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Acusphere Inc (ACUS) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2007

Acusphere Inc

CIK: 1115143 Ticker: ACUS

 

Exhibit 99.1


 

FOR IMMEDIATE RELEASE

 

Acusphere, Inc. Reports Q4 2007

Financial Results and Business Highlights

 

 

WATERTOWN, Mass., March 17, 2008

Acusphere, Inc. (NASDAQ: ACUS) today reported financial results for the fourth quarter and year ended December 31, 2007 and commented on its financial results and business highlights.

 

The Company is moving aggressively ahead on efforts to file its planned New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA) for its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension.  Acusphere has now successfully completed the aseptic validation process, a critical step in qualifying its commercial manufacturing facility for Imagify. In light of these achievements, which reflect the last new data needed, Acusphere is today announcing that it plans to file the NDA for Imagify in late April 2008.  Imagify is a Perfusion Stress Echo imaging agent for use in detecting coronary artery disease.

 

Major Accomplishments

·                  Continued potential financing and partnership discussions for Imagify with a wide range of parties

 

·                  Held constructive pre-NDA meetings with FDA as part of continued push for Imagify NDA filing preparation

 

·                  Imagify’s Phase 3 clinical results were presented at the prestigious American Heart Association meeting and Imagify’s safety and efficacy data was presented in Europe at the annual EuroEcho conference.

 

Business Priorities

Acusphere’s key current priorities are:

 

·                  Preparing and submitting the regulatory filings for Imagify

 

·                  Continuing active financing and potential partnership discussions for Imagify

 

The Company continues to focus on the steps necessary to submit an NDA for Imagify and support the Marketing Authorization Application (MAA) filing in Europe by Nycomed, its European partner.  Process validation efforts will continue beyond the NDA submission as will preparations for the FDA’s pre-approval inspection, which is expected during the second half of 2008.

 

 


The following information was filed by Acusphere Inc (ACUS) on Monday, March 17, 2008 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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SEC Filing Tools
Ticker: ACUS
CIK: 1115143
Form Type: 10-K Annual Report
Accession Number: 0001047469-08-002857
Submitted to the SEC: Mon Mar 17 2008 6:48:39 AM EST
Accepted by the SEC: Mon Mar 17 2008
Period: Monday, December 31, 2007
Industry: Pharmaceutical Preparations

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