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Additional information lodged with FDA for US clinical trial
13 / 08 / 2008
Sunshine Heart, Inc. (ASX: SHC) has today lodged additional information with the US Food and Drug Administration (FDA) in support of the Company's Investigational Device Exemption (IDE) application for approval to undertake a US clinical trial of Sunshine Heart's innovative C-PulseTM heart assist therapy.
Over the past twelve months, there has been a continuing dialogue with the FDA in relation to the Company's application initially submitted in June 2007. The additional information submitted today responds to a number of specific clinical and technical questions raised by the FDA in correspondence and meetings over the last 6 months. Sunshine Heart expects to receive a further response from the FDA within 30 days. The Company believes the additional information provided addresses all the issues raised by the FDA however the response may cause the FDA to invite the Company to provide further additional information.
Don Rohrbaugh, Sunshine Heart's CEO said: "This further filing is another substantial effort from the Company's regulatory and technical teams. Subject to approval, we currently plan to commence enrolling patients in the fourth quarter of 2008."
Following FDA approval of the IDE application, the Company will commence the planned US clinical trial which will involve approximately 20 patients. The Company has identified six leading medical institutions that will enroll patients into the trial and has initiated training for both surgical and clinical personnel from these institutions. They are:
Jewish Hospital, University of Louisville
Hershey Medical Centre, Pennsylvania State University
Northwestern University School of Medicine
Ohio State University Medical Centre
University of Alabama Medical Centre
University of Florida School of Medicine.
C-Pulse is a unique and innovative medical device that seeks to relieve and in some cases reverse the debilitating symptoms of moderate heart failure which if left untreated usually results in the sufferer experiencing repeat hospitalisations and a premature death. In the USA, there are approximately one million sufferers of moderate heart failure (1 in 300 people) who do not get sufficient symptomatic relief from the current
treatment regimens of drugs and CRT pacemakers. C-Pulse provides a treatment regimen for this unmet clinical need.
Following successful completion of the initial US clinical trial, the Company plans to seek FDA approval to undertake a larger clinical study of more than 100 patients in the US (a pivotal study) as a precursor to marketing C-Pulse in the USA. The Company will also seek CE Mark approval for C-Pulse based on the initial US clinical trial data which would enable the device to be marketed in the European Union and other countries accepting CE Mark.
In June, Sunshine Heart completed a $5.4 million underwritten rights issue and at 30 June 2008 had cash reserves of $9.8 million. The rights issue was strongly supported by Sunshine Heart's cornerstone investors. The funds raised are targeted for the US clinical trial. The Company expects to receive reimbursement of part of the clinical trial costs from US health insurance companies.
Over the past twelve months, there has been a continuing dialogue with the FDA in relation to the Company's application initially submitted in June 2007. The additional information submitted today responds to a number of specific clinical and technical questions raised by the FDA in correspondence and meetings over the last 6 months. Sunshine Heart expects to receive a further response from the FDA within 30 days. The Company believes the additional information provided addresses all the issues raised by the FDA however the response may cause the FDA to invite the Company to provide further additional information.
Don Rohrbaugh, Sunshine Heart's CEO said: "This further filing is another substantial effort from the Company's regulatory and technical teams. Subject to approval, we currently plan to commence enrolling patients in the fourth quarter of 2008."
Following FDA approval of the IDE application, the Company will commence the planned US clinical trial which will involve approximately 20 patients. The Company has identified six leading medical institutions that will enroll patients into the trial and has initiated training for both surgical and clinical personnel from these institutions. They are:
Jewish Hospital, University of Louisville
Hershey Medical Centre, Pennsylvania State University
Northwestern University School of Medicine
Ohio State University Medical Centre
University of Alabama Medical Centre
University of Florida School of Medicine.
C-Pulse is a unique and innovative medical device that seeks to relieve and in some cases reverse the debilitating symptoms of moderate heart failure which if left untreated usually results in the sufferer experiencing repeat hospitalisations and a premature death. In the USA, there are approximately one million sufferers of moderate heart failure (1 in 300 people) who do not get sufficient symptomatic relief from the current
treatment regimens of drugs and CRT pacemakers. C-Pulse provides a treatment regimen for this unmet clinical need.
Following successful completion of the initial US clinical trial, the Company plans to seek FDA approval to undertake a larger clinical study of more than 100 patients in the US (a pivotal study) as a precursor to marketing C-Pulse in the USA. The Company will also seek CE Mark approval for C-Pulse based on the initial US clinical trial data which would enable the device to be marketed in the European Union and other countries accepting CE Mark.
In June, Sunshine Heart completed a $5.4 million underwritten rights issue and at 30 June 2008 had cash reserves of $9.8 million. The rights issue was strongly supported by Sunshine Heart's cornerstone investors. The funds raised are targeted for the US clinical trial. The Company expects to receive reimbursement of part of the clinical trial costs from US health insurance companies.