Bioelectronics, generally defined, isn't new. Doctors Rune Elmqvist and Ake Senning implanted the first pacemaker in 1958. FDA approved the first spinal cord stimulator (SCS) in 1989.
While both solutions continue to help patients worldwide, smaller, more advanced technology has pushed bioelectronics into a new era. Researchers have developed novel methods to use electrical impulses to regulate the brain and/or nervous system, resulting in highly targeted, effective treatment.
"While SCS benefits last as long as the device stimulates, and the pacemaker continually keeps the heart on path, we treat and hope to modify the core underlying disease," said Anthony Arnold, CEO of SetPoint Medical, which develops bioelectronic therapy for chronic inflammatory diseases such as rheumatoid arthritis and Crohn's Disease. "Our device delivers a one- to four-minute dose per day—much like a drug—and then the body takes over."
Unlike a drug, SetPoint's device and others don't course through the bloodstream, causing unwanted side effects. This advantage, combined with an aging population, a rise in chronic disease and a move toward personalized medicine, has led to a new current of bioelectronics interest.
"This industry has the potential to disrupt the healthcare market," said Natasha Russkina, vice president of business development and corporate finance for BioSig Technologies. "We have large patient population with unmet clinical needs. We've seen significant breakthroughs in pharmaceuticals, but for a lot of people, they don't work. And often they don’t heal the underlying issue. Bioelectronic medicine explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases, thus essentially helping the body heal itself. With SCS alone, we've already seen people get their lives back."
GSK's Ambitious Investment
Bioelectronics got a jolt of attention when GlaxoSmithKline (GSK) and Google's Verily Life Sciences, an Alphabet company, teamed to form Galvani Bioelectronics. The two companies plan to invest about $700 million over seven years.
“Together, we can rapidly accelerate the pace of progress in this exciting field to develop innovative medicines that truly speak the electrical language of the body," said Moncef Slaoui, GSK’s Chairman of Global Vaccines.
Initial work will focus on inflammatory, metabolic and endocrine disorders, including type 2 diabetes. Galvani believes its first bioelectronic medicines could be ready within the next eight years.
Bioelectronics For Inflammation
Arnold believes SetPoint will have its platform on the market well before Galvani's estimated arrival. He's probably right.
In June, the company announced positive clinical results from a proof-of-concept study using bioelectronic technology to treat Crohn's Disease. Results showed more than 60% of patients achieved significant disease reduction.
Arnold says SetPoint is currently evaluating the system in U.S. clinical studies. The company estimates it will receive FDA clearance in the next few years.
SetPoint bases its platform on the Inflammatory Reflex, a mechanism discovered by SetPoint cofounder Kevin Tracy. The Inflammatory Reflex regulates the immune system by way of the central nervous system. By activating the Inflammatory Reflex with targeted electrical pulses to the vagus nerve, the body produces a systemic anti-inflammatory response.
"In patients with Crohn's or RA, the body is imbalanced," said Arnold. "Our technology is designed to regulate the body’s response by helping drive the biology to do its own job."
Clinical trial subjects receive a tiny rechargeable implant on the left vagus nerve. An iPad control application allows physicians to administer and manage electric doses.
Improving Signal Fidelity
Although BioSig's Pure EP doesn't directly treat disease, its advanced signal processing technology has potential to improve performance of other devices. It may also improve outcomes for atrial fibrillation (Afib), and ventricular tachycardia (VT) patients.
Afib and VT's abnormal heartbeats are characterized by high-frequency electrical signals that current devices can't easily see. Pure EP records and displays these high-frequency cardiac signals while reducing background noise and artifacts so clinicians can more precisely locate the tissue to ablate.
Pure EP's advanced bioelectric signal detection got the attention of Mayo Clinic, which signed a 10-year agreement to develop Pure EP applications. "Mayo Clinic was instrumental in our product development," said Russkina. "Our collaboration is structured around intellectual property and future technology development. We plan to establish new applications based on our core signal processing technology and determine where our signal processing competency can be of biggest benefit."