Tissue Genesis, Inc. has announced that effective immediately, the Tissue Genesis Cell Isolation System will be available to the European marketplace.
The Tissue Genesis Cell Isolation System is a fully automated system that recovers potentially regenerative cells from a patient's own fat in about an hour, with minimal operator intervention. No tissue pre-processing is required. The system accepts adipose (fat) tissue from the same device used for liposuctioning the tissue from the patient. The compact desktop unit readily fits into any clinical environment and uses preconfigured disposables for quick and easy assembly.
The company's Tissue Genesis Cell Isolation System has successfully completed safety certification testing necessary to complete its declaration of conformity, allowing the company to apply the CE mark. "The application of the CE mark on our cell isolation system is an exciting milestone and presents a tremendous opportunity for Tissue Genesis, as it represents further advancement into the international commercialization of our products and technology," said Anton C. Krucky, President and Chief Executive Officer of Tissue Genesis. "We look forward to continuing our research and development initiatives focused on applications that use a patient's own therapeutic cells to address a range of medical concerns."
The company expects to seek FDA approvals in the field of vascular disease for its point of care solution. Tissue Genesis is currently fulfilling a number of orders from two of its key Commercialization Consortium partners. Bioheart, Inc. -- a biotechnology company focused on autologous cell therapies for the treatment of chronic and acute heart damage -- recently ordered five systems for its European customers, which are expected to be delivered by the end of the year.
"This CE marking of the Tissue Genesis Cell Isolation System marks an important milestone for Bioheart as we transition into a commercial company," said Howard J. Leonhardt, Bioheart's Chairman, CEO and CTO. "We are extremely excited to commence shipping the systems to our customers."