Regenicin (OTC BB: RGIN) Orphan Status Approval for PermaDerm®
The FDA has granted Orphan Status approval for the PermaDerm® product, the only tissue-engineered skin prepared from autologous (patient’s own) skin cells consisting of both epidermal and dermal layers, which is indicated for catastrophic burn patients.
The FDA had previously designated PermaDerm® to be a biological/drug (permanent skin replacement) not a medical device (temporary skin replacement). PermaDerm® is the only skin replacement technology to receive this Biological/drug designation.
The Bottom Line: PermaDerm® consists of harvesting a small section of the patient’s own skin to be grown to graft an area one hundred times its size in as little as thirty days. These living, self-to-self skin graft tissues are intended to form permanent skin tissues that will not be rejected by the immune system of the patient, a critical possibility in porcine or cadaver skin grafts used today. PermaDerm® is being designed to not only save lives, but to reduce healthcare costs by decreasing the patient’s stay in the Critical Care Unit and to reduce the need for additional surgeries.
Regenicin (OTC BB: RGIN) is developing of and commercializing regenerative cell therapies to restore the health of damaged tissues and organs.