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Kingstec Celebrates FDA Nod for SetPoint Neuroimmune Device for RA

Kingstec is SetPoint Medical’s strategic manufacturing partner—the company played a crucial role in developing and manufacturing critical external components.

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By: Sam Brusco

Associate Editor

Photo: Kingstec.

Kingstec, a company specializing in project management, engineering, manufacturing, and logistics solutions, is celebrating SetPoint Medical’s recent U.S. Food and Drug Administration (FDA) approval of the SetPoint system.

The SetPoint system is the first neuroimmune modulation device to treat adults with moderate-to-severe rheumatoid arthritis.

Kingstec is SetPoint Medical’s strategic manufacturing partner. The company played a crucial role in developing and manufacturing critical external components, which include the durable, wearable patient charger, docking station, carrying case, and all related accessories that enable seamless communication with the implant and physician programming interface.

The company’s long-standing partnerships with ISO-certified facilities throughout Asia were integral in establishing scalable, validated processes for the breakthrough device.

“Bringing a first-in-class therapy like the SetPoint System to market requires not only innovation in science but also innovation in engineering and manufacturing,” said Wilson Chiu, president of Kingstec Technologies. “This FDA approval validates SetPoint’s approach to treating autoimmune diseases and demonstrates our ability to navigate the complex regulatory and manufacturing requirements of cutting-edge medical devices. We’re proud to have helped build the foundation for bringing this therapy to more than 1.5 million Americans living with RA.”

The SetPoint System uses targeted electrical stimulation of the vagus nerve to activate the body’s natural anti-inflammatory pathways, offering a device-based alternative without immune-compromising risks. Beyond RA, SetPoint is assessing the platform for additional autoimmune conditions like multiple sclerosis and Crohn’s disease.

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