ONWARD Medical $ONWD (+4,65 %) has received approval from the U.S. Food and Drug Administration (FDA) for a pivotal clinical trial. The Empower BP trial will test the company's ARC-IM system, an implantable neurostimulation technology.
The goal of this technology is to treat blood pressure instability in people with spinal cord injury - a common and previously under-treated problem. The study will be conducted at around 20 research centers in the USA, Canada and Europe.
The first patients are expected to be enrolled in the study this year. The ARC-IM system is the first neuroprosthetic system developed specifically for this application and has been approved by the FDA as a "Breakthrough Device" by the FDA.
Shamelessly summarized by the AI, source: https://www.pharmiweb.com/article/onward-medical-receives-fda-ide-approval-to-initiate-the-empower-bp-pivotal-study-with-the-arc-im-sy (Original press release as PDF available at https://ir.onwd.com/static-files/273fa49c-4a2c-40d5-99f1-ff80bbd353da)
