Neuronoff, a Cleveland-based neuromodulation company, has completed a three-month chronic large animal study demonstrating that its Injectrode platform can connect to off-the-shelf implantable pulse generators through standard Bal Seal connectors, removing a barrier that has kept minimally invasive electrodes out of long-term clinical use.
The Injectrode is a tripolar electrode with a helical platinum-iridium architecture, roughly 1.5 millimetres wide, delivered through an 18-gauge needle. That is small enough to eliminate the one- to two-inch incisions that remain standard practice for implanting spinal cord stimulators and other neuromodulation leads. In the animal study, a single remotely controlled IPG independently stimulated three anatomically distinct neural targets — the lumbar dorsal root ganglion, the lumbar dorsal ramus, and the sacral S2 foramen — each through its own Injectrode lead.
The connector compatibility is the commercially significant detail. Neuromodulation hardware today relies on proprietary lead-IPG pairings: a Medtronic lead works with a Medtronic generator, a Boston Scientific lead with a Boston Scientific generator. By using industry-standard Bal Seal connectors, Neuronoff is positioning the Injectrode as a universal front end. “Any IPG can now reach any nerve a physician can access with a needle,” said CEO Manfred Franke.
The company closed an oversubscribed $4.5 million round in late 2025, with participation from MedTech Angels. The funds are directed at scaling production to 1,000 units per year and preparing a limited United States launch. Neuronoff is targeting a 510(k) submission to the FDA by mid-2026 for an externally powered version of the system, with a fully implantable IPG-compatible configuration to follow.
One element of the commercial strategy is reimbursement. The Injectrode procedure aligns with existing CPT codes 64555 and 64590 for peripheral nerve stimulation, meaning physicians can bill for it without waiting for new payer codes to be established. The company estimates payer costs would fall by more than fifty per cent relative to conventional surgical implants.
Neuronoff has already passed a first-in-human milestone for lower back pain with no serious adverse events reported, though the company has not disclosed detailed clinical data from that trial. The target population is large: the company cites more than 50 million Americans living with chronic pain who currently lack alternatives beyond opioids and conventional surgery. Beyond pain, the platform’s ability to reach multiple nerve targets from a single generator opens potential applications in autonomic disorders, bladder dysfunction, cardiac conditions, and inflammatory disease.
The neuromodulation sector has seen a wave of miniaturisation and procedural simplification over the past year, from SetPoint Medical’s vagus nerve stimulator for rheumatoid arthritis to Flow Neuroscience’s at-home tDCS for depression. Neuronoff’s approach is distinct in that it does not build its own pulse generator at all, instead piggybacking on the installed base of existing IPG hardware and the physician workflows already built around it. Whether that IPG-agnostic model survives contact with device manufacturers who profit from proprietary ecosystems will be one of the commercial questions to watch as the company moves toward its launch.