Tissue Genesis applies CE Mark to tissue genesis cell isolation system
New research from the U.S. has found that a drug widely used to prevent premature births offers no benefit. Pregnant woman who enter into early labour are often given drugs to quieten the woman’s uterus and prevent premature birth. Pregnancy normally lasts 40 weeks and preterm births are defined as deliveries before 37 weeks of
Full Post: No benefit from nifedipine widely used to prevent premature births
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).”
Neuralstem, Inc. announced this morning that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a clinical trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The Company is planning to treat ALS patients through spinal injections of its stem cells via its
Full Post: Neuralstem files IND for amyotrophic lateral sclerosis stem cell trial
Neuralstem, Inc. announced today that it has entered into a collaboration with Professor Guido Nikkah Ph.D, of Albert-Ludwigs-University in Freiburg, Germany, to advance development of Neuralstem’s human neural stem cell therapies. The collaboration with Professor Nikkah will focus on Huntington’s disease. “We are pleased to have established this collaboration in Germany” said Richard Garr, Neuralstem President
Full Post: Neuralstem enters stem cell collaboration for Huntington’s disease in Germany
Multiple sclerosis is a disease caused by the loss of the myelinated sheath surrounding the nerve fibers of the spinal cord. Therapeutic hope for curing multiple sclerosis and other demyelinating diseases has included the possibility that stem cell transplants could help remyelinate the spinal cord. Accordingly, researchers from the University of Cambridge (UK) conducted experiments
Full Post: Intraspinal implant of mesenchymal stem cells may not heal the demyelinated spinal cord
A novel protein marker has been found that identifies rare adult liver stem cells, whose ability to regenerate injured liver tissue has the potential for cell-replacement therapy. For the first time, researchers at the University of Pennsylvania School of Medicine led by Linda Greenbaum, MD, Assistant Professor of Medicine in the Division of Gastroenterology, have
Full Post: Discovery of stem cells with potential to regenerate injured liver tissue
VistaGen Therapeutics and the Wisconsin Alumni Research Foundation (WARF) have signed a license for human embryonic stem cell patents for the development and commercialization of stem cell-based research tools. VistaGen, a biotechnology company based in South San Francisco, is one of the world’s leading companies focused on using the power of stem cell technology to
Full Post: VistaGen, WARF sign license agreement for human embryonic stem cell technology