Neuronoff
Cleveland neuromodulation company developing the Injectrode, a peripheral nerve electrode delivered through a single needle under local anaesthesia. Announced its first patient implant in a US Department of Defense-funded bladder-control trial for people with spinal cord injury in June 2026.
Overview
Neuronoff, led by chief executive Manfred Franke, is developing the Injectrode, a tripolar helical platinum-iridium electrode about 1.5 millimetres wide that is delivered to a peripheral nerve through an 18-gauge needle. The procedure avoids the incision of one to two inches used to place conventional neuromodulation leads. The company has reported a first-in-human milestone in lower back pain with no serious adverse events, without publishing detailed data.
Business model
Neuronoff does not build its own pulse generator. In a three-month large-animal study disclosed in April 2026, the Injectrode connected to off-the-shelf implantable pulse generators through industry-standard Bal Seal connectors, with one generator driving three separate nerve targets. The procedure maps to existing peripheral nerve stimulation CPT codes 64555 and 64590, so physicians can bill for it without new payer codes.
Latest
On 5 June 2026 Neuronoff announced the first patient implanted in a DoD-funded Phase 1/2 trial (NCT07264868) at UT Health Houston, led by Argyrios Stampas. The randomised, double-blind trial plans to enrol 21 people with neurogenic bladder after spinal cord injury across unilateral, bilateral and sham arms. Primary endpoints at four and eight weeks measure device performance, so the first readout will not establish clinical benefit.
Why it matters
If the bladder trial shows benefit, the Injectrode would compete in the same clinical space as Medtronic InterStim and implantable tibial stimulators, with a simpler procedure. Whether makers of proprietary lead and generator systems accommodate a generator-agnostic electrode is the open commercial question.
Coverage on InsideBCI
- 13 July 2026: The BCI category is broadening beyond motor restoration in 2026
- 6 June 2026: Cleveland startup Neuronoff implants its first patient in a US Department of Defense-funded trial of a needle-delivered nerve electrode for bladder control after spinal cord injury
- 5 April 2026: Neuronoff’s Needle-Delivered Electrode Works With Standard Pulse Generators in Chronic Animal Study