Haifa, Israel
Haifa, Israel

Pluristem Therapeutics is an Israeli company engaged in the development of human placental adherent stromal cells for commercial use in disease treatment. According to the company's website, it extracts adult stem cells exclusively from postnatal placentas. In 2012 a procedure involving a stem cell treatment developed by Pluristem saved the life of a 7-year-old girl suffering from bone marrow aplasia. Wikipedia.


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HAIFA, Israel, Dec. 27, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that it will collaborate with the New York Blood Center (NYBC) on preclinical studies of its Placental eXpanded (PLX)-R18 cells to enhance the efficacy of umbilical cord blood (UCB) transplantation. The project has been selected to receive a conditional award of $900,000 from Israel-U.S. Binational Industrial Research and Development Foundation (BIRD). Per the terms of the project, Pluristem will provide the PLX-R18 cells and the NYBC will be responsible for conducting and supporting the studies. Umbilical cord blood cells, a rich supply of stem cells, are transplanted to restore a patient's bone marrow cells. Stem cell transplant can treat leukemia, lymphoma, immune deficiency, genetic diseases and other cancers. Prior preclinical research has suggested that PLX-R18 helps cord blood stem cells to engraft more rapidly and effectively than if they are administered alone. The ability to affect speed and extent of engraftment is clinically important, because a patient remains vulnerable to severe infection and other serious complications until transplanted stem cells begin to make mature blood cells. Dr. Beth H. Shaz, Senior Vice President and Chief Medical and Scientific Officer of NYBC, commented, “This is an exciting opportunity to begin collaborating with Pluristem, using our considerable expertise and world-class facilities to explore the potential of Pluristem’s cells in a key hematologic research area. Based on previous data, we believe that PLX-R18 cells might contribute to a significant improvement in the success rate of umbilical cord blood transplants." “PLX-R18 is emerging as a promising multifactorial treatment for hematologic conditions. It can potentially speed engraftment of umbilical cord blood cells and stimulate the production of all three types of blood cells: white and red blood cells, as well as platelets. We believe this offers a clear advantage over current therapies. We are thankful for the BIRD foundation for their support of this important project,” stated Pluristem Chairman and CEO Zami Aberman. “Data from NYBC’s studies are expected to help round out the growing body of evidence for PLX-R18’s role in improving outcomes for patients living with hematologic diseases. We are very pleased that NYBC, a trusted source of cord blood and cellular therapies for practicing physicians and hospitals, is exploring the potential of PLX-R18’s use for future clinical applications,” Mr. Aberman added. Support for the transplantation of CD34+ cells from umbilical cord blood constitutes the third potential hematologic indication for PLX-R18. The U.S. Food and Drug Administration has cleared a Phase I clinical trial of PLX-R18 in the treatment of insufficient hematopoietic recovery following hematopoietic stem cell transplantation; the transplanted cells in this study can originate from bone marrow, peripheral blood, or umbilical cord blood. In addition, the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Disease (NIAID) is currently conducting a dose-evaluation study of PLX-R18 in large animals, in advance of a possible pivotal trial for PLX-R18 in the treatment of Acute Radiation Syndrome (ARS) via the Animal Rule regulatory pathway. Human efficacy studies will not be required for FDA approval. About PLX-R18 PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem received FDA clearance to initiate a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic stem cell transplantation. Preclinical data from trials conducted by Hadassah Medical Center, the National Institutes of Health and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic stem cells, thereby supporting the recovery of blood cell production. The NIH’s NIAID is supporting and conducting trials of PLX-R18 as a treatment for ARS, a severe, life-threatening condition caused by exposure to high levels of radiation such as would occur with a nuclear catastrophe. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market. New York Blood Center (NYBC) is a nonprofit organization that is one of the largest independent, community-based blood centers in the country. Founded in 1964, NYBC, along with its partner organizations Community Blood Center of Greater Kansas City (CBC) and Innovative Blood Resources (IBR), based St. Paul, Minnesota, collect approximately 3,300 units of blood products each day, serving local communities of more than 25 million people in New York, New Jersey, parts of Connecticut and Pennsylvania, the Kansas City metropolitan area, Minnesota, and Nebraska. NYBC and its partners, through its Comprehensive Cell Solutions, also provide a wide array of transfusion-related medical services, while NYBC’s National Cord Blood Program (NCBP) at the Howard P. Milstein Cord Blood Center is home to the world’s largest public cord blood bank. Comprehensive Cell Solutions is also home to a renowned research institute, which – among other milestones – led to the development of a Hepatitis B vaccine and innovative blood purification technology. Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss obtaining a $900,000 grant from the BIRD Foundation and the expected use of the grant, when we discuss the potential of PLX-R18 cells to accelerate the successful engraftment of transplanted cord blood cells and to be a multifactorial treatment for hematologic conditions, when we discuss our belief that PLX-R18 offers an advantage over current therapies; when we discuss the expectation that data from the research will help round out the growing body of evidence for PLX-R18’s role in improving outcomes for patients living with hematologic diseases, when we discuss the expected commencement of the preclinical studies of our PLX-R18 cells as support for CD34+ umbilical cord blood transplantation and the expected results of these studies, when we discuss the advancement of a possible pivotal trial for PLX-R18 in the treatment of ARS via the Animal Rule regulatory pathway, and when we discuss  PLX-R18’s potential to treat a broad range of hematologic indications, which together constitute a substantial global market. Further, Pluristem may not be granted the award if a Cooperation and Project Funding Agreement is not signed by March 31, 2017. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.


HAIFA, Israel, Dec. 06, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced a milestone in its development program for PLX-R18, which is being evaluated as a medical countermeasure in the treatment of the hematologic components of Acute Radiation Syndrome (ARS) by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). ARS is caused by exposure to very high levels of radiation, such as could occur in a nuclear catastrophe. The syndrome can cause severe illness or death. The U.S. Food and Drug Administration (FDA) previously advised Pluristem to conduct a pilot study in large animals to determine the optimal dosage of PLX-R18 as a treatment for the component of ARS that affects bone marrow function. The NIAID has now completed the dosing of the first cohort and is preparing to initiate dosing of the second and final cohort. Data from the completed study are expected in the first half of 2017. Based on these data the optimal treatment dose will be chosen for a pivotal large animal study designed to meet the requirements for a Biologics License Application (BLA) submission under the FDA’s Animal Rule regulatory pathway. The Animal Rule regulatory pathway allows for approval of treatments for diseases such as ARS in which human trials are not ethical or feasible. With this pathway, the FDA uses animal efficacy studies and human safety data as the basis for product approval. “We are pleased with the advancement to the second cohort of the study that will determine the optimal dose of PLX-R18 in preparation for a pivotal trial. The support and collaboration of the NIH’s NIAID have been instrumental in advancing PLX-R18 towards becoming an FDA-approved countermeasure ready for deployment in the case of a nuclear catastrophe,” stated Pluristem Chairman and CEO Zami Aberman. The NIAID has supported and completed two previous studies of PLX-R18, in which small animal models were used to evaluate the efficacy and mode of action of PLX-R18 as a potential treatment for the hematologic disorders associated with ARS. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life-threatening hemorrhage, infection and anemia. The more recent of the studies showed that intramuscular administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the treatment’s mechanism of action. NIAID’s initial studies of PLX-R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control group. PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem received FDA clearance to initiate a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. Preclinical data from trials conducted by the NIH, Hadassah Medical Center, and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market. Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the initiation of the dosing of the second cohort by NIAID; when we discuss the timing of receiving the data from the completed study; when we discuss our plan to conduct a pivotal large animal study in order to submit a BLA under the FDA’s Animal Rule regulatory pathway; when we discuss the possibility of approving PLX-R18 by the FDA as a countermeasure in the case of a nuclear catastrophe; and when we discuss the potential of PLX-R18 to treat a broad range of hematologic indications, which together constitute a substantial global market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.


News Article | November 14, 2016
Site: www.newsmaker.com.au

Wiseguyreports.Com Adds “Stem Cell Therapy -Market Demand, Growth, Opportunities and analysis of Top Key Player Forecast to 2021” To Its Research Database This report studies sales (consumption) of Stem Cell Therapy in Global market, especially in United States, China, Europe, Japan, focuses on top players in these regions/countries, with sales, price, revenue and market share for each player in these regions, covering Market Segment by Regions, this report splits Global into several key Regions, with sales (consumption), revenue, market share and growth rate of Stem Cell Therapy in these regions, from 2011 to 2021 (forecast), like United States China Europe Japan Split by product Types, with sales, revenue, price and gross margin, market share and growth rate of each type, can be divided into Autologous Allogeneic Type III Split by applications, this report focuses on sales, market share and growth rate of Stem Cell Therapy in each application, can be divided into CNS CVS GIT Wounds and Injuries Others Global Stem Cell Therapy Sales Market Report 2016 1 Stem Cell Therapy Overview 1.1 Product Overview and Scope of Stem Cell Therapy 1.2 Classification of Stem Cell Therapy 1.2.1 Autologous 1.2.2 Allogeneic 1.2.3 Type III 1.3 Application of Stem Cell Therapy 1.3.1 CNS 1.3.2 CVS 1.3.3 GIT 1.3.4 Wounds and Injuries 1.3.5 Others 1.4 Stem Cell Therapy Market by Regions 1.4.1 United States Status and Prospect (2011-2021) 1.4.2 China Status and Prospect (2011-2021) 1.4.3 Europe Status and Prospect (2011-2021) 1.4.4 Japan Status and Prospect (2011-2021) 1.5 Global Market Size (Value and Volume) of Stem Cell Therapy (2011-2021) 1.5.1 Global Stem Cell Therapy Sales and Growth Rate (2011-2021) 1.5.2 Global Stem Cell Therapy Revenue and Growth Rate (2011-2021) 7 Global Stem Cell Therapy Manufacturers Analysis 7.1 Cellular Dynamics International 7.1.1 Company Basic Information, Manufacturing Base and Competitors 7.1.2 Stem Cell Therapy Product Type, Application and Specification 7.1.2.1 Type I 7.1.2.2 Type II 7.1.3 Cellular Dynamics International Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.1.4 Main Business/Business Overview 7.2 Osiris Therapeutics 7.2.1 Company Basic Information, Manufacturing Base and Competitors 7.2.2 119 Product Type, Application and Specification 7.2.2.1 Type I 7.2.2.2 Type II 7.2.3 Osiris Therapeutics Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.2.4 Main Business/Business Overview 7.3 Vcanbio 7.3.1 Company Basic Information, Manufacturing Base and Competitors 7.3.2 133 Product Type, Application and Specification 7.3.2.1 Type I 7.3.2.2 Type II 7.3.3 Vcanbio Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.3.4 Main Business/Business Overview 7.4 Gamida Cell 7.4.1 Company Basic Information, Manufacturing Base and Competitors 7.4.2 Nov Product Type, Application and Specification 7.4.2.1 Type I 7.4.2.2 Type II 7.4.3 Gamida Cell Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.4.4 Main Business/Business Overview 7.5 Golden Meditech 7.5.1 Company Basic Information, Manufacturing Base and Competitors 7.5.2 Product Type, Application and Specification 7.5.2.1 Type I 7.5.2.2 Type II 7.5.3 Golden Meditech Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.5.4 Main Business/Business Overview 7.6 Celgene 7.6.1 Company Basic Information, Manufacturing Base and Competitors 7.6.2 Million USD Product Type, Application and Specification 7.6.2.1 Type I 7.6.2.2 Type II 7.6.3 Celgene Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.6.4 Main Business/Business Overview 7.7 Guanhao Biotech 7.7.1 Company Basic Information, Manufacturing Base and Competitors 7.7.2 Machinery & Equipment Product Type, Application and Specification 7.7.2.1 Type I 7.7.2.2 Type II 7.7.3 Guanhao Biotech Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.7.4 Main Business/Business Overview 7.8 Mesoblast 7.8.1 Company Basic Information, Manufacturing Base and Competitors 7.8.2 Product Type, Application and Specification 7.8.2.1 Type I 7.8.2.2 Type II 7.8.3 Mesoblast Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.8.4 Main Business/Business Overview 7.9 Vericel Corporation 7.9.1 Company Basic Information, Manufacturing Base and Competitors 7.9.2 Product Type, Application and Specification 7.9.2.1 Type I 7.9.2.2 Type II 7.9.3 Vericel Corporation Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.9.4 Main Business/Business Overview 7.10 Stemcell Technologes 7.10.1 Company Basic Information, Manufacturing Base and Competitors 7.10.2 Product Type, Application and Specification 7.10.2.1 Type I 7.10.2.2 Type II 7.10.3 Stemcell Technologes Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.10.4 Main Business/Business Overview 7.11 Beike Biotechnology 7.12 Cytori Therapeutics 7.13 Bioheart 7.14 Athersys 7.15 Geron 7.16 Pluristem Therapeutics 7.17 Fibrocell Science 7.18 Ocata Therapeutics


News Article | November 18, 2016
Site: marketersmedia.com

Wiseguyreports.Com Adds “Stem Cell Therapy -Market Demand, Growth, Opportunities and analysis of Top Key Player Forecast to 2021” To Its Research Database This report studies sales (consumption) of Stem Cell Therapy in Global market, especially in United States, China, Europe, Japan, focuses on top players in these regions/countries, with sales, price, revenue and market share for each player in these regions, covering Request for Sample Report @ https://www.wiseguyreports.com/sample-request/735687-global-stem-cell-therapy-sales-market-report-2016 Market Segment by Regions, this report splits Global into several key Regions, with sales (consumption), revenue, market share and growth rate of Stem Cell Therapy in these regions, from 2011 to 2021 (forecast), like United States China Europe Japan Split by product Types, with sales, revenue, price and gross margin, market share and growth rate of each type, can be divided into Autologous Allogeneic Type III Split by applications, this report focuses on sales, market share and growth rate of Stem Cell Therapy in each application, can be divided into CNS CVS GIT Wounds and Injuries Others Global Stem Cell Therapy Sales Market Report 2016 1 Stem Cell Therapy Overview 1.1 Product Overview and Scope of Stem Cell Therapy 1.2 Classification of Stem Cell Therapy 1.2.1 Autologous 1.2.2 Allogeneic 1.2.3 Type III 1.3 Application of Stem Cell Therapy 1.3.1 CNS 1.3.2 CVS 1.3.3 GIT 1.3.4 Wounds and Injuries 1.3.5 Others 1.4 Stem Cell Therapy Market by Regions 1.4.1 United States Status and Prospect (2011-2021) 1.4.2 China Status and Prospect (2011-2021) 1.4.3 Europe Status and Prospect (2011-2021) 1.4.4 Japan Status and Prospect (2011-2021) 1.5 Global Market Size (Value and Volume) of Stem Cell Therapy (2011-2021) 1.5.1 Global Stem Cell Therapy Sales and Growth Rate (2011-2021) 1.5.2 Global Stem Cell Therapy Revenue and Growth Rate (2011-2021) 7 Global Stem Cell Therapy Manufacturers Analysis 7.1 Cellular Dynamics International 7.1.1 Company Basic Information, Manufacturing Base and Competitors 7.1.2 Stem Cell Therapy Product Type, Application and Specification 7.1.2.1 Type I 7.1.2.2 Type II 7.1.3 Cellular Dynamics International Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.1.4 Main Business/Business Overview 7.2 Osiris Therapeutics 7.2.1 Company Basic Information, Manufacturing Base and Competitors 7.2.2 119 Product Type, Application and Specification 7.2.2.1 Type I 7.2.2.2 Type II 7.2.3 Osiris Therapeutics Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.2.4 Main Business/Business Overview 7.3 Vcanbio 7.3.1 Company Basic Information, Manufacturing Base and Competitors 7.3.2 133 Product Type, Application and Specification 7.3.2.1 Type I 7.3.2.2 Type II 7.3.3 Vcanbio Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.3.4 Main Business/Business Overview 7.4 Gamida Cell 7.4.1 Company Basic Information, Manufacturing Base and Competitors 7.4.2 Nov Product Type, Application and Specification 7.4.2.1 Type I 7.4.2.2 Type II 7.4.3 Gamida Cell Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.4.4 Main Business/Business Overview 7.5 Golden Meditech 7.5.1 Company Basic Information, Manufacturing Base and Competitors 7.5.2 Product Type, Application and Specification 7.5.2.1 Type I 7.5.2.2 Type II 7.5.3 Golden Meditech Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.5.4 Main Business/Business Overview 7.6 Celgene 7.6.1 Company Basic Information, Manufacturing Base and Competitors 7.6.2 Million USD Product Type, Application and Specification 7.6.2.1 Type I 7.6.2.2 Type II 7.6.3 Celgene Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.6.4 Main Business/Business Overview 7.7 Guanhao Biotech 7.7.1 Company Basic Information, Manufacturing Base and Competitors 7.7.2 Machinery & Equipment Product Type, Application and Specification 7.7.2.1 Type I 7.7.2.2 Type II 7.7.3 Guanhao Biotech Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.7.4 Main Business/Business Overview 7.8 Mesoblast 7.8.1 Company Basic Information, Manufacturing Base and Competitors 7.8.2 Product Type, Application and Specification 7.8.2.1 Type I 7.8.2.2 Type II 7.8.3 Mesoblast Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.8.4 Main Business/Business Overview 7.9 Vericel Corporation 7.9.1 Company Basic Information, Manufacturing Base and Competitors 7.9.2 Product Type, Application and Specification 7.9.2.1 Type I 7.9.2.2 Type II 7.9.3 Vericel Corporation Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.9.4 Main Business/Business Overview 7.10 Stemcell Technologes 7.10.1 Company Basic Information, Manufacturing Base and Competitors 7.10.2 Product Type, Application and Specification 7.10.2.1 Type I 7.10.2.2 Type II 7.10.3 Stemcell Technologes Stem Cell Therapy Sales, Revenue, Price and Gross Margin (2011-2016) 7.10.4 Main Business/Business Overview 7.11 Beike Biotechnology 7.12 Cytori Therapeutics 7.13 Bioheart 7.14 Athersys 7.15 Geron 7.16 Pluristem Therapeutics 7.17 Fibrocell Science 7.18 Ocata Therapeutics For more information, please visit https://www.wiseguyreports.com/sample-request/735687-global-stem-cell-therapy-sales-market-report-2016


News Article | November 15, 2016
Site: globenewswire.com

HAIFA, Israel, Nov. 15, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, reported financial results and provided corporate and clinical developments for the first quarter of fiscal year 2017, ended September 30, 2016. “During the first quarter we executed important additional steps to initiate our pivotal clinical trials, and expect to begin enrolling for our Phase III trial in critical limb ischemia during the first half of 2017. We have consulted with the European Medicines Agency (EMA) and are preparing for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) on a pivotal Phase III trial in recovery after surgery for hip fracture, anticipate completing patient enrollment in a multinational Phase II trial, and have clearance to start a Phase I trial with our second product, which has opportunities for interim data,” stated Pluristem’s Chairman and CEO Zami Aberman.  “We are very optimistic about our ability to conduct and fund pivotal Phase III studies that, given positive results, are expected to bring our PLX cells to commercialization in significant markets.” The U.S. Food and Drug Administration gave Pluristem positive feedback regarding its pivotal Phase III CLI trial. The Phase III trial is intended to support a biologics license application (BLA) in the U.S. Shortly following the end of the first quarter, the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) cleared Pluristem to begin enrolling in the UK for that trial. The trial will take place in the U.S. and Europe, where Pluristem’s CLI program was previously selected by the EMA for its Adaptive Pathways pilot project, which may allow for conditional marketing approval after a single pivotal study. In September, Pluristem conducted a symposium on peripheral artery disease at the Third National Conference of the German, Austrian and Swiss Societies of Vascular Medicine in Dresden, Germany. During the conference, a meeting was organized with leading vascular specialists to identify potential investigators for the CLI study. Pluristem has been preparing for a Phase III trial of PLX-PAD to evaluate its efficacy to improve recovery following surgery for femoral neck fracture, which is the most common type of hip fracture in the elderly population. Pluristem previously received scientific advice from the EMA on the study protocol as a single pivotal trial in this indication through the Adaptive Pathways Project, and plans to meet with the FDA in early 2017. The Company expects to complete enrollment of all 170 patients by the end of 2016 and to report trial results in late 2017. To date 167 patients have been enrolled. Dr. Hillard Lazarus of Case Western Reserve University was appointed as the Principal Investigator of Pluristem’s Phase I trial of PLX-R18 cells in the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The FDA previously cleared the Phase I trial to begin enrollment, and a leading contract research organization selected the sites for the trial. Pluristem is anticipating data from an ongoing dose-selection trial in acute radiation syndrome (ARS) being conducted and supported by the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases. Upon determining the optimal dose, a pivotal trial in large animals is planned and the results, if positive, will be used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway. Following the end of the first fiscal quarter, Pluristem signed a binding term sheet for an investment of approximately $30,000,000 by China-based Innovative Medical Management Co., Ltd., a healthcare-focused investment fund. Pursuant to the term sheet, approximately 16,890,000 shares of Pluristem common stock will be sold at $1.77 per share, in addition to warrants. Pluristem and Innovative Medical plan to enter into a definitive agreement no later than December 26, 2016. Financial Update: As of September 30, 2016, Pluristem had approximately $29.3 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company’s net cash used for operating activities was $3.9 million during the first quarter. Pluristem anticipates being well capitalized to conduct the clinical trials planned for initiation in the coming quarters, as well as ongoing R&D efforts to support development of future products. Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our financial position, closing of $30 million investment, timing and terms of such investment and sufficiency of capital resources, our plans with respect to our existing and future preclinical and clinical trials, including initiation, enrollment, successful completion reporting of results and timing of all of the above, discussions with regulatory agencies and receipt of favorable outcomes from such discussions.  These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.


News Article | December 10, 2016
Site: marketersmedia.com

— Aplastic Anemia Pipeline Market Companies Involved in Therapeutics Development are 3SBio Inc, Acceleron Pharma Inc, Amgen Inc, BioLineRx Ltd, F. Hoffmann-La Roche Ltd, Gamida Cell Ltd, Pluristem Therapeutics Inc, and Regen BioPharma Inc. Aplastic anemia is a syndrome of bone marrow failure characterized by peripheral pancytopenia and marrow hypoplasia. Symptoms include fatigue, pale skin, rapid or irregular heart rate, shortness of breath with exertion, nosebleeds and bleeding gums, prolonged bleeding from cuts, skin rash, dizziness and headache. Risk factors include exposure to toxic chemicals, treatment with high-dose radiation or chemotherapy for cancer, certain blood diseases, autoimmune disorders and serious infections. Treatment includes immunosuppressants and stem cell transplant. This research provides comprehensive information on the therapeutics under development for Aplastic Anemia (Hematological Disorders), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Inquire more about this research at http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=774110 The Aplastic Anemia (Hematological Disorders) pipeline guide also reviews of key players involved in therapeutic development for Aplastic Anemia and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Phase III, Phase II, Phase I, IND/CTA Filed and Preclinical stages are 1, 2, 1, 1 and 5 respectively. Aplastic Anemia (Hematological Disorders) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. Buy a copy of this research report at http://www.reportsnreports.com/purchase.aspx?name=774110 • The pipeline guide provides a snapshot of the global therapeutic landscape of Aplastic Anemia (Hematological Disorders). • The pipeline guide reviews pipeline therapeutics for Aplastic Anemia (Hematological Disorders) by companies and universities/research institutes based on information derived from company and industry-specific sources. • The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. • The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. • The pipeline guide reviews key companies involved in Aplastic Anemia (Hematological Disorders) therapeutics and enlists all their major and minor projects. • The pipeline guide evaluates Aplastic Anemia (Hematological Disorders) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. • The pipeline guide encapsulates all the dormant and discontinued pipeline projects. • The pipeline guide reviews latest news related to pipeline therapeutics for Aplastic Anemia (Hematological Disorders) • Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. • Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. • Find and recognize significant and varied types of therapeutics under development for Aplastic Anemia (Hematological Disorders). • Classify potential new clients or partners in the target demographic. • Develop tactical initiatives by understanding the focus areas of leading companies. • Plan mergers and acquisitions meritoriously by identifying key players and it’s most promising pipeline therapeutics. • Formulate corrective measures for pipeline projects by understanding Aplastic Anemia (Hematological Disorders) pipeline depth and focus of Indication therapeutics. • Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope. • Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline. For more information, please visit http://www.reportsnreports.com/reports/774110-aplastic-anemia-pipeline-review-h2-2016.html


News Article | February 13, 2017
Site: globenewswire.com

HAIFA, Israel, Feb. 13, 2017 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial update and corporate and clinical developments for the second quarter of fiscal 2017, ended December 31, 2016. “Driven by our commitment to help patients with serious, unmet medical needs, we are continuously working towards our goals for 2017 which will advance our cell therapy products towards commercialization, bring significant value to our shareholders and make an important difference in millions of patients’ lives,” stated Pluristem Chairman and CEO Zami Aberman. “While we move multiple indications into advanced stage clinical studies, we continue to maintain a significant advantage in the field with our commercial-grade cell production capacity, ground-breaking manufacturing technology, and proprietary GMP manufacturing facility that we own and operate. “Regenerative medicine in general, and PLX cell therapy in particular will have tremendous benefits on healthcare economics based on efficacy, the treatments’ non-invasive nature, and our production capacity enabling us to supply allogeneic cells to a broad population.” “Pluristem is well positioned to progress towards commercialization, and with a strong balance sheet for upcoming negotiations with potential commercial partners,” Aberman concluded. Financial Update: As of December 31, 2016, Pluristem had $21.9 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company’s net cash used for operating activities was $5.8 million for this quarter. In January 2017, the Company completed a public offering of common stock and warrants with gross proceeds of $17.25 million.  Pluristem also signed a binding term sheet for a $30M investment from Innovative Medical, a subsidiary of ZSVC. Finalization of the term sheet was delayed due to a new Chinese monetary policy. The parties continue the discussions with respect to the definitive agreement until they have received further clarification about such policies, which is expected during the first half of 2017. About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products entering pivotal trials in 2017. Pluristem has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic partnerships; relationships with major research institutions; and a seasoned management team. Safe Harbor Statement This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our financial position, the timing of execution of definitive agreements with Innovative Medical and the closing of their $30 million investment, the timing of the execution of definitive agreements with Sosei, the sufficiency of capital resources, our plans with respect to our existing and future preclinical and clinical trials, including initiation, enrollment, successful completion reporting of results and timing of all of the above, discussions with regulatory agencies and receipt of favorable outcomes from such discussions.  Further, although Pluristem has signed binding term sheets with each of Innovative Medical and Sosei, respectively, it may not be successful in negotiating definitive documentation with either party by the date expected or at all, and even if successful, the transactions may not be completed if the conditions to closing are not met. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.


HAIFA, Israel, Nov. 07, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the State Intellectual Property Office of the People's Republic of China has issued an allowance to Pluristem for its patent application titled, “Adherent Cells From Adipose or Placenta Tissues and Use Thereof In Therapy”. The patent addresses methods of treating Ischemic conditions such as CLI using placental cells. Additional patents of Pluristem in China cover methods of expending placental cells in a 3D apparatus, various therapeutic uses of placental cells and devices for a 3D culture of placental cells. “This most recent patent strengthens our intellectual property position globally, and specifically in the Chinese market. With our recent announcement of potential strategic partnership with Innovative Medical, we believe that PLX cell therapy products may have an important role in addressing the needs of China’s rapidly growing healthcare market and aging population,” stated Pluristem Chairman and CEO, Zami Aberman. Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss that our products may have an important role in addressing the needs of China’s rapidly growing healthcare market and aging population. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to  equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.


News Article | December 19, 2016
Site: globenewswire.com

HAIFA, Israel, Dec. 18, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, welcomes the approval of  U.S. Congress and President Obama of the 21st Century Cures Act, designed to accelerate the discovery, development, and delivery of 21st century cures. Pluristem believes its cell therapies will meet the criteria outlined by the Act as advanced regenerative therapies that can treat a wide range of disease. The bill puts the U.S. on the same playing field as many other developed countries including those in the European Union (EU) and Japan, which already have accelerated regulatory pathways for regenerative therapies. In Feb 2016, the CFDA has also released a notice saying it would give fast-track status to innovative products that fill the gap of unmet medical needs in the country. Pluristem’s strategy of pursuing accelerated pathways to market around the globe advances with a clinical program for CLI that is already being developed via both Europe’s Adaptive Pathways project and the Japanese PMDA under the new legislation for conditional marketing authorization for regenerative therapies. “The 21st Century Cures Act is an extremely significant healthcare legislation that may have a direct and beneficial impact on Pluristem’s clinical development programs and progress towards approval for our cell therapies,” stated Pluristem CEO Zami Aberman. “Pluristem has a robust portfolio of cell therapies that are designed to treat severe diseases where there is a high unmet medical need. The accelerated regulatory pathways for regenerative therapies around the globe should allow for early patient access to cell therapies, while also creating medical and economic benefits for the healthcare systems.” Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.


HAIFA, Israel, Dec. 13, 2016 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, welcomes and applauds the U.S. Congress’ passage of the 21st Century Cures Act. Pluristem believes its PLX-PAD and PLX-R18 cell therapies will meet the criteria outlined by the Act as advanced regenerative therapies that can treat a wide range of disease. The 21st Century Cures Act is expected by industry analysts to speed up drug development by accelerating the regulatory approval process, among other means. “The 21st Century Cures Act is an extremely significant healthcare legislation that may have a direct and beneficial impact on Pluristem’s clinical development programs and progress towards approval for our cell therapies,” stated Pluristem CEO Zami Aberman. “Pluristem has a robust portfolio of cell therapies that are designed to treat severe diseases where there is a high unmet medical need. The 21st Century Cures Act should allow for early patient access to cell therapies, while also creating medical and economic benefits for the U.S. healthcare system. The passage of this legislation in the world’s largest healthcare market reinforces Pluristem’s strategy of pursuing accelerated pathways to market around the globe.” Pluristem’s clinical program for CLI is already being developed via both Europe’s Adaptive Pathways project and the Japanese PMDA under the new legislation for conditional marketing authorization for regenerative therapies. Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company's proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss our belief that our PLX-PAD and PLX-R18 cell therapies will meet the criteria outlined by the 21st Century Cures Act as advanced regenerative therapies that can treat a wide range of disease, when we discuss the expectation that the Act will speed up drug development by streamlining the regulatory approval process, when we discuss the Act’s potential to have a direct and beneficial impact on our clinical development and approval pathways for our cell therapy candidates, and when we discuss our clinical plans regarding the treatment of CLI and improving recovery after surgery for hip fracture, including the plans for FDA protocol submission and possible use of the new U.S. regulatory pathway. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

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