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Sunshine Heart receives positive progress reports from Product Development Partners
10 / 07 / 2006
Sunshine Heart Company (ASX, SHC) today announced that it's US Product Partners have achieved significant milestones towards the supply of products in preparation for the start of a USbased clinical trial of the C-PulseTM mid-2007.
The Plexus Corporation, a US NASDAQ-listed corporation with over twenty years' experience in converting concepts into world-class products has successfully completed the initial durability testing of the critical components of the Wearable Driver. Plexus confirmed that the key life-style' requirements of the driver have been met, including the weight (approximately 1.5 kg),
battery life (6-8 hours with single battery) and noise level targets. The driver has state-of-the-art wireless programming communication to allow the physician to optimise its performance for each individual patient.
SHC also received the first production batch of C-PulseTM Cuffs from the Polymer Technology Group (PTG), Berkeley, CA. Delivery of these sterile clinical cuffs from PTG marks the completion of the manufacturing process development. A portion of the delivered cuffs will now be added to the Sunshine Heart's reliability cycle test program, where cuffs have already
exceeded the equivalent of four years of endurance.
Victor Windeyer, Sunshine Heart's Chief Operating Officer, indicated that: "Sunshine is on track to provide these critical C-PulseTM components for the US trial". He added that: "Sunshine Heart's outsourced model of utilising firstclass suppliers has been very cost effective, allowing Sunshine Heart to focus on business and clinical trial activities."
The Plexus Corporation, a US NASDAQ-listed corporation with over twenty years' experience in converting concepts into world-class products has successfully completed the initial durability testing of the critical components of the Wearable Driver. Plexus confirmed that the key life-style' requirements of the driver have been met, including the weight (approximately 1.5 kg),
battery life (6-8 hours with single battery) and noise level targets. The driver has state-of-the-art wireless programming communication to allow the physician to optimise its performance for each individual patient.
SHC also received the first production batch of C-PulseTM Cuffs from the Polymer Technology Group (PTG), Berkeley, CA. Delivery of these sterile clinical cuffs from PTG marks the completion of the manufacturing process development. A portion of the delivered cuffs will now be added to the Sunshine Heart's reliability cycle test program, where cuffs have already
exceeded the equivalent of four years of endurance.
Victor Windeyer, Sunshine Heart's Chief Operating Officer, indicated that: "Sunshine is on track to provide these critical C-PulseTM components for the US trial". He added that: "Sunshine Heart's outsourced model of utilising firstclass suppliers has been very cost effective, allowing Sunshine Heart to focus on business and clinical trial activities."