SetPoint Medical said today it won FDA investigational device exemption clearance to launch a trial of its proprietary bioelectronic device designed to treat patients with drug refractory rheumatoid arthritis.
The device is designed to be surgically placed on the vagus nerve to activate the body’s natural inflammatory reflex, the Valencia, Calif.-based company said.
“We are ready to build on the published positive data from our earlier first-in-human proof-of-concept study of bioelectronic therapy in RA, which significantly improved measures of RA disease activity in this difficult-to-treat patient population and also inhibited cytokine production. The new trial will evaluate SetPoint’s advanced generation proprietary miniaturized, rechargeable wireless implanted device. This novel device will be used to stimulate the vagus nerve in order to activate the efferent arm of the Inflammatory Reflex known as the Cholinergic Anti-inflammatory Pathway,” SetPoint chief medical officer Dr. David Chernoff said in a press release.
The multi-center study will explore the safety and efficacy of the device in adult patients with rheumatoid arthritis who have failed with multiple biological agents. The study is slated to enroll a total of 15 subjects between 22 and 75 at seven US centers, SetPoint Medical said.
“Gaining IDE approval for the clinical trial with our propriety device is an important milestone in moving our bioelectronic medicine program towards commercialization. This strengthens our resolve to give physicians a new therapeutic alternative designed to be safer and more cost effective for patients with not only RA but other chronic inflammatory diseases,” SetPoint Medical CEO Anthony Arnold said in a prepared statement.
In August, SetPoint Medical said it raised $30 million in a Series D equity financing round with funds slated to support continued development of its bioelectronic therapy for treating chronic inflammatory diseases.