Nevro (NYSE:NVR) announced that the FDA approved its Senza HFX iQ spinal cord stimulation (SCS) system.
Redwood City, California-based Nevro designed Senza HFX iQ to use artificial intelligence (AI) to learn from patients. The company says it’s the first such SCS system. It utilizes Nevro’s high-frequency 10 kHz therapy platform.
The company developed it to address the variability in pain from patient to patient. This helps to optimize and maintain long-term pain relief and improved quality of life.
Senza HFX iQ features an implantable pulse generator, the HFX trial stimulator, charger and HFX app. Nevro plans to launch it with algorithms specifically for treating chronic back and leg pain. These algorithms cover non-surgical back pain and painful diabetic neuropathy (PDN).
NVR shares were up more than 6% to $38.63 apiece in midday trading today on the news, announced yesterday evening. (MassDevice‘s MedTech 100 was up slightly.) Truist analysts described the approval as a “welcomed positive headline … following recent reimbursement setbacks.”)
Using patient data to guide treatment
The digitally-enabled system collects patient data and guides the user through a customized treatment pathway. Patients start on the program most likely to provide pain relief, based on the HFX Algorithm. The system recommends customized therapy adjustments informed by patient inputs and directly adjusts pain relief. It does so on the patient’s smartphone without the need for a separate manual remote.
By capturing patient and device data, the system enables sharing of patient-level outcomes with treating and referring physicians. The connected digital environment around the therapy allows for future updates and new features and capabilities, Nevro said.
The company plans to initiate a limited release of Senza HFX iQ in the U.S. this quarter. It penciled in a broad U.S. market launch for early 2023. Nevro also submitted for regulatory approval in Europe.
“HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care,” said D. Keith Grossman, chair and CEO of Nevro. “Pain is variable from patient to patient and over time. Using the big data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programs where patients have been more likely to get relief in the real world. HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend program changes.
“With HFX iQ, our goal is to provide physicians and patients the personalization needed to achieve and maintain the best possible long-term outcomes. We believe HFX iQ represents the future of SCS therapy.”