Nalu Medical, Inc. is a privately held medical device company specializing in next-generation neurostimulation technology for clinical conditions that remain poorly treated. Based in Carlsbad, California, the company brings together experienced entrepreneurs, engineers, and scientists with expertise in novel medical device technologies. The Nalu Neurostimulation System provides a compact neurostimulation platform for managing intractable chronic pain, reflecting the company’s vision of modernizing medical device technology and improving patients’ lives.

Why Nalu?

The Nalu Neurostimulation System features a compact implantable pulse generator (IPG) that delivers mild electrical impulses to modulate pain signals. The small size of the IPG gives physicians greater flexibility in selecting the implant location for chronic back or leg pain. The system also uses a thin lead that carries electrical pulses from the IPG to the targeted nerve. Nalu’s implant can be removed if the therapy is not suitable, and the system can be evaluated temporarily before permanent implantation.

A wearable Therapy Disc houses the battery and control components and attaches over the implanted IPG with an adhesive clip. The system includes two Therapy Discs, allowing one to be used while the other is charging. The disc can be removed when active stimulation is not required or when patients prefer not to wear it under swimwear or tight clothing. Therapy settings, including stimulation intensity and therapy programs, can be controlled through an iPhone or Android smartphone. Nalu states that its IPG may have a service life of up to 18 years, while the external battery eliminates the need for surgery to replace an implanted battery. System software can also be updated remotely, and the external batteries can be charged and exchanged in less than 60 seconds.

How Nalu Neurostimulation Works

Chronic pain can persist for months or years and may result from age-related changes in bones and joints, injuries that have not healed properly, or peripheral nerve injury and inflammation. Treatment options can include physical therapy, radiofrequency ablation, surgical procedures, over-the-counter and prescription medications, and other neurostimulation systems. When conservative treatments do not provide adequate relief, neurostimulation offers another option for chronic pain management.

Neurostimulation uses leads placed beneath the skin near a peripheral nerve to deliver mild electrical pulses that modulate nerve signals associated with pain. The Nalu Neurostimulation System uses a multi-component, non-integrated configuration comprising an implanted microstimulator, a separate electrode array, and an externally worn Therapy Disc. Physicians determine the appropriate placement of the micro-IPG and leads according to the location of the patient’s pain, while the Nalu app provides remote control of therapy settings.

Engineered for Intractable Chronic Pain

The Nalu micro-IPG uses proprietary advanced microelectronics to deliver electrical stimulation for pain management. The small footprint and external battery are designed to address some of the challenges associated with conventional implantable neurostimulation systems, while eliminating the need for surgery to replace an implanted battery. The multi-component configuration also provides flexibility in how the system is placed and used.

The Nalu Neurostimulation System is FDA-cleared for peripheral nerve stimulation (PNS) indications. It is indicated for pain management in adults with severe, intractable chronic pain of peripheral nerve origin, either as the sole mitigating agent or as an adjunct to other therapies used in a multidisciplinary treatment approach. The system is not intended to treat pain in the craniofacial region. Trial devices are used exclusively for stimulation trials lasting no longer than 30 days to evaluate efficacy before a recommendation for long-term implantation.

Clinical Evidence and Real-World Outcomes

Nalu Medical’s clinical evidence includes data from clinical studies and real-world use of its PNS system. The company reports an “80-50-70” outcome profile, with more than 80% of patients using Nalu, more than 50% achieving at least 50% pain relief by study end, and an average pain reduction of more than 70%. In the COMFORT clinical study, Nalu PNS recorded an 87% responder rate, defined as at least 50% pain relief, with 69% average pain relief. At 12 months, 92% of patients reported being satisfied or very satisfied with the system.

The company also reports real-world evidence covering more than 2,300 patients, 33 nerves and 34 nerve combinations, representing more than 4 million patient days of data. Nalu reports a 50% reduction in total medical costs one year after implantation compared with the year before implantation, along with reductions in opioid use, pharmacy costs, outpatient costs, and physician visits. Together, these clinical and real-world data provide evidence on pain relief, patient satisfaction, system use, and healthcare utilization associated with Nalu PNS.

THOMAS A. WEST | PRESIDENT & CEO

Thomas A. West has served as President and Chief Executive Officer of Nalu Medical and as a member of its board of directors since August 2022. Before joining Nalu, he served as President, CEO, and director of Intersect ENT from 2019 to 2022. Intersect ENT was acquired by Medtronic in May 2022. From 2015 to 2019, West served as Worldwide President of Diagnostic Solutions at Hologic.

West began his healthcare career at Johnson & Johnson, where he spent 23 years in leadership roles, including Worldwide President of Strategy and Business Development for the J&J Family of Diabetes Solutions Companies, Division President of LifeScan North America, and Division President of LifeScan EMEA. He has also served as an independent member of the Orthofix board of directors since 2021. West holds a B.A. in Politics and Economics from Princeton University and an M.B.A. from the University of Pennsylvania’s Wharton School.