Medical Devices

Porcine tissue treatment for wounds hopes for summer FDA clearance

A cheaper biologic for treating diabetic foot ulcers, bedsores and burns hopes to be on supply shelves in U.S. hospitals and wound centers by this summer.

Harbor Medtech Inc.’s NeuvoCell technology uses xenografts, or tissue from animals, to restart or support the healing of difficult chronic wounds.  The company has already raised $670,000 and is looking for almost a million more as it puts the finishing touches on its 510(k) application to the U.S. Food and Drug Administration.

The skin’s extracellular matrix (ECM), a 3-D structure of collagen and other proteins, is essential in the healing of wounds, but oftentimes it is destroyed by wounds from injury, disease and surgery. NeuvoCell uses porcine tissue to replace damaged or destroyed ECM and kick-start healing. Founder Jerry Mezger said he anticipates that it will be cleared for sale to hospital and wound care centers in the U.S. this summer.

With growth especially in devices and biologics, the market for advanced wound care was expected to be worth $6.7 billion in 2011, according to a Visiongain market report.


Similar products already on the market, like Advanced Biohealing’s Dermagraft, are not only costly but must be applied every seven to 10 days for up to 10 weeks and are only approved for use in diabetic foot ulcers, Mezger said. NeuvoCell costs less and must only be applied once or twice to wounds. Aside from diabetic foot ulcers, it can also be used for bedsores and burns.

Founded in 2010, the Irvine, California startup is using collagen crosslinking technology called BriDGE  licensed from Edwards Lifesciences because it didn’t work in its original application for heart valves.

No comments