Bioelectronics Corp (BIEL)

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Does this mean the ActiPatch box could just say "reduces swelling and be put on U.S. store shelves ?
"Product Description
ACTI PATCH HEEL PAIN THERAPY FDA market clearance for the treatment of edema . International Standards Organization (ISO) and CE (Conformité Européenne, French for European conformity) Cert. . Health Canada Market clearance for the relief of musculoskeletal pain The clinical effectiveness of the product has been well established. Testing performed at the Bioelectromagnetics Research Laboratory at the State University of New York has shown that ActiPatch Therapy provides an adequate dosage of electromagnetic energy for the treatment of soft tissue, and that its power at the skin level is equivalent to that of traditional high-power devices. The power level is six to nine orders of magnitude higher than that which is required to show a biological effect. It also demonstrated that the cumulative effect of continuous delivery provides greater therapeutic benefit than sporadic treatments. Clinical studies on ActiPatch Therapy in the areas of Inflammation, Pain and wound care are ongoing. Results from these clinical studies will be submitted to the US FDA for expanded indications for the use of ActiPatch range of products."