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The Next Frontier
Image-Guided Neurologics is poised to tap the growth in treatment of brain disorders

by Anne Straub
Brevard Technical Journal

The NAVIGUS system is shown attached to a model skull. Photo by Malcolm Denemark, © 2003.

A small Melbourne firm is trying to change the way doctors perform brain surgery.

Image-Guided Neurologics has developed a system it says improves the accuracy of navigating the brain, shortens the duration of the procedure and reduces patient discomfort.

The system, called Navigus, aims to replace the stereotactic head-frame now commonly used in neurosurgery. IGN bills its product as cheaper for hospitals and more accurate for doctors to use.

The company is poised to tap the growth in treatment of neurological disorders, including Parkinson’s disease, epilepsy and essential tremor.

“Neuro is the next frontier,” said Rudy Mazzocchi, president and CEO of IGN, which employs 24 people. “Cardiovascular has been the hot field for a long time,” but that area is becoming saturated with companies.

Navigus is driving the revenues of the 5-year-old company, which recently finished its fourth and final round of venture capital. Mazzocchi expects to see positive cash flow in about 12 months and forecasts the company will hit $6 million in sales this year. That would double last year’s figure.

Navigus uses a disposable trajectory guide that’s mounted directly to the skull using three titanium screws. The surgeon inserts a probe into the guide and pivots it, using a joystick-like device, to achieve the proper trajectory based on images of the brain. The trajectory is then fixed through a locking ring.

Current uses include biopsies, shunt placement and neuroendoscopy. Future applications would also include tumor removal, drug infusion to specific areas of the brain and the controversial practice of depositing stem cells to treat disorders, a use that’s now in clinical trials. But Mazzocchi, who holds a master’s degree in biophysics and has spent his career in medical-products companies, sees the greatest potential for Navigus in the field of neurostimulation.

Through neurostimulation, doctors implant electrodes that deliver controlled electrical pulses to targeted areas of the brain. Deep brain stimulation is used for patients with movement disorders such as Parkinson’s disease, essential tremor and dystonia.

Medtronic, the Minneapolis-based company that made its name developing cardiac pacemakers, has thrown its marketing muscle behind Navigus. The company also makes neurostimulators, known more informally as brain pacemakers.

“The head frame is tried and true; it clearly works. But it has some drawbacks that Navigus addresses,” said Joe McGrath, a Medtronic spokesman. The company has signed an agreement to help IGN commercialize the technology. “From a patient perspective, one of the toughest aspects of implantation is the discomfort the patient feels from the head frame.”

Patient comfort plays a role in physician decisions and is particularly important in the deep brain stimulation procedure, he noted, as the patient must be alert to cooperate in testing the stimulator.

The market is large and growing. “Brain stimulation is definitely becoming the standard of care for patients in advanced stages of movement disorders,” McGrath said.

Worldwide, more than 20,000 people have had brain stimulation technology implanted since the mid 1990s, according to Medtronic. The rate of implantation is expected to rise, based on the potential for treating Parkinson’s patients alone: About 10 percent of people with Parkinson’s are considered candidates for brain stimulation. In the United States, about 1 million people have the disease, meaning 100,000 could benefit from the technology, McGrath said.

Medtronic’s own growth illustrates the potential. The company’s neurological division generated $7 million in revenue in 1980. Today, that figure is $1.25 billion.

Mazzocchi sees uses beyond movement disorders, in cases involving obsessive-compulsive disorder, chronic obesity, depression, and more. And because the frameless surgery takes less time – half a day instead of a full day for a brain pacemaker implant, for example – more surgeries could be performed and more Navigus systems could be sold.

Today, the challenge includes convincing surgeons they can accurately target the desired area of the brain without the frame they’ve used for years. Mazzocchi calls it a training issue and is working with opinion leaders to increase the number of surgeons and hospitals that are using Navigus. He estimates the system holds about 20 percent of the market, with the frame being used for the other 80 percent.

Increasing that market share is less ambitious than the company’s original plan, which included emphasizing its system for performing neurosurgery inside the bore of conventional CT and MRI equipment. That procedure allows for real-time imagery, in which the surgeon can continually check a refreshed image of the procedure rather than images shot before the procedure began.

Promoting that system proved difficult because few hospitals have operating rooms that can accommodate it. IGN continues to nurture those hospitals as potential future customers.

For more information, see www.igneurologics.com.