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Xelestal+ Achieves MDR CE Certification
A New Milestone in Regenerative Aesthetics
Meridian Biomaterials is proud to announce that Xelestal+ has officially received MDR CE Certification, marking a significant milestone in our commitment to advancing safe, innovative, and science-driven aesthetic solutions.
This certification confirms that Xelestal+ meets the stringent requirements of the European Medical Device Regulation (MDR), reinforcing our dedication to quality, performance, and patient safety.
Meet Xelestal+
Xelestal+ is our next-generation Calcium Hydroxyapatite (CaHA) biostimulant, developed to redefine regenerative aesthetic treatments through advanced biomaterial engineering.
Built on three proprietary technologies—Manganese-Substituted Apatite Lattice, where manganese ions integrated within the CaHA lattice provide enhanced fibroblast protection Micro-Scaled Resilient Array, a novel particle architecture engineered to optimize surface-area dynamics and biostimulatory performance; and ColloAbilite, an advanced colloid engineering platform in which surface-energy minimization and sterically stabilized rheology act synergistically to maintain long-term dispersion stability and uniform particle distribution —Xelestal+ is designed to deliver enhanced structural support, controlled tissue integration, and long-lasting performance.
Its engineered CaHA particles feature a smooth surface, high density, and a tightly controlled particle size distribution, providing optimized injectability, reduced migration potential, robust collagen stimulation, and durable dermal reinforcement. The incorporation of manganese into the apatite crystal structure further reflects our innovative approach to biomaterial science, supporting the product’s distinctive identity and next-generation design philosophy.
A New Standard for Biostimulation
With MDR CE Certification now achieved, Xelestal+ is ready to bring its advanced regenerative technology
to healthcare professionals. This milestone represents more than regulatory approval—it is the beginning of a new chapter in biostimulant innovation.
Discover the future of regenerative aesthetics with Xelestal+.