PositiveID Corporation officials announce 2011 highlights and discuss the company's outlook for 2012.
William J. Caragol, chairman and CEO of PositiveID, states, "In 2011, we achieved a number of milestones including FDA clearance of iglucose(TM), 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, 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 Truemonitoring 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% 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.