Nalu Medical Secures $85 Million Series E Financing to Advance Minimally Invasive Chronic Pain Management Platform

Mar 13, 2024 09:00 CST Updated 09:00

Nalu Medical

Medical Device Developer

B Capital Group

Venture Capital Firms

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On March 6, Nalu Medical, a provider of long-term pain management solutions, completed an $85 million Series E financing round led by B Capital. Nalu offers a miniaturized implantable pulse generator (IPG) to alleviate chronic pain in patients. The company intends to use the proceeds to accelerate commercial growth, expand clinical and health economics evidence, continue product development, and scale up operations.

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Nalu Medical, founded in 2014 and headquartered in California, USA, specializes in developing minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System is a battery-free, micro-implantable pulse generator (IPG) that has received FDA approval for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) to alleviate chronic pain.

01 Chronic Pain Management Needs

Chronic pain is one of the most prevalent health issues today, severely impacting patients' quality of life. According to a WHO report, chronic pain affected 30% of the global population in 2019. In China, there are over 300 million individuals suffering from chronic pain, with 10 to 20 million new cases annually, and the patient demographic is showing a trend toward younger ages.

For chronic pain, current treatment modalities still fail to meet patients’ true needs. For example, although opioid analgesics can alleviate pain, their widespread use readily leads to drug tolerance and addiction. In recent years, spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), based on the “gate control theory of pain,” have gradually become important options for treating chronic pain and are internationally recognized as advanced therapies.

Due to the vast market size and high technical barriers, this market is primarily dominated by Medtronic (34%), Abbott (29%), and Boston Scientific (23%), which collectively account for over 80% of the neuromodulation market. However, their products are of the conventional type, consisting of an implantable pulse generator (IPG), electrodes, a test stimulator, a charger, and an external controller.

Implantable pulse generators are generally bulky, resulting in poor patient comfort post-implantation, while their operational complexity leads to a steep learning curve for physicians. Additionally, the high cost of traditional stimulators makes the expensive treatment unaffordable for many patients. Furthermore, the limited battery capacity of implantable pulse generators results in a short service life, making lifespan extension a key focus for the three major industry leaders.

02 Nalu Neurostimulation System

The Nalu System consists of a fully functional, battery-free, miniaturized implantable pulse generator (IPG) that is wirelessly powered by an external therapy disc and controlled via a smartphone-based remote control application. Despite its compact size, Nalu’s miniature IPG delivers therapeutic capabilities comparable to those of larger IPGs, with a system lifespan of 18 years. The Nalu Neurostimulation System has currently received FDA approval for spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) indications.

The system implanted in the patient consists of two components. One is the implantable pulse generator (IPG), which generates mild electrical pulses to interrupt pain signals before they reach the brain. The compact size of the Nalu micro-IPG allows for more flexible placement in the optimal position to treat chronic pain. The other component of the implanted system is the lead, which is positioned near the nerve area most likely to alleviate chronic pain, delivering the pulses generated by the IPG to the spinal cord or affected nerves to block pain signals.

The Therapy Disc is part of the Nalu Neurostimulation System, capable of wirelessly driving and sending stimulation commands to the Nalu Implantable Pulse Generator. The Therapy Disc is placed over the implant using an adhesive fixation clip or a relief strap, and can be controlled via integrated buttons or through a remote control application. In the initial Nalu kit, users will receive two Therapy Discs, which can be alternately charged and used.

The pain management system of the Nalu micro-IPG effectively alleviates chronic, intractable pain while minimizing disruption to patients’ lives. Among commercially available IPGs, the use of an external battery with the smallest footprint and a miniature IPG mitigates the adverse effects associated with implanted neurostimulation therapy. The Nalu Neurostimulation System features the following:

Compact Size: It is 1/27 the size of the largest commercially available IPG.
Minimally Invasive: A small device implanted subcutaneously.
Battery-Free System: Power is supplied externally by a replaceable wearable treatment pod, eliminating the need for implanted batteries and battery replacement surgery.
Easy to operate: Users can control the device via the therapy tray or mobile app.
Highly Upgradable: Wireless software upgrades without surgery.
Long-lasting Use: The micro-IPG has received FDA approval, with an expected service life of 18 years, for the long-term treatment of chronic intractable pain.
Reversible: If the patient chooses not to continue treatment, the physician may remove them.

In November 2023, the Company released clinical results on the use of the Nalu SCS System for treating patients with chronic, intractable pain in the trunk and/or extremities. All patients reported that the wearable therapy disc was comfortable and easy to use. Compared to baseline, secondary endpoints related to sleep, mood, functional impairment, and quality of life all demonstrated statistically significant improvements at three months. At the 2024 Annual Meeting of the North American Neuromodulation Society, Nalu presented interim data from the COMFORT RCT, further validating that the Nalu PNS System can provide sustained pain relief and improve quality of life. These findings reflect Nalu’s commitment to generating differentiated clinical and health economic evidence to support the broader adoption of its neuromodulation system products.

Author: Zhang Qiankun

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