KETONIX AB, is a privately held Swedish medical device company and MetaGenes Inc., is a Medical Food company involved in the dietary management of rare metabolic conditions based in the United States. Collectively, the companies have completed the FDA registration process for KETONIX, a portable, non-invasive, reusable ketone monitoring device (FDA Registration Number 862.1820). KETONIX AB had previously registered their Reusable Breath Ketone Analyzer in Sweden and the EU as a Class I Medical Device. The product is suitable for Medical Device Class I marketing in the United States and other international markets as an Over-the-Counter (OTC) Class I Medical Device. The product is manufactured according to the CE (Conformité Européenne) regulations for Class I Medical Device. Additionally the KETONIX company is a member of the Global Medical Device Nomenclature (GMDN) Organization. The KETONIX Breath Analyzer is used as a complement to dietary management (Ketosis) of weight loss, epilepsy, aging (mitochrondial disfunction), diabetes, cancer, and other neurological conditions by determining non-quantitative ketones in exhaled breath. KETONIX detects the presence of ketones and measures these results in a non-quantitative output of total plasma ketone concentrations. KETONIX should not be used to determine the degree of ketosis in medical crisis or therapies that require accurate plasma ketone measurements for monitoring.