The field of bioelectronics is at the intersection of biological systems and electronics. While it brings to mind cardiac pacemakers and vagus nerve stimulators, bioelectronic devices are, in fact, futuristic versions of these now-commonplace medical tools and differ from conventional electronic implants in two crucial aspects:
- Bioelectronic devices, as conceptualized by the innovation ecosystem, are grain-sized implants that can monitor and modulate electrical impulses in the body. Pacemakers would be comparatively gigantic and unappealing.
- Bioelectronics will have the ability to target individual or specific sets of neurons and control their activity. Conventional stimulators used for deep brain or spinal stimulation lack specificity; they target large tissue areas or a general clusters of neurons.
From Pharmaceuticals to Electroceuticals
All major organs of the body are connected to the brain or the spinal cord through a complex network of peripheral nerves that carry motion and sensory information. It is possible to tap into this neural network and modulate it as a means of controlling targeted organs. In essence, bioelectronics marks a shift from using medicines to target pharmacological pathways to using electronic implants to modulate neuronal pathways. This can help overcome several concerns in the pharma-dependent therapy space:
- Long-term medication, as in the case of epilepsy, can lead to receptor desensitization that can render the medicine ineffective.
- The U.S. Food & Drug Administration (FDA) estimates that between 45,000 and 90,000 deaths occur every year due to adverse reactions to prescription drugs.
- The threat of prescription drug abuse, accidental overdosing, and lack of medication adherence can all affect the efficacy of prescribed medicine.
- The cost of prescription medicine is a huge burden on the health care system. The United States alone spends an estimated $450 billion on prescription medicine every year spending is expected to exceed $600 billion by 2022.
Initiatives and Initiators: Projects Fueling Bioelectronics
Interest, investment, and media attention in this field has surged in recent years, with a number of international projects commissioned since 2013 to study the human brain and its numerous attributes. The European Union-funded Human Brain Project is an $11 billion, multi-disciplinary project to advance knowledge in the fields of neuroscience and brain-related medicine. In 2016, the U.S. National Institutes of Health announced a $250 million Common Fund program called Stimulating Peripheral Activity to Relieve Conditions to “understand the nerve-organ interactions and advance the neuromodulation field toward precise treatment of diseases and conditions for which conventional therapies fall short.”
Several companies have bioelectronics-related initiatives:
- Medtronic, a pioneer of cardiac pacemakers and electrical neuromodulation, is leading the wave of miniaturization—a necessary feature of bioelectronic medicine. Medtronic’s 10-year deep miniaturization program has resulted in Micra, the world’s smallest FDA-approved pacemaker.
- Israeli-based BlueWind Medical has two CE mark-approved neurostimulator products—Vivendi, for the management of chronic, intractable pain; and Renova, for overactive bladder. Both devices have a leadless stimulator component that is implanted in the vicinity of the tibial nerve cluster in the feet.
- Florida-based Stimwave has developed a suite of micro-stimulators—wireless, millimeter-thin, battery-less leads—that are implanted at the site for pain management. These leads are powered by an external wearable unit that uses Bluetooth to control the stimulation.
- SetPoint Medical is one of the few companies dedicated to using electrical stimulation to manage debilitating inflammatory diseases, including Crohn’s disease and rheumatoid arthritis. SetPoint’s proprietary platform includes an implantable microregulator, an external wireless control unit and a tablet interface for physician control.
- St. Jude Medical (acquired by Abbott Laboratories in 2017) has a portfolio of products for dorsal root ganglion and spinal cord stimulation for the treatment of chronic pain. These devices leverage St. Jude’s proprietary BurstDR technology, which mimics the body’s nervous system by firing intermittent pulses in order to alleviate physical pain.
- Pharmaceutical giant GlaxoSmithKline’s multimillion-dollar investment is perhaps the strongest indication that bioelectronics are the way of the future. GSK has invested in more than 50 start-ups and research projects that study disease biology and the means to manage them through neural signaling.
- In late 2016, Google parent company Alphabet (through its Verily life science division) announced a partnership with GSK to develop bioelectronic medicines. The new venture, named Galvani Bioelectronics, will be supported by an unprecedented $700 million fund over 7 years.
The Road Ahead
The partnership of one of the most innovative digital companies and one of the oldest pharmaceutical companies to pioneer a new class of medical devices has emboldened the innovation and investment communities. However, a full functional map of the human nervous system must be developed to determine which nerves control which organs.
Understanding the neural map and the birth of electronic medicine could define the coming decade in the way that cracking the genetic code and the birth of gene therapy defined the 1990s.
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