Xavant Technology is set to start selling its neuromodulation device for the treatment of pain in the U.S. through Bell Medical. The move follows the receipt of 510(k) clearance from the FDA, which deemed the device similar enough to Bioinduction’s Acticare to come to market.
Pretoria, South Africa-based Xavant’s Stimpod NMS460, like Acticare, is a transcutaneous electrical nerve stimulation (TENS) device. Such devices deliver electrical impulses to the affected area to cut the transmission of pain signals to the central nervous system. In the case of NMS460, the pulses are delivered by a handheld, low-frequency neuromodulator to provide symptom relief to patients with chronic intractable pain and help people suffering from pain after surgery or trauma.
Xavant designed Stimpod NMS460 to achieve these outcomes by equipping it to deliver two types of waveform, namely a monophasic square wave and a hybrid PRF waveform. The second of these waveforms is unique to NMS460. But the FDA ruled the device is sufficiently similar to Acticare to win 510(k) clearance despite the use of the novel waveform, which combines the monophasic wave with a radiofrequency wave.
With Acticare having notably higher peak current, average phase current and net charge than the NMS460, Xavant is looking to the novel waveform and design of the device to set it apart. The device features a nerve stimulator mapping probe based on that found in the NMS400, which Xavant believes makes it easier to identify the nerve and direct the current.
Competition within the TENS niche and wider pain market, plus Medicare’s 2012 rejection of the technology’s use in the treatment of chronic low back pain, suggests Xavant will do well to turn NMS460 into a big product. But CEO Corlius Birkill has sky-high aspirations nonetheless.
"We are thrilled at the news that our revolutionary device can now be used in the U.S.,” Birkill said in a statement. “This groundbreaking technology has the ability to help tens if not hundreds of millions of people just in the U.S.”