No, the Injectrode is only available for Investigational Use. Calm Medical is planning to submit for FDA clearance in 2027.

Calm Medical, LLC has a field-limited license to use the Injectrode for bladder indications. The Injectrode was developed by Neuronoff, Inc. and is continuing the work towards FDA clearance of the Injectrode for pain applications initially. Calm Medical is tasked with commercializing the Injectrode for Bladder applications utilizing the 510(k) and 510(k) de novo pathway.

The Injectrode itself is going to be the thinnest PNS and SNS device on the market once cleared, meaning it will fit through the smallest needle in the field. The smallest needle (18 gauge, 1.3mm outer diameter = 1/20th of an inch) means smallest chance for a visible scar after placement.

The Injectrode receives power from the outside of the body. The electrical power and waveforms are provided by an external pulse generator (EPG) that snaps magnetically onto a stimulating patch electrode. This stimulating patch is placed directly over where the Injectrode is implanted. When the EPG is powered on and stimulating, the Injectrode creates a conductive path for the electrical current to travel to the nerve target.

The Injectrode is deployed through an 18-gauge needle via ultrasound or fluoroscopy-guided placement. For more details on the specific steps taken with the full Injectrode delivery system, please refer to our placement procedure video.

Based on preclinical and clinical testing, the total time for the procedure will be less than 20 minutes. The steps on the OR table include preparing the skin for the procedure, injection of the local anesthetic, and waiting a few minutes for the anesthetic effect to establish, before taking fluoroscopy or ultrasound images/videos to plan out the placement trajectory, followed by actually placing the Injectrode and covering the needle puncture with a steri-strip and a cover bandaid. This is a timeline similar to a steroid injection, RF ablation, or even a dental filling.

Yes. The Injectrode has been designed to be explanted easily under local anesthetic (lidocaine, bupivacaine, etc.) and in under 20 minutes. The removal procedure is designed to align with standard reimbursement codes for the removal of the device (CMS 64585).

The clinician makes a small (less than 5mm) incision directly over the injection site. Using forceps, simply grab and pull and the Injectrode will "unzip" out of the body. The "unzipping" of the Injectrode can be observed in hydrogel and similarly in human cadaver and animal studies following chronic implant times. The future removal procedure will likely utilize an 18 gauge needle-based removal device that can be brought to the Injectrode with ultrasound or fluoroscopic guidance, where it grabs the Injectrode to allow a removal via needle. This will further reduce the risk of any visible scar, even after removal.

The Injectrode is hyperechoic and shows up as a "characteristic gray squiggle" that easily distinguishes from the surrounding tissue in an ultrasound image or video. Likewise, the Injectrode is clearly visible on fluoroscopy / x-ray allowing a placement of the needle and the Injectrode lead implant with visual feedback similar to how e.g. steroid injections are placed. Examples of fluoroscopy and ultrasound images and videos can be found here.

No. The stimulator (pulse generator) is outside the body. This approach enables the Injectrode to be placed via an 18 gauge needle (outer diameter 1/20 of an inch!) which is a smaller needle diameter than needles used in blood plasma donation.

The external pulse generator (EPG / stimulator) snaps onto stimulating patches through a magnetic coupling. The patch electrodes stick to the body with hydrogel pads. The smaller contact of the patch electrode is placed on the skin over the Injectrode implant location.

The clinician or their team will program the external pulse generator (EPG / stimulator) using the Clinician Programming Remote. A similar device is the patient remote that allows the patient to remote control the EPG.

The battery in the EPG is designed to enable several days of operation until there is a need to recharge. Recharging is done via the USB-C port on the EPG.

The EPG and Remote will be IP22 rated and is therefore not waterproof, but water-resistant (such as rain).

The first version of the PNS / SNS Injectrode F1 System will likely include an app exactly for that purpose. This app is currently in the RnD stage and it allows the remote control / adjustment of EPG settings via a cell phone. AI algorithms to optimize waveforms are anticipated to help with finding the right waveforms for each future patient's treatment situation.

General anesthesia, a method of medically inducing loss of consciousness that renders a patient unarousable even with painful stimuli, is not required for the placement of an Injectrode. Local anesthesia (e.g. lidocaine, bupivacaine, etc.) has been used in clinical and preclinical studies to place the Injectrode. This is similar to how a dental filling is being placed following a local bupivacaine injection.

The Injectrode is fabricated from platinum-iridium microwires and intermittently coated with polyolefin, leaving the tips of the Injectrode (stimulating anchor and subcutaneous collector) uncoated. There are one or more microholes that allow fluid ingression without affecting the ability of the Injectrode to focus the activation current right on the target of interest. The fluid ingression optimizes for MRI conditionality.

The PNS / SNS Injectrode F1 system utilizes a monopolar Injectrode. Preclinical work confirms that two monopolar Injectrodes on the same nerve enabled a quasi-bipolar setup, limiting off-target activation of any nearby neural structures. Calm Medical (via its partnership with Neuronoff, Inc.) has multi-contact versions (bipolar and tripolar) of the Injectrode in the Research and Development phase with the intent of design freeze and regulatory submission at a later point in time.

The Injectrode is constructed with a platinum-iridium helical microwire structure. Platinum-iridium is an exceptionally robust metal that provides outstanding resistance to both corrosion and mechanical wear. The helical structure enables the lead to conform to anatomical structures, be able to bunch and strongly anchor, while actively resisting migration (as shown in both clinical and pre-clinical studies).

Chronically (1 yr.), the maximal removal force of helical devices remained under 7.30 N, for which the Platinum–Iridium device's tensile failure force was 32.90 ± 2.09 N, resulting in a safety factor of 4.50. This means the force required to break the device is approximately 4.5 times greater than the force needed to remove it from tissue, ensuring safe and reliable explantation.

Preclinical testing validated that the helical design, combined with bunched anchors, effectively maintains position even during repeated leg flexion and full extension, preventing device dislodgement.

The Injectrode is being prepared for FDA submission as a chronic stage (>31 day), yet temporary treatment lead with an intended use for 3 months to allow future patients an easy way to experience neuromodulation therapy without the need for surgery. Our goal is to provide a micro-invasive pathway to try out neurostimulation similar to how patients today experience an injectable drug (e.g. steroid) as a therapeutic intervention.

The Injectrode is furthermore being prepared for FDA submission as a longer duration (~permanent) treatment lead with an intended use for 2 years. This extended-duration treatment would allow a patient to first try out neuromodulation for 3 months and then convert to the extended-term use case. We are evaluating a 10-year use case as well, but at this point in time focus on the 2-year option first.

Pre-clinical studies captured chronic (1m-12m) safety data in small and large models in the peripheral nervous system (PNS), sacral root / sacral nerve stimulation (SNS), dorsal root ganglion (DRG) and other locations. Histology data showed excellent biocompatibility. Sub-chronic clinical data (<30 day) confirmed excellent safety information. Leachables and Extractables testing is being done as part of the full biocompatibility testing. Internal (Injectrode) and external components of the system are being tested to complete the full data package for FDA and other regulatory bodies. Additional testing is still ongoing. FDA or other regulators have not yet reviewed these data.

Pre-clinical studies captured chronic (1m-12m) efficacy data in small and large models in the peripheral nervous system (PNS), sacral root / sacral nerve stimulation (SNS), dorsal root ganglion (DRG) and other locations. Evoked Compound Action Potentials (eCAP) data recorded with chronically placed Injectrode in the PNS and on the DRG confirm reliable activation of neural structures that are associated with treatments for chronic pain, complex regional pain, and other conditions. Sub-chronic clinical data (<30 day) confirmed that percutaneous and transcutaneous activation of nerves can drive the activation of paraspinal musculature, as visualized with ultrasound, physician palpation or study participant perception. Additional testing is still ongoing. FDA or other regulators have not yet reviewed these data.

Yes. Please contact us at info@Calm-Med.com to discuss joint preclinical work leading to the development of new clinical indications for the future. A joint phase 1 SBIR grant with a 6-12 month timeline is a great vehicle to gather safety and efficacy information to enable clinical follow-up work. Calm Medical (via its partnership with Neuronoff, Inc.) will assist with the grant writing submission process. We encourage postdocs, professors, and other researchers to develop SBIR and other grants with us to explore new opportunities for treatment by interfacing with the nervous system or organs of the body.

A joint phase I / phase II SBIR grant (or direct to phase II SBIR) with a 2-3 year timeline is a great vehicle to gather safety and efficacy / feasibility study information with the intent of engaging the FDA to discuss a pivotal trial design and subsequent clearance, likely as De Novo. Calm Medical (via its partnership with Neuronoff, Inc.) will assist with the grant writing and submission process. Please contact us at info@Calm-Med.com to discuss joint preclinical and clinical work leading to the development of new clinical indications for the future. We encourage clinicians and clinician researchers to develop clinical SBIR (and similar grants) with us to explore new opportunities for treatment by interfacing with the nervous system or organs of the body.

Our first indication for use, once FDA cleared, is aimed at treating chronic pain. However, the Injectrode technology is anticipated to be used to treat many conditions. Calm Medical (via its partnership with Neuronoff, Inc.) has ongoing preclinical work with research institutions to collect data for overactive bladder, neurogenic bladder, and hypertension indications. Neuronoff, Inc. has submitted grant applications to enable clinical studies for different pain, and bladder indications.

Early data show that the Injectrode may be MRI conditional. Human cadaver studies documented a MR imaging artifact extending to about 1mm from the Injectrode resulting in a total artifact diameter of 2.3 to 3.0 mm with the Injectrode in the middle. Additional research is underway and intended to be part of the first FDA clearance to enable MRI conditionality to be part of the first clearance.

Once FDA cleared, we are targeting different codes for different indications and locations. Big picture, we are aligned with the percutaneous placement of neurostimulation leads and single or multi-contact electrode arrays.

• PNS (tibial nerve):

  • Placement, single Injectrode: CMS 64555

  • Placement, two Injectrodes during same visit: CMS 64555x2

  • Removal, Injectrode, PNS, after chronic placement: CMS 64585

• Sacral roots - Sacral root Nerve Stimulation SNS:

  • Placement, single Injectrode, SNS: CMS 64561

  • Placement, two Injectrodes, SNS: CMS 64561-50

  • Removal, Injectrode, SNS, after chronic placement: CMS 64585

The Injectrode is designed for a chronic duration (e.g. 3 months, 2 years, etc.) percutaneous placement in the PNS. It aligns with the definition of CMS 64555 "Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve)" when placed in the peripheral nervous system (PNS). Likewise, the Injectrode is designed for a chronic duration (e.g. 3 months, 2 years, etc.) percutaneous placement on or near the sacral roots Sacral root Nerve Stimulation SNS). It aligns with the definition of CMS 64561 "Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement), including image guidance if performed."

This only applies once the Injectrode System has received regulatory clearance. While Medicare and many commercial payers cover tibial nerve stimulation via PNS and Sacral root Nerve Stimulation (SNS), providers are responsible for submitting accurate and appropriate codes, charges, claims and modifiers for services that are rendered. Payer policies vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. Providers should consult with payers, reimbursement specialists and/or legal counsel regarding any questions on coding, coverage or reimbursement matters.

The Injectrode is for investigational use only and not FDA-cleared. If you are interested in staying in the loop as we get closer to commercialization, please contact us here.

The Injectrode is not currently approved in any jurisdiction. FDA clearance is applicable in the US and Switzerland. Our first submission outside the US will likely be to Health Canada.

The Injectrode is designed and manufactured in an ISO 13485 and MDSAP certified facility. This certification enables regulatory submissions in MDSAP member countries, which include Canada, Australia, Japan, Brazil, and the United States. Expansion into the EU market is planned for the future.

The percutaneous Injectrode placement procedure is designed to require about the same time or less than a typical PNS and SNS (e.g. PNE trial) lead placement in clinical practice today. Pain clinics are optimized to enable steroid injections utilizing fluoroscopic visualization in less than 20 minutes of time on table. The time needed for a needle-based placement of an Injectrode is in the same ballpark. Pain clinics are optimized to enable needle-based radiofrequency (RF) ablation utilizing fluoroscopic visualization in less than 20 minutes of time on table. The time needed for a needle-based placement of an Injectrode is in the same ballpark.

The system is designed to enable 0.1 Hz to 1499 Hz waveforms. The PNS and SNS clearance may utilize a partial band of frequencies. The Injectrode has been tested with low-frequency DC, unipolar, bipolar, low and high-frequency stimulation, and high-frequency nerve block waveforms. Performance was adequate. First bladder use cases will utilize the 10Hz to 20 Hz band, with a focus on 14 Hz.

No. Earlier Injectrode designs were made from in-body curing polymer filled with electrically conductive particles that allowed the injection of the mixture into the body where it would cure in place, resulting in a flexible and electrically conductive structure (similar to a rubber band that can conduct electricity). These designs did not feature easy removability. The current Injectrode Is manufactured outside the body. During the Injection process it can anchor itself via bunching of a helical wire structure inside the body. This Injectrode design utilizes very fine metallic wires to achieve similar abilities (injectable via small needle, it can "flow" out of a needle when directed around a nerve etc.), and it adds an optimized design to be easily removable. Easy removal has been engineered into the helical wire structure design of the Injectrode, enabling placement by needle and removal via needle.

Please fill out the form here and we'll add you to our email list to notify you when Injectrode receives FDA clearance.

Yes, Calm Medical is open to exploring strategic partnerships in the neuromodulation space. Please reach out to us here to discuss potential collaboration opportunities.

Yes, Calm Medical welcomes discussions with potential investors interested in advancing our technology. Please contact us here to learn more about investment opportunities.