ARTICLE SUMMARY:
Nevro’s HFX-iQ is the first spinal cord stimulation system that uses artificial intelligence to adjust pain management algorithms based on an individual’s relevant pain metrics.
In the neuromodulation industry Nevro is a company of “firsts.” The clinical trial supporting approval of its HF10 device (now called Nevro HFX), was the first large, multicenter, prospective, randomized, controlled pivotal study of a 10 kHz high-frequency, paresthesia-free spinal cord stimulation system. (See “Nevro Shakes Up SCS: An Interview With Keith Grossman,” MedTech Strategist, August 18, 2021.) After its initial broad clearances for treating pain of the trunk and the legs, the company went after a novel indication in treating painful diabetic neuropathy, a condition that affects 20% of people with diabetes, gaining the first ever such FDA approval in July 2021.
In January 2022, the FDA granted Nevro another first, approving a nonsurgical back pain (NSBP) indication, ensuring that patients who aren’t candidates for back surgery and are refractory to non-operative therapies have a treatment option. Nevro still has the NSBP market to itself, which, the company estimates, is an $11.4 billion total addressable market (annually) that is only 5% penetrated. Nevro again demonstrated its leadership in March when it launched HFX-iQ, the first patient-responsive spinal cord stimulation system, which uses artificial intelligence to optimize and maintain pain relief based on patient responses.
