The FDA granted Setpoint Medical Corp. an investigational device exemption (IDE) approval to study its bioelectronic platform in rheumatoid arthritis (RA) patients. The Valencia, Calif.-based company expects to begin enrollment in a multicenter, double-blind, randomized, sham-controlled pivotal trial in patients with RA in the third quarter of 2020, Setpoint President and CEO Murthy Simhambhatla told BioWorld.
Despite seeing good growth in 2019, with net sales jumping to almost $2.4 million vs. $993,000 over the previous year, Electrocore Inc. has suspended its guidance due to uncertainty over COVID-19. The company previously said full-year revenue should be in the range of $7 million to $9 million.
London-based Livanova plc has entered a collaboration with Verily Inc., an Alphabet company, to enrich data from its RECOVER trial using tools and analytics developed by Verily. The study, which kicked off last September, is assessing the effectiveness of vagus nerve stimulation (VNS) therapy for patients with difficult-to-treat depression (DTD).