Nalu Medical, Inc., Announces Publication of Two Spinal Cord Stimulation Clinical Studies

Both studies report on clinical outcomes related to the use of the Nalu proprietary, multidimensional Pulsed Stimulation Pattern (PSP) waveform

Excerpt from the Press Release:

CARLSBAD, Calif.–(BUSINESS WIRE)–Nalu Medical, Inc. (“Nalu”), a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the management of chronic intractable pain for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications, announces the publication of two key studies in Neuromodulation: Technology at the Neural Interface.One publication discusses the potential mechanisms of action (MOAs) leveraged by a novel, multidimensional waveform Pulsed Stimulation Pattern (PSP) and the results of a pilot clinical study. The other publication reports on interim results from a first-in-human SCS clinical study evaluating the safety and performance of the Nalu Neurostimulation System, composed of a micro-implantable pulse generator (micro-IPG™) and a wearable Therapy Disc (power source and stimulation control).

Following are some highlights of the PSP pilot study report on the theory behind and design of the multidimensional PSP waveform along with pilot study results from 31 patients with chronic intractable pain:

• The PSP waveform is composed of three independently configurable temporal dimensions designed to target different MOAs.
• PSP yielded a greater reduction in both back and leg pain than traditional SCS (Back: -60% vs. -46%; Legs: -63% vs. -43%).
• PSP yielded higher responder rates for both back and leg pain compared with traditional SCS (61% vs. 48% and 78% vs. 50%, respectively).

“Up until now, neurostimulation waveforms for SCS have been a ‘one-note proposition’ for pain relief. One waveform leverages one unique MOA, much like playing a single musical note,” said Dr. Mehul J. Desai, President and Medical Director of the International Spine Pain & Performance Center and lead author of the PSP pilot study publication. “Pulsed Stimulation Pattern is more like playing a musical chord. Multiple MOAs are leveraged simultaneously for multimechanistic therapeutic relief. This represents an exciting new era for SCS, where we may provide patients with ‘broad-spectrum’ relief that may address their evolving pain patterns over the long term.”

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