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Tissue Genesis Applies CE Mark to Its Adult Stem Cell Isolation System

HONOLULU, Nov. 18 /PRNewswire/ -- Tissue Genesis, Inc., an innovator of advanced tissue engineering and cell therapy solutions, today 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)."

About Tissue Genesis, Inc.

Tissue Genesis, Inc. ( is a leader in adipose (fat) derived regenerative medicine solutions to address a wide range of therapeutic needs including vascular, cardiovascular, and other regenerative medical applications. The company expects its technology, expertise and products to isolate autologous adipose derived regenerative cells at the point of care for immediate patient needs. Through its business partners, such as Bioheart, SpineSmith, and Vet-Stem, the company is extending the development and application of its technology and platform products to reach worldwide markets in the potential wide use of cell therapy.

About Bioheart, Inc.

Bioheart, Inc. (Nasdaq: BHRT / is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient's quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell(R), is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. The Company's pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell(R) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins

About SpineSmith Partners, LP

SpineSmith Partners, LP ( designs, develops and markets implants and biologics for surgical fixation, correction and tissue regeneration of the spine. SpineSmith takes a different approach from other companies, utilizing a collaborative approach between scientists, engineers and spine surgeons. This approach results in the development of truly innovative biological and hardware technologies for use in the treatment of patients with spinal disorders. SpineSmith's unique, think-tank approach gives spine surgeons the ability to directly impact the direction of its product portfolio, ensuring applicability and achieving the highest standards of patient care.

About Vet-Stem, Inc.

Vet-Stem, Inc. ( was formed in 2002 to bring regenerative medicine to the veterinary profession. This privately held company is working to develop therapies in veterinary medicine that apply regenerative technologies while utilizing the natural healing properties inherent in all animals. In January of 2004, Vet-Stem introduced the first veterinary stem cell service in the United States. Since that time there has been rapid adoption of this technology for treatment of tendon, ligament, and joint injuries by the veterinary community. Studies have shown that mesenchymal stem cells can dramatically improve the healing of injuries and diseases that have had very few treatment options in the past.

Safe Harbor Statement

This press release contains statements, which may constitute "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Tissue Genesis, Inc., and members of its management as well as the assumptions on which such statements are based. There can be no assurance that Tissue Genesis will be able to commercially develop its therapeutic cell technology or products, that necessary regulatory approvals will be obtained, that any clinical trials will be successful, or that the proposed treatments will prove to be safe and/or effective. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. Important factors currently known to management that could cause actual results to differ materially from those in forward-statements include fluctuation of operating results, the ability to compete successfully and the ability to complete before-mentioned transactions. The company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.

SOURCE Tissue Genesis, Inc.
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