MENLO PARK, Calif., Aug. 7, 2012-- Neodyne Biosciences, Inc., today announced positive interim results from the REFINE Trial (Scar Prevention and the ClinicalEffectiveness 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 one of the most challenging scar-prone surgical procedures, 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 (POSAS), physician and patient preference, and enthusiasm to recommend and to use in the future.
"The interim results of this trial demonstrate a highly significant difference between Embrace therapy vs. standard-of-care in one of the most challenging wounds possible in terms of offloading tension, because a tummy tuck is closed under significant tension," said Dr. Rod J. Rohrich, Professor and Chairman of the Department of Plastic Surgery at The University of Texas Southwestern Medical Center at Dallas, and the lead investigator for the REFINE trial. "Given the success within this wound type, there is a high probability that the Embrace device will work in lower tension scars as well. This study offers further evidence that active compressive strain (mechano-modulation) can provide a better aesthetic outcome than current standards-of-care."
"I have been impressed with the Embrace technology since the first human study that I conducted in 2009. There is a large demand for a post-surgical scar therapy that actually works," said plastic surgeon Dr. Joshua Korman (Mountain View CA, an investigator participating in this study). "The data from this latest clinical trial confirm the positive effects that the Embrace technology has on the visual appearance of post-surgical scars."
"We are delighted with these interim results and believe that Embrace scar therapy can become the treatment-of-choice for those patients concerned with the risk of post-surgical scarring," said Bill Beasley, President and COO of Neodyne. "This confirming data will allow us to launch Embrace and successfully compete within the scar treatment market alongside Merz Pharmaceuticals LLC, Molnlycke Health Care, Johnson & Johnson (JNJ), Smith + Nephew (SNN), and multiple others."
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