Devices Drug Delivery Neurosurgery

 News Release - April 17, 2006

BrainLAB iPlan(R) Flow Software Opens New Avenues for Delivering Drugs to the Brain

Cooperative project between the German National Ministry for Education and Research and American National Institutes of Health leads to improved clinical results

WESTCHESTER, Ill., April 17 (HSMN NewsFeed) -- BrainLAB AG, a global leader in image-guided medical technology, today received confirmation from the FDA that its iPlan Flow software was approved for marketing in the United States. For the first time in the history of neurosurgery, this new software enables targeted medication delivery for the treatment of brain tumors. The National Ministry for Education and Research in Germany and the National Institutes of Health in the United States have provided research supporting the software's ability to allow surgeons to assess where and how medications need to be infused in order to reach specific cells within the brain.

Accurately treating brain tumors and neurodegenerative diseases such as Parkinson's and Alzheimer's disease has posed numerous challenges, primarily due to the Blood Brain Barrier (BBB) -- a tight coating of blood vessels, which protects the brain from harmful substances. This safeguard also blocks out many medications, preventing potentially effective treatments from entering the brain. To circumvent the BBB and allow for the delivery of larger drug molecules to the brain, neurosurgeons place catheters into the brain to infuse drugs directly. Clinical experience, however, has shown that it is extraordinarily difficult to achieve sufficient drug concentration in the correct areas as the fluid dynamics differ throughout different regions of the brain and even from patient to patient.

iPlan Flow facilitates targeted drug delivery to specific areas of the brain and can make the process considerably safer and more effective. Based on ongoing research from Dr. Raghu Raghavan and Dr. Martin Brady, both of Baltimore, MD, a computer uses Magnetic Resonance Imaging to render an individual three-dimensional map of the patient's brain. This map then calculates the distribution patterns of the medication. With this information, the doctor can now pre-operatively identify the location that the medication needs to be delivered to.

First results from scientists in Munich and Baltimore and clinicians at Duke University show that the new iPlan Flow software can help predict the fluid distribution in the brain with clinical accuracy. With support from the German National Ministry for Education and Research and the National Institutes of Health in the United States, further accuracy tests and clinical assessments are currently being performed.

Dr. John Sampson, a Neurosurgeon at the Duke University Brain Tumor Center, who has been instrumental in the development of iPlan Flow, said, "This software provides us with a tool that guides our delivery of the drug to the precise site of the target and helps prevent the drug from leaking out of the brain. It is critical to our success that the drugs we are delivering reach the intended site, and the software enhances our ability to accomplish this."

"We strongly believe that this program will enable pharmaceutical companies to better understand and manage drug delivery to the brain," said Dr. Christoph Pedain, who is responsible for BrainLAB's pharmaceutical guidance technologies. "In our opinion, this new software holds strong potential to improve the results of drug trials and heighten the probability of drug approval. This may help bring therapies to the market that previously failed due to inefficient delivery."

The new software will be available this summer.

About BrainLAB

BrainLAB, a privately held company headquartered in Munich, Germany, was founded in 1989 and is specialized in the development, manufacture, and marketing of medical technology for radiosurgery / radiotherapy, orthopedics, neurosurgery, and ENT. Among the products developed by BrainLAB are software and hardware components for image-guided surgery and radiotherapy as well as integrated systems for stereotactic radiosurgery. With around 2,170 systems installed in over 65 countries, BrainLAB is among the market leaders in image- guided medical technology. BrainLAB today employs 740 people worldwide and has 15 offices across Europe, Asia, North and South America and Australia.

For more information, visit BrainLAB at http://www.brainlab.com .

Source: BrainLAB

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