Aug 6, 2026
Sinclair's Kytogen® Defend Receives CE Mark, Bringing an Innovative Non-Animal CM-Chitosan Injectable to Europe
The milestone strengthens Sinclair's skin-quality portfolio and advances its global growth strategy
Sinclair, a global aesthetics innovator, today announced that Kytogen® Defend has received CE marking under the European Union Medical Device Regulation (EU MDR) and is expected to launch in Europe.
The milestone marks the arrival of an innovative injectable medical device based on non-animal carboxymethyl chitosan (CM-chitosan) and represents a significant advance in Sinclair's skin-quality portfolio and global expansion strategy.
Kytogen® Defend: A Next-Generation Chitosan Biomaterial for Skin Quality
Chitosan is a renewable, naturally occurring polysaccharide that has been studied and used across biomedical applications, including wound healing. Traditionally, chitosan has been derived from the exoskeletons of shrimp and crab. Kytogen® Defend takes a different route: it is formulated with CM Chitosan derived from Agaricus bisporus (white button mushroom), making it non-animal in origin and avoiding the use of animal-derived material.
CM Chitosan is a highly purified polysaccharide, developed using patented technology sourced from Belgium-based KiOmed Pharma. Its strong water-binding capacity underpins the product's performance: delivered by intradermal injection, Kytogen® Defend is designed to improve the appearance of skin quality, helping address the look of skin roughness and dryness.
Positioned for a Growing Skin-Quality Segment
As consumers increasingly prioritise natural-looking ageing and longer-term skin maintenance, Kytogen® Defend enters one of the fastest-growing segments in medical aesthetics. Injectable skin quality is widely recognised as an important growth driver for the industry, and as regulatory oversight continues to tighten, substantial demand remains for innovative products with appropriate regulatory status.
CE Marking Under the EU MDR Highlights Sinclair's R&D Capabilities
CE marking indicates that a medical device conforms to the applicable requirements of the European Union, including those relating to safety, performance and quality management. The EU MDR has established a particularly rigorous regulatory framework for medical devices. Supported by its European technical and clinical file, the CE marking of Kytogen® Defend demonstrates conformity with the applicable MDR requirements for safety, performance and manufacturing controls, while underscoring Sinclair's research, development and clinical-translation capabilities.
As part of the product's broader global development programme, a pivotal clinical investigation in China completed enrolment of all 500 participants in January 2026, providing a substantial data foundation for future registration in that market. These milestones reflect Sinclair's sustained investment in innovative aesthetic technologies.
Strengthening the Portfolio and Building an Integrated Aesthetics Ecosystem
Skin quality is widely recognised as a major emerging growth area in medical aesthetics. The CE marking and planned European launch of Kytogen® Defend bring Sinclair's strategic investment in this segment into commercial reality. With its innovative non-animal CM-chitosan technology, the product is positioned to meet growing demand in the injectable skin-quality segment.
Building on the regenerative-aesthetics momentum created by Ellansé, Kytogen® Defend adds further depth to Sinclair's portfolio, which spans injectables, energy-based devices, professional beauty and active skincare. As an injectable focused on skin quality, it is expected to complement Sinclair's existing regenerative, hyaluronic-acid and energy-based device portfolios. Data presented at AMWC indicate that 59% of consumers favour structured combination-treatment approaches, reflecting the broader shift towards multimodal treatment planning. Kytogen® Defend supports integrated aesthetic solutions spanning facial contouring, volume restoration, wrinkle correction and skin-quality improvement.
About Sinclair
Sinclair is a global medical aesthetics company. We design injectable and energy-based technologies not as products to sell, but as solutions built around the body's biology, tissue response and aesthetic outcomes. We measure success not by how much collagen a treatment produces, but by healthier tissue, healthier skin, and results that perform over time.
Sinclair is present in more than 55 countries.