Exhibit 99.1

 

 

AGA Medical Reports 2010 First Quarter Financial Results

 

First Quarter Net Sales Increase 15.4% to $51.3 Million; Gross Margin at 85.9%

 

Management Affirms 2010 Financial Guidance

 

MINNEAPOLIS, May 6, 2010 — AGA Medical Holdings, Inc. (AGA Medical) (NASDAQ: AGAM), a leading developer of interventional medical devices for the minimally invasive treatment of structural heart defects and vascular abnormalities, today reported financial results for the first quarter ended March 31, 2010.

 

Highlights of the first quarter of 2010 include:

 

·                  Received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to evaluate the safety and efficacy of its AMPLATZER® Cardiac Plug (ACP), which is designed to close the left atrial appendage. The trial is designed to demonstrate efficacy in preventing stroke in atrial fibrillation patients who are eligible to receive Warfarin, as well as safety of the device and the procedure;

 

·                  Settled a patent infringement lawsuit between AGA Medical and Medtronic, Inc. (Medtronic) relating to the January 2007 patent infringement action against the company, filed by Medtronic.  AGA Medical will make payments over four years to Medtronic in the total amount of $35 million.  This settlement covers all existing products, as well as any new products developed and commercialized by AGA Medical, using nitinol for the entire term of the patents in dispute, known as “the Jervis patents”; and

 

·                  Continued enrollment in its pivotal RESPECT clinical trial designed to study whether patent foramen ovale (PFO) closure is superior to medical management in preventing recurrent stroke, with 726 patients enrolled in the study and 1,352 patient follow-up years as of April 30, 2010.

 

Financial Results for First Quarter 2010 vs. First Quarter 2009

 

Net sales for the first quarter of 2010 were $51.3 million, a 15.4% increase over $44.4 million for the first quarter of 2009. On a constant currency basis, net sales grew 11.9% year over year.

 

John Barr, President and Chief Executive Officer of AGA Medical, commented, “With our first quarter results, we delivered a solid start to 2010.  We achieved sales growth across all of our product lines, with particularly impressive performance from our vascular products in all distribution channels.”

 

“We also continue to make significant progress in our clinical programs. Both receipt of FDA conditional approval to begin our ACP clinical trial in the U.S. and continued strong enrollment trends in our U.S. RESPECT clinical trial, are testaments to the strength of our clinical and regulatory capabilities,” Barr further commented.

 

 


The following information was filed by Aga Medical Holdings, Inc. on Thursday, May 6, 2010 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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