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bioelectronic medicine

SetPoint Medical Receives IDE Approval for U.S. Pivotal Trial to Study its Bioelectronic Platform in Rheumatoid Arthritis Patients

Important safety information

The SetPoint System is indicated for use in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs). Do not use if you have had a vagotomy or splenectomy, or if your healthcare provider determines that it is not safe for you to use the SetPoint System. Risks may include, but are not limited to, pain or infection after surgery, hoarseness, bruising, swelling, coughing and throat irritation.

For full safety information, please see Instructions for Use and our Important Safety Information. Individual results may vary. Please consult with your health care provider to determine if the SetPoint Therapy is right for you.

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Valencia, CA 91355

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