OBTAINING FDA APPROVAL FOR NANOTECHNOLOGY-DERIVED MEDICAL DEVICES: TWO DECADES OF EXPERIENCE
Northeastern University, USA
There is an acute shortage of organs due to disease, trauma, congenital defects, and most importantly, age related maladies. The synthetic materials used in tissue engineering applications today are typically composed of millimeter or micron sized particles and/or fiber dimensions. Although human cells are on the micron scale, their individual components, e.g. proteins, are composed of nanometer features. By modifying only the nanofeatures on material surfaces without changing surface chemistry, it is possible to increase tissue growth of any human tissue by controlling the endogenous adsorption of adhesive proteins onto the material surface. In addition, our group has shown that these same nanofeatures and nano-modifications can reduce bacterial growth without using antibiotics, which may further accelerate the growth of antibiotic resistant microbes. Inflammation can also be decreased through the use of nanomaterials. Finally, nanomedicine has been shown to stimulate the growth and differentiation of stem cells, which may someday be used to treat incurable disorders, such as neural damage. This strategy also accelerates USA FDA approval and commercialization efforts since new chemistries are not proposed, rather chemistries already approved by the FDA with altered nanoscale features. This invited talk will highlight some of the advancements and emphasize current nanomaterials approved by the USA FDA for human implantation.