Navigation Links
HeartWare Announces Move to an Expanded, Upgraded Manufacturing Facility

FRAMINGHAM, Mass. and SYDNEY, Australia, April 18 /PRNewswire/ -- HeartWare Limited (ASX: HTW) today announced that it is moving to an expanded, upgraded manufacturing facility in Miami Lakes, FL, USA. The new 59,000- square-foot facility, which is nearly twice the size of HeartWare's current facility, will enable a scaling up in manufacturing output and is expected to meet all of the Company's operational needs indefinitely.

The new facility, currently leased by Cordis Neurovascular, Inc., a division of Johnson & Johnson, includes fully-fitted offices, laboratories, wet labs, R & D facilities, conference rooms and executive meeting areas. Most importantly, it includes three clean rooms all of which are presently ISO Class 100,000 compliant and fully operational. The total clean room space exceeds 10,000 square feet.

The facility move, to be completed by the end of May, is not expected to impact the timing of HeartWare's regulatory process in the United States. HeartWare is working with the U.S. Food and Drug Administration (FDA) on the Company's application for an Investigational Device Exemption (IDE) to start a U.S. clinical trial for the HeartWare(R) LVAD System. Subject to approval from the FDA, HeartWare anticipates the U.S. trial to start during the current quarter.

The facility move will impact HeartWare's European regulatory timeline since the need for ISO certification is a key requirement for a CE Mark submission. HeartWare will schedule a regulatory audit of the facility as soon as practical following the completion of the move. This is expected to lead to receipt of CE Mark during the second half of 2008.

HeartWare Chief Executive Officer Doug Godshall said the new facility offered the opportunity to relocate to a high quality, purpose-built medical device facility at a significantly lower rental rate while also saving HeartWare the multi-million dollar costs and time to upgrade the clean room infrastructure at its current facility. In addition, as part of the agreement, HeartWare will acquire a number of items of specialist equipment at a nominal upfront cost.

"The decision by Cordis to relocate its neurovascular device manufacturing activities has proven extremely fortuitous for HeartWare," Mr. Godshall said. "It presents the opportunity for HeartWare to move into a fully equipped state-of-the-art medical device facility with sufficient manufacturing capacity to meet the anticipated rapid growth in demand for our products over coming years."

The new facility, located at 14000-14050 NW 57th Court, Miami Lakes, Florida, USA, is approximately 6 miles from HeartWare's current location in Miramar. HeartWare will relocate to the new facility in stages and take control of the clean rooms over a four-week period commencing on April 28. The leasehold agreement is for an initial term of three years and includes the option to extend for two consecutive periods of five years each

About HeartWare

HeartWare develops and manufactures miniaturized implantable heart pumps, or Left Ventricular Assist Devices (LVADs), designed to treat patients suffering from advanced heart failure. The Company is developing the industry's smallest and least invasive pumps, which it believes will be the key to unlocking the potential of a large and underserved market. The HeartWare(R) LVAD is a full-output pump designed to be implanted in the chest, avoiding the abdominal surgery generally required to implant competing devices. The device is currently the subject of an international clinical trial involving five investigational centres in Europe and Australia. A clinical trial in the U.S. is expected to begin in the first half of 2008.

For further information: US Investor Relations

Howard Leibman Matt Clawson

Director Corporate Development Partner

HeartWare Limited Allen & Caron, Inc.

Email. Email.

Tel. +61 2 9238 2064 Tel. +1 949 474 4300

SOURCE HeartWare Limited
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. HeartWare Selects Allen & Caron for Investor Relations and Corporate Communications
2. GHX Announces 2008 Best In Class Award Winners
3. AtriCure Announces Web Cast and Conference Call of First Quarter 2008 Financial Results
4. Huifeng Bio-Pharmaceutical (HFGB) Announces Participation in the 59th PHARMCHINA Expo
5. Zimmer Announces New Compliance Model
6. The Alliance for Lupus Research Announces 2008 Grantees
7. TeamStaff, Inc. Announces Results From Annual Meeting of Shareholders
8. CTG Announces 2008 First Quarter Conference Call and Webcast Information
9. Heartland Information Services Announces Alliance with M*Modal
10. Access Pharmaceuticals Announces New Data on Angiolix(R)
11. Eisai Corporation of North America Announces Appointment of Vice President of U.S. Corporate Communications
Post Your Comments:
(Date:10/13/2015)... ... 13, 2015 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... Commitment to Cure last night at the Mandarin Oriental in New York City. ...
(Date:10/13/2015)... ... 13, 2015 , ... Wimbledon Health Partners , the ... as well as pioneering the way for high schools, colleges and universities to ... Levitt as Chief Financial Officer. Levitt brings over 20 years of financial experience ...
(Date:10/13/2015)... ... October 13, 2015 , ... The added calories and sugar in ... So what is a parent to do? Registered dietitians from Retrofit , the ... this time of year. , “Halloween is a high-calorie holiday,” said Dara Aronow, ...
(Date:10/13/2015)... ... October 13, 2015 , ... The American Institutes for Research ... health staff caring for students who have experienced sexual assault and other trauma. The ... House during the Violence Against Women Act's 21st anniversary. , AIR ...
(Date:10/13/2015)... ... 2015 , ... CURE Media Group, the nation’s leading digital ... with the International Waldenstrom’s Macroglobulinemia Foundation (IWMF) to expand education and ... physicians. , “Waldenstrom’s Macroglobulinemia is a so-called ‘orphan disease’ that typically does ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... -- Families across the country have filed product ... pharmaceutical company,s blockbuster anti-nausea drug Zofran and congenital ... their fraudulent misrepresentations to prescribing physicians about the ...   Due to the large number of Zofran birth ... Panel on Multidistrict Litigation (JPML) has ordered that ...
(Date:10/13/2015)... LAS VEGAS , Oct. 13, 2015 ... field of vascular medicine and intervention through education and ... its annual conference,  VIVA 2015 . Sixteen trial results, ... be released for the first time on Monday and ... Vegas. --> --> ...
(Date:10/13/2015)... , Oct. 13, 2015   Generational Equity , ... businesses, is pleased to announce the acquisition of its ... Largo, Florida , by Meridian Biomedical, ... September 11, 2015. Florida ... --> Florida . To learn more, ...
Breaking Medicine Technology: