Nalu Medical Inc., announced the release of a next-generation Therapy Disc—a significantly smaller, lighter and more comfortable version of the external wearable that powers the Nalu micro-IPG^TM. With a 39% reduction¹ in volume from its previous generation, the new Therapy Disc enhances the overall patient experience, while preserving the system’s unique advantages. With this advancement, the Nalu Neurostimulation System may be an option for more individuals seeking relief from chronic pain to be treated using peripheral nerve stimulation (PNS).

This design improvement builds on the Nalu commitment to delivering a more patient-friendly approach to PNS. The unique design of the Nalu System, featuring a small, implanted pulse generator powered wirelessly by an external wearable disc, offers several advantages over traditional, fully implanted systems. By keeping the battery outside the body, the Nalu System enables a less invasive implant procedure, avoids the need for future battery replacement surgeries, and provides greater comfort, especially for patients targeting nerves in more sensitive or mobile areas of the body.

“This launch strengthens our ongoing mission to expand access and make peripheral nerve stimulation therapy a therapeutic option for a broader patient population,” said Tom West, CEO and President of Nalu Medical. “With our next generation Therapy Disc, more individuals seeking relief from chronic pain have options to be candidates for this clinically proven PNS therapy.”

Physicians are already seeing the impact of this next-generation design in clinical settings. Dr. Eric G. Cornidez, MD, MBA, Managing Partner & Chief Medical Officer, Pain Institute of Southern Arizona, who has been using the new Therapy Disc during its limited release, emphasized the significance of this product offering: “The Nalu System has consistently shown strong patient acceptance in our practice. With the reduced size of the next-generation Therapy Disc, we’re now able to expand its use to more nerve targets, particularly in the upper and lower extremities. In our experience, the new design has improved both comfort and overall patient satisfaction, providing the opportunity to enhance patient care.”

The Nalu System is supported by what we believe to be one of the largest real-world clinical data sets in PNS including both randomized control trials, real-world clinical evidence and health-economic data. The introduction of the next-generation Therapy Disc establishes Nalu as a leader in wearable neurostimulation and underscores a commitment to improving chronic pain therapy through meaningful, insight-driven innovation.

About Nalu Medical, Inc.

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 Neurostimulation 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 advantages associated with advanced waveforms, extensive programming options, robust software upgradability, and an expected service life of 18 years. The Nalu Neurostimulation 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 and ranking number 19 in the 2023 Deloitte Technology Fast 500. 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, and micro-IPG are trademarks of Nalu Medical, Inc.

[1] Data on file, Nalu Medical, Inc.

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