● On Market

Nalu Neurostimulation System

Nalu Medical — Neuromodulation Private

Overview

The Nalu Neurostimulation System from Nalu Medical reimagines spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) by replacing the large implanted pulse generator (IPG) with a miniaturized microchip — the world's smallest fully-implanted neurostimulator — that is powered transcutaneously from an external wearable device called the Patient Therapy Manager (PTM).

Conventional SCS systems require implanting a battery pack roughly the size of a deck of cards in the patient's flank or buttock, with replacement surgeries every 3–5 years. Nalu's approach implants only the chip — a device roughly the size of a large vitamin — directly at the spine or peripheral nerve target, while the battery and electronics remain in a small wearable worn on the body.

This architecture eliminates the most common complication drivers in SCS: battery depletion requiring revision surgery, lead-to-IPG connector failures, and IPG pocket pain. The system received FDA PMA approval in 2021 and is in active commercial expansion across US pain management practices.

Key Technology

🔬
Micro-IPG Architecture
Implanted chip is just 1.7cc in volume — implanted directly near target nerve tissue, not in a remote body pocket. Eliminates long lead extensions and connector failures.
📡
Transcutaneous Power Transfer
External PTM wearable delivers power and data wirelessly through the skin to the implanted chip. Patient wears PTM only during therapy sessions.
⚙️
SCS + PNS Capability
Single platform covers both spinal cord stimulation for axial and limb pain and peripheral nerve stimulation for focal pain syndromes.
🔋
No Battery Replacement Surgery
Because the implanted chip carries no battery, the IPG component never needs surgical replacement. External PTM is rechargeable and user-replaceable.

Indications

Chronic Back Pain Failed Back Surgery Syndrome Leg & Arm Pain Complex Regional Pain Syndrome Peripheral Nerve Pain

Regulatory Timeline

2015
Nalu Medical founded; micro-IPG concept development begins
2018
IDE study initiated; first-in-human implants completed in Europe
2021
FDA PMA approval for SCS; US commercial launch begins
2023
PNS indication expanded; next-gen PTM wearable released
2025
Growing commercial adoption; Series D financing closed for market expansion

Competitive Landscape

Differentiation vs. Medtronic/BSC/Abbott
Architecture vs. Conventional SCS
Medtronic, Boston Scientific, and Abbott all use traditional large-IPG architectures requiring flank implant and periodic battery replacement. Nalu's externalized power model is the only commercial alternative to eliminate implanted batteries entirely.