Stimwave Receives FDA Clearance for Opioid-Free Pain Management Wireless System

Stimwave Technologies, an innovator of wireless medical device bioelectronic technology, has received U.S. Food and Drug Administration (FDA) clearance for the WaveCrest Mobile iOS Platform patient controllers for opioid free pain management. This new system now gives patients iPhone and Apple Watch mobile control over WaveMaster multi-waveform automated programming for the Wireless Freedom Spinal Cord Stimulator (SCS) System for relief of chronic pain. The Freedom SCS System is the world’s first wireless, fully-programmable SCS neuromodulation device providing a life-changing technological breakthrough for the more than 90 million people in the United States who endure daily chronic back and leg pain.
 
WaveCrest Mobile allows a patient to use an iPhone, iPod touch, or Apple Watch to adjust their pain relief therapy. This is the first FDA-cleared software that allows the AppleWatch to control a neuromodulation device implanted inside the body. The software is designed to be easy to use and secure. WaveCrest Mobile enables pain sufferers to fine-tune the power level, visualize battery life, and modify programs that were pre-programmed by their clinician to control pain without opioids.
 
“Pain suffers are rapidly migrating to the Stimwave Freedom wireless pain relief system as an opioid free option to control their pain- and now they can adjust their therapy with the swipe of their finger through their Apple Watch or iPhone/iPod Touch discretely any time as needed,” said Stimwave Chairman and CEO Laura Tyler Perryman. “Transformation of pain treatment moving from opioids and pills to interventional solutions like Stimwave can only happen as a result of empowering the masses to take control of their pain, which is now as easy as 1-2-3 with WaveCrest Mobile.”
 
Stimwave’s Freedom Stimulators are implanted in an outpatient procedure with no need for general anesthesia, a large surgical incision or a bulky internal battery known to lead to numerous complications from other legacy older technologies. These products are expected to significantly reduce the lifetime cost of care for chronic pain patients and offer a safe, viable and effective alternative to opioids.
 
“Patients’ needs in pain management are unique and customized programming is a must. The Freedom System not only is the smallest option available for patients eliminating the complexities of an implanted lithium ion battery, but offers a wide variety of advanced programming features that the patient can choose through their mobile device,” said Dr. Ellen Lin, M.D., medical director of San Antonio’s Advanced Spine and Pain Center. “WaveCrest Mobile provides patients with a high-tech approach to controlling their pain through their mobile device and future features and upgradeability options they never had before.”
 
Utilizing the Stimwave Freedom System, clinicians utilize an iPad application to easily program the system using WaveMaster advanced therapy waveforms offering the ability to provide patients with the an array of programming waveforms, frequencies and combinations of options to ensure long term pain relief, all selectable from the AppleWatch or iPhone controller.
 
Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management.