Varberg, Sweden (January 15, 2016) – KETONIX AB, a privately held medical device company, announced today that they have completed the FDA registration process for the company’s reusable ketone monitoring device and have been assigned FDA Registration Number 862.1820. KETONIX has 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 NHS Medical Device Application process is currently underway in the United Kingdom and Ireland and shall be completed in due course. The KETONIX Breath Analyzer is used as a complement to dietary management (Ketosis) of epilepsy, aging, diabetes, cancer, and fertility 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 Breath Analysis should not be used to determine the degree of ketosis in medical crisis or therapies that require accurate plasma ketone measurements for monitoring.
Michel Lundell, President and CEO of KETONIX, stated “We are delighted that the FDA registration is done and have great distributors that are committed to health by way of nutrition, not drugs. Now we can provide superior delivery and support to the ketogenic therapeutic community”
KETONIX AB has announced the appointment of exclusive international agents and distributors in key markets. MetaGenes Inc. of Hagerstown, Maryland has exclusive rights for the distribution of the KETONIX “Reusable Breath Ketone Analyzer” in the United States and Canada. Mark De Fries, Chief Executive Officer of MetaGenes, commented that “KETONIX represents a dramatic and powerful, non-invasive, non-quantitative monitoring device for the presence of ketones in the breath of our intractable epilepsy patients. MetaGenes is a medical nutrition company focusing on the management of refractory epilepsy and other conditions that can be treated with the Ketogenic diet and the KETONIX medical device will be an important tool in ensuring the safe monitoring of ketones.”
KetoCo Ltd, located within the facilities of Newcastle University’s Biomedical Research Building at the Campus for Ageing & Vitality, shall act as the exclusive agent and distributor of KETONIX products in the United Kingdom and Ireland. Ms. Sarah McKenzie, CEO of KetoCo Ltd, is quoted as saying; “This is a breakthrough product for breath monitoring systems. Not only can you now keep control of your ketone levels at home or you can do it on the go using the battery pack on the move, with careful and regular monitoring, staying in ketosis has really, never been easier. You can adjust your diet accordingly depending on your readings and it acts like a compass, pointing you in the right direction. This is a wonderful tool, which would be welcomed with open arms in both the medical and lifestyle communities. We are proud to make these products available in the UK and Ireland.”
For information on KETONIX and its technology, please contact: Michel Lundell, Chief Executive Officer, KETONIX AB, Borgasgatan 12, Varberg Hallands Lan (SE-13) 43237 Sweden
KETONIX is a medical device firm engaged in the development of a new range of breath sensor monitoring devices and associated propriety software. KETONIX is the first reusable medical device that is designed to determine non-quantitative ketones in exhaled breath for those actively following the ketogenic diet for health or changing lifestyles.