In less than two weeks, Setpoint Medical Inc. mastered the power serve with the first approval of a neuroimmune modulation device to manage rheumatoid arthritis, followed by a $25 million second tranche of its series C and a $115 million series D financing round.
London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
At the four-day KIMES 2025 exhibition, more than 35,000 products and prototypes were on display. In the clamor, BioWorld engaged with three promising neurological disease-focused companies – Readycure Inc., Neurive Co. Ltd. and Vuno Inc. – that showcased innovative technology for conditions like Alzheimer’s disease and tinnitus at the Seoul-based event.
Setpoint Medical Inc. received U.S. FDA investigational device exemption approval to initiate a study of its neuroimmune modulation platform in people living with relapsing-remitting multiple sclerosis. Setpoint plans to launch the 60-person trial in 2025 to evaluate the use of its implantable neurostimulation device to slow or reverse the nerve damage characteristic of multiple sclerosis.
In what represents its first patenting, Roseville, Minn.-based Iveacare Inc. provides insights as to what its first therapeutic target will likely be since the developer of neuromodulation therapy devices emerged from stealth mode in April 2024 with the closing of $27.5 million series A financing.
Setpoint Medical Corp. reported positive topline results from its landmark RESET-RA study. The study evaluated the Setpoint system as a potential new neuroimmune modulation treatment for adults living with moderate-to-severe rheumatoid arthritis who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs.
In what represents the first patenting in the name of Houston-based Neurastasis Inc., company co-founders Kirt Gill and Joe Upchurch describe a head-worn apparatus for neural stimulation that can be used to treat or augment recovery from medical conditions, particularly ischemic stroke.
Researchers from Case Western Reserve University have filed for patent protection for a system and method for treating obesity or other gastric and/or metabolic disorders via closed-loop vagus nerve stimulation.
Aurimod GmbH’s CEO, Stefan Kampusch, reported filing patent protection for a device for auricular punctual stimulation and the treatment of pain that comprises a current generator for generating stimulation current pulses and electrical lines for connection to an electrode to be positioned on the ear.
Neuroimmune modulation using vagus nerve stimulation (VNS) reduced Crohn’s disease symptoms and improved patient quality of life, a study published in the Journal of Crohn’s and Colitis found. The research by Setpoint Medical Corp. could provide a better option for patients with the autoimmune disorder than biologics, which often fail to work over time and can cause significant adverse effects.
