Tissue Genesis gets European OK for medical device
Advertiser Staff
Tissue Genesis Inc., a Honolulu-based company focused on regenerative medicine solutions, has passed an important milestone in its efforts to commercialize its cell isolation system.
The company said its received European certification for the system that recovers regenerative cells from a patient's own fat to aid in repairing damaged tissues and help in other medical procedures.
The company said it recently completed safety certification testing, allowing it to carry the Conformite Europeene, or CE, mark that signifies it's met the health, safety and environmental requirements of the European Union.
Tissue Genesis said one of its partners, Bioheart Inc., has ordered five of the systems for European customers that are expected to be delivered by the end of the year. The system recovers potentially regenerative cells from a patient's own fat in about an hour. The system can use fat tissue extracted using a liposuction device.
The cells can be used in wound dressings or injected into damaged tissue and used to coat implants.
Tissue Genesis said it expects to get results from clinical trials in 2009 that can be used to apply for U.S. Food and Drug Administration approval.