Wind Stocks to Watch: (OTCBB: JUHL), (NYSE:MY), (TSX.V: CTW), (NasdaqGS: AMSC)
Point Roberts, WA - November 17, 2011 (Investorideas.com renewable energy/green newswire) Investorideas.com, a leader in renewable energy stock research, releases a trading and news alert for small and large cap wind stocks, Juhl Wind Inc. (OTCBB: JUHL), China Ming Yang Wind Power Group (NYSE: MY), Catch the Wind Ltd. (TSX-V: CTW.V) and American Superconductor (NasdaqGS: AMSC).
Juhl Wind, Inc. (OTCBB: JUHL) Reports Third Quarter 2011 Financial Results, Revenue Up 276%
Nine Months Revenue Increases over 245% from 2010, Company Holds Over $6 Million in Cash
Juhl, the Leader in Community Wind Power, reported Tuesday its results for the third quarter of 2011. Revenue for the third quarter 2011 was $3,259,000 compared to $867,000 in the third quarter of 2010, or an increase of 276%. In addition, for the nine months ended September 30, 2011 , the Company posted a record $10.9 million in revenue and $2.4 million in net income. Juhl Wind also reported continued growth in its cash position due to development fees, ending the first nine months of 2011 with approximately $6 million in cash.
Juhl Wind's stock closed up 5% at $0.63 in Wednesday's trading session following Tuesday's news.
American Superconductor (NasdaqGS: AMSC) was featured in commentary today, "5 Small Stocks With Home-Run Potential "at TheStreet. The stock is trading at $4.28, up 0.24 (5.94%) 12:15PM EST.
China Ming Yang Wind Power Group (NYSE: MY ), a leading wind turbine manufacturer in China , today announced that it has signed a strategic cooperation agreement with Guangdong Yudean Group Co., Ltd. ("Yudean") to foster off-shore wind power development in Guangdong province and to localize the production of multi-megawatt wind turbine generators ("WTG"). Yudean is the largest power generation company in Guangdong province.
According to the strategic cooperation agreement, Ming Yang will supply its 3MW, 5MW and 6MW Super Compact Drive ("SCD") WTGs to Yudean's off-shore wind power technology demonstration project in Xuwen, Zhanjiang. The demonstration project is expected to have a total power output of 200MW, and is located on the eastern coastal areas of Xinliao Island, Xuwen, Zhanjiang. Testing and evaluation for the off-shore wind resources and site selection have already been conducted.
Catch the Wind Ltd. (TSX-V: CTW.V), providers of laser-based wind sensor products and technology, announced yesterday that it will hold a conference call to discuss its third quarter results for 2011 on Tuesday, November 29, 2011 at 10:00 a.m. ET. In compliance with disclosure requirements for TSX Venture Exchange issuers, the Company will report its financial results on November 28, 2011 after market close. The stock is trading up 24% today on light volume.
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Thursday, November 17, 2011
Infrastructure/ Construction Stock News: Fireman's Contractors (OTCBB:FRCN) First Quarter Revenues Increases 109% over Fiscal Year First Quarter 2011
DALLAS and FORT WORTH, Texas - November 17, 2011 - Fireman's Contractors Inc. (OTCBB: FRCN) (OTCQB:FRCN.OB) and its board ofdirectors
are proud to announce that it had a increase of first quarter revenues of 109% from fiscal year first quarter revenue of 2011. The 2012 First quarter was July 1, 2011 through September 30, 2011 . The gross revenue is in addition to the 290% increase that the Company had in fiscal 2011, July 1, 2010 thru June 30, 2011.
Renee Gilmore , CEO of Fireman's Contractors, stated, "Continuing efforts to cultivate relationships with our commercial clients was the ultimate reason for our continued growth. This is an exciting time for Fireman's Contractors as we continue to increase our staff and professional representatives; we look forward to continuous future growth."
Recently Fireman's Contractors announced that it launched its Franchise Development Program after finalizing its Federal Disclosure Document required by the Federal Trade Commission. The Franchise Development Program aims to expand market share through franchise expansion. The Franchise Development Program is being lead by a team of highly successful experienced franchise development professionals that has successfully facilitated well over 7,000 franchises sales in their 300 cumulative years of franchise industry experience during the course of their careers.
For More Information about FRCN Please Visit: http://www.FiremansContractors.com
About the Fireman's Contractors:
FIREMAN'S CONTRACTORS Inc. (OTCBB: FRCN) is a full service contractor providing professional services for commercial and government clients. Services include Road Improvements, Pavement Maintenance, Seal Coating, Parking Lot Striping, Pavement Marking, Asphalt Maintenance and Repair, and ADA Compliance. Fireman's Contractors has completed its FDD requirements with the Federal Trade Commission and has developed franchise territories across the U.S. The Company's goal is to develop hundreds of new franchise locations in the next 24 to 48 months. Fireman's Contractors brings a professional value system delivering outstanding results through honorable customer relationships and repeat business. Local firefighters are supported by a portion of profits which are donated to local Firefighter Associations.
Founded by a Firefighter, Fireman's Contractors - Contractors You Can Trust (R)
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the control of management. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. Additional information respecting the factors that could materially affect the Company and its operations are contained in its annual report on Form 10K and Form 10-Q as filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statement.
Contact:
Fireman's Contractors Inc.
2406 Gravel Road
Fort Worth , TX 76118
Phone: 800-475-1479
info@FiremansContractors.com
http://www.Firemans-Contractors.com
Investor Relations Contact:John Pentony, IR Affiliates
Contact: john@iraffiliates.com
Tel: 469.252.3031
Public Relations Contact: Danielle O'Neal
Contact: PR@FiremansContractors.com
Tel: 800-475-1479
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DALLAS and FORT WORTH, Texas - November 17, 2011 - Fireman's Contractors Inc. (OTCBB: FRCN) (OTCQB:FRCN.OB) and its board of
Renee Gilmore , CEO of Fireman's Contractors, stated, "Continuing efforts to cultivate relationships with our commercial clients was the ultimate reason for our continued growth. This is an exciting time for Fireman's Contractors as we continue to increase our staff and professional representatives; we look forward to continuous future growth."
Recently Fireman's Contractors announced that it launched its Franchise Development Program after finalizing its Federal Disclosure Document required by the Federal Trade Commission. The Franchise Development Program aims to expand market share through franchise expansion. The Franchise Development Program is being lead by a team of highly successful experienced franchise development professionals that has successfully facilitated well over 7,000 franchises sales in their 300 cumulative years of franchise industry experience during the course of their careers.
For More Information about FRCN Please Visit: http://www.FiremansContractors.com
About the Fireman's Contractors:
FIREMAN'S CONTRACTORS Inc. (OTCBB: FRCN) is a full service contractor providing professional services for commercial and government clients. Services include Road Improvements, Pavement Maintenance, Seal Coating, Parking Lot Striping, Pavement Marking, Asphalt Maintenance and Repair, and ADA Compliance. Fireman's Contractors has completed its FDD requirements with the Federal Trade Commission and has developed franchise territories across the U.S. The Company's goal is to develop hundreds of new franchise locations in the next 24 to 48 months. Fireman's Contractors brings a professional value system delivering outstanding results through honorable customer relationships and repeat business. Local firefighters are supported by a portion of profits which are donated to local Firefighter Associations.
Founded by a Firefighter, Fireman's Contractors - Contractors You Can Trust (R)
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the control of management. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. Additional information respecting the factors that could materially affect the Company and its operations are contained in its annual report on Form 10K and Form 10-Q as filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statement.
Contact:
Fireman's Contractors Inc.
2406 Gravel Road
Fort Worth , TX 76118
Phone: 800-475-1479
info@FiremansContractors.com
http://www.Firemans-Contractors.com
Investor Relations Contact:John Pentony, IR Affiliates
Contact: john@iraffiliates.com
Tel: 469.252.3031
Public Relations Contact: Danielle O'Neal
Contact: PR@FiremansContractors.com
Tel: 800-475-1479
Follow FIREMANS CONTRACTORS, Inc. (OTCBB:FRCN) on Twitter.com
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Fireman's Contractors Inc. (OTCBB:FRCN), (OTCQB:FRCN.OB) is a featured construction stock on Investorideas.com
Visit the company profile to learn more: http://www.investorideas.com/CO/FRCN/
Disclaimer/ Disclosure: FRCN has compensated Investorideas.com ten thousand for three months of advertising. All info published is sourced from public files or the Company. This is not a solicitation go buy or sell securities.
Mining and Silver Investor Trading Alert: SilverCrest Mines (TSX-V: SVL, OTCQX: STVZF) Trades up over 12% on 2,536,522 Shares
November 17, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors issues a trading alert and news update for mining investors following SilverCrest Mines (TSX-V: SVL, OTCQX: STVZF) . The stock had a record volume trading session Wednesday closing up at $2.06, up 0.23 (12.57%) on 2,536,522 shares.
The stock has gained momentum and increased share price following Monday's news "
SilverCrest Mines (TSX-V: SVL, OTCQX: STVZF) Identifies Large Bulk Tonnage Target at La Joya; Hole 17 intercepts 205.2m Grading 92.7 gpt Silver Equivalent"
More about Silvercrest Mines (TSX-V: SVL, OTCQX: STVZF): videos , analyst commentary:
http://www.theaureport.com/pub/co/292
To view accompanying maps for the news release visit : http://media3.marketwire.com/docs/fourMaps.pdf
News:
SilverCrest Mines Inc. announced Monday, that data compilation for the Phase I drilling program and a newly received historic database has identified a large, near-surface bulk tonnage target at its La Joya property in Durango, Mexico. The compilation by SilverCrest has involved data and/or drill core review of 51 historic holes (14,786 metres) and 26 Company drill holes (5,716 metres) totaling 20,502 metres of drilling in 77 holes on the property. Verification or validation work completed by an Independent Qualified Person included review of 22 historic holes, Company drill information, geologic mapping, sampling, geochemistry, and historic airborne and ground geophysics. The compilation of these data will be incorporated into the upcoming NI43-101 Technical Report and resource estimate.
All 26 SilverCrest drill holes and 27 historic drill holes (verified with assays) intersected polymetallic mineralization that includes silver (Ag), copper (Cu), gold (Au), lead (Pb), zinc (Zn), tungsten (W) and molybdenum (Mo). Thirty three widely-spaced holes approximately 100 metres apart have identified a large, near-surface bulk tonnage target in the Phase I drilling area along the Main Mineralized Trend ("MMT") at La Joya.The MMT is defined, by using results from the Company's Phase I program and validated historic drill hole information, as a semi-continuous Ag-Cu-Au-Pb-Zn mineralized corridor with current "drilled-defined" dimensions of approximately 1,000 metres by 500 metres. The MMT includes a combination of wide vertical stockwork zones and multiple-stacked, polymetallic, stratabound horizons up to 230 metres in vertical thickness with grades ranging from 15.9 gpt to 202.4 gpt Ag equivalent*.
The remaining 44 holes that lie outside the Phase I drilling area have identified extensions to current mineralization along the MMT (see news release dated October 17, 2011) and have discovered a number of additional separate targets. Information from the historic database has extended the "overall" dimensions of the Main Mineralized Trend to greater than 2.5 kilometres in strike length by approximately one kilometre in width (see table on next page, attached maps and sections).
Full News release :http://www.investorideas.com/news/2011/mining/11142.asp
Contact:
SilverCrest Mines Inc.
Fred Cooper
(604) 694-1730 ext. 108 or Toll Free: 1-866-691-1730
(604) 694-1761 (FAX)
info@silvercrestmines.com
www.silvercrestmines.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
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Source - www.Investorideas.com
November 17, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors issues a trading alert and news update for mining investors following SilverCrest Mines (TSX-V: SVL, OTCQX: STVZF) . The stock had a record volume trading session Wednesday closing up at $2.06, up 0.23 (12.57%) on 2,536,522 shares.
The stock has gained momentum and increased share price following Monday's news "
SilverCrest Mines (TSX-V: SVL, OTCQX: STVZF) Identifies Large Bulk Tonnage Target at La Joya; Hole 17 intercepts 205.2m Grading 92.7 gpt Silver Equivalent"
More about Silvercrest Mines (TSX-V: SVL, OTCQX: STVZF): videos , analyst commentary:
http://www.theaureport.com/pub/co/292
To view accompanying maps for the news release visit : http://media3.marketwire.com/docs/fourMaps.pdf
News:SilverCrest Mines Inc. announced Monday, that data compilation for the Phase I drilling program and a newly received historic database has identified a large, near-surface bulk tonnage target at its La Joya property in Durango, Mexico. The compilation by SilverCrest has involved data and/or drill core review of 51 historic holes (14,786 metres) and 26 Company drill holes (5,716 metres) totaling 20,502 metres of drilling in 77 holes on the property. Verification or validation work completed by an Independent Qualified Person included review of 22 historic holes, Company drill information, geologic mapping, sampling, geochemistry, and historic airborne and ground geophysics. The compilation of these data will be incorporated into the upcoming NI43-101 Technical Report and resource estimate.
All 26 SilverCrest drill holes and 27 historic drill holes (verified with assays) intersected polymetallic mineralization that includes silver (Ag), copper (Cu), gold (Au), lead (Pb), zinc (Zn), tungsten (W) and molybdenum (Mo). Thirty three widely-spaced holes approximately 100 metres apart have identified a large, near-surface bulk tonnage target in the Phase I drilling area along the Main Mineralized Trend ("MMT") at La Joya.The MMT is defined, by using results from the Company's Phase I program and validated historic drill hole information, as a semi-continuous Ag-Cu-Au-Pb-Zn mineralized corridor with current "drilled-defined" dimensions of approximately 1,000 metres by 500 metres. The MMT includes a combination of wide vertical stockwork zones and multiple-stacked, polymetallic, stratabound horizons up to 230 metres in vertical thickness with grades ranging from 15.9 gpt to 202.4 gpt Ag equivalent*.
The remaining 44 holes that lie outside the Phase I drilling area have identified extensions to current mineralization along the MMT (see news release dated October 17, 2011) and have discovered a number of additional separate targets. Information from the historic database has extended the "overall" dimensions of the Main Mineralized Trend to greater than 2.5 kilometres in strike length by approximately one kilometre in width (see table on next page, attached maps and sections).
Full News release :http://www.investorideas.com/news/2011/mining/11142.asp
Contact:
SilverCrest Mines Inc.
Fred Cooper
(604) 694-1730 ext. 108 or Toll Free: 1-866-691-1730
(604) 694-1761 (FAX)
info@silvercrestmines.com
www.silvercrestmines.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
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Source - www.Investorideas.com
Wednesday's NASDAQ Top Percentage Gainers: CEDC, MU, TSRA, RJET
POINT ROBERTS - November 17, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors, reports on top percentage gainers on the NASDAQ for Wednesday November 16th. NASDAQ ended lower by 46.59 (-1.73%) to 2639.61.
Central European Distribution Corp (NASDAQ:CEDC) was the biggest percentage gainer and ended with a gains of 0.74 (24.18%) to $3.80 rebounding from its recent falls. The stock recently made a new 52-week low of $2.75.
Micron Technology, Inc. (NASDAQ:MU) gained 1.28 (23.44%) to $6.74 after A California Superior Court jury announced its decision in favor of the company related to a price-fixing case filed by the chip design company Ramous (NASDAQ:RMBS) against the company and Hynix Semiconductor. Shares of Rambus got crushed, plunging 60.59% to $7.11, posting a new multiyear low at $4.00.
Tessera Technologies, Inc. (NASDAQ:TSRA) gained 2.95 (20.39%) to $17.42 on very unusual volume of 4.07 million shares, compared to its average volume of 419K shares. Samsung Electronics Co., Ltd. exercised the renewal option in its Jan. 1, 2005 license agreement with Tessera, Inc. to extend the term of that license to May 17, 2017.
Republic Airways Holdings Inc. (NASDAQ:RJET) also climbed 0.54 (13.17%) to $4.64 after the company announced that it has signed an OnPointSM Fuel & Carbon Solutions agreement with GE Aviation. Under this agreement, GE’s Fuel & Carbon Solutions team will use decision software and fuel consulting and work with Republic Airways to identify and track operational improvements that could reduce the airline’s fuel spend by an average of 3%.
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POINT ROBERTS - November 17, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors, reports on top percentage gainers on the NASDAQ for Wednesday November 16th. NASDAQ ended lower by 46.59 (-1.73%) to 2639.61.
Central European Distribution Corp (NASDAQ:CEDC) was the biggest percentage gainer and ended with a gains of 0.74 (24.18%) to $3.80 rebounding from its recent falls. The stock recently made a new 52-week low of $2.75.
Micron Technology, Inc. (NASDAQ:MU) gained 1.28 (23.44%) to $6.74 after A California Superior Court jury announced its decision in favor of the company related to a price-fixing case filed by the chip design company Ramous (NASDAQ:RMBS) against the company and Hynix Semiconductor. Shares of Rambus got crushed, plunging 60.59% to $7.11, posting a new multiyear low at $4.00.
Tessera Technologies, Inc. (NASDAQ:TSRA) gained 2.95 (20.39%) to $17.42 on very unusual volume of 4.07 million shares, compared to its average volume of 419K shares. Samsung Electronics Co., Ltd. exercised the renewal option in its Jan. 1, 2005 license agreement with Tessera, Inc. to extend the term of that license to May 17, 2017.
Republic Airways Holdings Inc. (NASDAQ:RJET) also climbed 0.54 (13.17%) to $4.64 after the company announced that it has signed an OnPointSM Fuel & Carbon Solutions agreement with GE Aviation. Under this agreement, GE’s Fuel & Carbon Solutions team will use decision software and fuel consulting and work with Republic Airways to identify and track operational improvements that could reduce the airline’s fuel spend by an average of 3%.
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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Cleantech Stock Alert: Juhl Wind (OTCBB: JUHL) Trades Up on News of 276% Increase in Third Quarter Revenue
Point Roberts, WA - November 17, 2011 (Investorideas.com renewable energy/green newswire) Investorideas.com, a leader in renewable energy stock research, releases a trading and news alert for wind stock, Juhl Wind Inc. (OTCBB: JUHL).
As oil prices top the $100 barrel mark once again , investors that follow renewable energy stocks are looking for the winners within the sector. Following some major disappointments in solar stocks and the headlines of the Solyndra failure, a wind stock that is growing in revenue, net income and cash is gaining investor attention .
Juhl Wind's stock closed up 5% at $0.63 in Wednesday's trading session following Tuesday's news.
Juhl Wind, Inc. Reports Third Quarter 2011 Financial Results, Revenue Up 276%
Nine Months Revenue Increases over 245% from 2010, Company Holds Over $6 Million in Cash
Juhl Wind Inc. (OTCBB: JUHL), the Leader in Community Wind Power, reported Tuesday its results for the third quarter of 2011. Revenue for the third quarter 2011 was $3,259,000 compared to $867,000 in the third quarter of 2010, or an increase of 276%. In addition, for the nine months ended September 30, 2011 , the Company posted a record $10.9 million in revenue and $2.4 million in net income. Juhl Wind also reported continued growth in its cash position due to development fees, ending the first nine months of 2011 with approximately $6 million in cash.
"We are very proud of our results through the third quarter of 2011 as we continue a historic year for our company," stated Dan Juhl , Chairman and CEO of Juhl Wind Inc. "Our financial results are a direct result of our work on six major wind projects during a very difficult time in our economy - which we believe is direct evidence of Juhl Wind 's leading position in the energy industry. These projects include Adams , Danielson, Grant County , Valley View, Winona County and Woodstock Municipal. We have fully developed, managed construction and brought most of these projects into full service over the past two years and will be wrapping up work on all of them in the last quarter of this year."
"When combined with our previous experience, these projects bring our total project count to 20 wind farms - a level reached by few independent firms in this sector," added John Mitola , President of Juhl Wind . "Our performance in the face of such a difficult environment speaks for itself and we are confident that these results create a very strong base for our future growth."
Results for the nine-month period ended September 30, 2011:
* Revenue for the first nine months of 2011 was $10,937,000 compared to $3,170,000 for 2010, or an increase of $7,767,000 , or 245%. Revenue for the third quarter 2011 was $3,259,000 compared to $867,000 in the third quarter of 2010, or an increase of 276%. The increase in revenue for the nine months ended September 30, 2011 is primarily attributable to approximately $5.0 million of wind farm development fee revenue from three wind farm projects that completed financing arrangements during 2011 and approximately $1.7 million in revenue from the sale of our development rights in the Crofton Hills project.
* Our Operating Income of approximately $4,264,000 for the nine months ended September 30, 2011 is primarily attributable to the increased wind farm development fee revenue which provides high margin of profitability upon revenue recognition. Our operating income for the third quarter increased by approximately $1,019,000 , or 193%, from an operating loss of approximately $529,000 for the quarter ended September 30, 2010 to operating income of approximately $490,000 for the quarter ended September 30, 2011 . The increase in operating income for the quarter is primarily related to the sale of our development rights on the Crofton Hills project although we did see increases in investor relations expenses to heighten exposure of Juhl Wind 's stock and operating expenses associated with the take-over of the Woodstock wind farm during its lower wind production months.
* Our Net Income of $2,419,000 for the nine months ended September 30, 2011 represents a $4,328,000 improvement in the bottom-line from the comparative quarter a year ago. The increase in net income over the nine-month period is largely attributable to the increased revenue sources noted under revenue and operating income sections above. Our net income is impacted by inconsistent revenue patterns of our wind farm development services business as revenue recognition is significantly impacted by the timing of the completion and financing of wind farm projects.
* Basic and fully diluted earnings per share of $0.10 income per common share for the nine months ended September 30, 2011 compares to the $0.10 loss per common share for the comparative nine months ended in 2010.
* As of September 30, 2011 , the Company reported it held approximately $6.0 million in the form of cash and short term investments, which includes approximately $422,000 in balances that are restricted by a debt covenant.
A full analysis of results for the period ended September 30, 2011 is available in the Company's Form 10-Q, which is available on the Company's website at www.juhlwind.com.
About Juhl Wind Inc.
Juhl Wind is an established leader in Community Based Wind Power development and management, focused on wind farm projects throughout the United States and Canada . Juhl Wind pioneered community-based wind farms, developing the currently accepted financial, operational and legal structure providing local ownership of medium-to-large scale wind farms. To date, the Company has completed 19 wind farm projects and provides operations management and oversight across the portfolio. Juhl Wind services every aspect of wind farm development from full development and ownership, general consultation, construction management and system operations and maintenance. With its acquisition of the Woodstock Hills wind farm in April of 2011, the Company now owns and operates a 10.2 MW wind farm. Through its Next Generation Power Systems subsidiary ("NextGen'), Juhl Wind also provides full sales and service to smaller, on-site wind and solar projects in addition to our larger Community Wind Farms. Juhl Wind is based in Woodstock, Minnesota and is traded on the OTCBB under the symbol JUHL. Additional information is available at the Company's website at www.juhlwind.com or by calling 877-584-5946 (or 877-JUHLWIN).
Follow Juhl Wind , Inc. on Facebook HERE!
For more information, contact:
Juhl Wind Investor Relations
Jody Janson
Phone: (888) 438-JUHL (or 888-438-5845)
Email: jody@istockdaily.com
FORWARD LOOKING STATEMENTS
This news release includes forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements that reflect Juhl Wind 's current expectations about its future results, performance, prospects and opportunities. Juhl Wind has tried to identify these forward-looking statements by using words and phrases such as "may," "will," "expects," "anticipates," "believes," "intends," "estimates," "plan," "should," "typical," "preliminary," "hope," or similar expressions. These forward-looking statements are based on information currently available to Juhl Wind and are subject to a number of risks, uncertainties and other factors that could cause Juhl Wind 's actual results, performance, prospects or opportunities in the remainder of 2011 and beyond to differ materially from those expressed in, or implied by, these forward-looking statements and specifically those statements referring to any specific projects, prospective acquisitions and wind farm assets mentioned herein. New projects are subject to large, third party risks that may not be in control of Juhl Wind including the timing of funding and actual construction. While new wind farms noted from time to time are large-scale construction projects, Juhl Wind may not be the primary contractor for the provision of certain services, as it is in certain of its other projects. These risks are referenced in Juhl Wind 's current 8K or as may be described from time to time in Juhl Wind 's subsequent SEC filings; and such factors as incorporated by reference.
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Point Roberts, WA - November 17, 2011 (Investorideas.com renewable energy/green newswire) Investorideas.com, a leader in renewable energy stock research, releases a trading and news alert for wind stock, Juhl Wind Inc. (OTCBB: JUHL).
As oil prices top the $100 barrel mark once again , investors that follow renewable energy stocks are looking for the winners within the sector. Following some major disappointments in solar stocks and the headlines of the Solyndra failure, a wind stock that is growing in revenue, net income and cash is gaining investor attention .
Juhl Wind's stock closed up 5% at $0.63 in Wednesday's trading session following Tuesday's news.
Juhl Wind, Inc. Reports Third Quarter 2011 Financial Results, Revenue Up 276%
Nine Months Revenue Increases over 245% from 2010, Company Holds Over $6 Million in Cash
Juhl Wind Inc. (OTCBB: JUHL), the Leader in Community Wind Power, reported Tuesday its results for the third quarter of 2011. Revenue for the third quarter 2011 was $3,259,000 compared to $867,000 in the third quarter of 2010, or an increase of 276%. In addition, for the nine months ended September 30, 2011 , the Company posted a record $10.9 million in revenue and $2.4 million in net income. Juhl Wind also reported continued growth in its cash position due to development fees, ending the first nine months of 2011 with approximately $6 million in cash.
"We are very proud of our results through the third quarter of 2011 as we continue a historic year for our company," stated Dan Juhl , Chairman and CEO of Juhl Wind Inc. "Our financial results are a direct result of our work on six major wind projects during a very difficult time in our economy - which we believe is direct evidence of Juhl Wind 's leading position in the energy industry. These projects include Adams , Danielson, Grant County , Valley View, Winona County and Woodstock Municipal. We have fully developed, managed construction and brought most of these projects into full service over the past two years and will be wrapping up work on all of them in the last quarter of this year."
"When combined with our previous experience, these projects bring our total project count to 20 wind farms - a level reached by few independent firms in this sector," added John Mitola , President of Juhl Wind . "Our performance in the face of such a difficult environment speaks for itself and we are confident that these results create a very strong base for our future growth."
Results for the nine-month period ended September 30, 2011:
* Revenue for the first nine months of 2011 was $10,937,000 compared to $3,170,000 for 2010, or an increase of $7,767,000 , or 245%. Revenue for the third quarter 2011 was $3,259,000 compared to $867,000 in the third quarter of 2010, or an increase of 276%. The increase in revenue for the nine months ended September 30, 2011 is primarily attributable to approximately $5.0 million of wind farm development fee revenue from three wind farm projects that completed financing arrangements during 2011 and approximately $1.7 million in revenue from the sale of our development rights in the Crofton Hills project.
* Our Operating Income of approximately $4,264,000 for the nine months ended September 30, 2011 is primarily attributable to the increased wind farm development fee revenue which provides high margin of profitability upon revenue recognition. Our operating income for the third quarter increased by approximately $1,019,000 , or 193%, from an operating loss of approximately $529,000 for the quarter ended September 30, 2010 to operating income of approximately $490,000 for the quarter ended September 30, 2011 . The increase in operating income for the quarter is primarily related to the sale of our development rights on the Crofton Hills project although we did see increases in investor relations expenses to heighten exposure of Juhl Wind 's stock and operating expenses associated with the take-over of the Woodstock wind farm during its lower wind production months.
* Our Net Income of $2,419,000 for the nine months ended September 30, 2011 represents a $4,328,000 improvement in the bottom-line from the comparative quarter a year ago. The increase in net income over the nine-month period is largely attributable to the increased revenue sources noted under revenue and operating income sections above. Our net income is impacted by inconsistent revenue patterns of our wind farm development services business as revenue recognition is significantly impacted by the timing of the completion and financing of wind farm projects.
* Basic and fully diluted earnings per share of $0.10 income per common share for the nine months ended September 30, 2011 compares to the $0.10 loss per common share for the comparative nine months ended in 2010.
* As of September 30, 2011 , the Company reported it held approximately $6.0 million in the form of cash and short term investments, which includes approximately $422,000 in balances that are restricted by a debt covenant.
A full analysis of results for the period ended September 30, 2011 is available in the Company's Form 10-Q, which is available on the Company's website at www.juhlwind.com.
About Juhl Wind Inc.
Juhl Wind is an established leader in Community Based Wind Power development and management, focused on wind farm projects throughout the United States and Canada . Juhl Wind pioneered community-based wind farms, developing the currently accepted financial, operational and legal structure providing local ownership of medium-to-large scale wind farms. To date, the Company has completed 19 wind farm projects and provides operations management and oversight across the portfolio. Juhl Wind services every aspect of wind farm development from full development and ownership, general consultation, construction management and system operations and maintenance. With its acquisition of the Woodstock Hills wind farm in April of 2011, the Company now owns and operates a 10.2 MW wind farm. Through its Next Generation Power Systems subsidiary ("NextGen'), Juhl Wind also provides full sales and service to smaller, on-site wind and solar projects in addition to our larger Community Wind Farms. Juhl Wind is based in Woodstock, Minnesota and is traded on the OTCBB under the symbol JUHL. Additional information is available at the Company's website at www.juhlwind.com or by calling 877-584-5946 (or 877-JUHLWIN).
Follow Juhl Wind , Inc. on Facebook HERE!
For more information, contact:
Juhl Wind Investor Relations
Jody Janson
Phone: (888) 438-JUHL (or 888-438-5845)
Email: jody@istockdaily.com
FORWARD LOOKING STATEMENTS
This news release includes forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements that reflect Juhl Wind 's current expectations about its future results, performance, prospects and opportunities. Juhl Wind has tried to identify these forward-looking statements by using words and phrases such as "may," "will," "expects," "anticipates," "believes," "intends," "estimates," "plan," "should," "typical," "preliminary," "hope," or similar expressions. These forward-looking statements are based on information currently available to Juhl Wind and are subject to a number of risks, uncertainties and other factors that could cause Juhl Wind 's actual results, performance, prospects or opportunities in the remainder of 2011 and beyond to differ materially from those expressed in, or implied by, these forward-looking statements and specifically those statements referring to any specific projects, prospective acquisitions and wind farm assets mentioned herein. New projects are subject to large, third party risks that may not be in control of Juhl Wind including the timing of funding and actual construction. While new wind farms noted from time to time are large-scale construction projects, Juhl Wind may not be the primary contractor for the provision of certain services, as it is in certain of its other projects. These risks are referenced in Juhl Wind 's current 8K or as may be described from time to time in Juhl Wind 's subsequent SEC filings; and such factors as incorporated by reference.
About Investorideas.com - a leader in cleantech investor research
Investorideas.com was on the of the first investor sites covering investing in water and renewable energy stocks and has become a global go-to destination for investors researching the cleantech sector, with stock directories, company news, commentary from experts, research reports and industry resources and links. Investors can follow solar stocks commentary on our site with solar expert, J. Peter Lynch.
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Wednesday, November 16, 2011
Trading Alert: PositiveID (OTCBB:PSID) Trades up over 50% on FDA News
POINT ROBERTS - November 16, 2011 - www.InvestorIdeas.com, a globalinvestor research portal for independent investors issues a trading alert for medical technology stock, PositiveID Corporation (OTCBB:PSID), following news of its FDA clearance for iglucose(TM) mobile health system for diabetes. The stock has moved up over 52% on news with volume of over two million shares in morning trading.
PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
iglucose is a First-of-its-Kind Wireless Communication System for Diabetes Management
PositiveID to Begin Commercialization Efforts in First Quarter 2012
Full news: http://www.investorideas.com/news/2011/main/11161.asp
About PositiveID Corporation (OTCBB:PSID),
PositiveID Corporation, based in Delray Beach, Florida, is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
For more information on iglucose, please visit www.iglucose.com.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com Newswire
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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. Investorideas.com was compensated fifteen hundred to publish and distribute PositiveID Corporation press release by third party IR www.InvestorIdeas.com/About/Disclaimer.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
800-665-0411
Source - www.Investorideas.com
POINT ROBERTS - November 16, 2011 - www.InvestorIdeas.com, a global
PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
iglucose is a First-of-its-Kind Wireless Communication System for Diabetes Management
PositiveID to Begin Commercialization Efforts in First Quarter 2012
Full news: http://www.investorideas.com/news/2011/main/11161.asp
About PositiveID Corporation (OTCBB:PSID), PositiveID Corporation, based in Delray Beach, Florida, is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
For more information on iglucose, please visit www.iglucose.com.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com Newswire
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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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. Investorideas.com was compensated fifteen hundred to publish and distribute PositiveID Corporation press release by third party IR www.InvestorIdeas.com/About/Disclaimer.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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Source - www.Investorideas.com
Biotech Stock Alert; Aethlon Medical (OTC: AEMD) Releases Shareholder Letter
SAN DIEGO - November 16, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD) disclosed today that its Chairman and CEO, James A. Joyce , has issued the following letter to shareholders.
To our Shareholders:
Earlier this year, we introduced and began marketing the Aethlon ADAPT™ system, a technology platform that intersects the medical device and drug world to establish a new class of therapeutics that allow for the selective subtraction of disease-enhancing particles from patient circulation without adding drug toxicity. Not long ago, the medical community consensus was that it would not be possible for a medical device to remove harmful particles from circulation without also stripping out essential elements required for health. Well, as Walt Disney once stated, "Its kind of fun to do the impossible." I would add immensely challenging as well. Therapies that evolve from our platform hold the potential to alter the healthcare industry by unlocking the ability to attack disease survival mechanisms that are beyond the reach of drugs. Today, we are advancing ADAPT-based endeavors to address unmet medical needs in cancer, infectious disease, and now sepsis.
On October 3rd , we proudly disclosed that the first sale of our Aethlon ADAPT™ system occurred when we signed a $6.8 million contract with the UnitedStates of America . The contract resulted from our response to a "Dialysis-Like Therapeutics" (DLT) program offered through the Defense Advanced Projects Agency (DARPA). DARPA is a primary engine for innovation in our country and we are honored to be working with them on a project whose mission includes saving the lives of wounded soldiers. Under the DLT program, the Aethlon ADAPT™ system will be tested as a core technology component of a therapeutic device that would prevent sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers. In this application, the open architecture of our technology platform provides a therapeutic template to immobilize a combination of affinity compounds to selectively target sepsis-enabling factors in circulation.
DARPA estimates the successful development of this device would save thousands of lives and billions of dollars in the UnitedStates each year. In regards to the global opportunity, more than 18 million cases of sepsis are reported each year, with more than six million resulting in death. We have also been tasked by DARPA to advance a novel blood pump design that seamlessly integrates with therapeutic devices, yet reduces or eliminates the systemic administration of anticoagulants normally required during extracorporeal therapies.
Last week, we received our first milestone payment under the DARPA award, which officially transitioned our corporate status from development-stage to revenue stage organization. Now that we are contract proven, we plan to increase our efforts to market the Aethlon ADAPT™ system to government health and military agencies that seek innovative strategies to address life-threatening or debilitating disease conditions.
With each subsequent sale of the Aethlon ADAPT™ system, we reinforce the value of our therapeutic vision, reduce our reliance on the capital markets, and further establish a unique business model that allows us to generate revenue as we clinically advance pipeline therapies to market. Our technology platform also provides a basis to establish collaborative business relationships with biotechnology and pharmaceutical organizations that might have interest in pursuing a medical device regulatory and commercialization pathway for their affinity drug agents. As toxicity eliminates a majority of affinity drug agents from entering the market, we provide the opportunity to repurpose clinical stage affinity drugs as well as previous clinical dropouts.
On September 21st , we again leveraged the Aethlon ADAPT™ system to introduce a targeted breast cancer therapy known as HER2osome™ and enlisted clinical support from thought leaders in the cancer field. In this application, HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Our therapeutic goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer.
When we first initiated research into tumor-secreted exosomes, the consensus thought was that exosomes were nothing more than cellular garbage bags having no meaningful function. Today, exosomes have emerged to become an important new therapeutic target in cancer care, yet remain unaddressed with drug therapy. In a forthcoming disclosure, we will discuss some of our other exosome related endeavors. However, as it relates to breast cancer, research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin®, a leading monoclonal antibody treatment against the HER2+ breast cancer. Quite simply, we are developing HER2osome™ because we believe the resulting device will enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks. In this regard, the Aethlon ADAPT™ system provides a therapeutic template to immobilize both an anti-HER2 antibody and an exosome targeted affinity agent as a basis to simultaneously clear both targets from the circulatory system of HER2+ breast cancer patients. Like all Aethlon ADAPT™ derived therapies, HER2osome™ is designed for utilization on dialysis machines or CRRT systems already located in hospitals and clinics worldwide.
While this is certainly an exciting time for our organization, there is something else I want to address before concluding my letter. That is the treatment of Hepatitis C (HCV) infected individuals with our Hemopurifier®, which is the lead product in our ADAPT product pipeline. Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy.
Our HCV treatment results led us to ask the question, what if we administered Hemopurifier® therapy to non-dialysis patients when they initiated HCV drug therapy? To find the answer, we initiated our first clinical study in non-dialysis patients at the Medanta Medicity Institute in India . We already knew that rapid viral load depletion in the first few days of therapy correlated with patients who achieve a sustained viral response, the clinical definition for cure. Confidence in our study plan was further driven by knowledge that the Japanese Ministry of Health and Welfare had approved a non-specific dual plasmapheresis configuration that was shown to improve patient outcomes when administered in the first three days of HCV drug therapy. Based on these factors, our prior treatment outcomes, and the magnitude of HCV opportunity, we believed the Medanta study would contribute to improving shareholder value. We were wrong. Study delays, including protocol changes, patient recruitment challenges, and other mishaps instead contributed to an erosion of shareholder value. That said, I want to reinforce that there has been no indication that our Hemopurifier® isn't performing in the manner we had expected.
Certain delays may prove to be beneficial. On July 19 th, we met with FDA to discuss a proposal to initiate Hemopurifier® clinical studies in the U.S. During our meeting, we were asked if it was possible to measure the quantity of virus captured within the Hemopurifier® during treatment? Our answer was yes, as our science team had measured this data point on three previous occasions. Normally, our focus is to measure viral load changes in patient blood to quantify the potential for benefit. In response to FDA's question, we modified our Medanta study protocol so that we could incorporate this secondary data point in a revised IDE submission to FDA. With this change in place, our protocol is now being administered to enrolled patients at the Medanta Medicity Institute. Our primary endpoint goal remains to demonstrate that our Hemopurifier® improves both immediate and rapid viral response rates when combined with interferon versus interferon alone. We remain convinced that our Hemopurifier® will offer an enduring opportunity to improve current and future iterations of HCV drug therapies. However, with the advent of the Aethlon ADAPT™ system, we have transitioned to being revenue stage organization whose value should no longer be attributed to one product application. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company�s clinical programs or provide market clearance of the company�s products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier�s® ability to capture exosomes and the impact it may have on disease conditions, the ability to successfully complete the Medanta HCV study and achieve positive results, the company�s ability to raise capital when needed, the Company�s ability to complete the development of its planned products, the Company�s ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
SAN DIEGO - November 16, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD) disclosed today that its Chairman and CEO, James A. Joyce , has issued the following letter to shareholders.
To our Shareholders:
Earlier this year, we introduced and began marketing the Aethlon ADAPT™ system, a technology platform that intersects the medical device and drug world to establish a new class of therapeutics that allow for the selective subtraction of disease-enhancing particles from patient circulation without adding drug toxicity. Not long ago, the medical community consensus was that it would not be possible for a medical device to remove harmful particles from circulation without also stripping out essential elements required for health. Well, as Walt Disney once stated, "Its kind of fun to do the impossible." I would add immensely challenging as well. Therapies that evolve from our platform hold the potential to alter the healthcare industry by unlocking the ability to attack disease survival mechanisms that are beyond the reach of drugs. Today, we are advancing ADAPT-based endeavors to address unmet medical needs in cancer, infectious disease, and now sepsis.
On October 3rd , we proudly disclosed that the first sale of our Aethlon ADAPT™ system occurred when we signed a $6.8 million contract with the United
DARPA estimates the successful development of this device would save thousands of lives and billions of dollars in the United
Last week, we received our first milestone payment under the DARPA award, which officially transitioned our corporate status from development-stage to revenue stage organization. Now that we are contract proven, we plan to increase our efforts to market the Aethlon ADAPT™ system to government health and military agencies that seek innovative strategies to address life-threatening or debilitating disease conditions.
With each subsequent sale of the Aethlon ADAPT™ system, we reinforce the value of our therapeutic vision, reduce our reliance on the capital markets, and further establish a unique business model that allows us to generate revenue as we clinically advance pipeline therapies to market. Our technology platform also provides a basis to establish collaborative business relationships with biotechnology and pharmaceutical organizations that might have interest in pursuing a medical device regulatory and commercialization pathway for their affinity drug agents. As toxicity eliminates a majority of affinity drug agents from entering the market, we provide the opportunity to repurpose clinical stage affinity drugs as well as previous clinical dropouts.
On September 21st , we again leveraged the Aethlon ADAPT™ system to introduce a targeted breast cancer therapy known as HER2osome™ and enlisted clinical support from thought leaders in the cancer field. In this application, HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Our therapeutic goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer.
When we first initiated research into tumor-secreted exosomes, the consensus thought was that exosomes were nothing more than cellular garbage bags having no meaningful function. Today, exosomes have emerged to become an important new therapeutic target in cancer care, yet remain unaddressed with drug therapy. In a forthcoming disclosure, we will discuss some of our other exosome related endeavors. However, as it relates to breast cancer, research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin®, a leading monoclonal antibody treatment against the HER2+ breast cancer. Quite simply, we are developing HER2osome™ because we believe the resulting device will enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks. In this regard, the Aethlon ADAPT™ system provides a therapeutic template to immobilize both an anti-HER2 antibody and an exosome targeted affinity agent as a basis to simultaneously clear both targets from the circulatory system of HER2+ breast cancer patients. Like all Aethlon ADAPT™ derived therapies, HER2osome™ is designed for utilization on dialysis machines or CRRT systems already located in hospitals and clinics worldwide.
While this is certainly an exciting time for our organization, there is something else I want to address before concluding my letter. That is the treatment of Hepatitis C (HCV) infected individuals with our Hemopurifier®, which is the lead product in our ADAPT product pipeline. Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy.
Our HCV treatment results led us to ask the question, what if we administered Hemopurifier® therapy to non-dialysis patients when they initiated HCV drug therapy? To find the answer, we initiated our first clinical study in non-dialysis patients at the Medanta Medicity Institute in India . We already knew that rapid viral load depletion in the first few days of therapy correlated with patients who achieve a sustained viral response, the clinical definition for cure. Confidence in our study plan was further driven by knowledge that the Japanese Ministry of Health and Welfare had approved a non-specific dual plasmapheresis configuration that was shown to improve patient outcomes when administered in the first three days of HCV drug therapy. Based on these factors, our prior treatment outcomes, and the magnitude of HCV opportunity, we believed the Medanta study would contribute to improving shareholder value. We were wrong. Study delays, including protocol changes, patient recruitment challenges, and other mishaps instead contributed to an erosion of shareholder value. That said, I want to reinforce that there has been no indication that our Hemopurifier® isn't performing in the manner we had expected.
Certain delays may prove to be beneficial. On July 19 th, we met with FDA to discuss a proposal to initiate Hemopurifier® clinical studies in the U.S. During our meeting, we were asked if it was possible to measure the quantity of virus captured within the Hemopurifier® during treatment? Our answer was yes, as our science team had measured this data point on three previous occasions. Normally, our focus is to measure viral load changes in patient blood to quantify the potential for benefit. In response to FDA's question, we modified our Medanta study protocol so that we could incorporate this secondary data point in a revised IDE submission to FDA. With this change in place, our protocol is now being administered to enrolled patients at the Medanta Medicity Institute. Our primary endpoint goal remains to demonstrate that our Hemopurifier® improves both immediate and rapid viral response rates when combined with interferon versus interferon alone. We remain convinced that our Hemopurifier® will offer an enduring opportunity to improve current and future iterations of HCV drug therapies. However, with the advent of the Aethlon ADAPT™ system, we have transitioned to being revenue stage organization whose value should no longer be attributed to one product application. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company�s clinical programs or provide market clearance of the company�s products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier�s® ability to capture exosomes and the impact it may have on disease conditions, the ability to successfully complete the Medanta HCV study and achieve positive results, the company�s ability to raise capital when needed, the Company�s ability to complete the development of its planned products, the Company�s ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
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Gold Stock News; Castle Silver Mines Inc. files final prospectus for initial public offering and "spin-out" to shareholders of Gold Bullion Development Corp.
VANCOUVER - November 16, 2011 (Investorideas.com Mining stocks Newswire) - Gold Bullion Development Corp. (TSXV: GBB, OTC PINK: GBBFF) and Castle Silver Mines Inc., a wholly-owned subsidiary of Gold Bullion, announce that Castle Silver Mines has filed a final prospectus with the securities commissions of each of the provinces of Canada in connection with an initial public offering by Castle Silver Mines, and a secondary offering to the shareholders of Gold Bullion of shares of Castle Silver Mines by way of dividend in kind.
Initial Public Offering
Castle Silver Mines is effecting an initial public offering of 4,750,000 "flow-through" units at a price of $0.40 per unit, and a minimum of 3 million and a maximum of 5 million common share units at a price of $0.30 per unit, for maximum gross proceeds to Castle Silver Mines of $3.4 million. Each "flow-through" unit will consist of one common share of Castle Silver Mines and one-half of a common share purchase warrant. Each common share unit will consist of one common share of Castle Silver Mines and one common share purchase warrant. Each full warrant will entitle its holder to acquire one additional common share of Castle Silver Mines at a price of $0.50 for a period of 18 months.
The proceeds from the initial public offering will be used by Castle Silver Mines for exploration work on its Castle Silver Mine property, future property acquisitions and for working capital and general corporate purposes. A description of the recommended exploration program for the Castle Silver Mine property is summarized in the final prospectus, which is available under Castle Silver Mines' company profile on SEDAR at www.sedar.com.
The TSX Venture Exchange has conditionally approved the listing of the common shares of Castle Silver Mines, subject to, among other standard listing conditions, completion of the initial public offering for minimum gross proceeds of $2.8 million with satisfactory public distribution.
Industrial Alliance Securities Inc. is acting as agent for the initial public offering on a "best-efforts" basis. Castle Silver Mines has granted Industrial Alliance Securities an option to offer up to 750,000 additional common share units and up to 712,500 additional "flow-through" units, representing 15% of the number of units offered, to cover over-allotments, if any. The over-allotment option may be exercised at the offering prices for a period of 30 days from the date of closing of the offering. If Industrial Alliance Securities exercises the over-allotment option in full after a maximum offering, the total gross proceeds of the offering will be $3,910,000.
Closing of the initial public offering is expected to take place no later than December 15, 2011.
"Spin-Out" to Shareholders of Gold Bullion
Concurrently with the initial public offering, Gold Bullion Development Corp., the sole shareholder of Castle Silver Mines, will distribute an aggregate of approximately 1,950,000 common shares of Castle Silver Mines to the shareholders of Gold Bullion, by way of dividend in kind. Gold Bullion shareholders will receive one common share of Castle Silver Mines for approximately every 85 issued and outstanding Gold Bullion shares on the distribution record date. The record date for the distribution of the Castle Silver Mines shares will be set by the Board of Directors of Gold Bullion in accordance with the policies of the TSX Venture Exchange. Gold Bullion will issue a press release shortly, announcing the record date and the distribution ratio. Gold Bullion will retain approximately 7.8 million shares of Castle Silver Mines.
In the event of an initial public offering by Castle Silver Mines in a maximum amount of $3.4 million, investors in the initial public offering will hold 50% of the outstanding shares of Castle Silver Mines, Gold Bullion will hold 40% of the outstanding shares, and the shareholders of Gold Bullion will hold in the aggregate 10% of the outstanding shares.
Castle Silver Mines Inc.
Castle Silver Mines Inc. was incorporated in March 2011 as a wholly-owned subsidiary of Gold Bullion, for the purpose of taking over the silver assets and exploration activities currently carried on by Gold Bullion, so that Gold Bullion can devote itself solely to exploration for gold. Prior to the distribution record date, Castle Silver Mines Inc. will acquire the Castle Silver Mine property in Gowganda, Ontario from Gold Bullion, which comprises Gold Bullion's sole silver exploration property. After such transfer, Gold Bullion does not intend to be directly involved in silver exploration. Castle Silver Mines may acquire additional interests in silver exploration properties in the future.
Castle Gold Mines' common shares have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S registration or an applicable exemption from U.S. registration requirements.
About Gold Bullion Development Corp.
Gold Bullion Development Corp. is a TSX Venture-listed junior natural resource company focusing on the exploration and development of its Granada Property near Rouyn-Noranda, Qu�bec, and its Castle Silver Mine property in Gowganda, Ontario.
For more information on Gold Bullion Development Corp. (TSXV:GBB.V) (Other OTC:GBBFF.PK), visit our web site: http://www.GoldBullionDevelopmentCorp.com
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
"Frank J. Basa"
Frank J. Basa, P.Eng. President and Chief Executive Officer
Roger Thomas
Director
Tel.: (613) 292-2438
Progressive Investor Relations (Canada): Tel. (604) 689-2881 or e-mail info@progressive-ir.com
Torrey Hills Capital (United States) Tel. (858) 456-7300
VANCOUVER - November 16, 2011 (Investorideas.com Mining stocks Newswire) - Gold Bullion Development Corp. (TSXV: GBB, OTC PINK: GBBFF) and Castle Silver Mines Inc., a wholly-owned subsidiary of Gold Bullion, announce that Castle Silver Mines has filed a final prospectus with the securities commissions of each of the provinces of Canada in connection with an initial public offering by Castle Silver Mines, and a secondary offering to the shareholders of Gold Bullion of shares of Castle Silver Mines by way of dividend in kind.
Initial Public Offering
Castle Silver Mines is effecting an initial public offering of 4,750,000 "flow-through" units at a price of $0.40 per unit, and a minimum of 3 million and a maximum of 5 million common share units at a price of $0.30 per unit, for maximum gross proceeds to Castle Silver Mines of $3.4 million. Each "flow-through" unit will consist of one common share of Castle Silver Mines and one-half of a common share purchase warrant. Each common share unit will consist of one common share of Castle Silver Mines and one common share purchase warrant. Each full warrant will entitle its holder to acquire one additional common share of Castle Silver Mines at a price of $0.50 for a period of 18 months.
The proceeds from the initial public offering will be used by Castle Silver Mines for exploration work on its Castle Silver Mine property, future property acquisitions and for working capital and general corporate purposes. A description of the recommended exploration program for the Castle Silver Mine property is summarized in the final prospectus, which is available under Castle Silver Mines' company profile on SEDAR at www.sedar.com.
The TSX Venture Exchange has conditionally approved the listing of the common shares of Castle Silver Mines, subject to, among other standard listing conditions, completion of the initial public offering for minimum gross proceeds of $2.8 million with satisfactory public distribution.
Industrial Alliance Securities Inc. is acting as agent for the initial public offering on a "best-efforts" basis. Castle Silver Mines has granted Industrial Alliance Securities an option to offer up to 750,000 additional common share units and up to 712,500 additional "flow-through" units, representing 15% of the number of units offered, to cover over-allotments, if any. The over-allotment option may be exercised at the offering prices for a period of 30 days from the date of closing of the offering. If Industrial Alliance Securities exercises the over-allotment option in full after a maximum offering, the total gross proceeds of the offering will be $3,910,000.
Closing of the initial public offering is expected to take place no later than December 15, 2011.
"Spin-Out" to Shareholders of Gold Bullion
Concurrently with the initial public offering, Gold Bullion Development Corp., the sole shareholder of Castle Silver Mines, will distribute an aggregate of approximately 1,950,000 common shares of Castle Silver Mines to the shareholders of Gold Bullion, by way of dividend in kind. Gold Bullion shareholders will receive one common share of Castle Silver Mines for approximately every 85 issued and outstanding Gold Bullion shares on the distribution record date. The record date for the distribution of the Castle Silver Mines shares will be set by the Board of Directors of Gold Bullion in accordance with the policies of the TSX Venture Exchange. Gold Bullion will issue a press release shortly, announcing the record date and the distribution ratio. Gold Bullion will retain approximately 7.8 million shares of Castle Silver Mines.
In the event of an initial public offering by Castle Silver Mines in a maximum amount of $3.4 million, investors in the initial public offering will hold 50% of the outstanding shares of Castle Silver Mines, Gold Bullion will hold 40% of the outstanding shares, and the shareholders of Gold Bullion will hold in the aggregate 10% of the outstanding shares.
Castle Silver Mines Inc.
Castle Silver Mines Inc. was incorporated in March 2011 as a wholly-owned subsidiary of Gold Bullion, for the purpose of taking over the silver assets and exploration activities currently carried on by Gold Bullion, so that Gold Bullion can devote itself solely to exploration for gold. Prior to the distribution record date, Castle Silver Mines Inc. will acquire the Castle Silver Mine property in Gowganda, Ontario from Gold Bullion, which comprises Gold Bullion's sole silver exploration property. After such transfer, Gold Bullion does not intend to be directly involved in silver exploration. Castle Silver Mines may acquire additional interests in silver exploration properties in the future.
Castle Gold Mines' common shares have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S registration or an applicable exemption from U.S. registration requirements.
About Gold Bullion Development Corp.
Gold Bullion Development Corp. is a TSX Venture-listed junior natural resource company focusing on the exploration and development of its Granada Property near Rouyn-Noranda, Qu�bec, and its Castle Silver Mine property in Gowganda, Ontario.
For more information on Gold Bullion Development Corp. (TSXV:GBB.V) (Other OTC:GBBFF.PK), visit our web site: http://www.GoldBullionDevelopmentCorp.com
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
"Frank J. Basa"
Frank J. Basa, P.Eng. President and Chief Executive Officer
Roger Thomas
Director
Tel.: (613) 292-2438
Progressive Investor Relations (Canada): Tel. (604) 689-2881 or e-mail info@progressive-ir.com
Torrey Hills Capital (United States) Tel. (858) 456-7300
Visit the GBB showcase profile at Investorideas.com
Request News and Info on GBB
Disclosure, Disclaimer/ GBB is a paid advertising client on Investorideas.com and our mining portals.
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Disclosure, Disclaimer/ GBB is a paid advertising client on Investorideas.com and our mining portals.
Pharma and Biotech stocks News; BioSante Pharmaceuticals (NASDAQ: BPAX) Announces Positive LibiGel® Pharmacokinetic Study Results
LINCOLNSHIRE, Ill. - November 16, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced additional results from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Top line data from this study were announced on September 12, 2011. The pK study results indicate that LibiGel increases levels of free testosterone (the active testosterone component) in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
The pK study was conducted in 24 surgically postmenopausal subjects in three contiguous 21 day periods for a total of 63 days, in the absence of estrogen therapy (study period 1), with a concomitant transdermal estradiol patch (study period 2) and finally with concomitant oral estrogen (study period 3). LibiGel was dosed at 0.22 grams daily, the same dose as included in the two LibiGel pivotal safety and efficacy trials and safety study. The mean free testosterone level at baseline was 1.4 pg/ml. During the study, subjects in the pK study demonstrated a mean free testosterone of approximately 3.5 pg/ml on day 14, and 4.1 pg/ml on day 21 (at the end of study period 1) and approximately 4.5 pg/ml on study day 42 (at the end of 21 days of transdermal estradiol co-therapy in period 2). During study period 3, the mean free testosterone level was approximately 3.7 pg/ml. Free testosterone returned to baseline levels within 24 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued.
The levels of free testosterone in the LibiGel pK study were similar to those seen in the BioSante LibiGel Phase II efficacy trial which ranged from 2.8 pg/ml to 3.6 pg/ml. These levels also were similar to those reported in the two pivotal testosterone patch (Intrinsa) studies which showed efficacy in treating HSDD in estrogen-treated surgically menopausal women, which were 4.0 pg/ml at 12 weeks and 3.1 pg/ml at week 24 and 4.0 pg/ml at week 24, respectively. In a recent publication, it was shown that serum testosterone concentrations in normally cycling 30-year-old pre-menopausal women range from 1.2 pg/ml to 6.4 pg/ml. However, generally, blood levels are not compared between studies because different studies performed at different times with different assays can produce varying testosterone blood levels.
In the LibiGel Phase III clinical studies, baseline testosterone levels, although collected, are not an inclusion or exclusion criterion, per FDA suggestion, since therapy for HSDD is meant for symptomatic treatment of HSDD and not testosterone levels. BioSante plans to present the full pK study results at an upcoming medical meeting. The LibiGel pK study was conducted as part of the FDA-requested studies to be submitted in the LibiGel new drug application (NDA) which is anticipated in the fourth quarter of 2012.
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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy, approximately half of whom were taking concomitant estrogen therapy and half of whom took no concomitant estrogen therapy. 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.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued over 5,100 women-years of exposure, to date. The study will continue for a total of five years; however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
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 hypertension and diabetes. The objective of the safety study is to demonstrate 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.
Upon completion of the statistical analyses of efficacy trials and the safety study, BioSante intends to submit an NDA to the FDA, requesting approval of LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the fourth quarter of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead 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 II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an 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 future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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 report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
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LINCOLNSHIRE, Ill. - November 16, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced additional results from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Top line data from this study were announced on September 12, 2011. The pK study results indicate that LibiGel increases levels of free testosterone (the active testosterone component) in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
The pK study was conducted in 24 surgically postmenopausal subjects in three contiguous 21 day periods for a total of 63 days, in the absence of estrogen therapy (study period 1), with a concomitant transdermal estradiol patch (study period 2) and finally with concomitant oral estrogen (study period 3). LibiGel was dosed at 0.22 grams daily, the same dose as included in the two LibiGel pivotal safety and efficacy trials and safety study. The mean free testosterone level at baseline was 1.4 pg/ml. During the study, subjects in the pK study demonstrated a mean free testosterone of approximately 3.5 pg/ml on day 14, and 4.1 pg/ml on day 21 (at the end of study period 1) and approximately 4.5 pg/ml on study day 42 (at the end of 21 days of transdermal estradiol co-therapy in period 2). During study period 3, the mean free testosterone level was approximately 3.7 pg/ml. Free testosterone returned to baseline levels within 24 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued.
The levels of free testosterone in the LibiGel pK study were similar to those seen in the BioSante LibiGel Phase II efficacy trial which ranged from 2.8 pg/ml to 3.6 pg/ml. These levels also were similar to those reported in the two pivotal testosterone patch (Intrinsa) studies which showed efficacy in treating HSDD in estrogen-treated surgically menopausal women, which were 4.0 pg/ml at 12 weeks and 3.1 pg/ml at week 24 and 4.0 pg/ml at week 24, respectively. In a recent publication, it was shown that serum testosterone concentrations in normally cycling 30-year-old pre-menopausal women range from 1.2 pg/ml to 6.4 pg/ml. However, generally, blood levels are not compared between studies because different studies performed at different times with different assays can produce varying testosterone blood levels.
In the LibiGel Phase III clinical studies, baseline testosterone levels, although collected, are not an inclusion or exclusion criterion, per FDA suggestion, since therapy for HSDD is meant for symptomatic treatment of HSDD and not testosterone levels. BioSante plans to present the full pK study results at an upcoming medical meeting. The LibiGel pK study was conducted as part of the FDA-requested studies to be submitted in the LibiGel new drug application (NDA) which is anticipated in the fourth quarter of 2012.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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy, approximately half of whom were taking concomitant estrogen therapy and half of whom took no concomitant estrogen therapy. 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.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued over 5,100 women-years of exposure, to date. The study will continue for a total of five years; however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
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 hypertension and diabetes. The objective of the safety study is to demonstrate 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.
Upon completion of the statistical analyses of efficacy trials and the safety study, BioSante intends to submit an NDA to the FDA, requesting approval of LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the fourth quarter of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead 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 II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an 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 future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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 report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
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InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Medical Technology Stock Alert: U.S FDA Clears PositiveID's (OTCBB:PSID) iglucose System for Diabetes Management
DELRAY BEACH, Fla. - November 16, 2011 (Investorideas.com Newswire) - PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
William J. Caragol, Chief Executive Officer of PositiveID stated, "iglucose is a safe, flexible, convenient, cost-effective and straightforward solution that we believe will revolutionize the way people with diabetes manage their condition. iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance. This FDA clearance is an important validation of our product offering for PositiveID and we will work diligently to make iglucose available to everyone affected by diabetes in the near future."
PositiveID believes that marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers. The business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base. Over the coming months, PositiveID expects to launch initial roll-outs with several partners that it believes can lead to large orders of iglucose. PositiveID already has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada , and will look to add additional wireless partners.
For years the American Diabetes Association and U.S. Centers for Disease Control and Prevention ("CDC") have recommended that individuals with diabetes self-monitor and take a record of their glucose readings to their healthcare professionals. An American Association of Diabetes Educators ("AADE") positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not keep consistent and accurate logbooks.
iglucose 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 iglucose system collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan(R) OneTouch(R), marketed by Johnson & Johnson, and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. A wireless data plan is not required. The Company is continually adding to this list of supported glucose meters.
PositiveID surveyed healthcare professionals at the AADE annual conference regarding the Company's iglucose mobile health communication system to facilitate diabetes management and survey results showed 83 percent of diabetes educators believe using iglucose would improve patient outcomes; 82 percent of diabetes educators believe using iglucose would improve patient consults; and 76 percent of diabetes educators would recommend iglucose to their patients.
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. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S. , according to a study published in the British journal Lancet. 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.
For more information on iglucose, please visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation, based in Delray Beach , Florida , is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that iglucose makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes; the likelihood that iglucose is a safe, flexible, convenient, cost-effective and straightforward solution for people with diabetes to revolutionize the way they manage their condition; the likelihood that iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance; the likelihood that this FDA clearance is an important validation of the Company's product offering and the Company will work diligently to successfully make iglucose available to everyone affected by diabetes in the near future; the likelihood that the marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers; the likelihood that the business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base; the likelihood that over the coming months, the Company will launch initial roll-outs with several partners that can lead to large orders of iglucose; the likelihood that PositiveID has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada and will look to add additional wireless partners; the likelihood that iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition; the likelihood that the Company is continually adding to this list of supported glucose meters; the likelihood that diabetes educators believe using iglucose would improve patient outcomes; the likelihood that diabetes educators believe using iglucose would improve patient consults; the likelihood that diabetes educators would recommend iglucose to their patients; 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; the likelihood that the total cost of diagnosed diabetes in the U.S. is $200 billion; 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 iglucose and receive insurance reimbursement; 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
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
DELRAY BEACH, Fla. - November 16, 2011 (Investorideas.com Newswire) - PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
William J. Caragol, Chief Executive Officer of PositiveID stated, "iglucose is a safe, flexible, convenient, cost-effective and straightforward solution that we believe will revolutionize the way people with diabetes manage their condition. iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance. This FDA clearance is an important validation of our product offering for PositiveID and we will work diligently to make iglucose available to everyone affected by diabetes in the near future."
PositiveID believes that marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers. The business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base. Over the coming months, PositiveID expects to launch initial roll-outs with several partners that it believes can lead to large orders of iglucose. PositiveID already has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada , and will look to add additional wireless partners.
For years the American Diabetes Association and U.S. Centers for Disease Control and Prevention ("CDC") have recommended that individuals with diabetes self-monitor and take a record of their glucose readings to their healthcare professionals. An American Association of Diabetes Educators ("AADE") positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not keep consistent and accurate logbooks.
iglucose 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 iglucose system collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan(R) OneTouch(R), marketed by Johnson & Johnson, and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. A wireless data plan is not required. The Company is continually adding to this list of supported glucose meters.
PositiveID surveyed healthcare professionals at the AADE annual conference regarding the Company's iglucose mobile health communication system to facilitate diabetes management and survey results showed 83 percent of diabetes educators believe using iglucose would improve patient outcomes; 82 percent of diabetes educators believe using iglucose would improve patient consults; and 76 percent of diabetes educators would recommend iglucose to their patients.
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. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S. , according to a study published in the British journal Lancet. 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.
For more information on iglucose, please visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation, based in Delray Beach , Florida , is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that iglucose makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes; the likelihood that iglucose is a safe, flexible, convenient, cost-effective and straightforward solution for people with diabetes to revolutionize the way they manage their condition; the likelihood that iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance; the likelihood that this FDA clearance is an important validation of the Company's product offering and the Company will work diligently to successfully make iglucose available to everyone affected by diabetes in the near future; the likelihood that the marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers; the likelihood that the business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base; the likelihood that over the coming months, the Company will launch initial roll-outs with several partners that can lead to large orders of iglucose; the likelihood that PositiveID has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada and will look to add additional wireless partners; the likelihood that iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition; the likelihood that the Company is continually adding to this list of supported glucose meters; the likelihood that diabetes educators believe using iglucose would improve patient outcomes; the likelihood that diabetes educators believe using iglucose would improve patient consults; the likelihood that diabetes educators would recommend iglucose to their patients; 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; the likelihood that the total cost of diagnosed diabetes in the U.S. is $200 billion; 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 iglucose and receive insurance reimbursement; 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
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com Newswire
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. Investorideas.com was compensated fifteen hundred to publish and distribute PositiveID Corporation press release by third party IR www.InvestorIdeas.com/About/Disclaimer.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
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. Investorideas.com was compensated fifteen hundred to publish and distribute PositiveID Corporation press release by third party IR www.InvestorIdeas.com/About/Disclaimer.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
Tuesday, November 15, 2011
Biotech News Alert; Investor Update for BioSante Pharmaceuticals (NasdaqGM: BPAX); Jefferies Initiating at Buy: Positive Ahead of Phase III LibiGel Data
Point Roberts, WA - November 15, 2011 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues an investor update for BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX). Jefferies & Company, Inc. has initiated a buy rating on the stock with a price target of $5.00, driven by Phase III LibiGel testosterone gel.
Jefferies thinks investors should own BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX) in front of LibiGel P3 data in early December.
According to Jefferies & Company, Inc. "Our $5 PT is based on an SOTP valuation, driven primarily by a LibiGel DCF (out to 2026, discounted 15%). We assume a LibiGel partnership w/ traditional 15-25% royalties, but have milestones as upside to our model. Risks include: negative LibiGel P3 efficacy (Dec.) & safety (3Q12) results; LibiGel regulatory delay/rejection; and an inability to partner LibiGel."
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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under 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.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX)
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead 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 II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an 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.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
Harris D. McKinney
Alan Zachary
312-506-5220
azachary@harrisdmckinney.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 future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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 report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. 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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Source - Investorideas.com 800-665-0411
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
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Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Point Roberts, WA - November 15, 2011 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues an investor update for BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX). Jefferies & Company, Inc. has initiated a buy rating on the stock with a price target of $5.00, driven by Phase III LibiGel testosterone gel.
Jefferies thinks investors should own BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX) in front of LibiGel P3 data in early December.
According to Jefferies & Company, Inc. "Our $5 PT is based on an SOTP valuation, driven primarily by a LibiGel DCF (out to 2026, discounted 15%). We assume a LibiGel partnership w/ traditional 15-25% royalties, but have milestones as upside to our model. Risks include: negative LibiGel P3 efficacy (Dec.) & safety (3Q12) results; LibiGel regulatory delay/rejection; and an inability to partner LibiGel."
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). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under 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.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX)
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead 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 II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an 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.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
Harris D. McKinney
Alan Zachary
312-506-5220
azachary@harrisdmckinney.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 future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or 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, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. 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 report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. 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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