New Data Demonstrate Significant Long-term Improvement in Scarring using Neodyne Biosciences embrace® Advanced Scar Therapy

05/19/2014

Neodyne Biosciences reported a highly significant improvement in scarring for patients treated with embrace® Advanced Scar Therapy versus control at one-year follow-up in a randomized, controlled trial of the device. 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.

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.

Results:

• At 12 months, the mean VAS score for embrace-treated scars was significantly improved compared to control-treated scars, (difference = 0.39, 95 percent 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).

"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 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.

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