Sunshine Heart, Inc. (Sunshine Heart) has reported revenues of AUD0.42 million for the fiscal 2009, compared with the revenues of AUD0.44 million in the previous year-end. It also reported net loss of AUD8 million, or AUD2.8 per share, for the fiscal 2009, compared with net loss of AUD9.7 million, or AUD4.8 per diluted share, in the previous year-end.
Major milestones achieved during the year include:
Full approval of the feasibility trial by the US Food and Drug Administration (FDA)
Approval from the ethics committees (Institutional Review Boards) at all six university medical research hospitals.
Approval for US Medicare reimbursement for C-Pulse at all six clinical sites.
Initiation of the US clinical trial with the first implantation of C-Pulse into two patients at The Ohio State University Medical Center (OSU) in April 2009.
Continuation of enrolment in the trial.
Reimbursement (first sales) for the C-Pulse.
Research and development expenses:
Research and development expenses decreased by AUD2,130,076 in 2009 compared to 2008 reflecting lower expenditure on development and testing of a wearable driver unit. Salaries, consultants and employee benefits:
Salaries and consultants expense increased by AUD299,343 in 2009 compared to 2008. The impact of the reduction in the number of employees will be reflected in the financial year ended 30 June 2010.
The Group’s cash at June 30, 2009 was AUD2,013,816. During 2009, the net cash decreased by AUD7,758,801. The Group’s net operating cash usage for the year was AUD7,747,373 which represents a decrease of AUD1,404,489 compared to the year ended June 30, 2008.
During 2009 there was no proceeds from issue of ordinary shares compared to proceeds of AUD11,445,542 from the issue of ordinary shares in 2008.
Sunshine Heart expects to raise further monies during the 2010 financial year from the private placement and rights issue announced on August 10, 2009. These monies will be used to complete enrolment and patient follow-up in the US feasibility trial and prepare for the CE Mark application.
Sunshine Heart is a medical device company, committed to the commercialization of C-Pulse an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure.