Medical Device Daily Associate

A company developing products for the emerging neurotechnology market reported that it has gotten its first FDA clearance for a clinical device in the space, and it also provided an update on its centerpiece product.

Cyberkinetics Neurotechnology Systems (Foxborough, Massachusetts) said it obtained its first 510(k) clearance for the NeuroPort Cortical Microelectrode Array (NeuroPort Array) and NeuroPort Neural Signal Processor (NeuroPort NSP). Together, the two products comprise a neural monitoring system (the NeuroPort System) designed for acute inpatient applications and labeled for temporary (less than 30 days) recording and monitoring of brain electrical activity.

The company said that potential clinical applications for invasive brain monitoring with the NeuroPort in the U.S. include patients undergoing elective surgery for diagnosis and treatment of severe epilepsy (about 5,000 a year) and patients undergoing emergency craniotomies for brain injury and strokes (about 70,000 a year).

Cyberkinetics said the NeuroPort System is capable of providing neurologists and neurosurgeons a new resource to detect, transmit and analyze neural activity of patients who have undergone craniotomy.

The NeuroPort Array allows the collection of aggregate or individual neural signals from the cortical region of the brain, and the NSP enables their recording and analysis as a part of diagnosis and treatment. The system is covered by two issued patents, with system elements included in a number of additional patent applications.

"A lot of people think of us as the BrainGate company," said President and CEO Timothy Surgenor, referring to Cybernetics' brain implant system, designed to explore the ability of quadriplegic patients to control a computer cursor with their thoughts alone.

However, this "flagship product" is a complicated project and a longer-term initiative, he told Medical Device Daily.

Clearance of the NeuroPort System is an important first step in the company's strategy to develop a broad suite of products, he said, to diagnose, monitor and treat neurological diseases and injuries, and launches the company into a growing invasive brain monitoring market that Surgenor pegged at roughly $100 million annually.

Surgenor noted that the company wants to "leverage its components in parallel markets" while developing the BrainGate system. "In the NeuroPort area, we focused in on the fact that the world of detailed neurosensing has not really reached the neurologist." Essentially, he called the move to open up parallel markets as a faster revenue generator for the company, which has been public since its merger last year with Trafalgar Ventures (MDD, Oct. 11, 2004).

Besides wanting to please shareholders by generating some revenue, Surgenor noted that allowing surgeons to use the company's NeuroPort technology now will pay big dividends in the future.

"We believe that it will be valuable to have neurosurgeons and neurologists become familiar with, and more accepting of [the NeuroPort system], so that when the BrainGate is developed, people will be more accepting of the idea that this could become a long-term implant," he said.

Further out, the company plans on developing a fully implantable BrainGate neurotransmitter that will eventually replace the through-the-skin connector used in the current generation of the system. Surgenor envisions the new system employing short-range wireless telemetry to enable greater accessibility and mobility.

Cyberkinetics anticipates a limited market introduction of the NeuroPort System early in 2006 after completing manufacturing upgrades in 2005. It also is evaluating distribution strategies to support broad product launch before the end of 2006.

The company has begun looking at distribution partners for the NeuroPort. "This is not necessarily a product where we think we have enough potential to build an [internal] sales force," Surgenor said.

The company also provided an update on the status of the U.S. pilot clinical trial of the BrainGate System, with future updates to come on quarterly.

As of March 31, two patients have been implanted and are active in the pilot BrainGate trial, Surgenor reported.

The trial is being conducted under an IDE, allowing implantation in five patients with quadriplegia due to spinal cord injury, stroke or muscular dystrophy for a period of 12 months. That period ends in June.

In February 2005, interim results of the pilot study of the system were presented at the Association of Academic Physiatrists (Baltimore), summarizing initial findings from the first trial participant in six-month follow-up. The results show that the device appears to be functioning as planned and the first participant continues to be able to use the system to control a computer using thoughts alone. There have been no reported adverse patient events.

The current roster of BrainGate clinical sites includes Sargent Rehabilitation Center (Warwick, Rhode Island), Spaulding Rehabilitation Center (Boston) and the Rehabilitation Institute of Chicago. The Chicago site joined the trial during the most recent quarter.

"All of our clinical sites are actively engaged in recruiting additional patients into the BrainGate trial," said Surgenor, adding that the company is also making progress in developing the next generation of BrainGate software, including patient interface upgrades. "We look forward to working with our partners and with FDA to integrate those enhancements into the ongoing clinical trial," he said.

The BrainGate system is a brain/computer interface that consists of an internal sensor to detect brain cell activity and external processors that convert these brain signals into a computer-mediated output under the person's own control. The sensor is a tiny silicone chip about the size of a baby aspirin with 100 electrodes, each thinner than a hair, that detect the electrical activity of neurons.

The sensor is implanted on the surface of the area of the brain responsible for movement, the primary motor cortex. A small wire connects the sensor to a pedestal which extends through the scalp. An external cable connects the pedestal to a cart containing computers, signal processors and monitors which enable the study operators to determine how well a study participant can control his neural output.

The ongoing feasibility study will enroll up to five quadriplegic individuals between the ages of 18 and 60 who meet the study's selection criteria. The two primary goals of the study are to characterize the safety profile of the device and to evaluate the quality, type and usefulness of neural output control that patients can achieve using their thoughts.