|By PR Newswire||
|January 30, 2014 09:30 AM EST||
MENLO PARK, Calif., Jan. 30, 2014 /PRNewswire/ -- Neodyne Biosciences, a medical device company focused on the development and commercialization of innovative tissue repair devices to promote healing and minimize scar formation, today announced the publication of highly significant, favorable results in a prospective, randomized controlled study of its embrace® device, which mechanically offloads a uniform amount of tension from a newly formed scar to significantly reduce scarring and improve aesthetic outcomes following surgery. Results of the trial were published this week in Plastic & Reconstructive Surgery, the journal of the American Society of Plastic Surgeons.
"We're excited to share the results of this study, which further demonstrates our commitment to providing clinically proven technologies to both surgeons and patients looking to mitigate scarring," said Bill Beasley, President of Neodyne Biosciences.
The IMPROVE study enrolled patients who underwent surgery to revise pre-existing scars. 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.
- Evaluation of 6-month scar images by four independent plastic surgeons using the Visual Analog Scale (VAS) scale demonstrated a highly significant improvement in scar appearance following embrace® treatment (p < 0.005) vs. control.
- 90% of study participants indicated they were likely or very likely to use the embrace® treatment again.
- 100% of patients were "satisfied" or "very satisfied" with their results on the embrace® treated side.
The authors conclude that "the embrace® device represents a powerful new technology for significantly improving scar appearance following revision surgery."
The IMPROVE study publication follows a 2011 publication in Annals of Surgery showing highly significant results with the embrace® device in abdominoplasty indications. Results from another pivotal, multi-center randomized controlled trial of the embrace® device (REFINE) are scheduled to be presented at the American Society for Aesthetic Plastic Surgery Meeting, April 24- 29, in San Francisco.
Neodyne's first product, embrace® Advanced Scar Therapy, received 510(k) clearance from the US Food and Drug Administration (FDA) in September, 2011. embrace® Advanced Scar Therapy delivers a unique mechanism of action to off-load tension across a newly formed scar, and has been proven to significantly improve scar appearance in a randomized, controlled study.
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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1Citation of the Publication: Lim, AF, et al. The embrace Device Significantly Decreases Scarring Following Scar Revision Surgery in a Randomized Controlled Trial. Plast Reconstr Surg. 2014;133:398–405.
SOURCE Neodyne Biosciences, Inc.