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Sense of urgency for spinal device

FDA waiver sought to get experimental item on market

When Brandon Ingram was thrown from his car in a highway crash five years ago, he was told he would never walk again. But Ingram gradually regained some feeling below the waist. And now he can take steps with the assistance of a walker.

Ingram, who still uses a wheelchair, credits his faith in God with speeding his recovery. But Ingram, 27, also credits an experimental medical device, called the Andara Oscillating Field Stimulator System, which for six weeks delivered electrical pulses to his spine in an effort to spur the nerve cells to regenerate. "I'm very fortunate," said Ingram, who lives in Indianapolis.

Now the Foxborough company behind the device, Cyberkinetics Neurotechnology Systems Inc., is seeking a special waiver from the Food and Drug Administration to start marketing it to people with acute spinal injuries - without first having to prove the device is effective.

In recent years, dozens of other medical device makers have sought similar waivers, called the Humanitarian Device Exemption, which is designed to let companies market inventions for people suffering from medical problems that afflict no more than 4,000 people a year. The waiver is intended to encourage companies to market devices for rare medical problems, where the number of potential customers is low.

The FDA has granted at least 43 waivers since 1997, including three this year. Boston Scientific Corp. of Natick, Stryker Biotech in Hopkinton, and Abiomed Inc. in Danvers have all won such exemptions in the past.

In the case of Abiomed, the publicly traded company was granted a waiver a year ago to sell its Abiocor artificial heart to patients who are not candidates for conventional heart transplant surgery. The company says it expects to start selling the device later this year in a limited rollout to a handful of heart centers.

"It's a very positive thing for patients," said Michael R. Minogue, Abiomed's chief executive. While the company has tested the device on 14 patients since 2001, it likely would have taken considerably more time and money to undertake trials with hundreds of patients to win approval under the FDA's usual process for approving medical devices.

Abiomed is also planning to ask for an exemption for another product, the Impella pediatric pump, designed to help pump blood in sick infants for up to 2 1/2 weeks. (Abiomed is also continuing to seek conventional approval for other versions of the device.)

While they may be able to bypass clinical trials, companies still must clear some hurdles to get a waiver from the FDA, including providing evidence that a device is safe and is likely to benefit patients. In addition, companies are not supposed to earn a profit on sales through the waiver, though they are allowed to recoup millions of dollars in research expenses.

Also, the waiver process can be time-consuming. In fiscal year 2005, the FDA said it took an average of 6 months to approve applications. Abiomed said it waited more than a year to gain permission to sell its artificial heart. Cyberkinetics, which filed its application in February, is hoping to win clearance for the Andara OFS System as early as next month.

Cyberkinetics didn't invent the spinal technology; the company acquired it when it bought Andara Life Science Inc. for $4.6 million last year. The product, about the size of a pacemaker, is designed to be used in combination with existing drug treatments.

So far, there's limited data to show how well the Andara OFS System works. It has only been tested in 15 patients - enough to offer tantalizing clues that it could be helpful.

The initial results from the first 10 participants were published in the January 2005 issue of the Journal of Neurosurgery: Spine.

Ingram said the device "played a big role in my life."

But Cyberkinetics also has it skeptics. The company, which has 37 employees, rode a wave of national publicity a few years ago on the hopes of another product, BrainGate Neural Interface System.

The device was implanted into the brains of quadriplegics to enable them to move an object simply by thinking about it.

Some researchers, including neuroscientist Miguel Nicolelis, raised questions about BrainGate's effectiveness and the device is still in early trials. Cyberkinetics says years of additional research and testing are necessary before the device can win FDA approval.

Nicolelis is wary of the Andara OFS System as well.

"I have nothing good to say about this company," said Nicolelis, who works at Duke University Medical Center. "I see no solid science behind their latest attempt to make some quick revenue or save their stock price from collapsing altogether."

Cyberkinetics stock, which traded at around $2 per share two years ago, is now hovering around 50 cents amid mounting losses and shrinking reserves. At the end of June, it reported having $5.9 million in cash, down from nearly $12 million at the beginning of the year. Cyberkinetics said it believes it has enough money to last at least through the end of the year.

"We need to generate revenue," said Cyberkinetics chief executive Tim Surgenor. He said the exemption should enable the company to immediately begin selling the spinal device, at a price of about $40,000 to $50,000, to recoup some of its investment in the technology.

Cyberkinetics hopes the exemption will just be a first step, allowing it to initially serve a population of 3,500 patients - those who suffer the most serious spinal injuries each year - but later seek approval for a broader market.

The company said it is also working on a version of the device that could be used for the estimated 250,000 people who already have spinal cord injuries. And eventually it hopes to develop a version to treat acute injuries to peripheral nerves, opening up an annual market of another 350,000 patients - and a much larger potential revenue stream.

Todd Wallack can be reached at twallack@globe.com.

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