Natural materials
engineered to pharmaceutical standards
Our wound dressing platform is based on natural diatomite from carefully selected geological sources. Every batch is tested to pharmaceutical purity standards and validated against international regulatory requirements.
Raw Material Sourcing
We source diatomite from established European suppliers with decades of safety documentation. All raw materials are subject to independent third-party testing for particle size distribution, elemental composition, and contaminant analysis.
Safety Profile
Our reference benchmarks have been in continuous human use in European consumer health markets for 30+ years without significant adverse events. This established safety history significantly reduces clinical development risk and accelerates regulatory approval pathways.
Regulatory
alignment
Our manufacturing process and product specifications are aligned with ISO 13485 (medical device quality management), EU MDR requirements for Class IIa devices, and NMPA quality standards for China. Detailed technical documentation is available under NDA.