Neodyne Biosciences Announces Positive Interim Trial Results for Embrace
08/07/2012
Neodyne Biosciences, Inc. announced positive interim results from the REFINE Trial (Scar Prevention and the Clinical Effectiveness of a Novel Mechano-modulating Polymer), a randomized, control clinical trial designed to assess the efficacy and tolerability of the Embrace device for use in the management of closed hyper-proliferative (hypertrophic and keloid) scars. This interim analysis demonstrates the efficacy of Embrace therapy within an abdominoplasty (tummy tuck).
The results of the first 28 patients to complete the six-month assessment showed a highly significant difference between the expert blinded assessments of scar appearance for the Embrace treated as compared to the control (standard-of-care treated) incision sites (p=0.007). Additionally, all other efficacy and tolerability related parameters were strongly positive, and in favor of the Embrace treatment versus that of standard-of-care, including the Patient and Observer Scar Assessment Scales, physician and patient preference, and enthusiasm to recommend and to use in the future.