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Medical device firms across Minnesota have invested millions to develop products to heal open wounds, a $1.8 billion market that is expected to grow as the population ages and the number of people with type 2 diabetes climbs.
But many of these companies are struggling to get their treatments to the masses because insurance companies often refuse to pay for their products. Chronic wounds, which range from bedsores to surgical incisions that don't heal, differ from other ailments because of their varying types and stages. And there is disagreement within the medical community about the best way to treat them.
"When new technologies come out that are beneficial, the process is so darned slow," said Gary Goetzke, an insurance reimbursement consultant. "It's really hard to get Medicare and others to recognize good technologies and pay for it."
Still, medical device start-ups like Bloomington-based Advanced Healing Institute and Wound Care Technologies in Chanhassen are forging ahead. They say they've developed treatments that work better than traditional wound therapy like skin grafts. The companies have also found ways to get their treatments covered.
The Advanced Healing Institute has teamed up with Fairview Health Services to market its TruHeal system, which the company says actively monitors the wound in addition to closing it.
Kurt Larson, the company's chief operating officer, said the technology creates a pulsed magnetic field around the patient's wound, which encourages the regrowth of skin cells and accelerates the healing process. The company also uses a silver-based spray on the patient's wound to eliminate infection. The institute has a database that tracks the wound's progress and the hospital pays the company when the wound is healed.
Fairview gets the funds through the Minnesota Senior Health Options program, which is administered by the Minnesota Department of Human Services and nine HMOs.
The institute says its relationship with Fairview helps it to clear the reimbursement hurdle. The hospital also benefits because it avoids the long-term costs of treating the wound, along with related infections.
"We understand these types of patients are at risk; therefore, if we pay for wound care earlier rather than later, we actually avoid costs downstream," said Dr. David Moen, president of Fairview Physician Associates.
And Larson added, "waiting is not innovating."
So far, more than 6,000 patients have used the system, and the institute says nearly all of them have experienced faster healing. Julia Conrad, vice president of Fairview Partners/Senior Services, said one patient who dealt with a wound for 15 months was healed in eight weeks using TruHeal.
Larson said costs to treat a chronic wound can exceed $100,000. Its program can save health care providers up to 50 percent, he said.
Karin Christoferson, a Fairview patient, had a 10-inch open wound in her lower leg after her tendon was removed because of a bedsore. For more than a year, Christoferson kept changing the bandages on the wound.
Fairview recommended the TruHeal system and Christoferson started using it four months ago. The Brooklyn Park resident was skeptical at first, but she started seeing results two to three weeks after starting to use it.
Her doctor says the wound is now on its way to being completely healed.
"It seems to be working," said Christoferson, 71. "Why not keep it up?"
Meanwhile, Wound Care Technologies said it has been successful in getting insurance companies to pay for its treatment.
The company sells a device similar to a tourniquet, in which small metal anchors are put around a patient's wound. A line is wrapped around the anchors, along with a device that ensures the right amount of pressure is placed on the line each day, so the skin around the wound closes it up within days.
Marvin Huth of Shirley, Ill., had a wound on his left hip because of a recurring cancer tumor. At first, doctors warned him that he might have to remove skin from another part of his body in order to cover the gash, creating another open wound.
But when Huth, 73, came to the Mayo Clinic, his doctor used Wound Care's product.
"It was amazing," Huth said. "In six days, a pretty wide opening went down so they could put stitches on it."
But Wound Care has been hamstrung by its size, said CEO Paul Anderson. The company has only seven employees, making it tough to spread the word about its treatment.
"You can have a great product, but you need to have that sales and distribution relationship with doctors," said CEO Paul Anderson.
Still, insurance advocates say it's important that insurers receive sufficient evidence that the treatments work before approving reimbursement.
Goetzke, who has provided consulting to various medical device companies for 25 years, said companies that treat open wounds have faced the most difficulty getting reimbursement because of the varying degrees of wounds and because of the number of departments and doctors involved with treating them.
But Eileen Smith, a spokeswoman with the Minnesota Council of Health Plans, said they must ensure that patients are protected.
"Health plans get their money from employers and individuals," Smith said. "They have a responsibility to make sure they are spending that money as wisely as possible."
Wendy Lee • 612-673-1712