Study is big news for Vagus pioneer Tracey

Spread the word: Kevin Tracey (center) may be onto something with this nerve-stimulation thing.
By GREGORY ZELLER //

Medical science has taken an enormous step toward “using electronics to replace drugs.”

Kevin Tracey’s words sound downright science-fictional. And no, researchers cannot wave a medical tricorder and instantly cure ailments like “Star Trek” medic “Bones” McCoy.

But they’re getting closer to a world where high-tech implants – not pharmaceuticals – are the most effective treatments for inflammatory diseases like rheumatoid arthritis and Parkinson’s disease. A recent clinical trial in the Netherlands, the heart of a potentially groundbreaking study published this month by the prestigious journal Proceedings of the National Academy of Science, may be the sharpest evidence yet of the power of bioelectronic medicine.

In what researchers call the first successful experiment of its kind on human subjects, the study observed 17 rheumatoid arthritis patients ages 36 to 69 during 84 days of bioelectronic treatment – electrical stimulation of the Vagus nerve to encourage the body to heal itself.

According to the study, several patients – including some who had not responded to pharmaceutical treatments – showed significant improvements with no reported side effects. Some of the more severely afflicted patients were able to button their shirts or walk again; others were able to resume activities such as bike riding or tennis.

Tracey, CEO of Northwell Health’s Feinstein Institute for Medical Research and a recognized global bioelectronics pioneer, co-authored the paper with Paul Peter Tak, the lead investigator who ran the actual trial, and Anthony Arnold, CEO of California-based SetPoint Medical, a private biomedical company cofounded by Tracey.

The Feinstein Institute CEO has essentially defined the bioelectronic forefront for decades. Bioelectronic medicine, which targets the nervous system’s natural inflammation-blocking mechanisms with artificial devices, is not new – the pioneer references 20-year-old ideas combining immunology and neuroscience – but “to see an idea that old move forward and come to a time now where patients have benefitted is extraordinary,” Tracey noted.

“The data in this paper show that it’s possible to implant a chip to block inflammation in patients with rheumatoid arthritis,” he said. “The implications of this are we can now think about using bioelectronic devices as medicines.”

That’s terrific news for SetPoint Medical, which Tracey cofounded in 2006 to explore implantable neuromodulation devices. The company – which added another $15 million in 2015 to a Series C round that now stands at $43 million – has backing from Roslyn-based private equity fund Topspin Partners and a host of major-league investors.

The California company is in the process of relocating it 25 full-time employees into 14,000 square feet in a highly regarded Santa Clarita bioscience park already occupied by Boston Scientific – also a SetPoint Medical investor – and other top medical-device innovators.

The study is also great news for Sanguistat, the commercial identity of the Neural Tourniquet technology being developed by Feinstein Institute researchers in conjunction with the Battelle Memorial Institute, based on tech created by Tracey.

Sanguistat – which was formed this year by Feinstein Vice President Christopher Czura, Feinstein researcher Jared Huston and former Battelle chief scientist Chad Bouton – is working to commercialize a portable nerve-stimulation device capable of staunching blood loss in the operating room or in the field.

The study is vindication, naturally, of the 15-plus years Tracey has spent on the cutting edge of bioelectronic medicine research, and he’s bound to reference it in September, when he keynotes the New York Academy of Science’s Key Symposium 2016: Bioelectronic Medicine – Technology Targeting Molecular Mechanisms.

But the Feinstein CEO – who’s credited with the discovery of the inflammatory reflux, the natural mechanisms by which the central nervous system regulates the immune system – insists the study is most precious to millions of global patients suffering from inflammatory diseases like rheumatoid arthritis and inflammatory bowel disease. The study references 1.3 million adult Americans suffering from RA, while the Centers for Disease Control cites data pegging annual RA costs in the United States around $39.2 billion.

Considering the staggering numbers of patients suffering from inflammatory disorders ranging from Crohn’s disease – an inflammatory bowel disease that can affect any part of the gastrointestinal tract – to Alzheimer’s and other neurodegenerative diseases, the promise is clear, according to Tracey.

Even the “best, most powerful drugs we have today” can be ineffective against tough inflammatory diseases, he noted, and it’s “incredibly exciting” to see bioelectronics moving “into clinical scenarios where people can get better.”

“There are a lot of patients with serious inflammatory diseases,” Tracey said. “And they need other options.”


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