Electroceuticals Revolutionizing Health Care

Long Island Business News
Electroceuticals Revolutionizing Health Care
by Claude Solnik
August 16th, 2013

Kevin Tracey
Drug companies spend billions of dollars developing treatments and cures, but Dr. Kevin Tracey quietly chose another path – and is now sitting on a potential breakthrough of billion-dollar proportions.

At the Feinstein Institute for Medical Research in New Hyde Park, Tracey has developed an “electroceutical” device that treats rheumatoid arthritis by stimulating nerves with electrical impulses.
Revolutionary health-care ideas come along sometimes, changing diagnoses and treatments in fundamental ways. Betting that Tracey’s electroceutical device is such a game-changer, Long Island venture capital fund TopSpin Partners has backed SetPoint, a company based on Tracey’s tech.

That bet is paying off: Last week, the investment wings of medical-device developer Boston Scientific and British pharmaceuticals kingpin GlaxoSmithKline poured $27 million into SetPoint.

It’s a huge investment in Tracey’s pioneering methods, which the doctor, president of the North Shore-Long Island Jewish Health System’s Feinstein Institute, says could be expanded to treat a laundry list of human conditions.

“Stimulating a nerve to turn off information is the tip of the iceberg,” Tracey said. “We mapped one nerve circuit to do a particular thing. But we’re looking at identifying other nerves we can target to treat other diseases.”
Power on
Utilizing electricity to regulate heartbeats is nothing new – pacemakers were invented in 1958 – and juice flows through defibrillators and various treatments for conditions as varied as depression and Parkinson’s disease. But Tracey’s electroceutical device works differently.

“A pacemaker uses nerves to do a mechanical thing, to enhance the contraction of a muscle,” Tracey said. “The idea of electroceuticals is to use nerves to induce chemical things.”

Christopher Czura, Feinstein’s vice president of scientific affairs, likens electroceuticals to flicking neurological switches.

“Every organ is controlled by the brain,” Czura noted. “If we can understand how the brain sends signals through the nerves, we can harness those nerves.”

It may sound like a sci-fi plot, but the federal government buys it – to the tune of a $100 million investment in scientists mapping the human brain and determining how, exactly, neurons work. Tracey compared the brain-related research to the human genome project.

Enter companies like SetPoint, which will try to identify connections between neurons and diseases and turn them into treatments. Chief Executive Anthony Arnold considers his company’s dime-sized device, based on Tracey’s electroceutical research, “a novel approach” to treating inflammatory diseases.

“We believe we’ve got a competitive therapy,” Arnold said.
Discovering electricity
Tracey’s big idea began with a big question: Could nerves be activated electrically?
The answer lies in determining exactly how nerves control bodily functions, and the role they play in convincing the body to produce certain chemicals.

“Drugs have been made to target nerves in a specific way for 100 years,” Tracey said. “We’re proposing to target nerves with devices to make therapies for the next 100 years.”

To get there, the doctor is studying how nerves connect to the immune system – research that could eventually “replace the pharmaceutical industry,” he suggested. But there are some big challenges between here and there, including the often-slow pace of development when it comes to potentially major breakthroughs.

“You don’t have ‘eureka’ moments,” Czura noted. “Things happen over time. You put pieces together.”

The pieces started coming together when Tracey was testing a stroke-treatment drug, which he discovered interacted with nerves affecting the immune system. Inside the brain, the drug was “turning on a nerve,” he said.

Studying separate rheumatoid arthritis treatments, the doctor found the vagus nerve in the neck stimulated and slowed production of “tumor necrosis factor” molecules – the same TNF molecules targeted by blockbuster pharmaceuticals like Remicaid and Enbrel.

Tracey called them “$7 billion drugs” that work in half of patients or less, and noted they also have some toxicity. Remembering how the stroke-treatment drug influenced certain nerves, he set out to develop a nerve stimulator to interact with the vagus nerve, and essentially control TFN production.
Several animal trials followed.

“A number of researchers said, ‘It’s great, it works in animals,’” said Arnold, a mechanical engineer with a 20-year history of developing medical devices. “But a lot of money is lost trying to bridge the gap from animals to humans.”

Test patterns
Tracey continued polishing the product until it was ready for human trials. The first patient to have an electroceutical device implanted was a young Bosnian man who was left unemployed and homebound by severe rheumatoid arthritis; the patient had tried several pharmaceutical treatments and all had failed, Tracey said.

Tracey flew to Bosnia, where a neurosurgeon in Mostar implanted the computerized nerve stimulator. According to Tracey, the patient’s symptoms were gone within a week – and the device went on to prove successful in six of its first eight trials.

“I don’t want to use the word ‘cured,’ but they’re in disease remission,” Arnold said. “They don’t have any signs or symptoms.”

The American College of Rheumatology added to the momentum by publishing the results of the electroceuticals pilot study, and now SetPoint is gearing up for more random trials, all leading up to a big clinical trial.

But that will take time: Since the electroceutical device is not a drug, hundreds must be replicated for the clinical trial, and each must be surgically inserted. The studies are intense, not to mention expensive – north of $100 million, Arnold noted.

The insiders’ best guess: Electroceutical devices could be approved in Europe, for those willing to pay for them, in as little as three years, but it will take up to six years before U.S. insurers sign off.
That’s a long haul for sure, with several hurdles yet to cross. The pharmaceuticals industry won’t go away easily, and with electroceuticals research also underway at the Massachusetts Institute of Technology and the University of Pennsylvania, there’s no guarantee SetPoint can reach pay dirt first.
But Tracey’s Feinstein Institute has some aces in the hole – not only the direct guidance of a leading pioneer in the field, but the intellectual muscle of the National Institutes of Health and DARPA, both of which have supported Tracey’s electroceuticals work.

The stakes are high and the potential is enormous – as evidenced by the GlaxoSmithKline investment, which Tracey likens to the drug-maker hedging its bets.

“One of the largest pharmaceuticals companies has a seat at the table,” the doctor said. “That’s what’s so exciting about this. You’ve got a drug company saying these devices are important.”



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