MENLO PARK, Calif., Aug. 7, 2012 /PRNewswire/ -- Neodyne Biosciences, Inc., today 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 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."
About Embrace™ Advanced Scar Therapy
A new approach to scar management, Embrace Advanced Scar Therapy delivers mechano-modulation therapy to the injury site and surrounding tissues. The device includes a simple disposable applicator that transfers a predetermined level of strain to a single use adhesive silicone sheet, which is then adhered over the closed scar. This unique mechanism of action provides a uniform compressive strain, or stress-shield around a closed scar, which can minimize collagen proliferation and formation of scar tissue. The Embrace device has been FDA Cleared (September, 2011), and is currently being finalized for initial market release, anticipated in the fourth quarter of this year. The Neodyne Embrace technology is protected by numerous issued and pending patents.
About the REFINE Trial
The REFINE trial is a prospective, open label, randomized (subject as their own control), multi-center study designed to demonstrate the efficacy and tolerability of the Embrace device. Within patient control, a single Embrace dressing was randomized to one side, and applied one week after elective abdominoplasty surgery approximately 2 cm lateral to mid line. The control side treatment is per the surgeon's standard-of-care for scar minimization. Devices were re-applied weekly for a period of 12 weeks of wear. The trial's primary endpoint is the difference at six months between (expert panel / blinded) photographic assessments of scar appearance for the treated as compared to the control (standard-of-care therapy) side of the abdominoplasty scar. Additional efficacy and tolerability metrics include the quantification of changing visual and tactile aspects of scar over time (Patient and Observer Scar Assessment Scale - POSAS), and regular assessments of both surgeon and patient perception and satisfaction. Sixty six subjects undergoing elective de novo abdominoplasty procedures have been enrolled at 12 sites located within California and Texas.
About Neodyne Biosciences, Inc.
Neodyne Biosciences (www.neodynebio.com) is an evidence based privately held company developing and commercializing innovative tissue repair devices to minimize scar formation, restoring both function and aesthetic appearance. The company is developing stress-shielding devices capable of controlling the mechanical wound environment to ameliorate post-surgical scarring. Although the etiology remains unclear, mechanical forces such as surrounding skin tension and body movement have been demonstrated to increase fibrosis and scar formation. It is estimated that approximately 80 million major surgical procedures are performed in the United States each year and 230 million performed worldwide. Patient frustration with post-surgical scarring spans a variety of procedures with many seeking means of prevention and treatment.
SOURCE Neodyne Biosciences, Inc.