Celleration, Inc. announces that it has received clearance from the US Food and Drug Administration (FDA) to market its MIST Therapy System 5.0™. The clearance was obtained through the FDA de novo process, a part of the FDA Modernization Act of 1997 (FDAMA). The company believes that this clearance through the de novo process may provide potential market advantages. MIST Therapy is indicated for wound cleaning and maintenance debridement of wounds containing yellow slough, fibrin, tissue exudate, or bacteria, the removal of which is important for the healing process. This indication allows Celleration’s proprietary noncontact MIST Technology to be used on a variety of wounds including acute, traumatic, chronic, and dehisced wounds.
       Dr. William Ennis, medical director of the Wound Treatment Program at Advocate Christ Methodist Hospital in Chicago, Illinois, commented, “Wound healing progresses optimally by cleaning the wound bed, which removes devitalized tissue and high bacterial levels. The use of MIST Therapy is an attractive technology for healthcare professionals, since its use appears to enhance our ability to optimize the wound bed environment, thereby allowing these difficult-to-heal wounds to progress along the healing pathway.”
       For more information on Celleration, Inc. and the MIST Therapy System 5.0, call (952) 974-0490.