Nalu Medical announced publish of a real-world data (RWD) paper in the journal Chronic Pain and Management that affirms its peripheral nerve stimulation (PNS) device is a medically necessary chronic pain treatment.

The data from 2,273 patients implanted with the Nalu IPG (implantable pulse generator) PNS represents the largest published real-world dataset for a permanent PNS device the Carlsbad, Calif.-based company said. The device also boasted a 94% response rate measured by the respected Patient Global Impression of Change (PGIC) metric.

The RWD results further demonstrated a 50% total healthcare cost cut for patients who used the PNS, which the company hopes will pave the way to expanded private insurance coverage.

John Hatheway, MD, lead author of the paper, said, “The consistent improvements observed across a large, diverse sample of real-world clinic patients treated in multiple anatomic regions and nerve combinations emphasizes the broad applicability of PNS therapy delivered by the Nalu micro-IPG PNS system.”

The PNS system is a battery-free, miniature IPG wirelessly powered by a “Therapy Disc” worn externally. It’s controlled through a smartphone-based remote control app. The company says the micro-IPG offers similar treatment capabilities to larger IPGs, with advanced waveforms, various programming options, upgradability, and an 18-year expected service life.

The Nalu PNS is U.S. Food and Drug Administration (FDA)-cleared for both PNS and spinal cord stimulation (SCS). It was FDA cleared for whole-body MRI use in January.

“These real-world results provide unmistakable evidence that the Nalu micro-IPG PNS System is dramatically reshaping pain management,” said Nalu president and CEO Tom West. “No permanent PNS system has undergone greater scrutiny or shown comparable performance. We are thrilled to see that our groundbreaking technology is able to provide reliable long-term pain relief to such a broad spectrum of patients.”