What Neuronoff does

Neuronoff, Inc. is a privately held, development-stage medical device company developing the Injectrode platform — a minimally invasive neuromodulation system in which a platinum-iridium helical microwire electrode is delivered percutaneously through an 18-gauge needle and self-anchors beneath the skin to create a low-impedance path for electrical signals from an external pulse generator to a target nerve. The platform is being positioned as an alternative to invasive neuromodulation surgeries and to repeated corticosteroid injections for the treatment of chronic pain, with a procedure time under 20 minutes designed to fit standard pain clinic workflows. The core commercial product is the PNS Injectrode F1 System, comprising the implanted Injectrode, an external pulse generator, hydrogel stimulating patch electrodes, and clinician and patient remotes; a Handshake Adapter extends compatibility to incumbent Implantable Pulse Generators (Medtronic, Boston Scientific, Abbott, Nevro, Biotronik) for chronic long-term use after a 90-day 'Try Lead' evaluation period.

The company pursues a direct enterprise sales motion targeting interventional pain physicians, spinal surgeons, podiatrists, and pain management specialists, with a limited U.S. launch planned for 2026 following an FDA 510(k) submission targeted for mid-2026. Production is being scaled to 1,000 units annually, and reimbursement is being prepared around existing CMS codes 64555 (PNS placement) and 64585 (removal). The company has secured $9.1 million in non-dilutive grants from the DOD, NIH, DARPA, In-Q-Tel, and Ohio Third Frontier, and closed an oversubscribed $4.5 million seed financing round in October 2025. A wholly-owned subsidiary, Calm Medical, is being built to commercialize bladder dysfunction indications, and additional research is exploring cardiovascular (baroreceptor activation) and neurodegenerative applications. Neuronoff holds ISO 13485 and MDSAP certifications and operates from Cleveland, Ohio.

Name

Neuronoff

Legal name

Neuronoff, Inc.

Website

https://neuronoff.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Neuronoff is a Cleveland-based, pre-revenue medical device company developing the Injectrode — a minimally invasive, 18-gauge needle-delivered helical electrode for percutaneous neuromodulation to treat chronic pain and bladder dysfunction. The company is preparing an FDA 510(k) submission and limited U.S. launch in 2026, targeting interventional pain physicians and pain management specialists.

Ownership category

akta.pro rank

Product category

Neuromodulation Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK)

akta.pro secondary industries

Pain Medicine (Interventional/Neuropathic Pain) (HLAKAIAM), Neurourology & Voiding Dysfunction (HLAKAOAI)

Keywords

• Minimally invasive neuromodulation
• Peripheral nerve stimulation devices
• Implantable medical electrodes
• Chronic pain treatment devices
• External pulse generator systems

Headquarters

HQ city

Valencia

HQ country

Spain

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Supply Chain, Operations, Others, Marketing or Sales

Revenue model

1. Medical Device Sales: Neuronoff plans to commercialize the Injectrode system for chronic pain treatment following FDA clearance. The company is ISO 13485 and MDSAP certified, enabling international market access. Production scaling to 1,000 units annually is planned ahead of 2026 U.S. launch.
2. Research Grants and Partnerships: The company has secured $9.1 million in competitive grants from federal agencies (DOD, NIH) and state programs to advance the Injectrode platform. Additional grant applications are in process for clinical stage neurogenic and overactive bladder use cases.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Neuronoff develops and manufactures the Injectrode, a minimally invasive helical platinum-iridium electrode delivered through an 18-gauge needle for percutaneous peripheral nerve stimulation. The complete PNS Injectrode F1 System pairs the implanted electrode with an External Pulse Generator (EPG), hydrogel stimulating patch electrodes, and clinician and patient remotes to deliver drug-free neuromodulation for chronic pain. The platform is currently investigational, targeting FDA 510(k) clearance and a limited U.S. launch in 2026, with planned expansion into bladder dysfunction (via subsidiary Calm Medical), hypertension, and neurodegenerative disease indications.

Product overview

Neuronoff offers the Injectrode platform, a minimally invasive neuromodulation system designed to treat chronic pain and other conditions without surgery or drugs. The core product is the Injectrode, a helical electrode delivered via 18-gauge needle. The complete PNS Injectrode F1 System includes the Injectrode, External Pulse Generator (EPG), stimulating patch electrodes, clinician and patient remotes. The platform supports a Try Lead program for 90-day trials and envisions chronic use via Handshake Adapters connecting to IPGs or inductively powered Receivers. A subsidiary, Calm Medical, focuses on bladder dysfunction applications. The platform targets multiple therapeutic areas including chronic pain, bladder dysfunction, and hypertension, with the Injectrode compatible with major IPG manufacturers (Medtronic, Boston Scientific, Abbott, Nevro, Biotronik) via standard connectors.

Differentiator

Problem solved

Functional benefit

Brands

• Calm Medical: Wholly owned subsidiary of Neuronoff created to commercialize the Injectrode platform for bladder dysfunction (neurogenic and overactive bladder conditions).
• Try Lead
• True Lead

Products and services

• Injectrode A minimally invasive helical platinum-iridium microwire electrode delivered via 18-gauge needle for percutaneous peripheral nerve stimulation and neuromodulation treatments. The device creates a low impedance path for electrical signals from beneath the skin to target nerves, treating chronic pain and other conditions without surgery or drugs. For use by interventional pain physicians and pain management specialists.
• PNS Injectrode F1 System The complete peripheral nerve stimulation system consisting of the Injectrode implant, External Pulse Generator (EPG), stimulating patch electrodes, clinician programming remote, and patient remote. Enables drug-free pain treatment via transcutaneous stimulation delivered in standard clinic visits. For interventional pain physicians and pain management clinics treating chronic pain patients.
• External Pulse Generator (EPG) External pulse generator that delivers electrical signals and waveforms to the Injectrode through the skin via magnetic coupling to hydrogel patch electrodes. Powers the implanted electrode without internal batteries, eliminating the need for battery-replacement reoperations every 5-7 years. Used by clinicians with patients receiving Injectrode therapy.
• Clinician Programming Remote Device used by clinicians to program the External Pulse Generator settings and waveforms for patient treatment optimization. Companion device to the Injectrode F1 System.
• Injectrode Handshake Adapter A preclinical-stage proprietary adapter enabling connection of implanted Injectrodes to battery-powered Implantable Pulse Generators (IPGs) from Medtronic, Boston Scientific, Abbott, Nevro, Biotronik or to inductively powered Receiver circuits for chronic long-term therapy options beyond the initial 90-day Try Lead period. Enables interoperability with major neuromodulation IPG manufacturers.
• Resonance-Coupled Receiver An inductively powered internal driver circuit that derives energy from an externally worn power source (watch-sized) without requiring an implanted battery. Enables fully implanted therapy option with no battery replacement surgeries. Used with Injectrode systems for patients transitioning from Try Lead trial to chronic therapy.
• Try Lead Program A 90-day trial program allowing patients to experience neuromodulation without surgery using the Injectrode as a temporary Try Lead. Enables patients to assess therapy effectiveness before committing to chronic treatment. Includes initial package of 10 hydrogel stimulating patch electrodes designed for 2-4 days of use each. For chronic pain patients considering neuromodulation therapy.
• Calm Medical (Bladder Dysfunction Platform) A wholly-owned subsidiary of Neuronoff commercializing the Injectrode platform specifically for bladder dysfunction treatments including neurogenic bladder and overactive bladder through tibial and sacral nerve stimulation. Targets urology specialists and spinal cord injury treatment centers.

Quantifiable outcome

• Procedure time under 20 minutes comparable to steroid injection or RF ablation
• +3 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Five partnerships are on record, tiered core and minor.

• UT Health HoustoncoreStrategic or Co-development Partner · 5 June 2026Clinical trial partnership for DOD-funded randomized controlled trial evaluating the Injectrode for treating neurogenic bladder in spinal cord injury patients. Double-blind trial enrolling 21 participants across three groups at UT Health Houston under principal investigator Dr. Argyrios Stampas. Data will inform FDA pre-submission engagement for 510(k) de Novo submission.
• University of Wisconsin-MadisoncoreStrategic or Co-development Partner · 1 January 2024NIH R01 grant partnership for developing injectable electrode with embedded fiber optic visualization for posterior tibial nerve stimulation to treat overactive bladder. Five-year research collaboration.
• Case Western Reserve UniversitycoreStrategic or Co-development Partner · 1 January 2019NIH HEAL Initiative partnership for dorsal root ganglion stimulation to treat pain without opioids. Also involved in sacral root neuromodulation research and foundational Injectrode technology development through Dr. Andrew Shoffstall's lab.
• University of MichiganminorStrategic or Co-development Partner · 1 January 2019NIH HEAL Initiative collaboration partner for developing Injectrode as minimally invasive alternative for chronic pain treatment through dorsal root ganglion stimulation.
• University of PennsylvaniaminorStrategic or Co-development Partner · 1 January 2019NIH HEAL Initiative collaboration partner for developing Injectrode technology for pain management applications.

Scale indicators7 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• Medtronic: Largest neuromodulation incumbent with established SCS, DRG, and PNS product lines (Intellis, Vanta, etc.). Competes for the same physician customers and reimbursement codes that Neuronoff is targeting for the Injectrode.
• Boston Scientific: Major neuromodulation player (Precision Spectra, WaveWriter SCS systems) with deep pain physician relationships. Listed by Neuronoff as an IPG-compatible partner and competitor.
• Abbott: Owns the Proclaim DRG platform acquired from Spinal Modulation and broader neuromodulation portfolio. Same call point as Neuronoff and listed as a compatible IPG partner.
• Nevro: SCS-focused neuromodulation company (HFX/senza platform) competing for chronic pain share. Listed as a Handshake Adapter-compatible IPG partner and competitor for pain indications.
• Axonics: Sacral neuromodulation company with FDA-cleared systems for overactive bladder and fecal incontinence. Closest large-scale competitor for Neuronoff's bladder dysfunction strategy through its Calm Medical subsidiary.

Emerging players

• Saluda Medical: Emerging SCS company with evoked compound action potential (eCAP) closed-loop technology — directly analogous to Neuronoff's eCAP recording capability and targeting the same chronic pain neuromodulation segment.
• Mainstay Medical: Developer of restorative neurostimulation (ReActiv8) for chronic low back pain — adjacent mechanism targeting Neuronoff's primary chronic pain indication with a different implant approach.
• NXTSTIM: Early-stage neuromodulation company co-founded by Krishnan Chakravarthy, who also serves on Neuronoff's clinical advisory board. Comparable pre-commercial neuromodulation profile and overlapping pain physician network.

Direct peers

• Nalu Medical: Direct competitor in peripheral nerve stimulation. Nalu markets a small, battery-free, externally-powered implantable pulse generator system for PNS — overlapping with Neuronoff's Injectrode/E-PG architecture and competing for the same interventional pain physician call point.
• Curonix: Direct PNS competitor offering the Freedom Stimulator, an injectable electrode-based PNS system. Highly comparable mechanism (percutaneous placement, external power source) and overlapping chronic pain indication focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/neuronoff
• Xx.com/neuronoff

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries1 record

Funding overview

Funding rounds3 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Neuronoff