markets globally, Croma is dedicated to providing effective products that align with the needs of both healthcare professionals and patients.
Obagi saypha® MagIQ™ is backed by pivotal data from a study conducted in the US, which involved 270 patients and demonstrated its non-inferiority against a control product already approved by the FDA. This study met its primary performance criteria while also achieving secondary endpoints that underscore its efficacy and safety profile. Importantly, the trial engaged participants with all Fitzpatrick skin types, further validating the product’s effectiveness across a diverse population.
As Prinz noted, "This FDA approval substantiates the safety and performance of our saypha® filler technology, showcasing our commitment to delivering scientifically validated aesthetic solutions for physicians. We believe that this sets the stage for long-term success in the world’s largest aesthetic market."
The launch of Obagi saypha® MagIQ™ is not just a vital development for Croma-Pharma but also represents a new chapter in its relationship with Obagi Medical. By fusing European AH innovation with one of the most reputable names in medical-grade skincare in the US, this partnership holds great promise.
Croma-Pharma’s focus remains steadfast on product innovation within its portfolio of HA fillers, biostimulators, PDO threads, and botulinum toxin, equipping aesthetic practitioners with essential tools to achieve holistic treatment results.
About Croma-Pharma GmbH: Based in Leobendorf, Austria, Croma-Pharma GmbH is a family-owned entity leading the minimally invasive aesthetic sector, specializing in the industrial production of hyaluronic acid syringes. They offer a diverse aesthetic portfolio, including botulinum toxin, fillers, PDO threads, PRP, and skincare technologies that reach over 80 markets worldwide.
About Waldencast: Founded by Michel Brousset and Hind Sebti, Waldencast is dedicated to establishing a world-class operating platform in the beauty and wellness sectors. They focus on the development, acquisition, and acceleration of fast-growing, responsible brands. Their initial breakthrough came through the merger with Obagi Medical and Milk Makeup, which allows their brands to leverage the operational scale of a multi-brand platform while maintaining the unique identity of each brand.
About Obagi Medical: Obagi Medical is a pioneering skincare line built on extensive research and skin biology, boasting over 35 years of experience. Initially recognized for their leadership in hyperpigmentation treatment with the Obagi Nu-Derm® system, their products aim to address a range of skin issues such as premature aging, sun damage, discoloration, and acne. As the fastest-growing professional skincare brand in the US for 2024, Obagi Medical continues to empower individuals toward achieving healthy, beautiful skin. For more information, visit their website at https://www.obagi.com.
Developed by Croma-Pharma, the product will be imported into the United States by its strategic partner, Waldencast plc, under the Obagi Medical brand. This FDA approval signifies a remarkable achievement in Croma's strategy for global expansion, paving the way for new opportunities in the aesthetic medicine landscape. The commercial launch is anticipated for 2026, marking just the beginning of a broader multi-product rollout in the US market, including other promising innovations like saypha® ChIQ™ and more, pending additional regulatory approvals.
CEO Andreas Prinz expressed immense pride in being able to introduce their HA technology to the US market, emphasizing the collaborative efforts with Waldencast and Obagi Medical. He stated, "This approval fortifies our tradition of scientific excellence and innovation in aesthetic medicine." With over 110 million syringes produced and distribution across more than 80 markets globally, Croma is dedicated to providing effective products that align with the needs of both healthcare professionals and patients.
Obagi saypha® MagIQ™ is backed by pivotal data from a study conducted in the US, which involved 270 patients and demonstrated its non-inferiority against a control product already approved by the FDA. This study met its primary performance criteria while also achieving secondary endpoints that underscore its efficacy and safety profile. Importantly, the trial engaged participants with all Fitzpatrick skin types, further validating the product’s effectiveness across a diverse population.
As Prinz noted, "This FDA approval substantiates the safety and performance of our saypha® filler technology, showcasing our commitment to delivering scientifically validated aesthetic solutions for physicians. We believe that this sets the stage for long-term success in the world’s largest aesthetic market."
The launch of Obagi saypha® MagIQ™ is not just a vital development for Croma-Pharma but also represents a new chapter in its relationship with Obagi Medical. By fusing European AH innovation with one of the most reputable names in medical-grade skincare in the US, this partnership holds great promise.
Croma-Pharma’s focus remains steadfast on product innovation within its portfolio of HA fillers, biostimulators, PDO threads, and botulinum toxin, equipping aesthetic practitioners with essential tools to achieve holistic treatment results.
About Croma-Pharma GmbH: Based in Leobendorf, Austria, Croma-Pharma GmbH is a family-owned entity leading the minimally invasive aesthetic sector, specializing in the industrial production of hyaluronic acid syringes. They offer a diverse aesthetic portfolio, including botulinum toxin, fillers, PDO threads, PRP, and skincare technologies that reach over 80 markets worldwide.
About Waldencast: Founded by Michel Brousset and Hind Sebti, Waldencast is dedicated to establishing a world-class operating platform in the beauty and wellness sectors. They focus on the development, acquisition, and acceleration of fast-growing, responsible brands. Their initial breakthrough came through the merger with Obagi Medical and Milk Makeup, which allows their brands to leverage the operational scale of a multi-brand platform while maintaining the unique identity of each brand.
About Obagi Medical: Obagi Medical is a pioneering skincare line built on extensive research and skin biology, boasting over 35 years of experience. Initially recognized for their leadership in hyperpigmentation treatment with the Obagi Nu-Derm® system, their products aim to address a range of skin issues such as premature aging, sun damage, discoloration, and acne. As the fastest-growing professional skincare brand in the US for 2024, Obagi Medical continues to empower individuals toward achieving healthy, beautiful skin. For more information, visit their website at https://www.obagi.com.
Topics Health）
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