Animas Announces Notification to IR 1200 Users, Reaffirms Guidance.WEST CHESTER West Chester, borough (1990 pop. 18,041), seat of Chester co., SE Pa., W of Philadelphia; inc. 1799. Primarily residential, West Chester was long the trade and processing center for an agricultural region that is now mainly suburbs. , Pa. -- Animas Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :PUMP), a leading manufacturer of insulin pumps insulin pump n. A portable device for people with diabetes that injects insulin at programmed intervals in order to regulate blood sugar levels. , announced today that it will be notifying patients using the IR 1200 pump and their healthcare providers that, as a result of a recently-identified software bug A problem that causes a program to produce invalid output or to crash (lock up). The problem is either insufficient logic or erroneous logic. For example, a program can crash if there are not enough validity checks performed on the input or on the calculations themselves, and the computer , the operation of the pump as described in the IR 1200 User Guide differs from its actual operation when a patient suspends insulin delivery. All other pump functions operate in accordance with the User Guide. The User Guide states that when a patient suspends insulin delivery, the pump will provide an audible, vibrational and visual reminder that delivery has been halted. As a result of the software bug, the pump, in certain circumstances, provides only a visual reminder. The Company confirms that patients can continue to use their pump safely, with assurance and no loss of functionality, so long as they are aware they may receive only the visual reminder in the suspend mode, as opposed to audible, vibrational and visual reminders. Animas will formally contact patients, healthcare providers and distributors of this software bug and provide updated user information. The Company has also set up a special Help Line to handle customer inquiries. All IR 1200 pumps shipped between April 15, 2004 and September 25, 2004 are affected by this software bug. "We are sorry for any inconvenience this software bug may cause our customers," said Kathy Crothall, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Animas Corporation. "Animas is very committed to patient safety and product quality, and as such, we are taking the appropriately proactive steps to assure such safety." The Company has corrected the software and all IR 1200 pumps shipped after September 26, 2004 contain the corrected software. Animas reaffirmed its prior guidance for the third quarter of approximately $20-21 million for net revenue and $2.0-$3.0 million for net income, and for the year of approximately $60-$62 million for net revenue and a net operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. between $1 and $2 million. The Company expects that the cost associated with this software bug and corrective action A corrective action is a change implemented to address a weakness identified in a management system. Normally corrective actions are instigated in response to a customer complaint, abnormal levels if internal nonconformity, nonconformities identified during an internal audit or will be approximately $150,000, a charge to be taken in the third quarter. About Animas Corporation: Animas, a leading maker of insulin infusion pumps and related products, is dedicated to improving diabetes management This article is about the management of diabetes mellitus. For more on the disease itself see diabetes mellitus. Diabetes is a chronic disease with no cure as of 2007. It is associated with an impaired glucose cycle, altering metabolism. and making insulin pump therapy easier for patients with insulin requiring diabetes and healthcare professionals through product innovation, exemplary customer support and superior customer education. For more information on Animas, visit http://www.animascorp.com or call Animas Corporation at 877-937-7867. Statements in this press release or made by management from time to time regarding Animas Corporation that are not historical facts, are forward-looking statements and are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. Any such forward-looking statements are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. The following factors, among others, could cause Animas' actual results to differ materially from those described in a forward-looking statement: the technical issues or the failure of the IR 1200 to gain significant market acceptance; failure to capture recurring purchases of ancillary supplies by patients using Animas' pumps; any significant disruption with vendors; any failure to achieve and then maintain profitability; the failure of Animas' ezSet Infusion Set An infusion set is used with an insulin pump as part of intensive insulin therapy. The purpose of an infusion set is to deliver insulin under the skin. It is a complete tubing system to connect an insulin pump to the pump user: it includes a subcutaneous cannula, adhesive mount, to be fully-developed or commercially accepted; technological breakthroughs in diabetes monitoring, treatment or prevention that could render Animas' products obsolete; failure to comply with any FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or foreign regulations; an inability to attract and retain personnel; competition; an inability to adequately protect Animas' intellectual property; product liability lawsuits; and the failure to secure or retain third party insurance coverage or reduced reimbursement for Animas' products by third party payors. This list is intended to identify only certain of the principal factors that could cause actual results to differ. Readers are referred to the reports and documents filed from time to time by Animas Corporation with the Securities and Exchange Commission for a discussion of these and other important risk factors. Readers are cautioned not to place undue reliance on forward-looking statements, which are made as of the date of this press release. Animas Corporation undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or for any other reason. |
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