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 cur
|SOURCE HeartWare Limited|
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