It sounds like science fiction: a substitute for human skin, derived from human cells and used to treat difficult-to-treat diabetic foot ulcers. But it's a real product, called Dermagraft, manufactured and sold by a real company, Advanced BioHealing. The Connecticut-headquartered company is expanding its operations in Tennessee, part of an aggressive growth strategy to spread the word about its existing product and develop new ones.
"While progress has been made on the scientific and medical fronts, only a handful of companies, including ABH, have been able to execute a successful commercialization strategy," said Dean Tozer, Senior Vice President at Advanced BioHealing.
The treatment's promise is simple. A piece of tissue produced in the lab (according to company literature, it come from "human fibroblast cells derived from newborn foreskin tissue") is implanted into a wound that's having difficulty healing. The tissue can help kick start a stalled healing process -- critical for a condition that could otherwise lead to infection or amputation.
The company says it's been used some 200,000 times in more than 1,000 wound clinics.
There are some caveats, of course. Dermagraft should be used as part of standard wound care procedure. And the wounds themselves shouldn't have exposed tendon, muscle, joint capsule or bone. Adequate blood supply is needed, too.
The journey to this point has twisted and turned. Dermagraft was actually approved by the Food and Drug Administration nine years ago, and it was marketed first by Advanced Tissue Sciences and then by Smith & Nephew. The second company left the market in 2005; Advanced BioHealing bought up the rights and started selling Dermagraft again in 2007.
The company has big plans. There's the expansion in Nashville, Tenn., which was announced in June. Then there are other possible applications for Dermagraft. Last year, Advanced BioHealing began testing to see how venous leg ulcers reacted to the treatment. It's also seeing if Dermagraft can help with orthopedic soft tissue problems.
"With more than 171 million diabetics worldwide, ABH plans to continue expanding Dermagraft sales in the U.S., while seeking regulatory approval and commercial partnerships for Dermagraft in international markets," Tozer said.
There's another product in the pipeline, too. TransCyte, a skin substitute for burns, has already been approved by the FDA. Advanced BioHealing has been talking with the government about bringing the product to a wider, civilian audience.
As more patients deal with diabetes and its complications, more medical companies will try to sell doctors new and novel treatments. It's almost certain that a handful of these treatments will become standard. For Dermagraft -- and many others -- this is only the beginning.
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