Cytori - QuickView

Cytori (CYTX) had 2012 product revenues of $8.7m plus development contracts of $5.8m. The PureGraft system for autologous fat grafting and aesthetic body contouring has FDA 510(k) and EU CE mark approval and sold 5,000 units, up 46%. The Japanese approval of the Celution system for enriching adipose stem populations increased sales by $2m in Q4. Product sales in 2013 could be over $15m in the EU and Japan. The Phase II ATHENA chronic heart disease trial reports H114.

Chronic prioritised over acute into cardiac disease
In chronic ischemic heart disease, a safety and feasibility US study in 45 patients of Celution (ATHENA) is on track to report data in H114. This is now taking priority over the larger, 216-patient ADVANCE Celution trial in the acute AMI (specifically ST-elevation acute myocardial infarction). This study appears to be recruiting slowly and now has an end-2013 target of 25, with an interim analysis at 72 patients. The data date is thus unlikely to be Q315 as originally planned. The preceding 14-patient Phase I study (APOLLO) showed safety, with 11.7% vs 6.1% infract size reduction.

Is Celution an infarct solution?
Celution uses a cell mixture including various mesenchymal cells (38%, of which 1% might be stem cells), plus muscle (9%), endothelial (7%) and immune system cells (45%). A liposuction sample of 100ml has 45m cells with about 450,000 stem cells. The cells for injection are concentrated in a specialist, $100k bedside unit. The saleable disposable is a bag with a filter and tubing selling at $2,000-12,000. In ADVANCE, 20m cells, about 0.2m stem cells, are injected into the infarct using a catheter. In ATHENA, up to 40m cells are injected into all areas of the heart. Efficacy is expected to relate to the number of stem cells used. Cytori’s cell mix, including macrophages that can have a healing role, may be beneficial.

Valuation: 65% product growth in 2013 guided
Growth in 2012 was strong in Japan with $4m sales overall and nearly $2m in Q4 after Celution approval. In the EU, Celution has extended its CE mark to cover ischaemic disease, which will drive 2013 sales. The $106m US government BARDA (Biomedical Advanced Research and Development Authority) burn treatment contract was small in 2012 ($360k), but could become very significant if the next, $56m stage is reached. Management aims to grow 2013 product revenues by at least 65% to over $15m. A December fundraising means Cytori ended 2012 with $28.4m in cash (pro forma), suggesting its EV is currently $155m.

To Read the Entire Report Please Click on the pdf File Below.