CARLSBAD, Calif.–Nalu Medical, Inc (“Nalu”) is a Carlsbad, California-based company that has successfully miniaturized neurostimulation implants for the management of chronic intractable pain across a variety of targets with both spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) indications. Today the company announces publication of the SCS nPower™ US clinical study in the Pain Physician Journal that reports on clinical outcomes related to the use of the Nalu SCS System to treat patients suffering from chronic intractable pain of the of trunk and/or limbs, including unilateral or bilateral pain.
The SCS nPower US clinical study was a prospective, post-market observational study conducted at 15 comprehensive pain centers in the US. The Nalu Neurostimulation System was evaluated in 35 subjects with chronic low back and leg pain from baseline to 3 months. Highlights of the results include:
- 86% of subjects were “responders” (≥50% pain relief) in the low back and leg(s).
- 54% of subjects in the low back and 49% in the leg(s) were “high responders” (≥80% pain relief).
- 75% average pain reduction in the low back and 76% in the leg(s).
- The wearable Therapy Disc was reported by all patients to be comfortable and easy to use.
- Secondary endpoints regarding sleep, mood, functional disability, and quality of life all demonstrated statistically significant outcomes at 3 months compared with baseline.
According to lead author, Dr. Mehul Desai, “This study demonstrates best-in-class pain outcomes with the added benefit of a battery-free implant and minimally invasive procedure substantiated by a small, 1.5 cm incision. In addition to pain reduction, patients reported holistic improvements that may be attributed to the unique multi-dimensional waveform that potentially addresses up to 6 mechanisms of action simultaneously.”
Tom West, Nalu CEO, said, “In addition to strong clinical outcomes, the Nalu SCS System offers interventional pain specialists a treatment option that traditional SCS systems do not provide: a micro-IPG™ paired with a wearable battery. The implanted, battery-free micro-IPG is cleared by the FDA to last at least 18 years. Therefore, the risks and costs associated with repeated IPG replacement procedures are significantly reduced, while battery replacement surgeries are entirely eliminated. The strong nPower study results in SCS reflect Nalu’s commitment to providing differentiated clinical and health-economic evidence to support the adoption and use of our unique neurostimulation system for chronic intractable pain in both spinal cord stimulation and peripheral nerve stimulation.”
About Nalu Medical
Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.
About the Nalu Neurostimulation System
The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote control app. Despite its small size, the Nalu micro-IPG™ delivers treatment capabilities similar to larger IPGs as well as unique advantages associated with advanced waveforms, extensive programming options, exceptional upgradability, and an expected service life of 18 years. The Nalu System has been repeatedly recognized for its revolutionary technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit www.nalumed.com.
Indications for Use
Spinal Cord Stimulation — The Nalu SCS System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (≤30 days) to determine efficacy before recommendation for a permanent (long-term) device. Peripheral Nerve Stimulation — The Nalu PNS System is indicated for pain management in adults who have severe chronic intractable pain of peripheral nerve origin as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (≤30 days) to determine efficacy before recommendation for a permanent (long-term) device.
Nalu, the Nalu logo, micro-IPG, and nPower are trademarks of Nalu Medical, Inc.
The specific parameters used in the commercial use of the Nalu Neurostimulation System have evolved over time and are now different from the early set of programming parameters used in these clinical studies.
Any medical opinions expressed are those of the physician/medical providers. Individual experiences and outcomes may vary.