Aubrey, an advanced wound care company, has received clearance from the FDA to market its Awbat Plus product line in the US. The initial product line, Awbat, is already in use in the US and is planned for European launch later this year.
Both product lines are currently indicated for cleaning superficial burn wounds, for donor sites after hemostasis has been established, and as a protective covering for meshed autografts.
Awbat Plus consists of bioengineered wound dressings that are intended to close the wound and allow the body to heal in a moist environment. The company said that clinical studies have shown these conditions expedite healing with reduced pain.
Awbat Plus, which utilises the same silicone-nylon-collagen membrane as the Awbat product line, contains more collagen plus 5 additional biological components. It has been found by the FDA to be a combination product composed of device components as well as drugs, said the company.
Aubrey Woodroof, chairman and CEO of Aubrey, said: “The true potential of Awbat Plus will be found on more challenging and chronic wounds. Our next step is to conduct comparative studies to prove expanded clinical indications and demonstrate Awbat Plus will be an effective, alternative treatment choice for chronic wounds. We believe this product, with further clinical evidence and FDA review, has the potential to address the $2bn chronic wound dressing market.”
“We are pleased with clinicians’ acceptance of our initial product line to treat burn related wounds and look forward to the enhanced use of our products to aid in improving patient outcomes.”