BioCure's PVA embolic microsphere product has received 510(k) clearance from the FDA for the treatment of hypervascular tumors and arteriovenous malformations. The product, which has been licensed to Biocompatibles International plc, will be marketed under the trade name Bead Block. Precisely calibrated and compressible, the microspheres are made from PVA, a material already well-established in embolization therapy.Interventional radiologists use embolotherapy, minimally invasive catheter delivery of an embolic agent via a catheter, to block the flow of blood to tumors, fibroids and arteriovenous malformations and to fill aneurysms.Increasingly, this therapy is being used to treat uterine fibroids in women as a minimally invasive alternative to hysterectomy.

Biocompatibles expects to launch Bead Block in the coming months and to pursue clinical trials to gain regulatory approval for a uterine fibroid embolization indication.

"Bead Block will be a valuable addition to the interventional radiologist's portfolio," said Doug Redd, BioCure's principal investigator and Chief of Vascular & Interventional Radiology at Emory University Hospital in Atlanta."PVA has been used safely in the body for decades and calibrated microspheres have become the preferred design for embolization because they are far less likely to aggregate and cause blockage in the catheter than the widely used PVA particles.Since Bead Block is made from a PVA hydrogel, it offers the added benefit of compressibility, making the procedure quicker and easier."

BioCure is a medical device company based in Norcross, Georgia, a spin-off from CIBA Vision, a Novartis subsidiary.BioCure has an exclusive license to exploit certain biomaterials initially developed by CIBA Vision for contact lenses, in the field of medical devices outside of the ophthalmic field.The company is developing several new products based on its fast crosslinking PVA hydrogel technology.Its current focus is on embolic agents and catheters; beyond its PVA embolic microspheres, the company is well advanced in the development of a new breakthrough liquid embolic agent and catheter system for use in peripheral and neurovascular embolotherapy.Other planned projects include the use of this liquid embolic platform to delivery chemotherapeutic agents, for the treatment of cancer tumors, and biological agents, to promote aneurysm healing.Potential applications of the technology include tissue bulking for incontinence and gastroesophageal reflux disease, spray-on wound dressings, an injectable spinal disc prosthesis, drug delivery applications and soft tissue scaffolds.

"I am particularly pleased with two aspects of the FDA's rapid approval of our new embolic agent," said Dennis Goupil, Chief Technical Officer of BioCure."Firstly, it establishes the soundness of BioCure's fast crosslinking PVA hydrogel technology as a vehicle to commercialize new products that will help patients.Secondly, it is a reward for the hard work and dedication of BioCure's talented scientific team."