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HeartWare International Reports First Quarter 2011 Revenues of $18.0 Million; 68% Increase From $10.7 Million in First Quarter 2010
Date:5/5/2011

FRAMINGHAM, Mass. and SYDNEY, May 5, 2011 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenues of $18.0 million for the first quarter ended March 31, 2011.  This represents a 68 percent increase from $10.7 million in revenues for the first quarter of 2010.

"During the first quarter, we generated our second highest international sales results for the HeartWare® Ventricular Assist System.  We are appreciative of the strong support of our 56 customers in 18 countries, as 134 pumps were sold outside of the U.S.," explained Doug Godshall, President and Chief Executive Officer.  "The international markets accounted for 65 percent of our revenues, or approximately $11.7 million for the 2011 first quarter, up from $8.0 million in the first quarter of 2010."

"In the U.S., where first quarter revenues more than doubled to $6.3 million compared to $2.7 million in the first quarter of 2010, we now have 46 of the planned 50 U.S. sites approved for implantation in our 450-patient destination therapy study, and 121 patients have been randomized and enrolled," added Mr. Godshall.  "In the first quarter, we also received our largest allotment – 94 patients – granted by the Food and Drug Administration (FDA) in January under the Continued Access Protocol (CAP) for our bridge-to-transplant clinical study.  Participating hospital sites began the re-initiation process and have enrolled 28 patients in this third CAP cohort."

Total operating expenses for the first quarter of 2011 were $18.0 million, compared to $9.3 million in the prior year period.  Research and development expense was $9.3 million for the first quarter of 2011, primari
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SOURCE HeartWare International, Inc.
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2. HeartWare International Clinical Trial Shows 90% Survival at 180 Days
3. U.S. FDA Authorizes Expansion to 40 Clinical Sites for HeartWare U.S. Bridge-to-Transplant Clinical Trial
4. HeartWare International Reports Third Quarter Revenues of $7.5 Million
5. HeartWare to Present at 21st Annual Piper Jaffray Health Care Conference in New York City
6. HeartWare to Present at the UBS 2010 Global Life Sciences Conference
7. HeartWare to Present at Lazard Capital Markets Circulatory Assist Device Day
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11. HeartWare to Present at the Lazard Capital Markets 7th Annual Healthcare Conference
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