About SVFC's competition:
There are other companies using lipoaspirate tissue to manufacture stromal
vascular fraction. Companies, such as Cytori and Celltex, use an enzyme
(collagenese) to separate the SVFC's from the blood vessels in the adipose
tissue and they are being regulated by FDA as a drug, due to the fact that the
use of enzymes causes significant biologic manipulation.
Cytori, Celltex, Tissuegenesis, and others are utilizing a point of care device to
produce the cellular product. When factoring in the cost of the capital equipment
(as much as $70,000 each) and high disposal cost per case (as much as
$1,500), IntelliCell believes it has a superior laboratory system and process in
place.
Further, the point of care systems do not produce industry standard batch
manufacturing records demonstrating compliance with Quality Assurance that is
standard practice in any cGTP or cGMP facility. Specific cell counts, cell viability,
gram staining, endotoxin testing (all part of IntelliCell SOP's) are not included
with the point of care systems.