(a) The first stage is the removal (harvesting) of a sliver of dermal tissue, called a micro-organ (2-3mm diameter x 30-40mm length), from beneath the patient’s skin. This procedure is performed under a local anaesthetic, is intended to be performed in a physician’s office and is minimally invasive, so as to encourage rapid healing with little or no scarring. Generally, more than one micro-organ will be harvested from the patient (typically 4-5).
(b-e) The micro-organ is processed outside the body using a non-immunogenic adeno-viral vector to introduce the appropriate gene into the tissue’s cells and cause the cells to produce the desired protein, thus converting it into a sustained-action Biopump.
(f-i) Tests are performed during processing to determine the daily protein production from each Biopump. The appropriate number of Biopumps is thereby determined and then subcutaneously implanted back into the patient after one to two weeks. After implantation, Biopumps are designed to maintain protein levels in the blood within the therapeutic window for up to six months or more.
Medgenics believes this technology can be applied across the large and rapidly growing global protein therapy market including the following: