SetPoint Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel bioelectronic device for patients with rheumatoid arthritis (RA) who have incomplete response to, or are intolerant to multiple biologic drugs. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA as a potentially efficacious, yet less immunosuppressive option.
 
The Breakthrough Devices Program was launched by the FDA in 2018 to give patients and health care providers timely access to medical devices that provide for more effective treatment over existing approved products.
 
There are approximately 1.5 million Americans diagnosed with RA. Despite the effectiveness of biologic and targeted agents for the treatment of RA, many patients either do not respond, lose therapeutic response or are intolerant to these agents. SetPoint’s investigational bioelectronic medicine platform stimulates the vagus nerve to activate the endogenous inflammatory reflex and thereby reduce inflammation.
 
The Company has received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites across the U.S. The trial will evaluate the safety and effectiveness of the SetPoint bioelectronic platform in patients with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).
 
“This is a significant milestone for SetPoint that will enable interactive communication with the FDA, priority regulatory review for the U.S. market, as well as support reimbursement and patient access upon FDA approval,” said Murthy V. Simhambhatla, PhD, president and CEO of SetPoint Medical. “We look forward to initiating our pivotal trial in RA and working collaboratively with the FDA to advance the development of our novel platform.”