CareFirst BCBS Recognizes Nalu Neurostimulation System as Medically Necessary for Chronic Peripheral Pain, Expanding Access to 3.5 Million Covered Lives

CARLSBAD, Calif.--(BUSINESS WIRE)--Nalu Medical, Inc., a leader in miniaturized neuromodulation therapies for chronic neuropathic pain, is pleased to announce that CareFirst BCBS has issued an updated medical coverage policy designating the Nalu Neurostimulation System as medically necessary in treatment of chronic pain of peripheral origin. This change, effective August 4th, 2025, follows a review by CareFirst of Nalu clinical data, inclusive of the recently published COMFORT 2 confirmatory randomized control trial, and marks an important milestone in Nalu’s mission to expand patient and physician access to safe, innovative, drug-free alternatives for chronic pain relief.

This policy shift moves Nalu from its prior classification of “Investigational/Experimental” to “Medically Necessary” for eligible patients—opening access to more than 3.5 million additional covered lives in the Washington DC, Maryland and Northern Virginia area.

“CareFirst BCBS recognition of Nalu as a medically necessary therapy is a powerful validation of our technology, clinical evidence, and commitment to patient outcomes,” said Tom West, President and Chief Executive Officer of Nalu Medical. “We’ve built a robust body of published clinical data demonstrating that Nalu PNS provides safe, effective, and durable relief for patients living with chronic, intractable pain. These strong clinical results are further supported by health economic data demonstrating that use of Nalu PNS results in significant cost savings. We're proud to see a leading payer like CareFirst acknowledge that value, and we look forward to engaging with other health plans to expand access to this life-changing therapy.”

Chronic peripheral nerve pain is often debilitating and unresponsive to conventional therapies, including long-term medication and surgery. The Nalu Neurostimulation System offers a minimally invasive, drug-free alternative that delivers precise electrical stimulation to targeted peripheral nerves, providing long-lasting relief while reducing the risks of opioid dependency and avoiding systemic side effects.

About the Nalu Neurostimulation System

The Nalu System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG)¹ 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.

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.

Indications for Use

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.

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.

Nalu and the Nalu logo are trademarks of Nalu Medical, Inc.

[1] Data on file, Nalu Medical, Inc. 2025.