Company Receives FDA Clearance for Its iglucose System, Completes Easy Check Prototype and
Initial Testing, Completes Development of Glucose Sensor for GlucoChip, and Acquires
MicroFluidic Systems
Company Expects to Generate Revenue in 2012 Through Commercialization of iglucose and
Contract Awards for Its MicroFluidic Systems Subsidiary
DELRAY BEACH, Fla., Dec. 12, 2011 (GLOBE NEWSWIRE) -- PositiveID Corporation ("PositiveID" or "Company") (OTCBB:PSID), a developer of medical technologies and molecular diagnostic systems, today announced its 2011 highlights and discussed its outlook for 2012.
William J. Caragol, Chairman and CEO of PositiveID, stated, "In 2011, we achieved a number of milestones including FDA clearance of iglucose™, major advances with the development of our diabetes management products and the acquisition of MicroFluidic Systems, a leader in airborne biothreat detection technologies. More importantly, however, we look forward to additional successes in 2012, including generating revenues from the commercialization of iglucose and contract awards for MicroFluidic Systems."
2011 Highlights:
- Received FDA clearance for iglucose, a mobile health system for diabetes management, and successfully passed FCC requirements to sell iglucose in the U.S.
- Completed prototype of Easy Check™, a non-invasive breath glucose detection device, and announced results from preliminary laboratory testing that are within industry standards
- Completed Phase II development of GlucoChip™, a continuous glucose-sensing microchip, and proved a stable and reproducible, closed-cycle continuous glucose sensor that functions in human blood
- Acquired MicroFluidic Systems ("MFS"), a leader in biothreat detection technologies and molecular diagnostic systems
- Positioned MFS for key government programs, including the Department of Homeland Security's ("DHS") $3 billion BioWatch program
2012 Outlook
- Initial roll-out of iglucose through healthcare insurers and home-healthcare providers in first half of 2012; expected to be followed by larger orders of iglucose, generating revenue in 2012
- FDA submission of an integrated iglucose glucometer, a blood glucose meter with "iglucose inside" in the first half of 2012
- First clinical study of Easy Check to commence in first quarter 2012
- Results expected from bio-compatibility study with the Diabetes Research Institute at the University of Miami on the semi-permeable membrane to be used with GlucoChip
- Expected release of a request for proposal (RFP) by DHS for the $3 billion BioWatch program in the first quarter of 2012
- Additional contract award opportunities for proposals submitted by MFS
The FDA-cleared iglucose System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch®, marketed by Johnson & Johnson, and Nipro Diagnostic™ True™ monitoring systems, to a secure database via wireless cellular technology. The Company is also adding meters from Bayer Healthcare and Abbott to its list of meters compatible with the iglucose System. Meters from Lifescan, Bayer Healthcare and Abbott alone represented approximately 60 percent of the glucometer market in 2008, with revenues exceeding $5 billion.
As PositiveID continues to advance the next generation of iglucose technology and partners with glucometer manufacturers on the development of the iglucose glucometer, the Company is positioning itself to partake in the sale of glucometers and test strips, the global market for which is expected to reach $18 billion by 2015 according to an October 2010 Global Industry Analysts report. There are 26 million diabetics in the U.S. according to the American Diabetes Association. Remote patient monitoring devices have the fastest growing yearly revenue of any medical device sector, according to market research firm Kalorama Information. From 2008 to 2010, the growth rate was 23 percent and revenue is expected to double in the next four years due to the increasing percentage of the aging population in the U.S. and worldwide; successful cost-cutting as a result of implementing remote monitoring systems; and the health and cost benefits found through using remote device data with electronic medical records. The Company expects that partnering with glucometer manufacturers rather than manufacturing the device itself would enable it to offer an integrated glucometer and test strips at lower prices and therefore place them in the best competitive position.
With regard to PositiveID's subsidiary MFS, the 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 billion procurement and represents the first advancement in BioWatch technologies beyond manual collection and analysis by building a "lab in the box" detection system. At present, the Company believes there are only two technologies, one of which it owns in its M-BAND system, that can meet the requirements of Generation 3 BioWatch.
About PositiveID Corporation
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection. Its wholly-owned subsidiary, MFS, is focused on the development of microfluidic systems for automated preparation of and performance of biological assays. For more information on PositiveID, please visit www.PositiveIDCorp.com. ;
The PositiveID Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7717
Statements about PositiveID's future expectations, including the likelihood that the Company has a number of significant opportunities ahead, including initial roll-out of iglucose through healthcare insurers and home-healthcare providers in first half of 2012, expected to be followed by larger orders of iglucose, generating revenue in 2012; FDA submission of an integrated iglucose glucometer, a blood glucose meter with "iglucose inside" in the first half of 2012; first clinical study of Easy Check to commence in first quarter 2012; results expected from bio-compatibility study with the Diabetes Research Institute at the University of Miami on the semi-permeable membrane to be used with GlucoChip; expected release of an RFP by DHS for the $3 billion BioWatch program in the first quarter of 2012; additional contract award opportunities for proposals submitted by MFS; the likelihood that the Company is also adding meters from Bayer Healthcare and Abbott to its list of meters compatible with the iglucose System; the likelihood that the Company is positioning itself to partake in the sale of glucometers and test strips, the global market for which is expected to reach $18 billion by 2015 according to an October 2010 Global Industry Analysts report; the likelihood that remote patient monitoring devices have the fastest growing yearly revenue of any medical device sector, according to market research firm Kalorama Information; the likelihood that revenue is expected to double in the next four years due to the increasing percentage of the aging population in the U.S. and worldwide; successful cost-cutting as a result of implementing remote monitoring systems; and the health and cost benefits found through using remote device data with electronic medical records; the likelihood that partnering with glucometer manufacturers rather than manufacturing the device itself would enable the Company to offer an integrated glucometer and test strips at lower prices and therefore place it in the best competitive position; the likelihood that there are only two technologies, one of which the Company owns in its M-BAND system, that can meet the requirements of Generation 3 BioWatch; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize its diabetes management products including iglucose, and molecular diagnostic systems; the likelihood that the Company will generate revenue in 2012; the Company's ability to successfully take advantage of the BioWatch procurement; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.