The quest for regeneration
A Web-exclusive sidebar accompanying our August 2007 cover story, "Bridges to the brain."
Lawrence D. Maloney -- Test & Measurement World, 8/1/2007 2:00:00 AM
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While Cyberkinetics’ researchers continue to develop BrainGate, another of the company’s systems—Andara OFS—is preparing for commercial launch later this year.
In February, the company submitted a Humanitarian Device Exemption to the FDA for the implantable electronic device, designed to restore function to paralyzed individuals by regenerating injured spinal issue. Once the HDE is issued, Cyberkinetics expects to treat about 3500 patients a year with the $45,000 device.
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| Purdue biophysicist Richard Borgens developed the Andara system following many years of research with animals, such as dogs with naturally occurring spinal-cord injuries. |
Based on a system originally developed by Purdue biophysicist Richard Borgens, who heads that university’s Center for Paralysis Research, Andara features an implanted stimulator with an onboard oscillator timed to reverse the polarity every 15 min for more uniform tissue growth. About the size of a pacemaker, the battery-powered stimulator produces an electrical field of 500 to 600 μV/mm by way of six platinum-iridium-tipped electrodes. Three of the electrodes attach to the vertebrae at a distance of two disk segments above the area of injury, and the other three are placed at a similar distance below the injury.
Results from an initial 10-person clinical trial, directed by Dr. Robert Shapiro, professor of Neurological Surgery at the Indiana University School of Medicine, found that all participants showed significant gains in sensation, as well some improvement in hand, arm, and leg movement. “These were severely paralyzed individuals, worse off than even Christopher Reeve, and some of them have had life-changing recovery in abilities,” noted Borgens, who serves as a Cyberkinetics consultant. The company acquired the IP for the technology when it bought Andara Life Science, a Purdue incubator firm, in early 2006.
For Andara to be effective, patients typically need to be treated with the device within 18 days of a spinal-cord injury, and the device is typically removed after 14 to 16 weeks. But in April, Cyberkinetics received a patent for an enhanced system called Andara OFS Plus, which Cyberkinetics president and CEO Timothy Surgenor explained could extend the treatment window to paralyzed patients with older injuries.
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| The battery-powered Andara stimulator produces an oscillating electrical field of 500 to 600 µV/mm. Clinical trials have demonstrated the system’s ability to restore sensation to victims of spinal-cord injury. |
Andara OFS Plus combines stimulation and an implanted pump that delivers a neurotrophic drug, such as inosine, to the injured area. Surgenor estimated that the $150 million in potential annual revenue from the stimulator-only procedure could increase to more than $1 billion with the added drug-delivery component. The enhanced system could reach the European market as early as 2008, according to the company.
Compared to BrainGate, added Surgenor, getting Andara ready for market is nowhere near as daunting from a design and test standpoint. “The challenge was to take the epoxy-tube stimulator design developed in the laboratory at Purdue and upgrade it to a manufactured product without changing the essential function.”
To accelerate this process, Cyberkinetics contracted with Minnesota-based Minnetronix for development assistance, and with Texcel, a Massachusetts medical device manufacturer, for production of the implant. Key design changes included a titanium housing with an epoxy header and improved hermetically sealed lithium batteries.
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| Christine Decaria, director of product development for Cyberkinetics, monitored the testing work of two outside companies contracted to develop and produce the commercial version of Andara. |
Christine Decaria, director of product development for Cyberkinetics, monitored the development and testing at Minnetronix, as well as safety, susceptibility, and biocompatibility tests on prototypes conducted by TUV America in New Brighton, MN. according to IEC 60601 and EN 45502-1 standards. Accelerated life and shipping tests were performed by outside vendor DDL of Minneapolis. “As part of our quality plan, we’ll perform inspections during production to assure that the device is operating properly, the batteries are fully charged, the device electronics function appropriately, and the leads transmit the correct amount of current,” noted Decaria.
How good a job has Cyberkinetics done on preparing Andara for launch? Neurotech Reports, an industry newsletter, gave the system its “Gold Electrode Award” as the best new product of 2006. “We were impressed with the developer’s efficient transition from university research to commercial development,” said James Cavuoto, the newsletter’s publisher.
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