BioSphere requests US trial for fibroid treatment:
This article was originally published in Clinica
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.