Sebana Medical's SEBA™ innovation is a unique proprietary biologic delivery technology based on biodegradable PLGA-Matrix Microparticles into which EPO substance is embedded. It is possible to administer SEBA™ onto any quantity of fat tissue and control the release of EPO precisely at any desired rate, safely and cost-effectively for preventing fat resorption.
SEBA™ is an advanced slow-delivery technology for local subdermal administration of an injectable biologic-matrix dosage form. The proprietary technology is based on erythropoietin (EPO)-Poly-(Lactide-Co-Glycolic Acid) (PLGA)-Matrix Microparticles, into which EPO is embedded. The matrix is designed to biodegrade at the desired rate to assure a tightly controlled release of EPO over extended periods of time with low systemic absorption and adverse events, providing the required local therapeutic effect of the delivered EPO molecules on fat cells which are injected by fat transfer technique for soft tissue augmentation. The technology was developed at Sebana Medical by the Biomaterial Research Group in Nazareth, Israel and is fully owned and patented by Sebana Medical.
ACTIVE PHARMACEUTICAL INGREDIENT
Sebana Medical has demonstrated that local slow release of EPO in fat grafts (i) stimulates new blood vessel formation, (ii) suppresses the inflammatory response and (iii) block apoptosis of fat cells. EPO is a glycoprotein hormone which regulates the red blood cell mass and is well-known and safe therapeutic molecule. Recombinant human EPO (rhEPO) was originally approved by the FDA in 1989 as a biologic drug for treating anemia in patients with chronic kidney disease and for the treatment of anemia associated with cancer chemotherapy.
EPO-PLGA DELIVERY MATRIX
SEBA™ Matrix is formed in an aqueous solution by the polymerization of PLGA with EPO coated Dextran, using a proprietary technique named double-coat encapsulation process. The resulting PLGA matrix is porous at the microscale and contains a varying number of OH groups and water. By changing the manufacturing process parameters, it is possible to vary the number of the OH groups and specific surface area (from a dense matrix to highly porous), both having an influence on the biodegradation rate of PLGA. When PLGA comes into contact with body fluids, the matrix is slowly dissolved. The dissolution of the matrix takes place mainly through an erosion mechanism. The biodegradation process does not change the pH within PLGA nor in the surrounding tissue in contrast to most commonly used alternative drug delivery matrices.
HOW WE DO IT
For fat transfer, fat tissue is removed from other parts of the patient’s body, usually thighs, belly, and buttocks by liposuction. The fat is then processed into liquid and reinjected back into the desired area such as in breast reconstruction to restore and reshape the breast. SEBA™ is intended for being mixed with the harvested fat prior grafting. After fat is being grafted with SEBA™, EPO is slowly delivered over an enough period to protect the fat cells from being resorbed. The product labelling instructs the use of SEBA™ by plastic surgeons as an adjunct to, and not a substitute for, fat grafting treatment for breast reconstruction in the clinic. Since EPO is slowly released in the fat grafts, treatment with SEBA™ is applied only one time (during the procedure), as a single treatment with no need for additional treatments.
TECHNOLOGY WITH MULTIPLE APPLICATIONS
SEBA™ technology can be applied to an unlimited number of fat transfer indications. The PLGA Matrix is suitable for the delivery of EPO molecules at any concentration and on any quantity of injected fat tissue. SEBA™ is designed to be mixed with the harvested fat tissue before reinjection into the desired area for soft tissue augmentation and can be used for various periods of release (30 days to 6 months). Although mainly focused on EPO slow-delivery for a therapeutic solution to fat grafting in breast reconstruction, SEBA™ technology can be also used in other fat transfer indications such as in fat grafting for facial asymmetry, hand rejuvenation, HIV-drug related lipodystrophy, wrinkle removal, breast augmentation, buttock augmentation and penile enlargement.
SEBA™ is a unique product which has no competitors. Since SEBA™ is easy-to-use by plastic surgeons, SEBA™ will be the ultimate solution for preventing fat resorption. SEBA™ revolutionizes the fat grafting market and encourages plastic surgeons to use natural fillers over the currently existing expensive, non-lasting and unsafe synthetic fillers. Sebana Medical breakthrough science using EPO slowly delivered on fat cells with SEBA™ technology is novel and a next generation innovation which can safely and dramatically promote the fat grafting technique.