April 13, 2005

For Immediate Release

Cell Therapy, Tissue Engineering and Regeneration Showing Proof-of-Concept, Encouraging Continued Investment and Acquisition, According to New Report from MedMarket Diligence, LLC

FOOTHILL RANCH, CA — The technologies that have been under development for the engineering of tissues and cell-based therapies for over 25 years continue to face challenges in achieving specific, marketable applications more complex than engineered skin grafts, cartilage and bone. And, despite frequent advances and achievements in the laboratory and the infusion of huge amounts of capital, the bigger challenge for many companies dedicated to tissue engineering and cell therapy is to simply stay in business long enough to commercialize their products. Notwithstanding all of these challenges, many technologies are demonstrating proof-of-concept to the degree that they have engendered the continued financial support of the investment industry, the device industry, the pharmaceutical industry and others who remain convinced that the potential rewards of the long R&D process are within a manageable timeline, according to newly completed report by MedMarket Diligence.

"There is no question but that the potential markets for cell therapy and tissue engineering are huge," says Patrick Driscoll, President of MedMarket Diligence. "But a current market of roughly $150 million worldwide, earned against the backdrop of hundreds of millions of investment, point up that the industry is a long way from a breakeven point.  But even for this nascent industry, the preclinical successes as well as the limited markets already established appear to be sufficient to continue the investment and development drive toward realizing the market potential."

At this time, tissue engineering is occurring in the areas of Skin, Cartilage and Bone; the worldwide market for these areas is estimated to be $144.6 million. The total market by 2015, covering the areas of Skin, Bone, Cartilage, Cardiovascular, and Other (Dental and Organ Regeneration or Replacement) is predicted to be about $2.1 billion, with a compound annual growth rate of 28%.

The reasons behind the continued faith in the promise of realizable markets are the many procedures that are stirring up excitement in the biotech and tissue engineering world. These include growing cartilage, liver and neuronal stem cells from the patient’s own cells; regeneration of the pancreatic (beta) cells; regrowth of islet cells and transplant of these cells into the liver; and the stimulation of adult cells, such as white blood cells derived from a sample of the patient’s blood, to become adult stem cells. The race is heating up to develop potential therapies and to get them into late-phase clinical testing ahead of the competition. While the bulk of the potential market for tissue engineering and stem cell therapies will not be realized for up to ten years the level of near term potential and the ultimate upside is sustaining this activity.

At least 250 companies in the US, Europe and the Far East are working in tissue engineering and regenerative medicine. The larger pharmaceutical and medical device companies, albeit taking cautious and conservative steps to ensure positions in these markets, are indeed making careful investments and forming alliances that will lead to acquisitions of those tissue engineering biotechs that  are able to show both proof-of-concept and sales of their devices or processes.

Companies currently or up to recently active in tissue engineering and cell therapy include: 3DM Inc., Aastrom Bioscience Inc., Acorda Therapeutics Inc., Advanced Cell Technology, Inc., Advanced Medical Solutions PLC, Aeolus Pharmaceuticals, Alexion Pharmaceuticals, Amcyte, Inc., Anthrogenesis Inc. (Celgene Corp.), Arbios Systems Inc., Ariad Pharmaceuticals Inc., Arthrex Inc., Avax Technologies Inc., Aventis, Baxter International Inc., BD Biosciences, BeFutur Biotechnologies, Biocomposites, Biocoral Inc., Bioheart Inc., BioHybrid Technologies, BioLife Solutions Inc., Biomet, Inc., BioMimetic Pharmaceuticals, Bio Nova International, Bionx Implants, Inc. (CONMED Corporation), BioSyntech, BioTissue Technologies GmbH, Bio-Vascular Inc., Boston Scientific Corporation, BrainStorm Cell Therapeutics, Inc., Breonics, BresaGen Inc., Cambrex Bioproducts, CardioTech International Inc., Celadon Science, LLC, Celdyne Corporation, Celgene Corporation, CellECT Bio Inc., CellFactors Ltd, Cell Genesys Inc., Cell-Lining GmbH, Cell Pathways, Inc., Cell Science Therapeutics, Inc., CellSeed, Inc., CellTran Ltd, Celmed BioSciences, Inc. (Theratechnologies), Cerco Medical, Chiron, Chromos Molecular Systems, Inc., Chrysalis BioTechnology, Inc. (OrthoLogic), Clinical Cell Culture (C3), co.don AG, ColBar LifeSciences Ltd., Cook Group, CorCell, Inc., CRYO-CELL International, Inc., CryoLife, Inc., Curis Inc., Cytograft Tissue Engineering, Cytomatrix LLC, Dentigenix, Inc., Encelle Inc., EnduraTEC Systems Group, E.S. Cell International Pte Ltd, Exactech, Inc., Excorp Medical, Inc., FibroGen, Inc., Fidia Advanced Biopolymers, Gamida–Cell Ltd, Genta, Inc., Genetix Ltd, Genetix Pharmaceuticals Inc., GenVec, Inc., Genzyme Corporation, Genzyme Biosurgery, Genzyme Oncology, Geron Corporation, HemoCleanse, Inc., HepaLife Technologies, Inc., Immerge Biotherapeutics, Inion Ltd, Innogenetics (XCELLentis), InnovaCell Biotechnologie GmbH, Integra LifeSciences Inc., Interface Biologics Inc., Interpore Cross International Inc., IsoTis OrthoBiologics, ISTO Technologies Inc., Islet Sheet Medical, Islet Technology, Inc., Ixion Biotechnology Inc., Johnson & Johnson Inc. (Ethicon, DePuy), Kaleidos Pharma, Inc., Kensey Nash, Keratec, Kourion Therapeutics AG (ViaCell), Lifebank Inc., LifeCell Inc., Life Medical Sciences Inc., LifeStem Inc. (Calba Tech, Inc.), Linvatec Corporation Inc. (ConMed), MacroPore Biosurgery Inc., MaxCyte, Medtronic, MG Biotherapeutics, LLC, MicroIslet Inc., Millenium Biologix Inc., Musculoskeletal Transplant Foundation, Nephros Therapeutics Inc., NeuroGeneration, Inc., NeuroNova AB, Neuronyx Inc., Neurotech SA and Neurotech U.S. Inc., Novocell Inc., Oligene GmbH, Organogenesis Inc., Organ Recovery Systems, Ortec International Inc., OrthoLogic Corporation, Orthovita, Osiris Therapeutics Inc., OsteoBiologics, Osteotech, Polyganics Ltd, Poly-Med, Inc., Protein Polymer Technologies Inc., Progenitor Cell Therapy Inc., ProNeuron Biotechnologies, Inc., Protherics, PLC, ReGen Biologics Inc., Regeneration Technologies Inc., ReInnervate Ltd., Renaissance Cell Technologies, ReNeuron Ltd, Revivicor, Inc., Sanofi-Aventis, Sciperio Inc., Selective Genetics, Sertoli Technologies Inc., Smith & Nephew Ltd., Spiration Inc., Stem Cell Pharmaceuticals Inc., StemCells Inc., Stem Cell Sciences Ltd, StemCell Technologies Inc., StemSource Inc., Stryker Corporation, Surgical Dynamics Inc., Synovis Life Technologies, Inc., SyStemix, Inc., Targeted Genetics Inc., TEI Biosciences Inc., Tepha Inc., Theratechnologies Inc., Therics Inc., TiGenix N.V., Tissue Transformation Technologies Inc., TheraCyte Inc., TissueMed Ltd, Titan Pharmaceuticals Inc., TolerRx, Inc., Transition Therapeutics Inc, Triage Medical Inc., TriStem Corporation, Vesta Therapeutics, ViaCell, Inc., Vital Therapies, Inc., Vitrolife AB, VivoRx, Xcyte Therapies, Inc. and XCELLentis,

Details of the MedMarket Diligence report, "Worldwide Tissue Engineering, Cell Therapy and Transplantation:  Products, Technologies & Market Opportunities, 2001-2014," are available at www.mediligence.com/rpt-s515.htm.

MedMarket Diligence provides tactical decision-making solutions on medical technology to the medical products and investment industries. The company publishes the MedMarkets newsletter, a monthly analysis of the market implications of new medical technologies, and dedicated reports on technology markets.  For additional details, contact Patrick Driscoll at email or call 949-859-3401 or toll-free (in the U.S.). 1-866-820-1357.