Cytori Therapeutics, Inc. (CYTX) is working hard to develop and commercialize its innovative Celution System. Significant revenues from Celution System are essential for the long-term growth of Cytori.
Singapore’s Health Sciences Authority (HAS) approved Cytori’s Celution System for autologous re-implantation or re-infusion of a patient’s adipose-derived regenerative cells (ADRCs). Management expects its 2014 sales to be meaningfully impacted by the approval. The company is looking to get the system approved in other Asian markets which offer significant commercial potential.
Celution System is a tissue processing system to access the cells from a patient during surgery. The system uses a central device which requires single-use, per-procedure consumable cartridges. The company generates revenues through the sale from the central device as well as recurring revenues from the cartridges needed for each procedure.
We note that in Aug 2013, Cytori’s Celution System gained approval from the Australian regulatory body for commercial use for autologous re-implantation or re-infusion of a patient’s ADRCs. Last month, Cytori provided preliminary data from a study on the company’s cell therapy for treating patients suffering from scleroderma based. The investigator-funded, open-label, pilot study is being conducted in France. Scleroderma is a chronic autoimmune disease.
At the end of the two month follow-up period, no infection, ischemic complications or serious adverse events were observed in the study. Moreover, there was a significant improvement in the function of the hands. Moreover, there was a significant improvement in hand pain when measured by the visual analog pain scale.
The company is currently conducting Athena, a multi-center, double-blind, randomized placebo-controlled study for evaluating its cell therapy in 45 patients with chronic ischemic heart failure. The company expects to complete enrolling patients for the study by year end. Cytori expects to report 6-month top-line data from the study in the first half of next year.
Cytori carries a Zacks Rank #4 (Sell). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) and Endo Health Solutions Inc. (ENDP) with a Zacks Rank #1 (Strong Buy) and Alexion Pharmaceuticals, Inc. (ALXN) with a Zacks Rank #2 (Buy).