Cytori (CYTX) FY11 Achievements and Highlights
CYTX achieved important objectives towards validating Celution® technology in multiple large market indications;
- Clarified the US cardiovascular pathway with FDA;
- Raised cash to fund FY12 objectives;
- CYTX reported positive long-term outcomes from 2 clinical trials;
- Initiated an EU pivotal heart attack trial; and
- In 1/12 received FDA approval to initiate aUSclinical trial for chronic myocardial ischemia (CMI).
2012 Objectives:
- Advance product pipeline: Begin enrollment in ATHENA US CMI trial, broaden European CE Mark indications to include no-option CMI, expand the number of clinical trial centers enrolling patients in ADVANCE, and submit for a formal medical technology assessment in the UK for breast reconstruction to support reimbursement efforts;
- Build commercial business toward profitability: Grow product revenue to at least $9M, lower Sales & Marketing expenses, increase gross profit and expand market access;
- Reduce operating expenses: Approximately $6M reduction in Sales & Marketing and G&A expenses in 2012 to support an estimated $3M increase in R&D to fund our cardiac cell therapy clinical trials;
- Strengthen corporate foundation: Establish at least 1 new strategic partnership, obtain minimally dilutive or non-dilutive capital, and add new regulatory approvals.
CYTX’s progress in 2011 has resulted in several visible milestones early in 2012, including approval to initiate our US ATHENA trial, strengthening of global patent position, and positive guidance by a UK reimbursement authority regarding breast reconstruction,” said Christopher J. Calhoun, chief executive officer of Cytori. “For 2012, our priorities will be to invest in our cardiac development pipeline, build market access for breast reconstruction, manage our commercial business toward growth and profitability, and strengthen our capital position through strategic partnerships.”
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