Jul 18 2014
Akers Biosciences, Inc. (the "Company" or "Akers"), a leading designer and manufacturer of rapid diagnostic screening and testing products, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent covering Akers' Breath Ketone detection device.
The Breath Ketone detection device is based upon Akers' proprietary MPC Biosensor Technology, which permits the rapid identification of medical conditions through biomarkers in exhaled breath. The primary product being developed by Akers using the Breath Ketone detection device is the Breath Ketone "Check", which provides real-time diagnostic information that allows diabetics and/or their caregivers/healthcare providers to determine if they have a severe level of ketone (acid) build up in their body. Such ketone build up can cause a life-threatening medical emergency called ketoacidosis.
The estimated 28.5 million Type 1 (insulin-dependent) diabetics worldwide are at particular risk for ketoacidosis and require routine monitoring of their ketone levels. To date the medical industry relies on blood- and urine-based ketone testing methods, which are invasive, inconvenient, and/or expensive. Since breath and blood ketone levels are closely correlated, Akers' Breath Ketone "Check" is designed to offer healthcare professionals and their patients a convenient, accurate method, which can be completed anytime, anywhere, to quickly determine if an individual's ketone level is approaching a dangerous threshold requiring medical attention.
The device has further applications in the medical and non-medical weight management areas where the measurement of ketone production is used to monitor the burning of body fat. In fact, the Company is currently marketing a version of the product to weight loss centers.
Akers is in the process of obtaining FDA 510(k) clearance for Breath Ketone "Check" in the United States, which involves further clinical studies to complete the regulatory submission. The Company hopes to receive clearance in 2015.
The Company will continue the patent prosecution process for related foreign patent applications for Akers' Breath Ketone detection device in certain growth related jurisdictions, including Europe and Japan.
"When developing technologies which address such huge diagnostic markets as diabetes, having robust protection over the intellectual property is of paramount importance for safeguarding the value of our inventions," said Raymond F. Akers Jr., Ph.D, Executive Chairman. "This patent grant by the USPTO has been some years in the making and will serve as a blueprint for achieving faster grants in other jurisdictions," continued Dr. Akers.
"We believe the ability to help Type 1 diabetics monitor their ketone levels in a non-invasive, more convenient and less expensive way than is currently available will be a significant advancement in the management of a disease which affects tens of millions of people," added Dr. Akers. "We regard Breath Ketone "Check" as one of the Company's' high growth and cornerstone tests of the near future; obtaining US patent approval is a critical step in the commercialization process."