Despite FDA hurdles, SVFC is in good positionto expand into global plastic surgery market
Found this while doing some research on SVFC, from Jason Kolbert interview(whoever he is?)
"The good news is that cell therapy has virtually arrived. It's no longer a question of if, but when."On the other hand, the autologous model, like Cytori's or IntelliCell BioSciences Inc.'s (SVFC:OTCPK) adipose sonifcation process (cells are separated using sonic energy), could be very attractive for cardiac patients with CMI. If we think of the lowest of the low-hanging fruit, we think of anybody undergoing a tummy tuck. What is happening to that fat now? It's being thrown away. Imagine if that was reintroduced into your body for rejuvenation. Now the person getting liposuction is a candidate for stem cell therapy. Many physicians are actually doing this today under minimally manipulated and homologous guidelines. The area is in dispute and represents a gray area in terms of FDA regulations.
JK: I'd like to talk about IntelliCell BioSciences—and I know this will be controversial, only because its CEO, Dr. Steven Victor, is also the founder of ReGen Medical. ReGen Medical is a state-of-the-art hospital in midtown Manhattan that provides stromal vascular fraction cellular therapy, which contains stem cells, to patients today. The hospital is a beautiful, brand-new facility that treats high-end patients.
The therapy is provided to patients through physicians (orthopedists, urologists, plastic surgeons, etc.) that have practicing rights at ReGen Medical. The clinicians are allowed to put a patient's own cells back into his or her own body, provided the cells are not manipulated, processed or expanded. This is in accordance with the FDA's "minimal manipulation and homologous use" rule. The IntelliCell process, branded IntelliSonics, is similar to the Cytori process in that they both use lipoaspirate. But the IntelliCell process produces a different cellular population because, with its sonification (ultrasound) process, the blood components are not washed out. The stromal vascular fraction of IntelliCell contains the hematopoietic cells. The final product is quality-controlled, checked for any contamination and cell viability is measured. IntelliCell BioSciences has completed the preclinical protocols in anticipation of beginning a clinical trial for osteoarthritis of the knee under an FDA investigational new drug application in mid-2013. The company provides product today to ReGen Medical, and in doing so is building fantastic database of patient experience that will be used to focus on clinical applications.