CORRECTING and REPLACING Nalu Medical, Inc. Presents Long-term and Holistic Outcomes from the COMFORT RCT for PNS at NANS 2024

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NALU MEDICAL, INC. PRESENTS LONG-TERM AND HOLISTIC OUTCOMES FROM THE COMFORT RCT FOR PNS AT NANS 2024

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, presented interim data from the landmark COMFORT randomized controlled trial (RCT) at the 2024 North American Neuromodulation Society (NANS) Annual Meeting in Las Vegas, Nevada.

The ongoing COMFORT RCT is a randomized, controlled, post-market, open-label, minimal risk, multi-center clinical study focused on evaluating the effectiveness of peripheral nerve stimulation (PNS) therapy with the Nalu Neurostimulation System to treat chronic pain in the shoulder, low back, knee, or ankle/foot. The study is designed to develop 3-year data to demonstrate the sustained pain relief and quality of life improvements achievable with the Nalu PNS system.

Interim 12-month pain relief data (n=15)¹

• 87% of subjects were responders (≥50% pain relief)
• 73% average pain reduction

Holistic outcomes at 3 months (n=72)²

According to Dr. John Hatheway, first author and presenter of the oral report, “Clinicians recognize the value of combining pain relief with functional outcomes to provide a more comprehensive assessment of device effectiveness in treating chronic, intractable pain. In the COMFORT RCT, we are measuring variables that present this broader picture. Results show that the Nalu PNS System is truly unique. For the first time, clinicians have access to advanced technology that enables us to offer effective long-term therapy to a broader range of patients.”

Highlights of the presentation include the following:

• 98% of subjects using Nalu PNS experienced ≥50% pain relief and/or reported improvement compared with 21% of subjects who did not use Nalu PNS (p<0.001).
• 93% of subjects using Nalu PNS experienced ≥50% pain relief and/or reduced disability compared with 35% who did not use Nalu PNS (p<0.001).

“We are thrilled to see such promising results from our advanced micro-IPG in a rigorous RCT setting,” said Tom West, Nalu CEO. “The COMFORT RCT is intended to provide reliable evidence of the sustained effectiveness and impact on quality of life provided by Nalu PNS therapy and to expand the use of Nalu PNS to patients for whom physicians have limited options. Our approach to this research underscores our commitment to take a leadership role in generating evidence for continued and extended application of effective PNS therapy for chronic pain sufferers.”

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 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. Engel M, Song J, Guttierez G, et al. A report on interim long-term pain outcomes from the COMFORT PNS RCT. Presented at: North American Neuromodulation Society (NANS); January 18-21, 2024; Las Vegas, NV.

2. Hatheway J, Hersel A, Song J, et al. Composite (combined) outcomes from the COMFORT PNS RCT. Presented at: North American Neuromodulation Society (NANS); January 18-21, 2024; Las Vegas, NV.

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