The NIH and CDC granted researchers at the Feinstein Institutes for Medical Research at Northwell Health $700,000 to investigate an in-the-ear stimulator as a treatment for post-traumatic stress disorder (PTSD) in first responders to the attack on the World Trade Center 20 years ago. The researchers will enroll 30 World Trade Center first responders with chronic PTSD in a sham-controlled trial to test the effectiveness of a device that uses transcutaneous auricular stimulation of the vagus nerve, which has shown promise in preclinical studies.
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.
LONDON – Sleep disorder specialist Nyxoah SA hit the top end of its price range of €17 per share, raising €84.75 million (US$100) million in its initial public offering. Assuming full exercise of the over-allotment option, the company will have a market capitalization of €375.26 million. The shares began trading on Euronext Brussels (EBR:NYXH) on Sept. 18, and had a good first day, closing up 14.7%, at €19.50.
Israeli startup Bluewind Medical Ltd. has begun enrolling patients at U.S. sites in a pivotal trial of its Renova Istim implantable tibial neuromodulation system for the treatment of overactive bladder.
Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences.
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.
Electrocore Inc. has snagged an emergency use authorization (EUA) from the U.S. FDA for use of its Gammacore Sapphire CV noninvasive vagus nerve stimulation (nVNS) to acutely treat asthma exacerbations in known or suspected COVID-19 patients. The hand-held therapy can be used at home and in a health care setting.
Mainstay Medical Holdings plc has won U.S. FDA approval for its Reactiv8 implantable neurostimulation device. The company is eyeing a commercial launch of the system in early 2021. The FDA approved Reactiv8 as an aid in managing intractable chronic low back pain associated with multifidus muscle dysfunction in adults who have failed therapy and are not candidates for spine surgery.
The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature.