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11-05 :: May/June 2011
nanotimes
Companies Facts
stration (FDA) regarding the design of a new Phase 3 study of the company’s lead product candidate, Imagify™ Perflubutane Polymer Microspheres for Injectable Suspension. As previously announced, this new study, designed under the Special Proto- col Assessment (SPA) process, will compare stress ultrasound with Imagify to stress ultrasound without Imagify™ for the detection of coronary artery disease (CAD).
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Said Sherri C. Oberg, President and Chief Executive Officer, “We are delighted to have reached agree- ment with FDA on the design for a new Phase 3 trial for Imagify under the SPA Process. This is a critical milestone for Acusphere, and one that may reduce the level of risk for potential partners. We believe that this trial design will help provide clear evidence of Imagify’s superiority over stress ultrasound be- cause it enables myocardial perfusion assessment, a potential $2 billion market in the U.S. alone, and one that is growing. We continue to believe strongly in Imagify‘s potential for the condition proposed, and we remain committed to realizing that opportunity for the benefit of Acusphere and its shareholders.”
Based upon the agreement reached with FDA, Acus- phere is now able to provide a scope for the new Phase 3 trial. The company expects that this trial will cost approximately $15 million and require about 2 years to complete, based upon enrollment of 900 patients.
cusphere, Inc. (ACUS.PK), had reached an agreement with the U.S. Food & Drug Admini-
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ith the SPVQ4H series, ALPS ELECTRIC EUROPE GmbH offers waterproof detector
switches for automotive, industrial and home appli- cations. The actuator-type switches are remarkable for their high contact reliability at micro-current range and a long operating life of 300,000 switching cycles.
They have compact dimensions of 19.0mm x 5.4mm x 9.4 mm (W x D x H). Together with the actua- tor they provide a height of 18mm. The necessary operating force accounts for 3N. Depending on the version, the detector switches are available with two or three solder connecting wires as single-pole/ double-throw or single-pole/single-throw N/O or N/C switches.
The SPVQ4H series is rated for switching cur- rents of maximal 0.1A at 12VDC or 1mA at 5VDC respectively. Operating temperatures range from –40° C (-40° Fahrenheit) to +85° C (185° Fahrenheit). Further specifications include a maximum initial contact resistance of 500mΩ, an insulation resistance higher than 100MΩ at 500 VDC, and a voltage proof of up to 500VAC for one minute.
Furthermore, ALPS ELECTRIC EUROPE has de- veloped the HSCDTD004A geomagnetic sensor enabling electronic compass functions in smart- phones and tablet PCs. Mass production commenced in May 2011. The HSCDTD004A geomagnetic sensor, with its high-precision magnetic element optimized to increase sensor output, generates 30% less noise than the earlier model. This has improved
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