Ortec seeks HDE (Humanitarian Device Exemption) for skin product:
This article was originally published in Clinica
Executive Summary
Ortec International is seeking US FDA approval to market its Composite Cultured Skin (CCS) product as a treatment for four critical skin conditions under a Humanitarian Device Exemption (HDE). If the application is approved, the product, composed of a bioengineered bovine collagen matrix seeded with dermal and epidermal cells, will be used to treat patients suffering from epidermolysis bullosa, Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme. The New York-based company expects to receive notification from the FDA within 75 days. An HDE allows companies to market devices for treating conditions that affect less than 4,000 in the US.