South African Rugby and the U.S. National Football League (NFL) are actively studying ways to more quickly and reliably diagnose concussions and find more effective treatment for their sequelae. Researchers at the University of Birmingham and Marker Diagnostics Ltd. have identified a biomarker that signals a concussion has occurred, while a team at Electrocore Inc. is working with the NFL to address post-concussion headaches.
Bioelectronic medicine startup Setpoint Medical Corp. raised $80 million in a preferred stock financing co-led by new investors Norwest Venture Partners and Viking Global Investors. The company has also secured a line of credit for up to $65 million, bringing total access to capital to up to $145 million.
Microtransponder Inc. raked in $53 million in an oversubscribed series E round that exceeded its best previous fundraising by nearly 500% and brought the company’s total funds raised to date to $93 million. The new money will be used to commercialize the Vivistim paired VNS system, which received premarket approval in 2021 as what the FDA called the “first stroke rehabilitation option using vagus nerve stimulation.”
Several recent studies highlight the rapidly expanding applications for neuromodulation using bioelectronic devices. A pair of articles in the Journal of the American Heart Association and Journal of the American College of Cardiology focused on the benefits to patients with heart failure and those at risk of post-operative atrial fibrillation, respectively. A study published in Brain Stimulation found that 85% of tinnitus patients experienced resolution of their symptoms when using a neuromodulation device.
Vagus nerve stimulation (VNS) researchers notched another success with FDA approval of a drug-free rehabilitation system that uses the technology to help patients who have lost mobility in their hands and arms as a result of ischemic stroke regain function. Microtransponder Inc.’s Vivistim pairs rehabilitation exercises with VNS to enhance their impact. The clinical study evaluated by the FDA for the system's approval showed that Vivistim doubled the improvement in upper extremity motor function compared to supervised rehabilitative exercises alone at six weeks and 90 days.
A team led by researchers at the Institute of Bioelectronic Medicine at The Feinstein Institutes for Medical Research, the research division of New York’s Northwell Health, developed a long-term implant model for vagus nerve stimulation (VNS) in mice that enables study of bioelectronics in chronic disease. The research was published in Elife, with a full description of the surgical technique and methods for calibrating the stimulation dose to enable other labs to use the methods to advance bioelectronic medicine.
TORONTO – For Scott Kadwell, president of Markham, Ontario-based RSK Medical Inc., the distributor tagged to sell the Health Canada approved Gammacore Sapphire, the device represents “a shift from a business to business to a direct-to-consumer business model.” For Rockaway, N.J.’s Electrocore Inc. which developed the self-administered technology, it’s one more regulator to have greenlighted the FDA cleared, CE-marked device for treating intractable migraine and cluster headache.
Stimulating the liver with focused ultrasound decreased obesity, chronic inflammation and metabolic dysfunction in preclinical studies, reported GE Research and the Feinstein Institutes for Medical Research, the research arm of Northwell Health. In a study published in Scientific Reports, researchers demonstrated that nerve modulation with ultrasound in mice helped regulate neurons involved in food intake, glucose regulation and metabolism without negative side effects.
Researchers at the Feinstein Institutes for Medical Research, the research arm of New York-based Northwell Health, have developed a noninvasive method for targeting stimulation of the vagus nerve. Vagus nerve stimulation (VNS) offers promise for treatment of a wide range of conditions, given the nerve's extensive involvement in regulating many organs, but has been constrained by adverse effects caused by off-target activation of fibers.
A bioelectronic platform that stimulates the vagus nerve to reduce inflammatory activity and restore balance in the immune system is the ultimate aim of Setpoint Medical Inc. The Valencia, Calif.-based startup is preparing to start a U.S. pivotal trial for its most advanced program in rheumatoid arthritis (RA) later this year or early next.