Neuralytix, LLC

Real-time intraoperative nerve assessment Technology

Neuralytix iD3 is an MMG-based technology designed to enhance intraoperative surgical decision-making. The technology assists surgeons with nerve locating, mapping and the real-time assessment of neurophysiologic changes that may occur throughout the course of surgery. The result is an intuitive, surgeon-directed solution for objectively understanding how individual nerves are responding to surgery... prior to leaving the operating room.

INSPIRATION

"Conventional surgical techniques primarily rely on visualization and tactile feel to assess adequacy of decompression. Often times, visualization can be limited, such as in minimally invasive surgery, and tactile feedback is a subjective assessment that makes the evaluation of successful nerve decompression difficult."

- Wessell N, Khalil J, Zavatsky J, Ghacham W, Bartol S. Verification of nerve decompression using mechanomyography. Spine J. 2016 Jun;16(6):679-86.

"In spine surgery, we never truly know if we have done enough to decompress a nerve. We can feel the foramen, we can look at the nerve root, and we can try to determine if we have done a good job as surgeons, but we haven’t had an objective test in order to know whether we have made a difference on the nerve root itself."

- Jones, R. Quantitative assessment of nerve health following lumbar decompression. August 24, 2022. Webinar: https://www.vumedi.com/video/quantitative-assessment-of-nerve-health-following-lumbar-decompression/

"Making a judgement on the exact character of nerve dysfunction influences our treatment decisions and the prognosis for future nerve health. Permanent disability can be prevented with correct diagnosis and intervention. There is a pressing need to standardize and improve how we predict short- and long-term outcomes after injury and/or reconstruction and repair."

- Bourke G, Wade RG, van Alfen N. Updates in diagnostic tools for diagnosing nerve injury and compressions. J Hand Surg Eur Vol. 2024 Jun;49(6):668-680.

"The presence of variability in clinical practice is clear indication of the absence of an evidence-based approach in treatment."

- Berven, S. A multidisciplinary approach to the management of spinal disorders: quality and value considerations in a reforming healthcare economy. September 6, 2018. Webinar: Seattle Science Foundation. https://www.youtube.com/watch?v=Y_ub2IrRJE4&list=PLyptnEaqO5i4cTuHPMKquJHflorwkZ8hd&index=2

NERVE DECOMPRESSION ASSESSMENT

THE PROBLEM

Nerve compression is often associated with pain, paresthesia, dysesthesia, numbness, and/or weakness.

Decompressive surgery is frequently indicated after failure of conservative treatment and/or severe neurologic deficit.

THE CHALLENGE

Conventional surgical techniques primarily rely on visualization and tactile feel to assess adequacy of decompression.

Often times, visualization can be limited, such as in minimally invasive surgery, and tactile feedback is a subjective assessment that makes the evaluation of successful nerve decompression difficult.†

THE SOLUTION

MMG is an effective tool that can be used to differentiate normal and compressed nerves by quantifying the MMG response to an electrical stimulation current.

MMG allows surgeons to measure the effect of decompression, judge its effectiveness in real time, and eliminate the subjectivity seen in tactile feedback methods.†

† Wessell N, Khalil J, Zavatsky J, Ghacham W, Bartol S. Verification of nerve decompression using mechanomyography. Spine J. 2016 Jun;16(6):679-86.

DECOMPRESSION ASSESSMENT - CASE REPORT

"A 65-year-old female patient presented with severe low back pain, radiating pain to the left buttock, thigh and knee, and left knee extension weakness. Conservative treatment with epidural steroid injections and physical therapy was insufficient in treating her symptoms. MRI imaging showed a left far lateral disc herniation at L3–4. A MIS tubular far lateral discectomy was planned with the use of MMG. The skin incision was made 5 cm off the midline, overlying the L3–4 space. A 15 mm tubular retractor was placed between the transverse process and the pars. The soft tissue was dissected with the use of the microscope. After the identification of the transverse process, the lateral aspect of the facet joint, and the pars, the intertransverse ligament was incised and removed. The pedicle and exiting nerve root were identified. Prior to decompression, the MMG stimulus threshold was greater than 10 mA. After obtaining the stimulus threshold, the disc at L3–4 was incised, and the discectomy was performed. After the exiting nerve root was deemed adequately decompressed, the MMG stimulus threshold did not change. It was decided to further explore the disc space caudally, and an additional disc fragment was identified and removed. After removal, the MMG stimulus threshold decreased from greater than 10 mA to 3 mA. After surgery, the patient was observed for 3h in recovery and demonstrated adequate mobilization without pain. The patient was safely discharged home on the same day."

- Sommer F, Hussain I, Willett N, Hamad MK, Ikwuegbuenyi CA, Navarro-Ramirez R, Kirnaz S, McGrath L, Goldberg J, Ng A, Mykolajtchuk C, Haber S, Sullivan V, Gadjradj PS, Härtl R. Implementation and Feasibility of Mechanomyography in Minimally Invasive Spine Surgery. J Pers Med. 2025 Jan 23;15(2):42.

DECOMPRESSION ASSESSMENT - CASE REPORT

“One of the cases that opened my eyes early to the benefits of MMG, was a gentleman that was a wildfire firefighter. He came to me after having a work injury that had caused a large disc herniation. This disc herniation was at L4-5. After the disc herniation he had an acute foot drop. He saw an orthopedic spine surgeon where he was fighting fires in the northwest, and they performed a microdiscectomy on him. His footdrop didn’t resolve and so when he came back home to Flagstaff, he sought out further care and came to my office. We worked him up, received a new MRI, and found that he had some retained stenosis and some retained disc material in the area. So I sent him for conservative treatment to see if we could get him better without surgery, but ultimately he failed conservative treatment and required a revision microdiscectomy. When I went in, which was his second operation, I performed a revision microdiscectomy, decompressed the nerve root, and at that time it was before I was using MMG. So, I felt like I had done a really good job for the patient. And when he woke up from surgery, he actually did have some improvement in footdrop, but still had footdrop. We waited a year until we realized his footdrop wasn’t getting any better. So, I obtained a new MRI and realized that I too, like the first surgeon, had performed a slightly inadequate decompression that had left the nerve compressed as there was still a piece of disc under the L5 nerve root that had tracted down behind the L5 vertebral body, that I didn’t know was there. I took him back to surgery for the 3rd surgery now, which was my 2nd surgery, and I was using MMG at that time. I tested the nerve root and it was testing abnormal. I searched around the nerve root and found that disc herniation, I removed the disc herniation, tested the nerve again, and it was still testing abnormally. I followed the nerve root down, and found that there was an accessory disc that was along the pedicle of L5, and had extruded, and was sitting there, and I didn’t notice it on MRI because it was right next to the L5 pedicle. I removed that piece of disc and the nerve immediately returned to normal. I feel like, if this patient would have had MMG on the first case, we could have avoided two additional cases on a young patient. When he woke up from that operation, he had 4/5 strength in his anterior tibialis, and within 6-weeks he had full strength of his anterior tibialis, was walking normally and was back to work."

NERVE SAFETY

THE PROBLEM

Nerve injury is an inherent risk of spine surgery. Minimally invasive surgery increases this risk due to the reduced ability for surgeons to directly visualize neural structures.

Precisely locating and mapping nerves is imperative for safe surgical access, especially in procedures such as the lateral transpsoas approach, in order to safely navigate the lumbar plexus.

Similarly, revision procedures can prove challenging given the difficulty to discern between neural vs scar tissue.

THE CHALLENGE

Conventional technologies rely on electromyography (EMG) to help reduce the likelihood of nerve injury during surgery.

EMG is an invasive needle-based technology requiring a specially trained technologist for procedural setup.

EMG signals are prone to electrical interference due to the 'electrically noisy' nature of operating rooms and often require a neurologist or neurophysiologist to assist the surgeon with signal interpretation.

EMG introduces unnecessary procedural complexity and cost for many surgical applications.

THE SOLUTION

MMG has recently emerged as a non-invasive mechanical counterpart to EMG, devoid of needles, hardened against electrical interference, and does not require EMG experts for setup and interpretation.

The result is an intuitive, surgeon-directed technology utilizing skin-surface mounted accelerometer sensors to measure the mechanical response of muscle following electrical nerve stimulation.

MMG significantly reduces procedural complexity and cost, while enabling utilization in surgical procedures previously inaccessible due to economic constraints, such as non-instrumented decompression.

indications for use

This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.

The device is intended to identify relative changes in the conduction and neural transmission ability of the nerve throughout a surgical procedure by measuring and comparing the minimum amount of electrical stimulation current (mA) required to induce a measurable MMG response (MMG nerve response threshold).

Examples of surgical applications which may require mechanomyographic (MMG) monitoring:

Minimally invasive and open spinal surgery involving spinal fusion cages, screws, rods, plates, discs and biologics.
Minimally invasive, open and endoscopic, direct and indirect nerve decompressions, discectomies, laminectomies, laminotomies, facetectomies, foraminotomies.
Treatment of nerve compression, stenosis, degenerative disc disease, disc herniation, spondylolisthesis.

FDA cleared under K243636