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chief medical officer, and Peter Coffaro, a one-time competitor of Dremel’s in med device sales, has signed on as Amp’s director of sales and marketing.
Shortly after I walked in to meet these guys, I gave them the furrowed-brow look about how in the heck a radio-frequency device is supposed to help with tissue healing. They launched into a long discussion about the device’s mechanism of action that told me I’m not the first person to give them that strange look. Robins walked me through a long explanation of how various animal studies, and human trials, have shown that pulse radiofrequency waves can increase the binding of calcium to calmodulin, a signaling molecule. That reaction leads to a cascade of effects in which nitrous oxide gets produced, increasing vasodilation (more blood flow in tissues), and decreasing production of an inflammatory protein called IL-1 beta.
This will be the year in which Amp finds out if that biochemical hypothesis really means much to people recovering from knee or shoulder surgery.
Back in December, Amp announced it was ready to start enrolling the first of 100 patients in a study that will randomly assign patients to get its device or a placebo during their recovery from total knee replacements. Since pain is notoriously tough to measure objectively in clinical trials—many studies ask patients to subjectively score their pain on a scale of 1 to 10—Amp is hoping to get some harder data that will be valuable for physicians, patients, and insurers. The main goal is to see how much the Amp device can reduce the use of morphine-equivalent pain meds over two weeks. Secondary goals of the study will look at the extent to which Amp can bring down knee swelling, range of motion, pain severity, and use of other pain medications.
Around the same time in December, Amp put another portion of its cash to work in testing its device against shoulder pain following rotator cuff surgery. That study will enroll 102 patients who are randomly assigned to get the Amp device or a placebo, with a main goal of showing Amp can reduce narcotic pain medication usage during the first week. The secondary goals include things like self-reported reduction in pain severity, and improved quality of life.
It’s possible that Amp could have the results in hand before the end of the year, Dremel says, because these are relatively short trials. There are always plenty of things that can pop up in trials, even when they appear successful on the surface. Things like whether patients find it convenient to wear the device throughout the day, or whether it’s too cumbersome, or difficult to operate. There’s always inertia to fight, in a field where physicians prescribe pain meds so much they barely give it a second thought. And there are competitors here, like Irvine, CA-based VQ OrthoCare, which makes the Bionicare—although Dremel is quick to note that patients on that device need to spend many more hours using the device before seeing its benefits.
Right now, Amp has just a small team of six people, while leaning on the parent company for basic business functions and the folks at Seattle-based Stratos Product Development for help with product design. But when I walked into their Westlake Center headquarters, I surmised there was room for at least 20. We’ll find out later this year whether Amp will be in position to fill some of those desks.