Intellicell Biosciences Inc (fka SVFC)

[Toeinmouth]

SVFC Technology

We use a proprietary, patented technology developed by our founder, Dr. Steven Victor, which provides us with the ability to extract, separate and process the stromal vascular fraction cells from the blood vessels in adult adipose (fat) tissue in about one hour. We believe that our technology produces the most cells from the least amount of fat (60 cc) at the lowest cost and the least amount of manipulation when compared to other technology or processes currently available that employ manipulative processes or enzymes to achieve cell separation. Further, all cells manufactured using our technology and proprietary process are done so under strict United States Food and Drug Administration (“FDA”) cGTP guidelines and SOPs that we have established.

We believe that stromular vascular fraction (“SVFs”) derived from the application of our proprietary process yield a functionally diverse population of cells that are synergistic and able to communicate with each other and with other cells in their local environment. We also believe that since we do not have to wash out the blood and do not digest the extracellular matrix versus competitors’ enzymatic protocols that our product is superior. The mixture of cells has multiple functions and is highly integrated and we believe more potent than adipose stem cells themselves.

We further believe that IntelliCells™, when returned to a patient’s own body by way of same-day same clinical procedure (autologous treatment) and delivered via Point of Care, have little or no risk of disease transfer, rejection or allergic reaction. We also believe that IntelliCells™ have the potential to treat a wide variety of clinical conditions involving orthopedic, gastrointestinal, periodontal, aesthetic and other conditions or disorders.

Our Strategy

We plan to focus our initial efforts on regenerative medicine in the areas of orthopedics, sports medicine, pain, aesthetics and periodontal diseases. According to arthritistoday.org , at least 25 million people nationwide are affected in the world of orthopedics, sports medicine and pain, which, just nationally, makes that a penetrable market into the billions of dollars. Likewise, according to Research and Markets Aesthetics Report and Global Data’s market report for the periodontal market, the aesthetics and periodontal markets make up at least a minimum of $750 million and over a billion dollar market, respectively. We will focus on orthopedics including osteoarthritis, aesthetics, pain, periodontal and other indications by making our Intellicells™ available to practicing physicians using Regen Medical’s office based surgical center (“OBSC”). We plan to establish and install our cGTP cellular processing labs in ambulatory surgery centers and hospitals to make our cellular product available to a wide range of physician specialties to use under the practice of medicine. We believe that we may also be able to license our technology for wound care, cardiac, gastrointestinal (colitis/ileitis), multiple sclerosis and autism to other companies in the regenerative medicine field.

In addition to our core focus noted above in which we provide cGTP cellular processing labs, we also intend to expand our areas of focus, as we are able to locate and partner with parties interested in utilizing or licensing our technology for other areas. In this regard, we intend to engage in a multi-pronged approach with respect to the utilization and commercialization of our proprietary process that will involve entering into technology licensing agreements and related service agreements with physicians and physician practice groups, that we will enable to practice our cell therapy procedures in our US facilities. We will also be seeking to enter into technology licensing agreements or other arrangements that cover particular international territories or countries as described in greater detail below.

Another focus of our business development will involve engaging in and our coordinating Institutional Review Board (”IRB”) approved clinical studies at prominent medical centers, some of which studies may also be the subject of Investigational New Drug applications (“IND’s”) with the goal of obtaining medical or regulatory approval for significant clinical indications, where, if and as required, of the Intellicells™ produced with our proprietary process. We have recently formed a wholly-owned subsidiary, ICBS Research, Inc., through which we plan to engage in research and development activities by collaborating with university based research organizations. We have started our first FDA IND study that will be on osteoarthritis of the knee with Dr. James Andrews and inVentiv as our CRO. We believe these activities may lead to additional patents and intellectual. ICBS Research, Inc., our wholly owned subsidiary, will also coordinate scientific research with world class researchers to learn more about the Intellicell™ process and the use of the cells in medical procedures and as to how it may be used as a more efficacious delivery mechanism or as to how it may be co-administered in conjunction with other medical therapies. In the future Intellicell plans to conduct human clinical studies under an IND in osteoarthritis of the knee, diabetic ulcers of the lower extremities, multiple sclerosis, periodontal gum recession and dermal wrinkles to obtain FDA approval where such approval may be necessary.

We are also exploring and undertaking, either on our own or in collaboration with one or more third parties, providing a service for the collection, processing and storage of autologous cells. We intend to market this service to liposuction patients in addition to any patient who might want to store their SVFs for future use.

Our Competitive Advantage

We believe that our proprietary process offers significant advantages over other competing processes or technologies currently being employed that utilize enzymes or other manipulative methods to harvest or culture cells, including:

We believe that our process is in compliance with existing FDA regulations – under current FDA Guidelines for human cell and tissue based products (HCT/P) (based on FDA regulations found at 21 C.F.R. § 1271), patients are allowed to use their own HCT/P for just about any indication, so long as the use of those cells is autologous (a situation in which the donor and recipient are the same person), the cells are minimally manipulated, the clinical use is homologous, and the procedure takes place as a single procedure as defined by the physician.

Our procedure takes place during the same office visit. The point of care nature of the process is a required element of the protocol required by our licenses, and is emphasized in our technician and physician training.

We believe that the number of adult autologous stem cells and other progenitor cells that comprise the SVF’s that are harvested from the tissue through the use of our proprietary process are significantly higher than the number of cells produced through the use of other technology or processes currently available that employ manipulative processes or enzymes to achieve cell separation.

We had engaged Millipore, a division of Merck, to perform a CD (cluster of differentiation) antibody flow cytometry study which has confirmed the high-quality composition of the IntelliCells™.


We believe that our patented process provides significant time and cost efficiencies at the point of care- using our proprietary ultrasound cavitation technique, SVFs can be separated at low cost and in less time, as compared to competing technologies that utilize enzymes.
http://ih.advfn.com/p.php?pid=nmona&article=62160312

GO SVFC