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Hacking the Body Electric


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A microregulator implant made by SetPoint Medical is designed to stimulate nerves to reduce inflammation.

Electroceuticals are a class of medical devices that focus on evoking a response from the body through the use of electrical signals, instead of drugs.

Credit: Patrick T. Fallon

Electricity has been used for medical purposes for well over a century, in such applications as X-rays, pacemakers, and hearing aids. A new technological innovation in healthcare is the advent of electrical pharmaceuticals, also known as electroceuticals and bioelectronics, medical devices that hold the potential to replace many drugs, as well as their side effects.

Explains Laura Perryman, chairman and CEO of Stimwave, a Pompano Beach, FL, manufacturer of micro-sized, wireless, injectable medical devices for neurology, "Electroceuticals are a new class of medical devices that focus on evoking a neurophysiological response from the cellular functions of the body, utilizing electrical signals instead of chemicals at the receptor level."

As medical devices have become small enough to be practical for implantation, they are being used to treat targeted tissues or organs, where previously only chemicals/medications could be utilized. Electroceuticals, in short, are medical devices that treat ailments with electrical impulses by targeting neural circuits or organs, Perryman says.

"Bioelectronics begins and ends at the same places that the pharmaceutical industry begins and ends," says Kevin Tracey, president of the Manhasset, N.Y.-based Feinstein Institute for Medical Research, the research branch of the Northwell Health healthcare network.

Tracey outlines the process to develop a treatment in the pharma industry: "You pick a disease, and you pick a target. Then, you screen for drugs or molecules to hit the target, and then you test them and sell them.

"It is the same in bioelectronics," Tracey goes on. "We pick a disease and identify a target, but rather than screen for molecules or drugs to hit the target, we discover, search, or screen for neurocircuits that control the target in the body. Then, from the neurocircuits knowledge gained, we develop the specifications for a bioelectronic device to control the nerve to control the target."

With that knowledge, Tracey says, "Now you don't need the drug. That is the power of the story; it is so simple. When you go through the logic of it, it makes more and more sense."

According to Tracey, there is a subtle difference between neuromodulating devices that alter or modulate nervous system functions—like deep-brain stimulators, cardiac pacemakers, and even early-generation vagus nerve stimulators—and bioelectronic devices.

John Cornwell, CEO of Neurome, a bioelectronics start-up in Menlo Park, CA, explains further that a pacemaker does not communicate with the nervous system or tell the heart to do anything in particular; it simply detects when the heart slows to an unhealthy rate, and resets it to a pace sufficient to ensure sufficient blood and oxygen are delivered to all parts of the body.

"Rather than using some chemical entity or peptide or biologic, we are going downstream from the receptors a drug hits," Cornwell says, as the electroceutical will deliver a signal that looks like what a drug would induce in the nervous system. "An electroceutical is literally meant to be an electronic or signal replacement for a pharmaceutical. That is the real distinction between electroceuticals and pharmaceuticals."

Adds Tracey, "If I could dissolve your body in a solution that would eradicate everything except all of the nerves of your body, you would still pretty much look like you." Almost every cell in the human body is touched by or surrounded by nerves; the hardwired network is there, ready to transmit information. Over millions of years of evolution, he explains, each of these neural networks has been refined to maintain balance (homeostasis) and health.

"What bioelectronics does is basically hack, target, or tap into those evolutionary circuits that maintain health," Tracey says.

Bioelectronic signals are extremely complex, Cornwell says, describing them as complicated trains of signals that have complex relationships in terms of intervals and timing, requiring complex mathematical representation.

"There are many applications for electroceuticals, from pain management to cardiac function to neuropathy or even incontinence," says Perryman, who adds that there are also electroceutical applications for treating the symptoms of diabetes, depression, and migraines.

Neurome's Cornwell says physical conditions that appear most directly applicable for bioelectronic treatment include those in which there is some disequilibrium in the body—metabolic disorders such as management of blood sugar levels, wakefulness in terms of circadian rhythms, immune systems management, epilepsy, and cluster headaches.

The Path to Personalized Medicine

To Cornwall, "Electroceuticals are a new paradigm, so the regulatory infrastructure has to come up with new ways to evaluate their efficacy, safety, and delivery."

"Electroceutical placement and fixation within the body is done in a clinical environment," Perryman says. "It is a skillset that needs to be taught to clinicians, so the learning curve will likely hold back rapid adoption for the first several years."

Perryman says the patient is awake and providing constant feedback on the therapy as it is applied in real time. She says the therapy is customized for each individual patient, to ensure the devices are placed appropriately and that settings are optimized to their specific needs.

Cornwell adds that in terms of personalized medicine, from a regulatory viewpoint, you can't come up with a customized molecule for every person; however, "With bioelectronic medicine, you create a feedback loop." He explains that if one is trying to control some physiological parameter like blood pressure or blood sugar, they could use one of the many real-time sensors now (or soon) available to watch that condition, and "You can use our type of technology to modulate that parameter right to whatever your desired setpoint is."

He adds, "To the extent you can create these feedback loop-type systems, we think the market opportunity is pretty significant."

Biohacking

Tracey says mechanistic knowledge derived from working in the laboratory on basic mechanisms, both molecular and neuro-scientific, is what informs bioelectronic medicine.  "That is the promise of the future," he says. "We are moving from the past, an era where we were making devices, putting them in, turning them on, and seeing what happens.

"The future is where we will start with a specific target. Maybe it is a transcription factor, or a receptor in cancer, and we map the neurocircuits to that specific target with a specific question, and then build devices to hit those targets."

Cornwell points out the signals of the nervous system have been recorded for half a century, but were thought to be too noisy and too messy to interpret. "Today, your phone has enough computing power to do the requisite processing to make sense of these signals. It is the intersection of computing, biology, and artificial intelligence."

Humans are systems, and all systems can be hacked, Cornwell says. "That's what we are, we are biohackers."

John Delaney is a freelance technology writer based in Brooklyn, NY, USA.


 

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