Category Archives: Cell Therapy

NEW YORK, Oct. 10, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), an emerging leader in the fast growing cell therapy market, announced today that a new article published by the International Scholarly Research Network provides further evidence that AMR-001, NeoStem's lead product candidate through its Amorcyte subsidiary, appears capable of preserving heart muscle function following a large myocardial infarction. Amorcyte demonstrated in its Phase 1 trial that AMR-001 preserved heart muscle function when a therapeutic dose of cells was administered. No patient experienced a deterioration in heart muscle function who received 10 million cells or more whereas 30 to 40 percent of patients not receiving a therapeutic dose did. The new study shows that cardiac muscle function sparing effects are evident even earlier after treatment than previously shown.

The article titled "Assessment of myocardial contractile function using global and segmental circumferential strain following intracoronary stem cell infusion after myocardial infarction: MRI Feature Tracking Feasibility Study" by Sabha Bhatti, MD, et al. appears in ISRN Radiology Volume 2013, Article ID 371028 and is published online at http://www.isrn.com/journals/radiology/2013/371028. The publication by Dr. Bhatti and colleagues, including Dr. Andrew Pecora, Chief Medical Officer of NeoStem, supports the finding that AMR-001 preserves heart function. Previously, Amorcyte, a NeoStem subsidiary, showed that six months after STEMI AMR-001 improved blood flow to the heart and preserved heart muscle. By using cardiac magnetic resonance imaging, specifically measuring circumferential strain of the left ventricle, the authors show that AMR-001's effects are evident by three months after STEMI.

AMR-001's angiogenic and anti-apoptotic mechanisms of action indicate that preservation of heart muscle function should start within weeks and be evident in fewer than 6 months. This publication, based on blinded analysis of Amorcyte's Phase 1 data, confirms the expected time course for AMR-001's mechanism of action. In the context of previously published results, these effects are durable.

Amorcyte is developing AMR-001, a cell therapy for the treatment of cardiovascular disease, and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving cardiac function and preventing adverse clinical events after a large myocardial infarction.

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, as mentioned above, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to (i) the Company's ability to manage its business despite operating losses and cash outflows, (ii) its ability to obtain sufficient capital or strategic business arrangement to fund its operations, including the clinical trials for AMR-001, (iii) successful results of the Company's clinical trials of AMR-001 and other cellular therapeutic products that may be pursued, (iv) demand for and market acceptance of AMR-001 or other cell therapies if clinical trials are successful and the Company is permitted to market such products, (v) establishment of a large global market for cellular-based products, (vi) the impact of competitive products and pricing, (vii) the impact of future scientific and medical developments, (viii) the Company's ability to obtain appropriate governmental licenses and approvals and, in general, future actions of regulatory bodies, including the FDA and foreign counterparts, (ix) reimbursement and rebate policies of government agencies and private payers, (x) the Company's ability to protect its intellectual property, (xi) the company's ability to successfully divest its interest in Erye, and (xii) matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem Announces New Publication That Supports Positive Results of AMR-001 for Treatment of AMI

NEW YORK, Oct. 10, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), an emerging leader in the fast growing cell therapy market, announced today that a new article published by the International Scholarly Research Network provides further evidence that AMR-001, NeoStem's lead product candidate through its Amorcyte subsidiary, appears capable of preserving heart muscle function following a large myocardial infarction. Amorcyte demonstrated in its Phase 1 trial that AMR-001 preserved heart muscle function when a therapeutic dose of cells was administered. No patient experienced a deterioration in heart muscle function who received 10 million cells or more whereas 30 to 40 percent of patients not receiving a therapeutic dose did. The new study shows that cardiac muscle function sparing effects are evident even earlier after treatment than previously shown.

The article titled "Assessment of myocardial contractile function using global and segmental circumferential strain following intracoronary stem cell infusion after myocardial infarction: MRI Feature Tracking Feasibility Study" by Sabha Bhatti, MD, et al. appears in ISRN Radiology Volume 2013, Article ID 371028 and is published online at http://www.isrn.com/journals/radiology/2013/371028. The publication by Dr. Bhatti and colleagues, including Dr. Andrew Pecora, Chief Medical Officer of NeoStem, supports the finding that AMR-001 preserves heart function. Previously, Amorcyte, a NeoStem subsidiary, showed that six months after STEMI AMR-001 improved blood flow to the heart and preserved heart muscle. By using cardiac magnetic resonance imaging, specifically measuring circumferential strain of the left ventricle, the authors show that AMR-001's effects are evident by three months after STEMI.

AMR-001's angiogenic and anti-apoptotic mechanisms of action indicate that preservation of heart muscle function should start within weeks and be evident in fewer than 6 months. This publication, based on blinded analysis of Amorcyte's Phase 1 data, confirms the expected time course for AMR-001's mechanism of action. In the context of previously published results, these effects are durable.

Amorcyte is developing AMR-001, a cell therapy for the treatment of cardiovascular disease, and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving cardiac function and preventing adverse clinical events after a large myocardial infarction.

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, as mentioned above, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to (i) the Company's ability to manage its business despite operating losses and cash outflows, (ii) its ability to obtain sufficient capital or strategic business arrangement to fund its operations, including the clinical trials for AMR-001, (iii) successful results of the Company's clinical trials of AMR-001 and other cellular therapeutic products that may be pursued, (iv) demand for and market acceptance of AMR-001 or other cell therapies if clinical trials are successful and the Company is permitted to market such products, (v) establishment of a large global market for cellular-based products, (vi) the impact of competitive products and pricing, (vii) the impact of future scientific and medical developments, (viii) the Company's ability to obtain appropriate governmental licenses and approvals and, in general, future actions of regulatory bodies, including the FDA and foreign counterparts, (ix) reimbursement and rebate policies of government agencies and private payers, (x) the Company's ability to protect its intellectual property, (xi) the company's ability to successfully divest its interest in Erye, and (xii) matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem Announces New Publication That Supports Positive Results of AMR-001 for Treatment of AMI

MANCHESTER, Conn., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Charter Medical, Ltd., a division of Lydall, Inc., (LDL) announced today that it has recently launched the new EXP-Pak(TM) cell expansion containers intended for the expansion and culture of non-adherent cells. The launch of this exciting new product family allows Charter Medical to provide enabling technology critical to the rapidly growing cellular therapy market. The family of closed-system cell expansion containers offers a broad size range from 500mL to 5L and end-user validated cell expansion rates and recovery.

Joe Petrosky, Vice President of Global Marketing and Sales for Charter Medical, stated, "We are excited with the launch of the EXP-Pak(TM) cell expansion product family. The EXP-Pak(TM) containers complement our closed-system solution approach and play a key role in supporting the development of new cellular therapies."

Dale Barnhart, President and CEO of Lydall, stated, "I am pleased with the launch of this product family for cellular therapy which represents a strategic growth opportunity. It further demonstrates our commitment to being the global supplier of choice as we grow our presence in this emerging segment."

About Lydall, Inc.

Lydall, Inc. is a New York Stock Exchange listed company, headquartered in Manchester, Connecticut. The Company, with operations in the U.S., France, and Germany and offices in Europe and Asia, focuses on specialty engineered products for the thermal/acoustical and filtration/separation markets. Charter Medical, Ltd., a Lydall subsidiary, is a vital fluids management company focused on providing products to separate, contain and transport vital fluids in the blood and cell therapy market and the biotech and pharmaceutical industries. Lydall(R) is a registered trademark of Lydall, Inc. in the U.S. and other countries. All product names are trademarks of Lydall, Inc. or Charter Medical, Ltd.

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Charter Medical Launches New EXP-Pak(TM) Cell Expansion Containers for Cellular Therapy Applications

Doctors at the All India Institute of Medical Sciences (AIIMS) have conducted a stem cell transplant on a multiple sclerosis (MS) patient. They believe this is the first recorded case of an autologous stem cell therapy where the donor and recipient are the same person for MS in the country.

Six months after the transplant, doctors say the spread of MS, an autoimmune disease that affects the brain and spinal cord, appears to have been contained but the therapy cannot be declared a success until the patient is monitored for at least a year.

International trials have demonstrated that this transplant can restrict the spread of the disease in advanced patients, and may even reverse symptoms in early stages in some patients.

Thirty-two-year-old Rohit Yadav, a commerce graduate from Delhi University, was diagnosed with the neurological disorder in 2010. In March this year, after trying all possible conventional treatment options, doctors at AIIMS finally decided on stem cell therapy.

Dr Kameshwar Prasad, professor of neurology who has been monitoring Yadav, said: The primary purpose of autologous stem cell transplant is to control the spread of lesions. We extract the patients own stem cells, treat and inject the stem cells back. Ever since the procedure, the patient has been completely stable. To the best of our knowledge, this is the first case of stem cell therapy for MS.

In MS, the bodys own immune system attacks the myelin sheath that coats nerves, slowly destroying the central nervous system. Symptoms range from numbness and weakness in the limbs to sudden loss of balance and coordination, blurred vision and paralysis and, at the most advanced stage, disability.

... contd.

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Fingers crossed at AIIMS after stem cell transplant for MS, first in country

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 contract and a Phase 2 option from the National Cancer Institute (NCI) valued up to $1,683,503. The SBIR Contract funds the development of CLT-009, a first-in-class, human allogeneic Megakaryocyte Progenitor Cell therapy for the treatment of thrombocytopenia in cancer patients and allows the Company to conduct studies to enable an Investigational New Drug (IND) Application to be filed with the FDA in the next two years.

Thrombocytopenia is characterized as a significant reduction in the concentration of circulating platelets. Platelets are crucial in the process of coagulation to stop bleeding, and thrombocytopenia can increase the risk of severe bleeding in patients. It is becoming an increasingly common problem among oncology patients and a significant dose-limiting toxicity, especially in the treatment of hematological malignancies. Chemotherapy and radiation therapy are the most common causes of thrombocytopenia because the platelet-producing cells, megakaryocytes, and their precursors are highly sensitive to myelosuppressive cytotoxics and ionizing radiation. Thrombocytopenia typically occurs during the initial cycles of high-dose chemotherapy and radiation therapy, usually 614 days after administration. According to Datamonitor, the estimated incidence of cancer patients who suffer from significant chemotherapy-induced thrombocytopenia worldwide was approximately 200,000 in 2008.

Occurrence of severe thrombocytopenia may require dose reductions for chemotherapy regimens which can impact subsequent disease control and survival, especially in the treatment of hematological malignancies such as acute leukemia and high-risk myelodysplastic syndrome. Current treatment options include platelet transfusions which are costly and labor intensive and are associated with risks such as contamination and transmission of viral and bacterial infections. Recombinant human interleukin-11 is the only approved agent for chemotherapy induced thrombocytopenia but its use is limited and has only modest efficacy and significant side effects. CLT-009, a human Megakaryocyte Progenitor Cell product, would be an alternative treatment option, providing the critical megakayocyte progenitor cellular support to rapidly produce platelets in vivo and shorten the duration of severe thrombocytopenia following chemotherapy treatment.

We are delighted to receive this contract from NCI to support the development of our novel, off-the-shelf, platelet product and address a high unmet need, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. This contract allows us to not only leverage our experience in developing cellular therapies but also provides us with the ability to bring CLT-009 closer to the clinic. Our unique product portfolio, which now includes CLT-009, along with our CLT-008 myeloid progenitor cell product and our therapeutic antibodies targeting cancer stem cells, demonstrates our continued commitment to developing novel products for the benefit of cancer patients.

In addition to this SBIR contract, Cellerant has previously received grants from the National Institute of Health (NIH) in 2008 2010 to conduct research studies in platelet recovery which it has successfully completed. In its previous studies, Cellerant demonstrated that megakaryocyte progenitor cells were able to produce human platelets in preclinical models with in vivo functionality similar to that of normal human platelets.

This program is funded with Federal funds from the National Institute of Health, Department of Health and Human Services, under Contract No.HHSN261201200076C.

About CLT-009

CLT-009 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Megakaryocyte Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional platelets in vivo. Cellerant is developing CLT-009 as an effective treatment for chemotherapy and radiation-induced thrombocytopenia in cancer patients.

About Cellerant Therapeutics

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Cellerant Awarded SBIR Contract Funding to Develop CLT-009 for Treatment of Thrombocytopenia

A company with the first FDA-approved personalized cell therapy for reducing wrinkles has raised $45 million in a private stock sale. The financing was sought to improve manufacturing capacity for the therapy and advance other uses for it such as treating burn victims, according to a company statement.

Fibrocell Sciences aesthetic therapeutic, Laviv, secured got the green light from the U.S. Food and Drug Administration last year. Laviv uses individuals fibroblast cells to reduce nasolabial fold wrinkles, creases on the face that start from the outer corners of the nose and go down to the corners of the mouth. It also has an acne therapy in phase 3 clinical trials and a burn scar therapy in phase 2 trials.

The Exton, Pennsylvania biopharmaceutical companys personalized cell development platform technology isolates, purifies and multiplies a patients fibroblast cells, connective skin cells that make collagen.

Additionally, Fibrocell agreed to a strategic collaboration with biotechnology firm Intrexon which can provide genome engineering, cell processing, and cell system engineering, among other services, to help advance Fibrocells personalized cell therapy program.

As part of the financing deal, Third Security LLC will get two seats on Fibrocells board.

Personalized stem cell development fits into the broader category of personalized medicine, regarded as the future of medicine in which therapies will be better targeted to individuals and more effective.

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Biopharma with personalized cell therapy raises $45M in stock sale, forges collaboration deal

British researcher John Gurdon and Shinya Yamanaka from Japan have shared the Nobel prize for medicine or physiology.

The two pioneers of stem cell research were awarded the prize for transforming specialised cells into stem cells, which can become any other type of cell in the body.

John Gurdon discovered in 1962 that the specialisation of cells is reversible. In a classic experiment, he replaced the immature cell nucleus in an egg cell of a frog with the nucleus from a mature intestinal cell. This modified egg cell developed into a normal tadpole. The DNA of the mature cell still had all the information needed to develop all cells in the frog.

Shinya Yamanaka discovered more than 40 years later, in 2006, how intact mature cells in mice could be reprogrammed to become immature stem cells. Surprisingly, by introducing only a few genes, he could reprogram mature cells to become pluripotent stem cells, i.e. immature cells that are able to develop into all types of cells in the body.

These groundbreaking discoveries have completely changed our view of the development and cellular specialisation.

By reprogramming human cells, scientists have created new opportunities to study diseases and develop methods for diagnosis and therapy.

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Stem Cell Researchers Share Nobel Medicine Prize

SAN DIEGO--(BUSINESS WIRE)--

Cytori Therapeutics (CYTX) announced that three oral presentations related to its cell therapy are being presented today at the 10th annual International Federation for Adipose Therapeutics and Sciences meeting. The findings provide insights into the mechanisms-of-action for Cytoris cell therapy. One study identified high levels of micro-RNA (miRNA) markers in human tissue thought to play a role in the repair of tissue injury resulting from ischemia, or lack of blood flow. Two additional characterization and comparative analysis studies on human tissue reaffirmed cellular characteristics of Cytoris cell therapy and distinguished the safety, viability and cell make-up as compared to cell outputs derived from alternate approaches.

Results from all three studies have important implications for how the cells repair injured tissue and on the safety and viability of cell-based treatments derived from adipose tissue, said John Fraser, Ph.D., Chief Scientist of Cytori Therapeutics. Mechanisms identified in our miRNA analysis are consistent with our prior clinical and preclinical data, which suggest these mechanisms include angiogenesis, immune-modulation, and remodeling and wound repair. The miRNA study provides baseline data, which we can apply to our U.S. ATHENA clinical trial in refractory heart failure patients and other activities including our recently announced contract with BARDA for thermal burns.

In one study, miRNA profiles were assessed in adipose-derived stem and regenerative cells (ADRCs) derived from human tissue samples. The purpose was to determine which miRNA markers are expressed, miRNA variability from patient to patient, cellular functions of miRNA, and to establish a baseline miRNA population on healthy patients to compare against patients with a specific disease. Specifically, miRNA markers associated with angiogenesis, tissue remodeling and wound repair, and modulation of the immune response were found to be highly represented in ADRCs.

Our two additional characterization and comparative analysis studies evaluated alternate processing techniques and reaffirmed our proprietary enzyme-based process using Celution is the clear gold standard, added Dr. Fraser. If the composition of a cell population extracted from adipose tissue by an alternative process is not equivalent to Cytoris ADRC population, one cannot claim equivalence to ADRCs in terms of safety or efficacy in preclinical or clinical outcomes.

The characterization and comparative analysis studies reaffirmed the high cell yield and viability as well as the heterogeneity in Cytoris cell therapy approach. Cytoris cells are derived with a proprietary formulation of clinical grade enzymes which break up the connective tissue and which are removed at the end of the process. Cytoris cell mixture includes adipose-derived stem cells, based on the measure of colony forming units, and a high yield of CD34+ cells. By contrast, data in these studies showed that alternate approaches such as ultrasound or emulsification, contained little to no adipose-derived stem cells, a high concentration of red and white blood cells, and did not meet the key criteria for safe clinical use.

About Cytori

Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution system product family. http://www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements including our ability to apply this data to our ATHENA study and other projects are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2011. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.

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Multiple miRNA Markers Associated with Angiogenesis and Tissue Injury Repair Expressed in Cytori’s Cell Therapy

WALTHAM, Mass.--(BUSINESS WIRE)--

Histogenics, a regenerative medicine company combining cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration, announced today that it has been named to the FierceMedicalDevices Fierce 15 list, designating it as one of the leading medical device and diagnostic companies of 2012. FierceMedicalDevicesEditors Mark Hollmer and Damian Garde, in conjunction with Editor-in-Chief John Carroll and Executive Editor Ryan McBride, chose this years winners based on their top management teams, notable financial backing, and promising technologies and market opportunities.

We have worked hard over the past year, securing $49 million in financing and adding key new staff, investors and board members, so that we are now in the position to focus our full attention on continued successful clinical and regulatory execution for NeoCart cartilage regeneration implant, which is currently enrolling patients into the Phase 3 IND clinical study, and the EU regulatory development of our VeriCart cartilage repair scaffold, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. We believe our product candidates have the potential to transform the treatment of cartilage injury with the goal of returning some of the estimated 1.8 million patients each year in the U.S. and E.U. that undergo arthroscopy for knee cartilage defects to their pre-injury level of activity.

Nailing down $49 million in financing in July reinforces the notion that this regenerative medicine company stands out for doing things differently.One example how: The company is well underway enrolling patients in a Phase 3 trial for NeoCart, a cartilage implant that uses a patients own cells to build it before treating cartilage lesions in the knee, said Hollmer.

NeoCart is an autologous neocartilage tissue implant in an ongoing Phase 3 clinical program that utilizes the patients own cells to regenerate cartilage in patients suffering from cartilage lesions in the knee.VeriCart, is a single-step, cell-free collagen scaffold uniquely designed to be used in conjunction with the patients own stem cells to repair small cartilage defects frequently observed in meniscal and anterior cruciate ligament repair procedures. Histogenics is seeking regulatory clearance in the European Union for VeriCart.

An internationally recognized e-newsletter reaching more than 34,000 medical device and diagnostic industry professionals, FierceMedicalDevices provides subscribers with a quick authoritative briefing on the days top stories, with a special focus on clinical studies, FDA/EMEA regulations and post-marketing. Sign up is free at http://www.fiercemedicaldevices.com/signup.

About FierceMarkets

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About Histogenics

Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company ProChon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.

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Histogenics Honored as a 2012 “Fierce 15” Company by FierceMedicalDevices