Aug 6, 2026
Sinclair Aesthetics wins EU CE mark for Kytogen Defend, a non-animal-derived CM-chitosan injectable
A new injectable for the skin that brings carboxymethyl chitosan into aesthetic medicine for the first time — now CE-marked under the EU MDR.
Sinclair Aesthetics has secured CE marking under the EU Medical Device Regulation for Kytogen Defend, an injectable skin-quality device built on non-animal carboxymethyl chitosan (CM-chitosan) — believed to be the first of its kind to reach aesthetic medicine.
The clearance opens the way for a European launch and adds a skin-quality injectable to the company’s portfolio.
Under the CE mark, Kytogen Defend is indicated for superficial tissue filling and for improving skin aspect — such as roughness — and epidermal hydration on the face and décolleté in adults with dehydrated skin.
The material is a highly purified carboxymethyl chitosan developed using patented technology from Belgium-based KiOmed Pharma. Unlike conventional chitosan — extracted from the shells of shrimp and crab — it is derived from the edible white mushroom Agaricus bisporus, making it non-animal in origin and avoiding the shellfish-derived source used in conventional chitosan.
Chitosan itself is a renewable polysaccharide with a long history in biomedicine, used in applications ranging from wound dressings to surgical materials. Sinclair Aesthetics says the material’s water-binding properties are designed to improve the appearance of skin quality and address the look of roughness and dryness.
As part of a global development programme, a pivotal clinical investigation in China completed enrolment of 500 participants in January 2026 in support of future registration there.
The launch enters what is widely regarded as one of medical aesthetics’ fastest-growing areas. Injectable “skin quality” — the skin-booster category — has become a significant growth driver as consumers shift toward natural-looking ageing and longer-term skin maintenance.
Kytogen Defend adds further depth to Sinclair Aesthetics’ portfolio, which spans injectables, energy-based devices, toxins and active skincare. Data presented at AMWC indicate that 59% of consumers favour structured combination-treatment approaches, reflecting the broader shift towards multimodal treatment planning. It complements integrated solutions across facial contouring, volume restoration, wrinkle correction and skin-quality improvement.
About Sinclair Aesthetics
Sinclair Aesthetics is a global medical aesthetics company committed to innovating solutions designed for precision, personalization and performance. Its innovation engine spans eight global research laboratories, with a portfolio of seven regenerative biomaterial platforms, two toxin technologies and seven energy-based technologies. Sinclair Aesthetics is present in more than 55 countries.