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Biotech / Medical
ABMD - Replacement Heart System
An SI Board Since February 1999
Posts SubjectMarks Bans Symbol
147 14 0 ABMD
Emcee:  Lynn Type:  Unmoderated
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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ReplyMessage PreviewFromRecsPosted
147$ABMD (ABioMed, Inc) Does Impella (from ABMD)Affect Predicted AKI Risk? Study Shtech101-November 8
146Why Abiomed Stock Is Jumping TodayInvestors liked the medical device maker'stech101-November 1
145Abiomed Announces Q2 FY 2020 Revenue of $205 Million and 29.4% Operating Margin tech101-November 1
144If You Like EPS Growth Then Check Out Abiomed (NASDAQ:ABMD) Before It's Too tech101-September 12
143ABMD: Analyst Ratings & Price Targets tipranks.comJulius Wong-10/29/2018
142World's Smallest Heart Pump Fuels Red-Hot Medtech Stock Lynn-9/28/2018
141:) :) Without looking how my make-me-groan stocks are doing, just reading your rLynn-9/25/2018
140Then you must be feeling great between yesterday and today. Go ABMD!dominoe-9/25/2018
139Hey, thank you, dominoe. I have been a tad bit gloomy over a few stocks I recentLynn-9/24/2018
138Data Presented at TCT 2018 Shows Use of Impella and Best Practices Increases CarJulius Wong19/24/2018
137Dont look now but we are soaring on positive news of our impact on lowering mortdominoe-9/24/2018
136You haven't been around since 2005, Ken, hope you are fine. Looking back at Lynn-9/15/2018
1357 Tech Stocks Sporting Amazon-Like Growth Louis Navellier InvestorPlace SeptembLynn19/14/2018
134Analyst Ratings & Price Targets on Abiomed tipranks.comJulius Wong-9/9/2018
133What Analysts Expect for AbiomedMike Benson Market Realist September 5, 2018 ALynn-9/8/2018
132Abiomed Announces Approval in India for the Impella 2.5®, Impella CP® Lynn27/26/2018
131Why Abiomed Inc. Stock Is Sinking Today Keith Speights, The Motley Fool July 26Lynn17/26/2018
130Abiomed (ABMD) Q1 Earnings Lag Estimates Zacks Equity Research July 26, 2018 ALynn-7/26/2018
129Abiomed Announces Q1 FY 2019 Record Revenue of $180 Million, Up 36% Over Prior YLynn-7/26/2018
128Will Flagship Impella Drive Abiomed's (ABMD) Q1 Earnings? Zacks Equity ReseLynn-7/11/2018
127Newbie Abiomed edges out Netflix as S&P 500’s top YTD gainer [graphic] JesLynn17/2/2018
126Call it wishful thinking, but I think the ABMD BOD has a 2:1 stock split in mindLynn-6/26/2018
125I shall post the entire article after this, but the article says some fund managLynn-6/7/2018
124I am doing a copy/paste of the entire article in IBD, not just the section on ABLynn16/4/2018
123Abiomed's Shares Doubled. What Happens Next? The sizLynn16/2/2018
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