Nalu Medical presented interim data from its landmark COMFORT trial at this year’s North American Neuromodulation Society (NANS) meeting.
 
The COMFORT trial is a post-market, open-label clinical study evaluating effectiveness of peripheral nerve stimulation (PNS) therapy using the Nalu Neurostimulation System to treat chronic pain in the shoulder, low back, knee, or ankle/foot. The study aims to develop three-year data to show sustained pain relief and quality of life improvements possible with the Nalu PNS system.
 
Interim 12-month pain relief data showed 84% of subjects were responders (more than 50% pain relief). 73% average pain reduction was demonstrated, as well.
 
Holistic outcomes at three months showed that 98% of subjects using Nalu PNS had more than 50% pain relief and/or reported improvement, compared to 21% of those who didn’t use it.
 
According to Dr. John Hatheway, first author and presenter of the oral report, “Clinicians recognize the value of combining pain relief with functional outcomes to provide a more comprehensive assessment of device effectiveness in treating chronic, intractable pain. In the COMFORT RCT, we are measuring variables that present this broader picture. Results show that the Nalu PNS System is truly unique. For the first time, clinicians have access to advanced technology that enables us to offer effective long-term therapy to a broader range of patients.”
 
“We are thrilled to see such promising results from our advanced micro-IPG in a rigorous RCT setting,” said Tom West, Nalu CEO. “The COMFORT RCT is intended to provide reliable evidence of the sustained effectiveness and impact on quality of life provided by Nalu PNS therapy and to expand the use of Nalu PNS to patients for whom physicians have limited options. Our approach to this research underscores our commitment to take a leadership role in generating evidence for continued and extended application of effective PNS therapy for chronic pain sufferers.”
 
Last month, Nalu published results from its nPower U.S. clinical study in Pain Physician Journal.