PositiveID, an emerging growth company and developer of advanced technologies for diabetes management as well as sophisticated airborne bio-threat detection systems for America’s homeland defense industry, today announced its accomplishments for the first quarter of 2012, including its positioning for the $3.1 billion BioWatch contract and the continued progress with the Company’s development and clinical study of its innovative diabetes management products.
PositiveID’s First Quarter 2012 Operational Highlights
• Positioned its M-BAND airborne bio-threat detection system to take part in the Department of Homeland Security’s $3.1 billion BioWatch Gen-3 opportunity, which is expected to be released in the third quarter of 2012
• Partnered with the Diabetes Research Institute at the University of Miami and Schneider Children’s Medical Center of Israel to support the development of the Company’s diabetes management products, including Easy Check™ and GlucoChip™
• Commenced clinical study of PositiveID’s Easy Check, a non-invasive breath glucose detection device, at Schneider Children’s Medical Center of Israel under the leadership of world-renowned endocrinologist Prof. Moshe Phillip; the study is expected to be completed by year-end 2012
• Finalized its first-in-class development of a fully synthetic glucose sensing system to be used in its GlucoChip and measure glucose levels within the body, which is considered to be a critical step in the development of an artificial pancreas
• Awarded U.S. Patent for first-of-its-kind Dragonfly detection system for molecular biological diagnostics
“We continued to make great strides in all areas of our business in the first quarter of 2012, and are executing on our plan to bring these important technologies to market,” stated William J. Caragol, Chairman and CEO of PositiveID. “We are seeing early positive results from our Easy Check testing, and remain optimistic that the significant benefits of our M-BAND system set us apart from the competition, thereby solidifying our position with large partners for the $3.1 billion BioWatch opportunity. Additionally, we are preparing for the initial roll-out of our FDA-cleared iglucose in the second quarter of this year through home-healthcare providers and healthcare insurers.”
M-BAND is the only system of its kind that was demonstrated in the field under the DHS Science and Technology (“S&T”) BAND Program. PositiveID’s patented M-BAND biodetector was developed under a competitive award from DHS S&T, and M-BAND was the only successful system to emerge from the BAND program. BioWatch program is the nation’s first early warning network of sensors to detect biological attacks. Because of the rapid decision cycle and the need for a deployment of medical countermeasures, the ability to quickly identify a biological agent will potentially save lives. Generation 3 of BioWatch is a planned, $3.1 billion procurement. At present, the Company believes there are only two technologies, one of which is its own M-BAND system, which can meet the requirements of Generation 3 BioWatch.
Designed in a miniaturized format for use at the point-of-care or in the field, PositiveID’s Dragonfly™ Rapid MDx Cartridge-based diagnostic system provides the ability to deliver molecular diagnostic results from a sample in less than 30 minutes. Dragonfly has been proven effective for a broad range of biological detection including radiation-induced cell damage within the human body, strains of influenza and other common pathogens and diseases such as E. coli, methicillin-resistant staphylococcus aureus (MRSA) and human papilloma virus (HPV). The system offers the precision of molecular diagnostics in an easy-to-use cartridge format that minimizes the possibility of human error. Typical current molecular diagnostic testing can take hours or even days, requires highly trained personnel and includes multiple handling steps. Dragonfly enables accurate diagnostics leading to the potential treatment scenarios at the point of care that are not possible with existing systems, thereby positioning PositiveID to enter the clinical diagnostics market.
PositiveID’s Easy Check, currently under development in Israel, is a non-invasive breath glucose detection device that measures the level of acetone in a patient’s exhaled breath and correlates that acetone level to a measure of blood glucose. The Easy Check technology is based on a patent-pending reagent cell that mixes a patient’s exhaled air with a proprietary chemical compound, triggering a chemical reaction. The reaction is measured and software in the Easy Check device then interprets the measurement and correlates the patient’s acetone level to the level of glucose in the body. The goal of Easy Check is to eliminate a patient’s need to prick his or her finger multiple times per day to get a blood sugar reading. With the American Diabetes Association estimating that over 25.8 million children and adults in the United States, or 8.3 percent of the population have diabetes, the overall market for a device such as Easy Check remains a significant opportunity for the Company.
Positioned for the same sizable market, PositiveID has completed its first-in-class development of a fully synthetic glucose sensing system that is the mission-critical component of its GlucoChip, a glucose-sensing microchip to measure glucose levels within the body for people with diabetes. PositiveID and its partner RECEPTORS LLC believe they are the first to develop a fully synthetic, stable, sensitive, selective sensing system that is responsive to glucose in human plasma, which is considered to be a critical step in the development of an artificial pancreas. GlucoChip is based on PositiveID’s Patent No. 7,125,382 for an “Embedded Bio-Sensor System.”
PositiveID’s FDA-cleared iglucose™ system is a wireless communication device that eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition. iglucose uses mobile technology to seamlessly communicate blood glucose readings from an individual’s data-capable glucometer to the iglucose diabetes management portal, where, with the user’s consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax. iglucose does not require the use of a cell phone or a wireless plan. The Company expects the initial roll-out of iglucose to commence in the second quarter of 2012.
Let us hear your thoughts below: