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News

HeartWare moves to expanded manufacturing facility in Florida

HeartWare : 21 April, 2008  (Company News)
HeartWare is moving to an expanded, upgraded manufacturing facility in Miami Lakes, Florida, USA.
The new facility, currently leased by Cordis Neurovascular, a division of Johnson and Johnson, includes fully-fitted offices, laboratories, wet labs, R and D facilities, conference rooms and executive meeting areas. The facility includes three clean rooms all of which are presently ISO Class 100,000 compliant and fully operational. The total clean room space exceeds 10,000ft2.

The facility move, to be completed by the end of May 2008, is not expected to impact the timing of HeartWare's regulatory process in the USA. HeartWare is working with the US Food and Drug Administration (FDA) on the company's application for an Investigational Device Exemption (IDE) to start a US clinical trial for the HeartWare LVAD System. Subject to approval from the FDA, HeartWare anticipates the US 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,' 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 six 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

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