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Friday, February 24, 2012

Biotech Stocks Sector Snapshot and Podcast: VVUS, INFI, SNTS on the Move

New York, NY - February 24, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for notable sector gainers VIVUS, Inc. (NASDAQ: VVUS), Infinity Pharmaceuticals (Nasdaq:INFI) and Santarus, Inc. (NASDAQ:SNTS).

Investorideas.com sector snapshot podcast for biotech stocks, for trading as of Thursday February 23 rd:

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VIVUS, Inc. (NASDAQ: VVUS) closed up with massive gains at $18.73, up $8.18(77.54%) with after hours trading moving it to $!8.95, up another 0.22 (1.17%).The day's high on the stock was $21.44 on over 58 Million shares. The stock's monster move was on news that the FDA Advisory Committee had recommended the approval of Qnexa for the treatment of obesity in adults

Infinity Pharmaceuticals (NASDAQ:INFI) closed up at $7.15, up 0.84 or (13.31%). The Company announced on Tuesday that they will be presenting at the Cowen and Company 32nd Annual Health Care Conference on Monday, March 5th

Santarus, Inc. (NASDAQ:SNTS) finished the day at $5.01 up 0.51(11.33%). The Company announced Wednesday that they have entered into a settlement agreement with Lupin to resolve pending patent litigation involving GLUMETZA

About VIVUS

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. www.vivus.com.

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Biodefense Stocks to Watch in 2012; PositiveID (OTCBB:PSID) and Northrop Grumman (NYSE: NOC) Opportunities with BioWatch

New York, NY - February 24, 2012 - (Investorideas.com Newswire) Investorideas.com, a leader in research for independent investors presents an investor snapshot of Homeland Security and Biodefense stocks , PositiveIDCorporation (OTCBB: PSID) and Northrop Grumman (NYSE: NOC), two potentially qualified biodetector systems suppliers for BioWatch Gen-3.

The Department of Homeland Security Office of Procurement Operations anticipates soliciting final Phase II RFP for the first or second quarter of FY 2012.The Gen-3 detection system will be a fully autonomous network of biodetectors that will continuously monitor the air for biothreat agents.

In a recent interview with Investorideas.com. Mr. William J. Caragol, Chairman and Chief Executive Officer of PositiveIDCorporation (OTCBB: PSID) noted, "Our MicroFluidic Systems ("MFS") subsidiary, is a leader in biothreat detection technologies and molecular diagnostic systems, and developed its M-BAND technology under contract from DHS over the past eight years. We believe our M-BAND, a Microfluidics-based Bioagent Autonomous Networked Detector, is one of only two technologies that is compatible with DHS' procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP. This opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID. "

PositiveID Corporation (OTCBB: PSID) announced it will present its M-BAND (Microfluidics-based Bioagent Autonomous Networked Detector) system at the 10th Annual American Society for Microbiology ("ASM") Biodefense and Emerging Diseases Research Meeting, to be held February 26-29, 2012, in Washington, DC at the Omni Shoreham Hotel. PositiveID will jointly exhibit M-BAND with The Boeing Company and Hamilton Sundstrand.

Northrop Grumman's (NYSE: NOC) biodefense division will be a key player in Biowatch as it moves forward, with previous contracts announced back in 2010. Northrop delivered critical assay technology to DHS as part of the company's BioWatch Gen-3 contract .The assay represents the key technological component of Northrop Grumman's BioWatch Gen-3 system.

According to the company's press release, Northrop Grumman's Advanced Concepts & Technologies Division is providing its Next-Gen Automated Detection Systems (NG-ADS) for independent laboratory and field testing at military and national laboratories.

"Automating the bio-detection process in these next generation instruments will provide much earlier warning of a bio-terrorism attack," said Dave Tilles, vice president of homeland defense programs at Northrop Grumman. "It will operate 24 hours per day, 365 days per year, in select cities across the nation. Earlier warning will allow the nation's public health and safety officials to reduce exposure, distribute medication sooner and proactively manage the response to a bio-threat."

As the RFP for Biowatch moves forward in 2012, investors can follow the money flow from DHS as qualified biodetector systems are contracted and deployed.

More info on Biowatch; follow the updates:

https://www.fbo.gov/index?s=opportunity&mode=form&id=2372ab5f30917fdbacca73f3fa5f0e9c&tab=core&_cview=1

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Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation ( OTCBB:PSID ) featured biotech company on Investorideas.com for 3 months effective January 30, 2012. Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp

BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894

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PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
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Thursday, February 23, 2012

Biopharmaceutical Stock to Watch: VIVUS (NASDAQ: VVUS) Massive Move on FDA Approval of Qnexa®

New York, NY - February 23, 2012 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for biopharmaceutical stock VIVUS, Inc. (NASDAQ: VVUS). The stock is trading up at$18.92 8.37(79.34%) with a day high of $21.44 on volume of over 51 Million shares.
VIVUS, Inc. (NASDAQ: VVUS) reported yesterday that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. www.vivus.com.
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BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
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Tuesday, February 21, 2012

Biodefense Stock News: PositiveID (OTCBB:PSID) to Present M-BAND at ASM Biodefense and Emerging Diseases Research Meeting February 26-29

DELRAY BEACH, Fla., February 21, 2012 - (Investorideas.com Newswire) PositiveID Corporation's (OTCBB: PSID) subsidiary MicroFluidic Systems (“MFS”), a developer of molecular diagnostic systems, announced today it will present its M-BAND (Microfluidics-based Bioagent Autonomous Networked Detector) system at the 10 th Annual American Society for Microbiology (“ASM”) Biodefense and Emerging Diseases Research Meeting, to be held February 26-29, 2012, in Washington, DC at the Omni Shoreham Hotel. PositiveID will jointly exhibit M-BAND with The Boeing Company (NYSE:BA) and Hamilton Sundstrand.
M-BAND, developed under contract for the Department of Homeland Security by MFS, is an early warning system designed to detect the intentional release of aerosolized biological agents . It runs autonomously for up to 30 days, continuously analyzing air samples, typically in high-traffic areas, for the detection of bacteria, viruses, and toxins with results in as little as three hours. Results from individual M-BAND instruments are reported via a secure wireless network in real time to give an accurate and up to date status for fielded instruments in aggregate. Designed with a high level of operational flexibility, M-BAND can be remotely set to detect for DNA-based pathogens alone, with or without either RNA-based organisms or toxins, or for all three types of pathogens simultaneously at remotely programmable intervals.
According to the ASM, approximately 1,000 leaders and decision makers in the field of biodefense will participate in the Biodefense and Emerging Diseases conference to discuss the critical research necessary to defend against the growing threat of bioterrorism and shape the future of the biodefense research agenda.
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.
Statements about PositiveID's future expectations, including the likelihood that PositiveID will present its M-BAND system at the ASM Biodefense and Emerging Diseases Research Meeting; the likelihood that PositiveID will jointly exhibit M-BAND with The Boeing Company and Hamilton Sundstrand; the likelihood that approximately 1,000 leaders and decision makers in the field of biodefense will participate in the Biodefense and Emerging Diseases conference to discuss the critical research necessary to defend against the growing threat of bioterrorism and shape the future of the biodefense research agenda; 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 M-BAND; 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.
Contact:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
Published at the Investorideas.com Newswire and syndicated blogs
Learn more about PSID at Investorideas.com
http://www.investorideas.com/CO/PSID/
Disclaimer /Disclosure : Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and  company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
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Thursday, February 16, 2012

Medical Technology Stock Alert; PositiveID (OTCBB:PSID) Achieves Positive Preliminary Results From Diabetes Research Institute Study at the University of Miami

DELRAY BEACH, Fla. - February 13, 2012 (Investorideas.com newswire) - PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management, announced today positive preliminary results from its biotransport research study with the Diabetes Research Institute ("DRI") at the University of Miami relating to PositiveID's GlucoChip(TM). GlucoChip is a glucose-sensing implantable microchip, currently under development with partner RECEPTORS LLC, for individuals with diabetes. Preliminary results demonstrate that the membrane materials to be used with GlucoChip allow for successful movement of glucose from body fluids.
PositiveID's first animal studies were designed to test the membrane materials that will be the interface between the glucose sensing device and the in vivo environment by evaluating the ability of glucose to pass through the membrane to the sensing device (glucose transport).
Robert E. Carlson, Ph.D., President and Chief Scientific Officer of RECEPTORS, said, "These first studies were successfully completed with the demonstration that a glucose tracer readily enters the device from surrounding body fluids. We are currently implementing the next phase of these studies, which will focus in more detail on both the kinetics of transport, which will determine how quickly the device will be able to respond to changes in glucose levels in the body, and on the long-term biocompatibility of the membrane."
PositiveID Chairman and CEO William J. Caragol said, "We believe the preliminary results from our research study at the DRI are not only positive but also promising as we proceed with our development. By achieving early confirmation that the membrane materials we will use with GlucoChip allow for movement of glucose from fluids in the body into the glucose-sensing device, we have begun to eliminate one of the significant hurdles of this potentially ground-breaking development project."
PositiveID and RECEPTORS LLC have completed prototype development of a stable and reproducible, closed-cycle continuous glucose-sensing system, which is the mission-critical component of GlucoChip. Continued positive results from the biocompatibility and biotransport study would position PositiveID to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip.
GlucoChip is based on the PositiveID's Patent No. 7,125,382 for an "Embedded Bio-Sensor System." The Embedded Bio-Sensor System patent covers a bio-sensor system that utilizes radio frequency identification technology and includes a remote transponder in wireless communication with an implantable, passively-powered, on-chip transponder. PositiveID now has five patents and patents pending surrounding the development of GlucoChip.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
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 preliminary results demonstrate that the membrane materials to be used with GlucoChip allow for successful movement of glucose from body fluids; the likelihood that these first studies were successfully completed with the demonstration that a glucose tracer readily enters the device from surrounding body fluids; the likelihood that the next phase of these studies, which will focus in more detail on both the kinetics of transport, will determine how quickly the device will be able to respond to changes in glucose levels in the body, and on the long-term biocompatibility of the membrane; the likelihood that the preliminary results from PositiveID's research study at the DRI are not only positive but also promising as the company proceeds with its development; the likelihood that by achieving early confirmation that the membrane materials PositiveID will use with GlucoChip allow for movement of glucose from fluids in the body into the glucose-sensing device, the company has begun to eliminate one of the significant hurdles of this exciting development project; the likelihood that the prototype development of a stable and reproducible, closed-cycle continuous glucose-sensing system is the mission-critical component of GlucoChip; the likelihood that continued positive results from the biocompatibility and biotransport study would position the company to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; 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 complete this research study of the membrane materials to be used in GlucoChip of Easy Check; PositiveID's ability to complete development of and commercialize GlucoChip; 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.
CONTACT:
Allison Tomek
561-805-8000
atomek@positiveidcorp.com
PositiveID Corporation (OTCBB:PSID) is a featured biotech company on Investorideas.com
Visit the company profile: http://www.investorideas.com/CO/PSID/
Disclaimer/ Disclosure: Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. PositiveID Corporation (OTCBB:PSID) featured biotech company on Investorideas.com for 3 months effective January 30,2012 . Compensation: two hundred fifty thousand 144 shares for news release publication, syndication on blogs and related sites and email distribution and  company profile . More info: www.InvestorIdeas.com/About/Disclaimer.asp and disclosures: http://www.investorideas.com/About/News/Clientspecifics.asp
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894

Chairman and CEO of PositiveID (OTCBB: PSID) Discusses Catalysts for 2012 in Diabetes Market and Homeland Security Market

Chairman and CEO of PositiveID (OTCBB: PSID) Discusses Catalysts for 2012 in Diabetes Market and Homeland Security Market




New York, NY- February 16, 2012 – (Investorideas.com Newswire) Medical Technology Stock news alert: Investorideas.com, a leader in research for independent investors presents an exclusive Q&A interview with Medical technology stock, PositiveID Corporation (OTCBB: PSID). Mr. William J. Caragol, Chairman and Chief Executive Officer discusses the catalysts for 2012 for both its diabetes management technologies and its Homeland Security airborne bio-threat detection technology.



Q: Investorideas.com

We noted that late last year the Department of Homeland Security (“DHS”) Office of Health Affairs began the procurement process for the deployment of an autonomous biodetection system called BioWatch Gen-3. Can you give investors insight as to the potential 2012 opportunities for the Company’s airborne bio-threat detection technology (M-BAND) in this process?



A: Mr. William J. Caragol, Chairman and Chief Executive Officer

Our MicroFluidic Systems (“MFS”) subsidiary, is a leader in biothreat detection technologies and molecular diagnostic systems, and developed its M-BAND technology under contract from DHS over the past eight years. We believe our M-BAND, a Microfluidics-based Bioagent Autonomous Networked Detector, is one of only two technologies that is compatible with DHS’ procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP. This opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID.



Q: Investorideas.com

With your three diabetes management technologies, Easy Check™, GlucoChip™ and iglucose™, can you give investors a quick summary of some of the recent key developments announced by the Company and some of the key drivers for 2012?



A: Mr. William J. Caragol, Chairman and Chief Executive Officer

We continue to make significant progress with each of our diabetes management products. Starting with Easy Check, our non-invasive breath glucose detection device, we completed a prototype device in 2011 and achieved positive preliminary results in early testing that are within industry standards. We recently announced the initiation of a clinical study of Easy Check with Schneider Children’s Medical Center in Israel, led by a world leading endocrinologist. We expect to have results from that study later this year.



Moving on to GlucoChip, a continuous glucose-sensing microchip, we have completed Phase II development and proved a stable and reproducible, closed-cycle continuous glucose sensor that functions in human blood. We also recently provided an update on a biotransport study we are conducting with the Diabetes Research Institute at the University of Miami, which has yielded positive preliminary results. We will continue to provide updates on our progress over the next few months. As those results develop, we will look to work with a partner to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip



Last but not least, we received FDA clearance for iglucose, which is a mobile health system for diabetes management, in late 2011, and are now preparing to roll-out this product with health insurers and home-healthcare providers. As we look ahead to the rest of 2012, we expect that the initial roll-out of iglucose in the first half of the year will be followed by larger orders and partnering agreements.



Q: Investorideas.com

Your technology takes management of diabetes to the clouds literally. With the iglucose technology, the data stored in the diabetes management portal can be shared automatically by text messaging or email. How significant a breakthrough is this for family members, caregivers and healthcare professionals and most importantly, the patient?



A: Mr. William J. Caragol, Chairman and Chief Executive Officer

The value proposition of iglucose is to provide an individual with diabetes flexibility and wireless connectivity to better manage their condition and stay in touch with loved ones. With iglucose, an individual no longer has to keep manual logbooks – iglucose automatically pulls the data from a glucometer and sends it to the cloud. Patients can continue to use their preferred blood glucose meter and there is no cell phone or data plan required. iglucose simplifies diabetes management by automating the process of providing blood glucose readings to healthcare professionals for more informed communication and treatment decisions. iglucose also provides peace of mind for family members that their loved ones are testing and what their values are.



Q: Investorideas.com

Easy Check is your 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. With a rapid growth of diabetes in children how significant is it to have a technology that could eliminate a patient's need to prick his or her finger multiple times per day to get a blood sugar reading?



A: Mr. William J. Caragol, Chairman and Chief Executive Officer

Being able to provide the diabetes community with a non-invasive method of testing their blood sugar is often called the “Holy Grail” of diabetes management. Certainly for children, offering non-invasive testing is even more important and appealing. Many times, people with diabetes do not test as often as prescribed by their physician due to the pain and inconvenience of drawing blood.



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.



Statements about PositiveID's future expectations, including the likelihood that its M-BAND is one of only two technologies that is compatible with DHS’ procurement for Gen-3 of Biowatch, which has a total value of more than $3 billion over approximately five years, as described by the DHS in their draft RFP; the likelihood that this opportunity, relative to the provision of biodetectors and the renewables, represents a very significant opportunity for PositiveID; the likelihood that PositiveID will continue to make significant progress with each of its diabetes management products; the likelihood that PositiveID will have results from its Easy Check clinical study later this year; the likelihood that PositiveID will continue to provide updates on its progress with GlucoChip over the next few months; the likelihood that as those results develop, PositiveID will look to work with a partner to incorporate the glucose-sensing system with a micro-electromechanical system signal transduction unit and the electronics of a radio frequency identification microchip to complete development of GlucoChip; the likelihood that PositiveID is now preparing to roll-out this product with health insurers and home-healthcare providers; the likelihood that the initial roll-out of iglucose in the first half of the year will be followed by larger orders and partnering agreements; the likelihood that iglucose simplifies diabetes management by automating the process of providing blood glucose readings to healthcare professionals for more informed communication and treatment decisions; 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 complete development and commercialize Easy Check, GlucoChip and iglucose; the likelihood that PositiveID will participate in BioWatch Gen-3; 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.



Contact:

Allison Tomek

561-805-8000

atomek@positiveidcorp.com



Learn more about PSID at Investorideas.com

http://www.investorideas.com/CO/PSID/



About InvestorIdeas.com:

InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.

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Thursday, February 9, 2012

Biotech stocks News; BioSante Pharmaceuticals (NasdaqGM: BPAX) Reports Positive LibiGel® Safety Data Review for Phase III Program

LINCOLNSHIRE, Ill. - February 9, 2012 (Investorideas.com Newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects. The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women.
BioSante reported that with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.53 percent. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33 percent, which is in line with the ages of the subjects enrolled in the study.
"The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification, as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased with the low number of CV events to date and we believe it is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante.
Subjects have been enrolled in this study for an average of 19.3 months. More than 2,500 subjects have been enrolled in the study for more than a year and over 830 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.
"BioSante's LibiGel Phase III safety study continues," said Stephen M. Simes, BioSante president & chief executive officer. "We plan to meet with the FDA to determine the best path forward for the program, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year. We have instituted appropriate cost savings in order to minimize the continuing cost of the safety study. Although LibiGel did not meet the co-primary or secondary endpoints in two Phase III efficacy studies, BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including, for example, hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
About LibiGel
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). BioSante continues to analyze the LibiGel data from the two pivotal Phase III efficacy trials first reported on December 14, 2011. These trials were double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. Initial analysis of the efficacy data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences from placebo, results indicated that LibiGel performed as predicted based on previous experience with testosterone products for FSD. Unfortunately, the placebo response in the two efficacy trials was overwhelming; and therefore, LibiGel's results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase I and Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to its products and the LibiGel development program, including in particular the LibiGel safety study and the anticipated timing of BioSante's decision whether to continue the safety study, BioSante's future burn rate and cash runway and other statements identified by words such as "will," "continue," "could," "believes," "intends," "expects," "anticipates," "plans," "may," "potential," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, additional analyses of data from the LibiGel efficacy trials and any other LibiGel clinical trials, including the safety study, may be inconsistent with previously announced results or previously conducted clinical trials or may produce negative or inconclusive results; there may be varying interpretations of data produced by clinical trials; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the success of clinical testing, the success of BioSante's licensees or sublicensees and BioSante's future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante's product development programs, its future burn rate and its need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante's current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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azachary@harrisdmckinney.com
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