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 AAVC’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 have 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 patent pending process provides significant time and cost efficiencies at the point of care- using our proprietary ultrasound cavitation technique, AAVCs can be separated at low cost and in less time, as compared to competing technologies that utilize enzymes.
We also believe that IntelliCells™ have the potential to treat not only aesthetic conditions, orthopedic and sports injuries, and pain, but also a wide variety of clinical conditions involving cardiac, gastrointestinal, periodontal, and autistic disorders. In that regard, we will be seeking to undertake clinical studies in partnership with well-known universities and hospitals for the following indications and markets:
Application Market Osteoarthritis Internal Medicine and Orthopedic Gum Regeneration Periodontal Non-healing Diabetic Ulcers Wound healing Multiple Sclerosis Internal Medicine Cartilage Regeneration Orthopedic and Sports Medicine Tendon Repair Orthopedic and Sports Medicine Facial Lines and Wrinkles Aesthetic Medicine Chronic Migraine Headache Neurological Bone Regeneration Periodontal and General Surgery Hair Regeneration Aesthetic Medicine