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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.