SetPoint系统在波士顿Beth Israel Deaconess医疗中心完成首例手术

Only FDA-approved neuroimmune modulation therapy for rheumatoid arthritis is now available to adults throughout New England.

, /PRNewswire/ -- SetPoint® Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, today announced that the first patient has been treated with the SetPoint® System at Beth Israel Deaconess Medical Center (BIDMC) in Boston. The procedure was performed by Joshua P. Aronson, M.D., functional neurosurgeon at BIDMC.

The SetPoint System is the first-and-only U.S. Food and Drug Administration (FDA)-approved neuroimmune modulation therapy for adults living with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). The system includes a small, implantable neurostimulator that delivers targeted stimulation to the left vagus nerve, activating the body's innate anti-inflammatory pathways that help regulate the immune activity associated with RA.

"The SetPoint System reflects a significant evolution in neuromodulation, applying a targeted, device-based approach to a disease that has long been treated pharmacologically," said Dr. Aronson. "An outpatient procedure now opens a fundamentally different treatment pathway for patients with rheumatoid arthritis."

More than 1.5 million Americans live with RA, a chronic autoimmune disease in which the immune system attacks healthy tissue, causing joint pain, bone erosion, deformity, reduced mobility and long-term disability. There is no cure, and many patients do not achieve or sustain adequate disease control with existing DMARD therapies.

"Treating the first patient in Boston with the SetPoint System marks an exciting milestone for people living with rheumatoid arthritis and for our clinical community," said Brian J. Stout, M.D., rheumatologist at BIDMC. "Neuroimmune modulation offers a different mechanism of action for patients whose disease is not managed with initial biological agents. Being able to offer an alternative to immunosuppressives with a different mechanism expands the treatment options we have for managing RA."

The first procedure of SetPoint Therapy at BIDMC marks a milestone as health systems and rheumatologists in the greater Boston area begin to expand their treatment options for rheumatology patients.

"Boston's academic medical centers are among the leading programs in healthcare. We are grateful to work with forward-thinking clinicians in the region," said Murthy V. Simhambhatla, Ph.D., president and chief executive officer of SetPoint Medical. "We appreciate their leadership, which is expanding access to SetPoint Therapy for people throughout New England living with rheumatoid arthritis."

Boston joins a growing list of U.S. markets where patients can access SetPoint Therapy as rheumatology practices, neurosurgeons and health systems expand availability nationwide.

About the SetPoint System

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. It should not be used 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 at spm.care/ISI.

Individual results may vary.

About SetPoint Medical

SetPoint® Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases. The company's FDA-approved SetPoint System is the first neuroimmune modulation therapy available for people living with rheumatoid arthritis, offering a novel, device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. SetPoint's proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. With a vision to redefine the care of autoimmune conditions, SetPoint is also planning to evaluate its platform technology for other conditions including multiple sclerosis and Crohn's disease. Learn more at www.setpointmedical.com.

Dr. Aronson and Dr. Stout have not been compensated in connection with this press release.

SOURCE SetPoint Medical