Tissue Regenix Group is rolling out its DermaPure decellularized dermis product across the U.S., the British devicemaker said. Initial shipments by the company’s stateside manufacturer, Community Tissue Services, are set to begin this week.

DermaPure works by taking human donor skin and removing the DNA and cells, using tissue Regenix’s patented dCELL process to leave a natural biological scaffold that can be placed in the wound. The product aids natural healing by attracting the patient’s own cells to the wound site, the company said.

The regenerative tissue product is primarily intended for use by physicians in acute settings as a skin substitute, Greg Bila, president of Tissue Regenix, told Device Daily Bulletin. Physicians can use DermaPure as they see fit to replace skin as an overlay, he said, adding the company “doesn’t claim specific indications” for the product as it is homologous and can be used wherever skin needs to be replaced.

Bila said the company met with the FDA in May and expects to be granted a Medicare Q code, allowing for the product’s use in outpatient settings beginning next year.

Bila predicts the product will prove cost-effective compared with multiple grafts, as only one application of the biologic scaffold is needed to help patients heal. He added that Tissue Regenix is about to start a U.S. study to gauge DermaPure’s cost versus other treatment applications.

Tissue Regenix estimates the U.S. wound healing device market at about $1.4 billion a year. Roughly 6.5 million U.S. patients are currently afflicted by chronic wounds, the company says. — Kellen Owings

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