Arch Therapeutics Inc (ARTH)

[Polyphemus]

cars100cars - Adhesion barriers for abdominal wounds are Class III devices, requiring a pma from FDA. FDA criteria for pma for such devices has made approvals difficult to obtain, and clinical use in US of the approved devices has been modest due to effectiveness issues. More regulatory success with these devices has been had in Europe via CE mark. My understanding is that commercial uptake in Europe for such devices has been slow. Your surgeon's comments are correct; post operative adhesions in abdominal and OB/GYN procedures remain important unsolved clinical problems. There were no data reported by MIT researchers that shed light on the potential use of AC5 as an adhesion barrier. Based on MIT publications, the use of AC5 for a surgical hemostat is a stretch as the researchers reported no evidence of platelets at the investigational wound sites. Based on the published data, it seems that a tissue sealant might be the most likely type of device to emerge using AC5 technology. At present, ARTH is reportedly focused on using it in a topic wound dressing (Class II device). Time and reported data will tell.