May 11, 2008
Knobias Clip Report (05-09-2008)
By admin
Submitted By Knobias ClipReport
CYTX: Management Discusses Increasing Demand for Celution(R) 800 System
Cytori Therapeutics, Inc. (CYTX) reported a first quarter loss today of $8.27 million, or $0.34 a share, from $8.67 million, or $0.43 a share, a year earlier. Analysts had expected a loss of $0.36. The Company reported $153,000 in product revenue, the first time it has recognized Celution System-based revenue.
The Celution(R) 800 System separates and concentrates a patient’s own adult stem and regenerative cells from adipose (fat) tissue to be delivered back to the patient during the same surgical procedure. Adipose tissue is the richest and most accessible known source in the human body of adult stem cells. By comparison, it contains a hundred times more stem cells in the same amount of bone marrow, a commonly-used source for stem cells. While most adult stem cell therapies can take days or weeks of culturing, a meaningful dose can be extracted from adipose tissue in about an hour without the need for further manipulation. This enables “real-time” treatment in the clinical setting, in which a patient can have their own cells harvested and administered without the cells ever leaving the hospital or surgery room.
The system has been introduced in Europe into the plastic and reconstructive surgery market and launched in Japan for cryopreserving a patient’s own stem and regenerative cells. Clinical trials are ongoing or planned in cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. The Company’s goal for 2008 is to introduce the device to select surgeons and hospitals in Europe and Asia-Pacific to build familiarity with the device ahead of the broader market launch anticipated to follow the completion of the planned clinical studies.
Christopher J. Calhoun, the CEO of Cytori Therapeutics, stated in a conference call today, “Demand for the Celution 800 System has been very encouraging within the European and Asian reconstructive surgery market. In the first quarter, we sold every Celution System and every consumable set that we produced. We also carried a meaningful backlog of orders into the second quarter. Each week, we are seeing more and more physician interest in the technology. Many are contacting us directly and, as a result, increasing cutomer flow through our sales funnel. We remain comfortable with our previous revenue guidance of $10 million to $12 million. We are targeting 75-80 systems in the market by year-end.”
He explained, “We are taking concrete steps to respond to this demand. We are increasing our production capability by adding a second manufacturing shift and outsourcing certain component assemblies. This will allow us to sell more units in Q2 and beyond. We have also expanded our customer sales and training capabilitiesin Asia and Europe. This will allow us to significantly expose more physicians to the technology and solves an important bottleneck in the field. We will also expand our internal sales teams in those regions.”
“We are currently working on several meaningful ways to expand our balance sheet and minimize dilution to our shareholders, while we continue to transform the company to meet the product demand that we see in the market.”
Cytori recently announced that the RESTORE II post-marketing breast reconstruction study has begun. This study has been designed to support reimbursement and market adoption of the Celution 800 System for use in this application. The study will evaluate up to 70 partial mastectomy patients undergoing reconstructive surgery to restore the volume and contour lost from removal of breast tissue associated with tumor removal.
Marc H. Hedrick, M.D., President of Cytori Therapeutics, noted, “Once physicians and nurses have seen what this technology can do, they cant go back to their old ways of doing things. We are seeing physicians working under broad regulatory claims that are taking this technology and applying it to other applications. Doctors often come to us with new ideas and indications. We never cease to be amazed at what doctors can come up with that you didn’t fully anticipate.”
The Company’s StemSource(R) Cell Bank commercialization efforts are ongoing by Green Hospital Supply, Cytori’s exclusive cell bank distribution partner in Japan. Green Hospital Supply, with the support of Cytori, is working closely with a targeted selection of large private and academic hospitals to receive the first StemSource Cell Bank orders in Japan. Additionally, Cytori is working directly with potential StemSource Cell Bank customers in Asia and Europe to expand the market for its fully developed cell banking products and systems.
Dr. Hedrick added, “We are nearing the close on several programs for these banks in Japan, that we will be announcing soon. We will then move into the installation, training and set-up process.”
Mr. Calhoun concluded, “This quarter has been transformational. While we are in the very early days with this technology, and many more challenges remain, the combination of the breadth of opportunity, lack of meaningful competition and quality of our technology and team make the grand and audacious goal of a Celution System in every hospital and major clinic around the world possible.”
Visit 1800blogger to see all of our industry leading blogs.
Topics: Uncategorized |
Comments
« Market Comments Submitted by Nick at Ambitions as a Stock Trader | Home | Market Scan for Small Cap Stocks on May 9, 2008 »
