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 Acusphere, Inc.
May 19, 2009 04:05 PM Eastern Time 

Acusphere, Inc. Announces Prepayment of Equipment Loans

TEWKSBURY, Mass.--(BUSINESS WIRE)--Acusphere, Inc. (ACUS.PK) today announced that it has prepaid its equipment loans with Oxford Finance Corporation and Massachusetts Development Finance Agency. These transactions, in combination with the previously disclosed prepayment in full of General Electric Capital Corporation debt, represent total debt reduction of $3.8 million. After such prepayments, the Company has approximately $2.4 million in unaudited cash which is expected to fund operations to the end of the third quarter of 2009 based on the current operating plan.

The Company continues to discuss its New Drug Application (NDA) with the U.S. Food & Drug Administration (FDA) for its lead product candidate, Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension, a Perfusion Stress Echo imaging agent targeted for use in detecting coronary artery disease. The Company previously announced that it had received a complete response from the FDA for Imagify in February 2009, FDA’s target date under the Prescription Drug User Fee Act (PDUFA). The response was largely consistent with the feedback received at the Advisory Committee meeting in December 2008, and discussions that continued with FDA in January 2009. In general, FDA’s response stated that additional clinical work would be required to support approval. Discussions with FDA continue regarding the design of the clinical program.

About Acusphere, Inc.

Acusphere is a specialty pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microsphere technology. We are focused on developing proprietary drugs that can offer significant benefits such as improved safety and efficacy, increased patient compliance, greater ease of use, expanded indications or reduced cost. Our lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, is a cardiovascular drug for the detection of coronary artery disease, the leading cause of death in the United States, for which a New Drug Application (NDA) was submitted to the U.S. Food & Drug Administration (FDA) in April 2008 and filed in June 2008. Imagify and the Company's other product candidates were created using proprietary technology that enables Acusphere to control the porosity and size of nanoparticles and microspheres in a versatile manner that allows them to be customized to address the delivery needs of a variety of drugs. For more information about Acusphere visit the Company's web site (www.acusphere.com).

Forward-looking Statements

The above press release contains forward-looking statements, including statements regarding, the NDA submission for Imagify and likelihood of regulatory approval and the commercial opportunity for Imagify. There can be no assurance that Imagify will be approved for the indication the Company is seeking, or at all. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including anticipated operating losses and existing capital obligations, uncertainties associated with research, development, testing and related regulatory approvals, including uncertainties regarding regulatory evaluation of the Company's statistical analysis plan and clinical trial results and uncertainties regarding the potential effects of not achieving clinical endpoints, limited time to date for the Company to review the details of the clinical trial results, capital needs and uncertainty of additional financing, uncertainties regarding the cost, timing and ultimate success of the qualification of the Company's commercial manufacturing facility in accordance with applicable regulatory requirements, complex manufacturing, high quality requirements, lack of commercial manufacturing experience, dependence on third-party manufacturers, suppliers and collaborators, uncertainties associated with intellectual property, competition, loss of key personnel, uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. The Company notes that effective as of March 3, 2009, pursuant to a Form 15 filing made with the SEC, it is not currently required to file periodic reports with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this press release or to reflect the occurrence of unanticipated events.

Contacts

Acusphere, Inc.
Sherri Oberg, 617-925-3444
IR@acusphere.com

 Acusphere, Inc.

Company Information Center

Acusphere, Inc. RSS feed for Acusphere, Inc.

NQB:ACUS

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