By Mary Stuart
Published in the March 13, 2015 Issue (Vol. 2, No. 5)
Medical devices often take a back seat to drugs as a first-line treatment for various diseases and disorders, even though drug therapy can have significant downsides, including compliance issues, cost, and systemic side effects. Implantable devices are often overlooked because of the high costs and risks of surgical procedures and potential complications from long-term implants. However, companies working in the field of neuromodulation are beginning to challenge this status quo. They believe that targeted delivery of electrical fields to specific nerves or organs provides an opportunity to create a local, tailored, and reversible therapeutic effect that rivals drugs. The term “electroceutical” has recently been coined to describe the therapeutic use of electrical impulses in the body, and this growing field has attracted investments from both device and pharma companies.
The field of neuromodulation is most advanced in the treatment of chronic pain. Medtronic Inc. introduced the first spinal cord stimulator to the market in the 1970s. Spinal cord stimulation (SCS) utilizes an implantable power source and leads with electrode contact pads to create electrical fields near targeted nerves in order to modulate their signals to the brain. In the case of pain, the goal is to block the pain signals emanating from nerves that lie along the spinal cord. However, there is a great opportunity for innovative companies that can address the limitations of current SCS devices, which include migration, infection, MRI incompatibility, and lack of efficacy, among other disadvantages.
One young company, Stimwave Technologies, Inc. has set out to do just that. In Q4 2014, Stimwave received FDA clearance for the world’s first injectable, wireless, microtechnology neuromodulation device for the relief of chronic back and leg pain. The clearance was obtained just over three and a half years after the company was founded and on substantially less than $10 million in funding from a group of angels that includes medical device insiders Thomas Fogarty, MD, David Auth, PhD, and Robert Anderson, to name a few. Over one hundred patients have already been implanted with the device, and the company is putting in place the infrastructure for full-scale worldwide commercialization.