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Friday, Mar 29, 2024
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Device from Small Biotech Gets Advanced by FDA

In what could be a breakthrough development for a small Valencia biotech, SetPoint Medical Corp. has received approval from the Food and Drug Administration to launch a pilot study on its main product. SetPoint has developed surgically-implanted, wireless device that uses electrical signals to stimulate the body’s immune system in a way that activates anti-inflammatory processes. Back in 2012, it became the first company to publish the results of a human study that suggested a bioelectronic device could be effective in treating rheumatoid arthritis, an autoimmune condition that affects approximately 1.3 million adults in the United States, according to the American College of Rheumatology. Obtaining what’s called an investigational advice exemption is a key step in bringing a medical device to market, as it allows a company to conduct clinical trials without having to comply with regulations for commercial products. The results are typically used as part of a premarket approval application with the FDA, the final hurdle before a device can be sold to U.S. consumers. “Gaining (the exemption) for the clinical trial with our proprietary device is an important milestone,” Anthony Arnold, chief executive of SetPoint, said in a statement. “This strengthens our resolve to give physicians a new therapeutic alternative designed to be safer and more cost effective for patients.” The forthcoming trial will take place with 15 patients in seven locations. Unlike the first study, this one will test the effectiveness of the device in patients suffering from rheumatoid arthritis that appears resistant to standard drug therapies.

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