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SOURCE Neodyne Biosciences, Inc.
REFINE Pivotal Multi-Center, Randomized, Controlled Trial results published online ahead of print in Plastic & Reconstructive Surgery, the journal of the American Society of Plastic Surgeons.
MENLO PARK, Calif., May 15, 2014 /PRNewswire/ -- In the largest randomized, controlled trial to date of the embrace® Advanced Scar Therapy device, Neodyne Biosciences reported a highly significant improvement in scarring for patients treated with embrace® versus control at 1-year follow-up. embrace® Advanced Scar Therapy actively relieves the tension surrounding a healing scar to minimize scar formation and uses technology initially developed at Stanford University and subsequently licensed to Neodyne Biosciences.
"These data further support the long-term value proposition of embrace, which has now been shown to improve results out to one year post-surgery. The differences were highly significant between embrace-treated and control-treated groups when analyzed by independent, blinded reviewers using the Visual Analog Scale [VAS]," said Geoffrey Gurtner, MD, FACS and Co-Founder of Neodyne Biosciences.
The REFINE trial enrolled patients who underwent abdominoplasty procedures, a challenging indication for scarring since the incision is closed under maximum tension. Half of each newly closed incision was selected randomly to be treated with the embrace® device. The remaining portion of the incision served as the "control" side and was treated according to the plastic surgeon's standard of care.1
- At 12 months, the mean VAS score for embrace-treated scars was significantly improved compared to control-treated scars, (difference = 0.39, 95% confidence interval [0.14, 0.66], p = 0.027).
- Both subjects and investigators found that embrace-treated scars demonstrated significant improvements in overall appearance at 12 months using the Patient and Observer Scar Assessment Scale (POSAS), (p = 0.02 and p < 0.001, respectively).
"The differences at one year between the embrace-treated and control-treated scars were highly significant, showing no regression to the mean and an extremely positive long-term benefit in scar reduction with the embrace device," said Michael Longaker, MD, FACS and Co-Founder of Neodyne Biosciences.
"Neodyne is committed to providing clinically proven technologies to both surgeons and patients looking to minimize scarring," said Bill Beasley, President of Neodyne Biosciences, "embrace® is the first scar management product of its kind, and to our knowledge, no other scar treatment is backed by the same wealth of clinical data."
1The Published Ahead-of-Print Article can be found at: http://journals.lww.com/plasreconsurg/Abstract/publishahead/A_Randomized_Controlled_Trial_of_the_embrace_R_.99487.aspx
About Neodyne Biosciences, Inc.
Neodyne Biosciences (www.neodynebio.com) is an evidence based 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.
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