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Abiomed: Replacement heart system meets reliability criteria [.22344]Sorry to include all of this...in a hurry! By Bridge News New York--Feb 11--Abiomed Inc. today said its implantable replacement heart meets the company's reliability criteria under its ongoing growth program. As full systems, including internal batteries and electronics, were up to the reliability criteria, the company is considering clinical trials on patients, which require FDA approval. Abiomed plans to start human trials in 2000. * * * The following is the text of today's announcement with emphasis added by Bridge News. BridgeStation links to company data have been inserted at the end: ABIOMED Reports Progress With Its Replacement Heart Business Editors, Health/Medical Writers NEW YORK--(BW HealthWire)--Feb. 11, 1999--ABIOMED, INC. (PRONOUNCED "AB-EE-O-MED"), (NASDAQ:ABMD) ANNOUNCED TODAY THAT ITS IMPLANTABLE REPLACEMENT HEART HAS REACHED AN IMPORTANT MILESTONE UNDER THE COMPANY'S ONGOING RELIABILITY GROWTH PROGRAM. FULL SYSTEMS, INCLUDING INTERNAL BATTERIES AND ELECTRONICS, BELONGING TO THE SECOND PILOT PRODUCTION LOT PLACED UNDER FORMAL TESTING, HAVE MET THE COMPANY'S RELIABILITY CRITERIA FOR THEIR USE IN SOME BRIDGE-TO-TRANSPLANT INDICATIONS, SHOULD THE COMPANY ELECT TO PURSUE THIS PATIENT CATEGORY. ACTUAL USE FOR THESE INDICATIONS WOULD REQUIRE FDA APPROVAL. THE ANNOUNCEMENT WAS MADE AT THE ING BARING FURMAN SELZ CONFERENCE ON Emerging Medical Technology. Dr. David M. Lederman, Chief Executive Officer, indicated at the Conference that "the ABIOMED Reliability Growth and Qualification Program began in 1998." He explained that "it is a formal testing program intended to demonstrate performance and durability of the full system under a range of simulated physiological conditions over increasing periods of time. The ongoing tests are conducted in an intensely monitored laboratory environment. The reliability growth data are derived from tests of multiple systems belonging to continuously improving successive production lots. Each successive generation incorporates improvements learned from the previous generation. Under this program, each successive lot is expected to yield increasing reliability milestones." Dr. Lederman added: "AS THE VARIOUS RELIABILITY MILESTONES ARE REACHED, THE COMPANY, IN CONSULTATION WITH INDEPENDENT MEDICAL ADVISORS, INTENDS TO DEFINE PATIENT INDICATIONS THAT ARE MEDICALLY AND ETHICALLY APPROPRIATE AND WILL APPLY FOR REGULATORY PERMISSION TO BEGIN CLINICAL TRIALS UNDER APPROVED PROTOCOLS." He concluded that: "the next production lot to enter reliability evaluation will incorporate, among others, configurational refinements for optimal human fit. POSITIVE RESULTS FROM THESE TESTS ARE CRITICAL TOWARD ACHIEVING THE COMPANY'S GOAL OF INITIAL HUMAN TRIALS IN THE YEAR 2000." The ABIOMED Replacement Heart is intended to restore the lives of patients who would otherwise die from heart failure from various causes. The Company estimates that there are more than 100,000 people dying each year in the USA from acute myocardial infarction, chronic ischemic disease or congestive heart failure who could benefit from this device. In contrast to other implantable cardiac assist devices, which leave failing or diseased natural hearts in place, the ABIOMED Replacement Heart replaces the severely diseased heart. Based in Danvers, Massachusetts ABIOMED, INC. DEVELOPS, MANUFACTURES AND MARKETS INNOVATIVE CARDIOVASCULAR PRODUCTS AND IS A LEADER IN THE RESEARCH AND DEVELOPMENT OF ADVANCED HEART ASSIST AND REPLACEMENT SYSTEMS., The Company's BVS-5000 is the most widely used FDA-approved cardiac assist device and the only FDA-approved device for all patients with reversible heart failure. The Company's Implantable Replacement Heart is in an advanced stage of development and intended to extend the lives of patients who would otherwise die from heart failure. For BridgeStation version 6.26 or higher: 240-day Price History Media://Analytics/Pages:ABMD-Price-History:/cmd=US;ABMD[1350MOV3]/DAT=L240 Two-day intraday price chart: Media://Analytics/Pages:ABMD-intraday:/cmd=US;ABMD[7334ID2] Trailing 12 months Earnings per Share Media://Analytics/Pages:ABMD-EPS:/cmd=US;ABMD[1584EPS] Summary of the company's fundamentals: Media://Analytics/Pages:ABMD-Fundamentals:/cmd=[CF]US;ABMD/MNU News stories on this company from Bridge News Media://NewsSearch::/Source=mar/Symbol=US;ABMD/go/newest/Search Send comments to email address: equity@bridge.com Feb-11-1999 14:50 GMT Symbols: US;ABMD Source BridgeNews Global Markets Categories: I/MDV R/US CAP/STOCKS CAP/INDEX MR/NEWS | ||||||||||||||
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