The FDA ruled recently that CollPlant‘s Vergenix product, human recombinant collagen grown from genetically modified tobacco plants, will be treated as a device as opposed to a pharmaceutical. This will make the approval process easier for CollPlant and get them to market quicker.
We reported on CollPlant’s collagen expressing tobacco back in 2006 and Vergenix is the company’s flagship product. Vegenix will be used as a dressing for acute and chronic wounds to facilitate healing and act as a scaffold for fibroblasts and epithelial cells to bridge wounds.
From the company’s website:
Vergenix™ Wound Dressing is an advanced wound care device indicated for the treatment of acute and chronic wounds. Based on Collage rh™ collagen, Vergenix™ Wound Dressing is composed of pure recombinant human collagen type I produced in transgenic tobacco plants. The entire manufacturing process involves no animal-derived or human-derived materials. Therefore, Vergenix™ offers a non-allergenic and a pathogen-free scaffold for a safe and physiologically relevant environment. Vergenix™ Wound Dressing is an excellent choice for safe and successful wound management.
Video and links below the fold:
Product page: Vergenix Wound Dressing Sheet…
Globes: FDA rules CollPlant wound dressing a device…