NuVasive dominates the lateral spine market with Medtronic being a distant second. Kern Singh, MD, and his colleagues with Avaz Surgical are trying to level the playing field with new technology focused on quantitative imaging.
The Next generation of Neuromonitoring technology
Current EMG-based neural monitoring technology has limitations. Patient comorbidities and anesthetic agents affect EMG monitoring thereby potentially increasing the risk of neural injuries with lateral-based procedures.
Dr. Singh and his partners founded Avaz Surgical in 2010 to help develop the next generation of neural guidance and quantitative imaging techniques. The company has been privately funded along with contributions from Sachin Gupta, co-founder, investor and biomedical engineer of SPG Capital.
The Avaz imaging technology is designed to be the size of a pencil—around the same dimensions as the dilators currently being used for minimally invasive tubular surgery. The Avaz technology is hardware agnostic and runs an algorithm in real time to highlight the nerve and vascular structures for the surgeon by outlining its presence, detailing the structures’ distance from the probe in millimeters and by providing an audible feedback.
Surgeons hear a beeping as they move closer to the nerve and blood vessel similar to the noise you hear when you put your car into reverse. "The surgeon can either use the visual feedback or he can rely on the audible feedback never looking away from the surgical field”, says Dr. Singh.
Current EMG technology has an 85 percent true detection rate and a 20 percent false positive detection rate due to patient comorbidities and anesthetic agents. However, the Avaz quantitative imaging technology has demonstrated a positive detection rate of greater than 99 percent in the animal testing. Furthermore, EMG does not have the ability to provide real-time feedback regarding nearby life-threatening blood vessels.
The physical characteristics of the Avaz technology are also advantageous. The processor is the size of an iPhone for easy mobility. The screen depicts the nerve and blood vessel detection, and tells the surgeon how many millimeters he is away from the undesired structure. The surgeon can move the probe around thereby avoiding the nerve and blood vessel while a flashing color display and audible beeping delineates the safe path.
"You don't need additional technology or a neuromonitoring technician during the procedure because the algorithm tracks the procedure in real time. A nurse practitioner can scan your shoulder, knee or back and you can identify the nerve immediately," says Dr. Singh, making this technology applicable for peripheral nerve procedures commonly done for pain management and orthopedic procedures (such as hip, knee and shoulder surgeries).
Tackling the lateral learning curve
Only around 25 percent of surgeons have done lateral procedures in part because they fear nerve damage. The learning curve for lateral procedures is steep, but the quantitative imaging technology makes it easier.
"Avaz can help eliminate the learning curve allowing new surgeons to adopt the technique and avoid neural injury. Lateral surgery is powerful and can be a tool in the outpatient setting as well as to help correct deformity," says Dr. Singh.
Dr. Singh and his colleagues have conducted over 50 rabbit surgeries and then 25 cadaver procedures with the technology. In addition, Avaz is currently collecting data for simulated peripheral nerve blocks under an approved IRB study with over 15 patients currently enrolled.
Most recently their proprietary and patented technology was utilized to collect data during two live surgeries under an IRB-approved investigation "We just recently validated the technology in two patients and we hope to acquire more data in order to continue to refine the algorithm," says Dr. Singh.
Bringing the technology to market
Several major spine and imaging companies have expressed interest in the technology due to its ability to disrupt the lateral surgery market and beyond.
"Imagine if we put the technology on a burr and it could shut off the burr if it got too close to the nerve or blood vessel," says Dr. Singh. "Several companies want to hook it up with a robot's hand for surgery." Dr. Singh and his team are spending considerable energy working with his intellectual property counsel, Manish Mehta, a patent attorney who specializes in medical devices, to leverage the full extent of the technology.
"Minimally invasive surgery adoption has been poor because there is poor visualization and learning curves are steep," says Dr. Singh. "But new technology can make the procedure powerful, quick and outpatient. If the surgeon can perform these procedures outpatient and reduce hospitalizations and readmissions, they will lower the total cost of care."
The disposable probe costs less than $200 per case, around the same cost as the standard EMG electrodes. Avaz is in the process of obtaining FDA clearance for the technology, which could become commercially available and viable in nine months. In addition, there are other spinal and robotic surgical applications possible in the near future.
"For technology to be successful nowadays in spine, it has to have a straightforward FDA approval pathway and a cost basis that makes sense. New technology can't be adding to the cost of the procedure," says Dr. Singh. "In addition, the technology should not change the way the surgeon practices, it should be complementary as to facilitate the adoption. In this case, the probe is the same that the surgeon currently uses for tubular surgery. If you can meet these criteria, it's easier to get the technology to the market and in the surgeon’s hands."