An Ohio start-up company wants to capture a chunk of the $450 million market for medical dressings to treat moist wounds, such as bedsores or burned skin, by using polymers and absorbent compounds called hydrocolloids.
The company's first product is a skin-contact adhesive system to hold ostomy bags onto a patient's body, and the moist-wound dressing.
``Nursing homes can lose their license if they don't heal bedsores appropriately well,'' said James Grigg. He teamed with a friend, Dr. William Smith, medical director of an Indiana nursing home, to create Grigg Smith Industries.
Bedsores are caused by unrelieved pressure on body tissue, which happens when a patient remains in the same position for long periods of time.
But the entrepreneurs want to go much farther - into the new arena of ``intelligent'' dressings that release medicine directly into a wound. The founders say their product's structure makes it better suited than competing wound dressings to hold medicine and dispense it over time.
``Hydrocolloids are the backbone of the moist-wound-dressing industry,'' Smith said. ``What we have is a new way to provide hydrocolloid to the market.'' He said GSI's product offers lower price and improved performance. ``It can deliver massive amounts of pharmaceuticals and deliver it in a controlled way.''
Mixed into the hydrocolloid are natural healing substances called alginates, byproducts of algae.
Last year, the partners bought the assets of Veriseal Healthcare Products of Solon, Ohio, including one extrusion line and four U.S. patents. They moved the equipment to Alloy Extrusion Co., a compounder and contract manufacturer in Brimfield, Ohio. Production began early this year.
For now the company is based out of Grigg's home in Novelty, Ohio.
Smith and Grigg made a presentation before Ohio Polymer Enterprise Development earlier this year at the University of Akron. OPED's goal is to link technologies developed at Ohio universities with businesses.
Smith, who is medical director of Heritage Regency, an extended-care center in Richmond, Ind., said GSI has a novel product that will not degrade in a moist, open wound, even after days of use. According to Smith, research into hydrocolloids began in the late 1970s. The resulting commercial dressings can break down as pieces are dislodged into the open wound. That means nurses have to change them more frequently, a painful experience for a bedridden patient.
The nursing home or hospital feels the pain, too - financially, as it tries to extract payment from number-crunching medical insurance companies.
GSI has applied for Medicare approval for the dressings. ``If Medicare won't cover this, you haven't got a chance in the world to get into these markets,'' Smith said.
Hydrocolloids absorb water, similar to the hydrogels in a diaper, but are more advanced, since hydrocolloids deliver medicine.
About 10 companies have hydrocolloid-based wound dressings, but Smith said those competitors cannot extrude in levels as thin as GSI's product. Plus the GSI dressings have a 357 percent absorptive rate. The inner hydrocolloid layer converts to a gel upon contact with moisture from the wound.
The GSI dressing comprises a film covering a foam layer of hydrocolloid, covered with another film. The production line at Alloy Extrusion extrudes the material and laminates layers together. The production line can make 2.5 million wound dressings a year.
GSI is negotiating to acquire a plant in Florida that will complete the process, cutting the dressings into the proper sizes, sterilizing the product by irradiation and doing final packaging, Grigg said in an interview Sept. 6.
The company recently started a PharmScience Division to market a wound-patch for animals to veterinarians. ``It'll hold onto animal fur,'' Grigg said.
Helping start new Ohio polymer companies is the goal of the Akron-based OPED, run by Ronald Clark. During the University of Akron meeting, Clark linked GSI up with other researchers, entrepreneurs and even the Greater Akron Wound Care Society, a coalition of three local hospitals, UA and Kent State University.
Although GSI already was in business before connecting with OPED, Smith said the organization has helped the firm make contacts and navigate the regulatory process for drug-delivery products.
``They are helping us to commercialize our Phase II, which is going to take more capital. It's going to take more labor intensiveness,'' Smith said.
One contact made at the OPED meeting was with Chris Woolverton, an associate professor of microbiology at KSU. Before he joined Kent State, Woolverton worked at the American Red Cross, which developed various types of wound dressings. One hand-held device, resembling a can of shaving cream, can be used by soldiers to stop bleeding, as it mixes two compounds together at the press of a button, he said.
Woolverton said it may be possible to put antibiotics or other drugs into the device.
Dan Smith, a University of Akron chemistry professor, outlined his research into electrospinning very thin fibers. He said a continuous-fiber dressing could be spun at a factory and impregnated with medicine, or even a scent.