CardioTech International Inc. has received Food and Drug Administration clearance to manufacture and market its hydrogel wound and burn dressing, opening the door to what the company's top executive said is a potential $300 million global market.
The dressing, made from CardioTech's patented hydrophilic polyurethane technology, is placed directly on a wound, where it absorbs fluids and provides protection without requiring removal of the dressing for inspection, according to Michael Szycher, founder and CEO of the polyurethane-based medical goods maker.
``When you take the dressing and put in water, it absorbs five times its weight,'' he said. ``It expands a little, but not much, and nothing out there can match it. And it aids in the healing process.''
The dressing can be used for skin ulcers, pressure sores, abrasions, lacerations, incisions and burns, including those associated with chemical, dermabrasion and laser resurfacing procedures, he said.
CardioTech plans to outsource production of the burn and wound dressing, rather than invest in new machinery and additional personnel to manufacture the product at its plants in Woburn and Plymouth, Minn., where it makes medical goods and produces medical grade polyurethanes for use in implantable devices.
The firm has selected an original equipment manufacturer which has worked with CardioTech on the use of the technology during the last two months, Szycher said. He did not divulge the name of the firm.
``We don't have the machinery, and big machinery is needed,'' he said. ``It would cost a lot to buy the equipment and hire people, who would then have to be certified, and that would take a long time. We'll probably have manufacturing set up in July, begin building inventory and have it on the market in early September.''
The clear dressing ``represents a market opportunity of over $300 million worldwide at the wholesale level,'' he said. ``Two other companies have something close to this, but as far as I know, our product is the only polyurethane-based hydrogel dressing available. We'll market the dressing but we're also looking for partners. We're aiming at wholesalers, manufacturing representatives...the entire open market.''