Recombigain
Recombigain: A human recombinant amelogenin therapy for hard and soft tissue regeneration.
Regulatory Path: Registered as a Medical Device Class III in Israel. Same regulatory path for Europe (MDR 2017/745) and USA (21-CFR).
Novel technology: The protein is manufactured in a recombinant production process– no animal source ingredients.
Purity: A single active ingredient carefully crafted into a patented formulation.
Efficacy: A potent rAmelX enamel matrix amelogenin protein.
Non leak formula: A thermodynamic formulation – liquid in the refrigerator and a thick viscous mucoadhesive gel in body temperature. Transforms in seconds.
Reproducibility: A batch consistent production process with exactly 0.5mg/g rAmelX per syringe.
Cost effectiveness: One syringe per package and a one step application (no need for a pre-application gel).