Cytori Therapeutics Inc (San nDiego, Calif) said U.S. health regulators approved its device that is able to processes a patient’s own fat tissue for use in aesthetic body contouring, sending its shares up 20 percent.
The approval for the aesthetic device, PureGraft, also improves the probability for approval of the company’s stem cell processing device that uses similar technology. The approval was done under the FDA’s abbreviated review process for devices that are judged similar to existing products. It is expected to become available in the US this quarter, while approval from European regulators is anticipated by midyear.
The company’s Celution system processes fat tissue into several types of cells that can be potentially be used for various therapeutic purposes.
The company has been in the red as it continues to develop products, though it does have several items on the market now. Its stock through Thursday doubled since early October amid optimism about Cytori’s fat-grafting efforts.
The company is also seeking marketing approval for PureGraft in Europe, which is expected in the first half of 2010.
[Source: Wall Street Journal/Reuters]
