|
||||||
|
Arrow International, Inc., Reports Modifications in Cardiac Assist Strategy Discontinues Development and Marketing of Arrow LionHeart® LVAS Writes Off Remaining Investment of $2.8 Million Continues CorAide ™ Program READING, PA, April 7, 2005 – Arrow International, Inc. (Nasdaq: ARRO) reported today that after carefully considering a wide range of medical, patient care and economic factors, its Board of Directors has unanimously voted to discontinue the development, sales and marketing programs related to its LionHeart Left Ventricular Assist System (LVAS). Carl G. Anderson, Jr., Chairman and Chief Executive Officer, stated, “The Arrow LionHeart program established a new level of technological achievement. We could not have asked for a better, more talented or dedicated team to bring it to clinical use and commercial use in Europe under a CE mark. We and the cardiac assist field in general are fortunate to have benefited from the efforts of the best technical and clinical minds involved in mechanical cardiac assist technology today, including our valuable partners at Penn State Milton S. Hershey Medical Center. “However, as any responsible public company must do, Arrow has been closely monitoring the progress of our LVAS program. We have reviewed ventricular assist technology trends, considered our experience marketing the device in Europe, the input we received from the medical community, as well as the data and analysis of the outside consultants we retained to analyze the long-term commercial opportunity of this program. In addition, we have thoroughly assessed the significant additional time and investment required to maximize the potential of the LionHeart. Based on careful consideration of all of these factors, we have determined that the LionHeart is not economically viable for Arrow, as it would not realize adequate returns for Arrow shareholders in an acceptable period of time. Therefore, the Company will discontinue its LionHeart program. We are, however, fully committed to providing the necessary ongoing technical and clinical support for the one patient who is currently implanted with the device,” Mr. Anderson concluded. In addition, based upon the Board's decision, Arrow will continue the clinical trial of its CorAide continuous flow ventricular assist device in Europe. The Company believes the CorAide’s smaller size, less invasive surgical approach and inherently simpler design promises better opportunities for broader market acceptance. In February 2005, CorAide devices were implanted in two patients in Bad Oyenhausen, Germany in conjunction with the Company’s clinical trial. As Arrow reported on March 21, 2005, both patients continue to recover as expected. As previously reported, there were no sales of the Company’s LionHeart devices during either of the first two quarters of fiscal year 2005. As a result, the Company made a provision in its second fiscal quarter of $2.1 million, or $0.03 diluted earnings per share, for LionHeart inventory in excess of anticipated requirements. In addition, based upon the Board of Directors decision, the Company will write off in the second fiscal quarter ended February 28, 2005 its remaining investment in LionHeart, which includes $2.8 million in manufacturing equipment and components. The write-off will be included in the Company’s unaudited financial statements reported in its Form 10-Q for the second quarter of fiscal year 2005, which is scheduled to be filed on Monday, April 11, 2005, as previously announced. Company Information Arrow International, Inc. develops, manufactures and markets a broad range of clinically advanced, disposable catheters and related products for critical and cardiac care. The company’s products are used primarily by anesthesiologists, critical care specialists, interventional radiologists, surgeons, emergency and trauma physicians, cardiologists, electrophysiologists and other healthcare providers. Arrow International’s news releases and other company information can be found on the on its website at http://www.arrowintl.com. The Company’s common stock trades on The Nasdaq Stock Market® under the symbol ARRO.
|
![]() |
|||||