SetPoint Medical has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial evaluating its neuromodulation platform for patients with relapsing-remitting multiple sclerosis (RRMS). The trial, planned to commence in 2025, will investigate the potential of vagus nerve stimulation to promote remyelination and reduce inflammation in MS patients.
The multicenter, randomized, double-blind, sham-controlled pilot study will enroll up to 60 participants across multiple sites in the United States. This study aims to evaluate the safety and efficacy of the SetPoint System in modulating the immune response and potentially reversing myelin damage, a key characteristic of MS.
The SetPoint System: How It Works
The SetPoint System is an implantable, rechargeable neurostimulation device designed to target the vagus nerve. Once implanted in the neck via a minimally invasive procedure, the device delivers electrical stimulation to the vagus nerve daily. This stimulation is intended to activate innate anti-inflammatory pathways and restore immune balance, potentially reducing demyelination and promoting remyelination.
According to SetPoint, preclinical models have demonstrated the technology's ability to reduce demyelination and promote remyelination, offering a novel approach to address the underlying pathology of MS. The company will be evaluating numerous endpoints, including safety assessments, electro-physiologic measurements, imaging, and functional and clinical outcomes, such as visual acuity and disability scores.
Addressing Unmet Needs in MS Treatment
Multiple sclerosis, an autoimmune disease affecting nearly one million people in the U.S., leads to the damage of the myelin sheath, disrupting signals between the brain and body. While current treatments can manage symptoms and slow disease progression, there are no approved therapies that directly address the root cause of MS which is the damage to the myelin sheath.
David Chernoff, M.D., Chief Medical Officer of SetPoint Medical, stated, "We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area. The results from our studies in validated preclinical models of MS suggest that the SetPoint System has the potential to address the urgent unmet medical need for novel therapies that reduce demyelination and promote remyelination – providing new hope for people living with MS."
Regulatory Pathway and Previous Successes
The SetPoint System has been granted Breakthrough Device Designation by the FDA and was accepted into the Total Product Life Cycle Advisory Program (TAP) in March 2024. These designations are designed to expedite the development and review process for innovative medical devices that address unmet medical needs.
SetPoint Medical recently announced positive topline results from the RESET-RA clinical study, which investigated the technology in patients with moderate-to-severe rheumatoid arthritis. The randomized trial involving 250 participants met its primary endpoint with low adverse event rates, demonstrating the potential of the SetPoint System in another autoimmune condition.
The Neuromodulation Market
The neuromodulation market is experiencing rapid growth, driven by technological advancements and the increasing viability of neuromodulation as an alternative to traditional medication. GlobalData estimates the global neuromodulation device market will reach $11.4 billion by 2033, up from $6 billion in 2022.
