California-based Nalu Medical has announced positive long-term data from the COMFORT randomised controlled trial (RCT) of its peripheral nerve stimulation (PNS) device to treat chronic pain.
The ongoing COMFORT randomised controlled trial (RCT) is evaluating the Nalu neurostimulation system for the treatment of pain in the shoulder, lower back, knee, ankle, or foot. After 12-months, 87% of subjects using the Nalu system achieved more than 50% pain relief, with a 73% average pain reduction.
At the three-month mark, 98% of Nalu system users experienced significant pain relief or improvement, compared to only 21% in the non-Nalu group. Similarly, 93% of Nalu PNS users reported more than 50% pain relief or reduced disability, compared to only 35% in the non-Nalu group.
In the announcement accompanying the data, CEO of Nalu Tom West said: “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.”
The Nalu neurostimulation system comprises a battery-free, compact implantable pulse generator (IPG) called the Nalu IPG. As well as PNS, the device can target spinal cord stimulation (SCS). The device holds US Food and Drug Administration (FDA) approval for both PNS and SCS.
Earlier this month, the company raised $65m in a Series E funding round to further development and commercialisation efforts.
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The results were announced as part of the 2024 North American Neuromodulation Society Meeting (NANS) in Las Vegas, Nevada between 18-21 January.
Boston Scientific also revealed data at NANS 2024, announcing that its WaveWriter Alpha SCS neurostimulation system can reduce pain in chronic pain patients by 50%, shown by one-year data of the SOLIS trial.