BioSphere requests US trial for fibroid treatment:
This article was originally published in Clinica
Executive Summary
BioSphere Medical has filed an investigational device exemption application with the FDA to begin US trials of its microsphere embolisation technology as a treatment for uterine fibroids. The Embosphere microspheres, which has shown potential for uterine artery embolisation in animal studies, could provide a less invasive alternative to surgery for women with the condition, said the Marlborough, Massachusetts-based company. The product is already CE-marked in Europe and has been submitted to the FDA for treating hypervascularised tumours and arteriovenous malformations.