Aubrey receives FDA clearance to market bioengineered wound dressings in U.S.

Jan 28 2010

Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Administration (FDA) to market the AWBAT Plus product line in the United States. This represents a significant milestone for the company as it is the second product line to be launched in the company's two year history. The initial product line, AWBAT, continues to gain adoption in burn centers throughout the US and is planned for launch in Europe later this year.

Like the initial AWBAT product line, AWBAT Plus consists of bioengineered wound dressings that are intended to close the wound and allow the body to heal in a moist environment. Clinical studies have shown these conditions expedite healing with reduced pain. The company Chairman and CEO Aubrey Woodroof, PhD, feels that the true potential of AWBAT Plus will ultimately 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," stated Woodroof. "We believe this product, with further clinical evidence and FDA review, has the potential to address the $2 billion chronic wound dressing market."

Aubrey Inc. employs principles of biochemistry and bioengineering to provide clinicians with more advantageous temporary skin substitutes. In clinical evaluations it has been found that AWBAT expands upon the attributes of existing temporary skin substitutes in its attempt to fulfill the ideal properties of bioengineered alternative tissues. AWBAT Plus, which utilizes the same silicone-nylon-collagen membrane as the AWBAT product line, contains significantly 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.

"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," stated Woodroof.

AWBAT and AWBAT Plus product lines are currently indicated for clean superficial burn wounds, for donor sites after hemostasis has been established, and as a protective covering for meshed autografts. .