Terms such as ‘bioelectronics’, ‘neuromodulation’, ‘neural interfaces’ and ‘closed loop’ have been used in scientific circles for a while now; but what are they all, what’s all the fuss about? And why is the healthcare industry (not to mention investors) getting so excited about them? This series aims to answer these and other questions to give a high-level understanding of what’s going on in this space. Over the course of this series, we’ll also cover the neuromodulation landscape, lessons that can be learned from existing therapeutics, and finish by exploring the future of bioelectronic medicine.
What are bioelectronics?
As the term itself suggests, ‘bioelectronics’ is the field of scientific study combining biology and electronics. Specifically, to achieve a desired physiological response in the body following the application of an electrical pulse or ‘stimulation’. An example of this is the pacemaker. Although its first inception occurred in the 1930s, it wasn’t till 1958 after the circuit transistor was invented that it became a refined and fully implantable component, capable of correcting abnormal heart rhythms with electric stimulation.
Since then, science and technology have advanced in miniaturisation and complexity to produce many life-changing electronic implants. Cochlear implants improve moderate to severe hearing loss in adults, children, and babies by electrically stimulating the cochlear nerve in the inner ear.
Technological advances in the last decade have also led to technology not just providing electrical stimulation, but also reading physical and chemical changes in the body. Continuous Glucose Monitors or CGMs, fitted subcutaneously to the skin on the arm or belly have proven to be a growing market for those with diabetes. In fact, even non-invasives such as heart rate and activity trackers have grown exponentially as a market in recent years, as buyers realise the benefits of a healthy lifestyle. And where bioelectronics encompasses the whole range of devices affecting or reading the body, neuromodulation (though related) is a field of study on its own.
What is neuromodulation?
To answer this we need to take a step back and look at the body’s nervous system; a vast network of neurons that direct, control, and respond to bodily states via a complex language of electrical signaling.
The nervous system is made up of the Central Nervous System (the brain and spinal cord) and the Peripheral Nervous System (the nerves extending throughout the body and connecting to the CNS).
Information on everything from how to tell muscles to pick up a cup, to how to regulate blood flow, travels bidirectionally in real-time between the CNS and PNS to efficiently manage organ function to avoid fatigue and failure.
The breakdown of the nervous system can lead to correct signals failing to be delivered to the relevant destination or organ, giving rise to a variety of chronic diseases. Including cardiovascular diseases, diabetes, and arthritis.
This is where neuromodulation comes in. Neuromodulation is essentially the alteration of nerve activity, following the introduction of electrical stimulation or pharmaceutical drugs, which would activate or inhibit the nerve.
What’s the difference between a neural interface and a closed-loop neural interface?
We know that the nervous system has its own language which gets communicated bidirectionally up and down the PNS. If we can decode it, we can find out what’s going wrong with the signal and as described above, ‘modulate’ it. Neural biomarkers are single words within the language of the nervous system, that detect variations and abnormalities. They're valuable indicators of normal biological processes and are used to test whether the body is responding to a treatment for a disease or condition. In this way, biomarkers give us a deeper understanding of chronic disease progression and serve as a target for therapy development.
A neural interface is a device that could sit in one of four places:
1. On the cortical surface of the brain
2. Implanted into brain tissue (such as with Deep Brain Stimulation)
3. Within the spinal cord
4. On a nerve in the PNS
These devices read neural signals from the body, but also electrically stimulate it when the clinician deems appropriate. In this case, the heart rate and other information external to the nerve will be monitored and reviewed to help the clinician decide what the stimulation parameters should be.
On the other hand, a closed-loop neural interface works completely independently. It works to stimulate a nerve only when it needs to, in response to an algorithm that has been uploaded to it based upon non-neural inputs (such as heart rate, bodily position, and 6 minute-walk-test results). A closed-loop system could update its settings by itself without clinician intervention. Providing adjustable, personalised neuromodulation treatment for the patient.
Neural: The new wave in precision medicine
The reason for the push for new therapeutic developments is clear: The development of drugs for certain diseases is slowing down as drugs are becoming more and more expensive and taking longer to discover and develop. For example, despite many new and innovative advances in treating heart disease, the last major drug breakthrough was in the 60s and 70s with the introduction of the beta blocker. And though it’s still regarded as a valid first line of defense, according to the World Heath Organisation (1) heart disease is still the number one cause of death globally. This absolute need in the healthcare industry for new innovations to support or replace existing treatments is what’s driving new technologies like neural engineering to take precision medicine to the next level.
And while the millionaire playboys of the world are working on using neural interfaces to operate TVs and computers, its pioneers like BIOS Health that are leading the way into personalised, precision medicine with machine learning AI and neural read/write software (2).
“At BIOS we’re developing AI-powered neural interfaces to allow us to read and write neural signals as a new data modality in healthcare. The nervous system is the body’s internet, it’s how the brain tells the organs what to do in real-time, the genome is the hard drive, it puts information there and stores it. It gets it years later, but the nervous system is for real-time communication, and by using AI we can decode it, use biomarkers to see how a disease is progressing, and we can change those electrical signals. In doing so, we’ve delivered a therapeutic, we’ve treated a disease.” Oliver Armitage CSO, BIOS Health
Next time, we’ll be looking at the neuromodulation landscape and its regulatory authorities. To view the whole of SciPro’s ‘Building Neural Digital Therapeutics’ with BIOS CSO Oliver Armitage, click here. Or download the whitepaper to find out more about how BIOS is decoding the neural control of the heart with our machine learning technology and read/write software.