BresaGen wins FDA approval for catheter

In a step towards improved application of cell therapies, South Australian company ABCBresaGen (ASX: BGN) has gained US Food and Drug Administration (FDA) approval to market a catheter designed for the delivery of therapeutics to the brain.

The catheter, specially designed using biomaterials to reduce damage to cells, can now be marketed for intracranial delivery of stem cells and drugs in patients with such diseases as stroke and neurodegenerative disorders.

BresaGen's chief scientific officer, Dr Allan Robins, said that the cell delivery catheter aimed to reduce damage to brain tissue.

"The catheter tip is visible under magnetic resonance imaging (MRI), allowing cells to be delivered to target locations with greater accuracy than possible with currently used catheters," Dr Robbins said.

He said the design and use of biomaterials in its creation reduced the shear force stress on cell membranes as cells are injected through the catheter.

Scientists and engineers at the University of Minnesota, Virginia Commonwealth University and the University of Toronto developed the device. The University of Minnesota has granted the exclusive marketing rights to the catheter to BresaGen.

In addition to the catheter technology, BresaGen has customised imaging software to allow tracking of the catheter during implantation to ensure precise cell delivery to targeted areas in the brain.

The company holds three patents and has six patent applications in this area with a research and development program operating through the three North American universities.

Robins pointed to studies that showed Parkinson's disease symptoms could be improved by transplanting dopamine-secreting cells into the striatum of the brain, with accurate cell delivery a critical part of the procedure.

A proprietary catheter and method for delivering living cells into patients with neurological diseases, such as Parkinson's, was therefore a major step toward the commercialisation of this treatment, he said.

BresaGen's president and CEO Dr John Smeaton said the FDA approval significantly extended the company's cell delivery program.

"BresaGen is developing a comprehensive cell therapy product line that includes cells derived from stem cells, catheter devices to accurately deliver the cells into target locations, and imaging technologies to evaluate pre and post-operatively the condition of the local tissue environment," he said.