Nalu Medical Presents 3-Month Data on the nPower-AUS Study at the 2021 North American Neuromodulation Society Meeting
by CARLSBAD, Calif. (PRWEB) January 15, 2021
Nalu Medical, Inc. (“Nalu”) announces 3-month clinical data from the ongoing Australia nPower-AUS Study were revealed today at the 2021 North American Neuromodulation Society (NANS) Annual Meeting. The nPower-AUS study is a 12-month prospective, multi-center clinical trial scheduled to be completed later this year that evaluates the management of chronic intractable pain of the legs and/or back in 27 subjects implanted with the Nalu Neurostimulation System. Per the study protocol, data is collected at 30, 90, 185 and 365 day intervals post activation.
The Nalu Neurostimulation System, a novel micro implantable pulse generator (mIPG) system enabled by nPower™ technology, is cleared for treating intractable chronic pain using spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS). Key advantages of the Nalu Neurostimulation System are its miniaturized design and lack of implanted battery. Power is supplied externally, which removes common issues associated with implantable batteries1 and need for replacement surgeries2.
Of these 27 subjects implanted, 24 completed 3 months follow-up and the data showed:
- Treatment with the Nalu Neurostimulation System reduced pain in the leg by 79% (n=24; p<0.0001) and the back by 77% (n=23; p<0.0001).
- Treatment response, defined as ≥ 50% pain relief, was noted in 83% (20/24) of subjects treated for leg pain and 78% (18/23) of subjects treated for back pain.
- Overall comfort score for continual wear of the external power source was 0.4 (n=24) with 0 being very comfortable and 10 being very uncomfortable.
- “The favorable patient response to treatment, quality of life improvements, comfort and ease of use are important outcomes for clinicians,” said Dr. Bruce Mitchell of Melbourne Australia and lead investigator in the nPower-AUS Study. “These initial data suggest the Nalu device, an exceptionally small IPG, provides a robust treatment for patients in support of clinical efficacy.”
- “Consistent with our early investigations, the data presented today provide early and additional confirmation of system effectiveness,” said Earl Fender, Nalu’s President and CEO. “We look forward to the 12-month results of this study and those from a multi-center trial (nPower-US) that is underway in the U.S. to study the Nalu Neurostimulation System’s effectiveness in a larger population.”
References:
1. www.fda.gov/medical-devices/letters-health-care-providers/conduct-trial-stimulation-period-implanting-spinal-cord-stimulator-scs-letter-health-care-providers?utm_campaign=2020-09-03%20Conduct%20a%20Trial%20Stimulation&utm_medium=email&utm_source=Eloqua
2. Costandi S, Mekhail N, Azer G, et al. Longevity and Utilization Cost of Rechargeable and Non-Rechargeable Spinal Cord Stimulation Implants: A Comparative Study Pain Pract. 2020;10.1111/papr.12926.
About Nalu Medical
Nalu Medical, Inc. is a privately-held, medical device company located in Carlsbad, California. Our team of seasoned medical device professionals have developed the next generation of miniaturized medical devices. The result is a novel, versatile and upgradeable technology platform that we believe will allow us to address several poorly met needs in the market. Our mission is to modernize, improve, and broaden the therapeutic capabilities of miniaturized medical devices, thus improving lives of people today and addressing the demands of medicine tomorrow.
About the Nalu Neurostimulation System
The Nalu Neurostimulation System, an implanted treatment for managing intractable chronic pain, consists of a fully-featured micro-Implantable Pulse Generator (mIPG™) free of an implantable battery and powered by an externally worn Therapy Disc and controlled by the patient via a smartphone app. The Nalu mIPG is built upon the nPower™ microchip platform that delivers outputs similar to larger IPGs but with additional capabilities around waveforms, programming modes and upgradability. The Nalu mIPG is currently cleared by the FDA for both Spinal Cord Stimulation and Peripheral Nerve Stimulation indications with an expected service life of 18 years. 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 intractable chronic 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, mIPG and nPower are trademarks of Nalu Medical, Inc.