AARDS Research Medical Director Dr. Norman B. Gaylis Recognized as First Physician in the United States To Implant New FDA-Approved Device for the Treatment of Rheumatoid Arthritis

AVENTURA, Fla., Aug. 6, 2025 /PRNewswire/ -- AARDS Research (Arthritis & Rheumatic Specialties) is celebrating a milestone in the treatment of rheumatoid arthritis. With the Food and Drug Administration's recent approval of The SetPoint System, an implant device that offers hope to more than 1.5 million Americans incapacitated by rheumatoid arthritis, the medical community is heralding the groundbreaking development as a significant advancement in the field of bioelectronics. Dr. Norman B. Gaylis, AARDS Medical Director and Principal Investigator, is the first physician in the U.S. to treat patients with the innovative device.

"We are thrilled to see the FDA recognize the efficacy of this technology, and we are honored that our research clinic was selected as the first to treat patients with the SetPoint implant," said Gaylis. "We started seven years ago with two pioneering patients who have experienced sustained success with the therapy, and since then we have continued to enroll and treat a large number of patients in follow-up trials, contributing significantly to the body of evidence that helped bring this device to market."

Gaylis added that the device is a major departure from standard rheumatoid arthritis treatments, which are typically managed with medications. The small implant is surgically placed in the neck, where it stimulates the vagus nerve for one minute each day—harnessing the power of the brain and nervous system to reduce the inflammation that causes debilitating RA symptoms.

"The SetPoint implant has been life-changing for our patients with moderate to severe RA, and particularly those who were resistant or did not respond well to pharmaceuticals," Gaylis noted. "Unlike most drugs for RA that suppress the immune system and put patients at risk, our research has shown, this innovative device resets the immune system. Even more encouraging is our patients have reported no adverse events."

Gerline Brutus of Fort Lauderdale is among the first patients treated by Dr. Gaylis with the SetPoint device at AARDS. She began treatment at age 48 after struggling with debilitating RA that did not respond to medication. Now 55, she says she's regained her independence and resumed hobbies she once loved, including exercising and bicycling.

"I was in so much pain before that I had trouble getting out of bed and I needed help with household chores and running errands," she said. "Now I can do everything on my own and it's amazing!"

The FDA's approval of The SetPoint System marks a transformative moment in autoimmune disease therapy, ushering in a new wave of therapeutics in the field of bioelectronic medicine. With its ability to modulate inflammation through targeted neural stimulation, clinical trials using the device are already underway for other autoimmune conditions, including lupus, Crohn's disease, multiple sclerosis, and inflammatory bowel disease.

ABOUT AARDS

With decades of clinical research experience and participation in more than 150 clinical trials, AARDS has been at the forefront of cutting-edge medical discovery for more than 40 years. From autoimmune disorders and rheumatoid arthritis to nationally acclaimed COVID long-haul studies, the center has consistently delivered hope to patients who have exhausted standard treatments. Many therapies evaluated at AARDS Research have received FDA approval and now help manage complex chronic diseases. The latest success with SetPoint's device is a testament to AARDS' leadership in clinical research and its unwavering commitment to patient-centered innovation.

For more information, visit www.rheum-care.com.

For interviews with Dr. Norman B. Gaylis or patients who have been treated with the SetPoint device, contact Rhonda Price at [email protected]

ABOUT DR. NORMAN B. GAYLIS M.D., F.A.C.P., M.A.C.R.

Dr. Norman B. Gaylis, M.D., F.A.C.P., M.A.C.R., is recognized as one of the country's top leaders in the field of arthritis and related diseases. He is also a practicing Master Rheumatologist based in Miami, Florida. Dr. Gaylis has presented numerous scientific papers at medical meetings around the world, and he is the author of a number of research articles on rheumatoid arthritis, systemic lupus erythematosus, and other autoimmune disorders. He is continually active with the American College of Rheumatology (ACR) and is currently a member of its board. In 2015, he established the Norman B. Gaylis, MD Research Award for rheumatologists in community practice, awarded annually for the support of research in clinical practice. In 2017, he was one of the recipients of the prestigious Master of the American College of Rheumatology designation, the highest honor that the College bestows on its members. He is actively involved in clinical research trials and has been a Principal Investigator for more than 150 new pharmaceutical products.

Contact:
Rhonda Price
(561) 371-9407
[email protected]

SOURCE AARDS