Regenacyn is formulated from the company’s Microcyn Technology platform and is designed to address the underserved consumer scar management market.
The company said that the hydrogel has been clinically shown to improve the texture, color, softness and overall appearance of scars.
The product will be sold through plastic surgeons and OBGYNs to patients and is intended for the management of old and new hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds.
The company secured a 510(k) OTC clearance from the US Food and Drug Administration (FDA) for the Regenacyn Advanced Scar Management Hydrogel in December 2013.
As part of the FDA 510(k) review process, the company carried out a double-blind, multi-centre randomized clinical trial to show equivalency to a predicate device in scar management.
A total of 40 patients are enrolled in the trial that was conducted at four US investigative sites over 16 weeks.
Qualified scars included linear or widespread hypertrophic or keloid scars and the age of target scars ranged between three months and one year.
Investigators assessed the qualified scar using the Vancouver Scar Scale (VSS), which evaluates scar vascularity, height/thickness, pliability and pigmentation.