Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.
"We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux™ technology. This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain. We are eager to closely collaborate with the FDA as Wavegate works toward advancing the state of the art."
Erich Wolf, MD, PhD, Chief Executive Officer
"This designation underscores the urgent need within our society for more effective treatments of chronic, debilitating pain."
StimuLux™ is a component of Wavegate Corporation's Ellipse neuromodulation platform which integrates multiple patented technologies which aim to systematically address unmet clinical needs within the neuromodulation industry.
About Wavegate Corporation
Wavegate Corporation is a privately-held start-up neuromodulation company focused on developing and commercializing a suite of technological innovations including: waveform-independent closed-loop adaptive stimulation, a stimulation paradigm for modulation of both ascending and descending spinal cord pain pathways, new implant geometry for reduced surface contact pressures, rapid lead anchoring, and others.