Medical devices include any "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article . . . intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease . . . or intended to affect the structure or any function of the body . . . which does not achieve any of its principal intended purposes through chemical action within or on the body . . . and which is not dependent upon being metabolized for achievement of any of its principal intended purposes."
Devices are regulated under Section 201 (h) of the Food, Drug and Cosmetic Act, as amended by the Medical Device Amendments of 1976 and the Safe Medical Device Act of 1990. There is a need to develop a device for reliable routine inactivation of different HIV strains associated with medical devices. Such a device may fall into the FDA's Orphan Products category (i.e., one affecting fewer than 200,000 people in the United States).
Aphios will develop a virus inactivation medical device by utilizing a rapid and generally applicable virus inactivation technique for both enveloped and nonenveloped viruses based on supercritical and near-critical fluids (SuperFluids™) technology. SuperFluids™ are normally gases which, when compressed, exhibit enhanced solvation, penetration and explosive decompression properties. SuperFluids™ are used to permeate and inflate the virus particles. The overfilled particles are then decompressed and, as a result of rapid phase conversion, rupture at their weakest points. The SuperFluids™ CFI (critical fluid inactivation) process inactivates enveloped viruses by a lipid solubilization mechanism and nonenveloped viruses surrounded by a tough protein capsid through the physical disruption of viral particles while preserving biological activity and integrity of the treated product.
Aphios' specific aims and milestones are as follows: (1) establish SuperFluids™ CFI conditions to inactivate > 6 logs of HIV-1 (greater than one million particles of HIV-1 per milliliter); (2) design a CFI virus inactivation device for medical devices; and (3) evaluate technical and economic feasibility of the CFI device versus alternate strategies. The problem of virus inactivation is such a serious issue that many possible methods of inactivation should be considered. Aphios' proprietary method has many attractive features, the complete removal of solvents being one strong component of this process.
Research leading to the development of this technology was partially funded by Small Business Innovative Research (SBIR) grants from the National Science Foundation and a prestigious $2 million Advance Technology Program (ATP) grant from the National Institute of Standards and Testing (NIST), Department of Commerce.
Aphios Corporation is a biopharmaceutical technology and product company with a focus on developing research tools and industrial processes for the improved discovery, manufacturing, delivery and safety of naturally derived and genetically engineered therapeutics for the treatment of cancer, AIDS and other infectious diseases in a cost-effective manner.