I’d like to take a moment to discuss one of the hottest trends in healthcare today, Bioelectronic medicine. The practice is an emerging and rapidly expanding field of healthcare that utilizes the electrical signals within cells to treat and diagnose disease and injury. Through a combination of electrical signaling and biomolecular responses, the human body has the inherent ability to recognize and repair deviations that stray from normal functioning. Bioelectronic medicine uses the body’s native homeostasis mechanism to diagnose and treat disease and injury without the use of medication or invasive medical techniques. Electrical signals simply initiate the process whereby the cell membrane can be penetrated, allowing the signaling between neurons and neurotransmitters, which is controlled by the type of receptors carrying the dedicated signals from the brain.
At BioSig Technologies, our proprietary PURE EP System, a novel biomedical signal processing device, was designed to improve clinical information for electrophysiology studies and cardiac catheter ablation procedures: procedures that test the electrical activity of the heart to determine where an abnormal heart rhythm originates. The PURE EP System is robust, user-friendly, and gives the surgeons the ability to be flexible with the filters, bandwidth and frequency, thus improving the accuracy of the recorded data. Some key features include the ability to see high quality bipolar and unipolar intracardiac signals, improved dynamic range for both large and small signals with similar resolution, and the ability for different filtering options to be applied to the signal. In the future, the great minds at BioSig Technologies, Inc. hope to expand and apply the PURE EP System to multiple fields of bioelectronic medicine, ultimately resulting in shorter hospital stays, cost savings, and more people seeking treatment for often debilitating health conditions.
The current market for bioelectronic medical devices is promising. Increased annual growth rates relate directly to demand. The diagnosis and treatment of the electrical system of the heart, such as the ablation of tissue causing errant signals, is the purest application of bioelectric medicine. The most recent MD&D report shows that global electrophysiology market revenues will grow 10.6% annually, from $4.0 billion in 2016 to nearly $6.65 billion in 2021. The FDA recently presented at the Heart Rhythm Society 2017 and spoke of the importance of technological innovation in the electrophysiology field.
Furthermore, cardiac rhythm implants, such as pacemakers and ICDs used to manage tachycardia and fibrillation, were a $10 billion industry in 2016 that is growing at a 2.6% annual rate. Spinal cord stimulation therapy, such as the implantation of a pulse generator to induce paresthesia to reduce pain, is a $1.7 billion industry, and is growing at an 11% annual rate. Spinal cord stimulation is the most common neurostimulation application at present. Vagus nerve stimulation, the electrical stimulation of the vagus nerve to treat refractory epilepsy, treatment-resistant depression, obesity, anxiety, and chronic migraines, is a $358 million industry, growing at 10%-real annual rate.
The ecosystem of bioelectronic medicine has started to attract some of the biggest names in Silicon Valley. In 2016, Google (Verily Life Sciences) and GlaxoSmithKline have formed Galvani Bioelectronics. The parent companies have agreed to invest up to $715M over the next seven years into the UK headquartered Galvani Bioelectronics. Initial work will centre on establishing clinical proofs of principle in inflammatory, metabolic and endocrine disorders, including type 2 diabetes, where substantial evidence already exists in animal models; and developing associated miniaturised, precision devices.
This sector has tremendous opportunity for growth and is something that we will continue to explore and attempt to leverage to improve competitive advantage, increase market share and enhance overall shareholder value.