FDA Classifies CollPlant Wound Dressing Sheets as a Medical Device-Collagen Made From Tobacco Plants-Regenerative Medicine (Bio-
Posted Aug 29 2010 7:41pm
One comment up front here is good use for tobacco plants in healing wounds so there’s another market for the plant. Tobacco companies I am guessing will see this as a plus. Device licensing is a shorter amount of time than what is required for drugs.
The product is a sheet containing a scaffold made up of human type collagen to treat acute and chronic wounds, venous ulcers, diabetic ulcers, surgical wounds, abrasions, and second-degree burns.
Much like some bio identical drugs, the tobacco plant produces Procollagen which is a natural beginning for collagen. Procollagen is normally a protein found in the human body so the collagen produced is new.
This is very interesting technology to be able to use plants to produce collagen and also has it’s place in areas of plastic surgery. If you visit the website you can get a better idea of how their regenerative medicine scaffold and sheets work and hopefully this will receive FDA approval soon. BD
The US Food and Drug Administration (FDA) has ruled that the CollPlant Holdings Ltd's (TASE: CLPT ) wound dressing product, Vergenix, will undergo the certification process by the Center for Devices and Radiological Health (CDRH), which oversees medical devices.
Vergenix Wound Dressing is wound care sheet composed of pure recombinant human collagen scaffold that provides a moist wound healing environment. The product, a type I collagen, is produced by transgenic tobacco plants. It is designed to treat acute and chronic wounds, such as pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, abrasions, and second-degree burns