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
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I/MDV R/US CAP/STOCKS CAP/INDEX MR/NEWS
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