When we think about bioelectronic technology, we imagine cyborgs, maybe with red artificial eyes and bionic hands. But, the real merger of man and machine will be based more on biology than nuts and bolts. Today implanted defibrillators, eye implants, artificial tissues and the management of chronic diseases in the nervous system are turning thousands of people in breathing cyborgs without changing their appearance.
What Is Bioelectronics?
“If you were to tell someone that you were going to implant a chip in their his or her eye so that he or she could see again after being blind for decades, that person would tell you that you are dreaming. Turning this dream into reality has been worth it all,” said Mark Humayun, a Professor of Ophthalmology and Director of the University of Southern California Roski Eye Institute in Los Angeles.
Recently, Dr. Humayun received the National Medal of Technology and Innovation for the invention, development, and application of bioelectronics in medicine, including a retinal prosthesis for restoring vision to the blind, thereby significantly improving patient quality of life. This first approved retinal implant will help patients with inherited retinal disease that affects both eyes and restore their sight.
Ophthalmology is one among millions of ways where improvements can be made to the human body. As a branch of nano-science, bioelectronics handles sensors, frameworks, actuators and develop them in bio-subatomic devices for applications in healthcare. The next technological revolution will come as medtech develops the ability to interface natural and synthetic cellular systems. The hybrid structures will be able to communicate with a user, can be sensed, measured and will have the power to manipulate body systems.
The National Institute of Health’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program, the Defense Advanced Research Projects Agency’s ElectRx, HAPTIX programs, and Galvani Bioelectronics therapies program are leading the charge with the most advanced efforts in bioelectronics over recent decades.
However, there is a major need for improvements even in our time.
Photo: Northwestern University
Revolutionary Breakthroughs Goes First
Researchers began working with electronic devices that interface with the body in the late 90s. The bioelectronic field has been able to move forward recently with the development of more complex devices and novel materials that have been engineered down to the nanoscale. These revolutionary breakthroughs in our ability to miniaturize device components, create flexible and biocompatible materials, and design more efficient and expandable components for computation and power.
Reducing the side-effects, miniaturization, cost reduction and creating a closed-loop architecture (sampling, transmission, storage) still present significant challenges. To make this infrastructure safe and private, developers need to properly link implants, data receivers, digital assistants and personal devices into a single network.
Furthermore, understanding the biological map of the body, which can differ from person to person, and is programmed genetically at birth, is perhaps the greatest challenge currently ahead of ‘bioelectronic engineers’. Nerves that appear quite discreet and robust as they leave the spinal cord branch, divide and eventually end in what appears to be frayed, microscopic tufts buried in connective tissue on organs, arranged in patterns that in many cases are completely unknown. Even the tools to map these structures are just now being developed.
Well-known neurosurgeon Kevin Tracey, pioneer in bioelectronics and CEO of the Feinstein Institute for Medical Research, sees the potential of this new field of medicine to be precise than drugs at reaching their targets.
The main problem with drugs is that they not only treat diseased cells, but also go everywhere else in the body. Even the best drugs have a side effect on other organs. If bioelectronics technology enables real-time monitoring of treatment adherence and effectiveness, the impact on mortality and morbidity outcomes could be profound.
Devices And Applications Ready To Treat Diseases
In most cases bioelectronics refers specifically to its applications for neuromodulation. In this case, researches focus on devices and technologies that are intended to directly modulate activity in the dysfunctional neural circuits giving rise to disease.
Several pharmaceutical companies are already investing in ‘electroceuticals’ — devices that can modulate nerves — to treat cardiovascular and metabolic diseases.
Targeted neuromodulation is already approved for treating urinary incontinence, chronic neuropathic pain, and sleep apnea and it is being investigated for use in a rapidly expanding list of other conditions, including rheumatoid arthritis, Crohn’s disease, diabetes, hypertension and heart failure.
Five of the most promising devices that currently dominate neural stimulation from a clinical perspective are:
- Cochlear implants that stimulate the auditory nerve to treat profound hearing loss
- Spinal cord stimulation for the treatment of severe chronic pain
- Vagal nerve stimulation to treat epilepsy and depression
- Deep-brain stimulation to alleviate the motor disorders associated with Parkinson’s disease and essential tremor
- Sacral root stimulation to provide bladder control in spinal cord injury
In addition to these five, there are many devices and projects in development or an early stage of commercialization.
Pioneers in Bioelectronics
According to the International Diabetes Federation, one in 12 people globally has diabetes. A rapidly growing diabetic population will propel the demand for blood glucose monitoring devices. Such a trend could drive the bioelectronics and biosensors market from 2016 to 2024. In the coming years, the global bioelectronic market may be driven by a high incidence of diseases and demand for diagnostic and tracking devices, such as cardiac pacemakers and other implantable medical devices.
Hexa Research in Bioelectronics and Biosensors Market Analysis 2013 forecasted that the global bioelectronics and biosensors market was estimated at USD 11.4 billion. The analysis shows that the market size of bioelectronic medical devices in 2016-2024 will exceed USD 28 billion.
The first steps in attracting public and private awareness to neuroscience was initiated by U.S. president Barack Obama’s administration. The BRAIN Initiative started by the Obama administration was aimed to advance neuroscience and develop therapies for brain disorders. Neuroscientists hoped to perfect a technique for identifying the brain wiring underlying any behaviour and control that behaviour by activating and deactivating neurons.
Inspired by the Human Genome Project, the BRAIN Initiative was aimed to help researchers uncover the mysteries of brain disorders, such as Alzheimer’s and Parkinson’s diseases, depression, and traumatic brain injury (TBI).
Compared to past large-scale, government-led research efforts, the BRAIN Initiative was as large as the human genome initiative, the voyage to the moon, and the development of the and atomic bomb and has generated several hundred exabytes of vital medical data.
In 2016, GlaxoSmithKline PLC and Google announced that they would pursue bioelectronics research and development. The pharma giant and online-business innovator teamed up in 2016 and created Galvani Bioelectronics. This partnership included a $700 million investment in the new company that will use high-tech devices to fight diseases by targeting electrical signals in the body.
Another startup pursuing medtech is SetPoint Medical that focused on treating patients with inflammatory diseases using vagus nerve stimulation. SetPoint Medical is a medical startup that is developing implantable devices using bioelectronic technology. Founded in 2006, the company was funding by GSK and Boston Scientific.
Photo: SetPoint Medical
The field of bioelectronics has received contributions from corporations and startups like these, but also from entrepreneurs, government and neuroscience researchers as well.
Will Rosellini, CEO of Nexeon MedSystems Inc.,the entrepreneur and researcher who founded Microtransponder (MTI), is developing a device for the treatment of stroke and tinnitus using vagus nerve stimulation. Will Rosellini pointed out that they focused on treating patients with deep neurological disorders such as Parkinson’s disease and essential tremor.
Nexeon is ready to use Deep Brain Stimulation (DBS) that works much like a pacemaker, but instead affecting the heart it actually attaches to the brain where it can help regulate a malfunctioning network within the nervous system.
As Rosellini said, their system brings together important market innovations and senses the patient’s brain activity to better understand the various diseases and then find the right response to change the disease state.
Will Rosellini also founded and led Sarif Biomedical LLC, a microsurgery company, and Lexington Technology Group LLC. Together with MIT and neuroscientists from the University of Texas in Dallas, Rosellini’s team discovered paired vagal nerve stimulation (VNS) as a therapy for the treatment of tinnitus and stroke.
Photo: Newsday / Chris Ware. Dr. Kevin Tracey, the pioneer of an emerging science called bioelectronic medicine, at the Feinstein Institute for Medical Research in Manhasset in July.
Another innovator and neurosurgeon, Kevin Tracey, focuses on finding therapies for patients with rheumatoid arthritis. He’s known for his work with tumour necrosis factor (TNF), a protein important in the regulation of the immune system. In patients with rheumatoid arthritis, the immune system makes too much TNF, which leads to inflammation and joint pain.
In 1998 Tracey began his pioneering work in the field that hasn’t been particularly speedy. Yet, even sceptics see potential in this research. Clinical trial data published in the Proceedings of the National Academy of Sciences (PNAS) show the results of Tracey and his team. They set out to understand the underlying molecular mechanism behind TNF and found that the vagus nerve played an important role in TNF regulation. “This is a real breakthrough in our ability to help people suffering from inflammatory diseases,” said Tracey.
Despite the fact that some people don’t respond to vagal stimulation, over the course of several years, 18 people with rheumatoid arthritis have been successfully implanted with stimulators. People with autoimmune disorders are starting to take notice.
How will bioelectronics converge with other sectors in the next 10–20 years? The ability to get all the information from real-time neural connections, imaging, wearable diagnostic devices, and many other sources will give needed awareness for patients and medical professionals.
Bioelectronics is ready to manage the spread of diseases and even going to replace the pharmaceutical industry as we know it. Instead of popping pills, someday chronic diseases will be treated with implantable devices that adjust the electrical signals in the nervous system and be connected to nearly every organ in the body.