Tissue Genesis applies CE Mark to tissue genesis cell isolation system
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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.”
In addition to the Bioheart license and distribution agreement, SpineSmith LP — a developer of implants and biologics for surgical fixation, correction and tissue regeneration of the spine — recently provided two Tissue Genesis Cell Isolation Systems, expected to be used in spinal fusion study.
“We expect the study of the use of Tissue Genesis Cell Isolation System fat derived stem cells to be a significant milestone for tissue regeneration. We look forward to helping surgeons harness the tremendous benefits of autologous adult stem cells from adipose for their spinal fusions,” commented Kevin Dunworth, founder of SpineSmith.
Tissue Genesis also has a license and distribution agreement with Vet-Stem, Inc. “The CE mark is major milestone for the company. As the licensee for the world veterinary markets, the CE mark adds credibility and professionalism to a system that is already the leader in its class,” Bob Harman, DVM, Vet-Stem CEO.
“Clearly, a demand for our technology exists,” added Krucky. “We are committed to manufacturing and delivering systems of the highest quality to our current partners, as well as to potential licensees. The application of the CE mark on our Tissue Genesis Isolation System is a major step toward our commitment to European patients who will benefit from our technology — We help you heal yourself(TM).”
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