This follows clearances from U.S., E.U., German, and South Korean regulators
HAIFA, ISRAEL, July 31, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa. The latest approval comes from Israel’s Ministry of Health and follows similar clearances from the U.S. Food and Drug Administration, the European Union’s Qualified Person, Germany’s Paul Ehrlich Institute, and the South Korean Ministry of Food and Drug Safety.
“This latest regulatory clearance further validates our proprietary cell manufacturing processes, which we believe are state-of-the-art and unmatched in the cell therapy arena. Our Haifa facility has the capacity to produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value” stated Pluristem CEO Zami Aberman. “This latest approval also exemplifies our strategy of working with multiple regulatory bodies in order to establish Pluristem as a leading developer of cell therapies and to set the standards for this area of manufacturing,” added Aberman.
Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured in sufficient quantities to support late-phase clinical trials and commercial demand at time of regulatory approval. Pluristem manufactures its products in full compliance with the U.S. Food and Drug Administration (FDA) and European Medicines Agencies (EMA) current Good Manufacturing Practices (cGMP). Pluristem believes that control of the production process is critical for the successful manufacture of cell therapies and invests significantly in developing highly efficient, cutting-edge culturing systems for its range of PLX cell products.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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 what it takes to be a successful company in our industry, or that regulatory bodies see our proprietary 3D manufacturing process as a valid and sustainable commercial scale solution for cell therapies, or when we discuss the capabilities of our new facility and how they potentially translate into significant economic value.. 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 surgical 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.
Contact:
Pluristem Therapeutics Inc.: Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Key Opinion Leader Dr. Baha Sibai will discuss preeclampsia, a disease that costs the
U.S. $7 billion annually
HAIFA, ISRAEL, July 22, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that it will host an investor breakfast on Wednesday, July 23 in New York City. Prof. Baha M. Sibai, MD, a renowned expert in preeclampsia, will present an overview of this disorder, a leading cause of maternal deaths and premature births. Pluristem’s CEO, Zami Aberman, will then speak about the potential of Pluristem’s cells to treat this unmet medical need.
The presentations, followed by a question-and-answer session, will be webcast live beginning at 8am Eastern Time. The webcast and accompanying presentation materials will be accessible live at http://lifesci.rampard.com/20140723/.
Preeclampsia is one of the leading known causes of premature births, stillbirths and early neonatal and maternal deaths. If left untreated it can progress to eclampsia, the life- threatening occurrence of seizures during pregnancy. The only definitive treatment for preeclampsia is abortion or delivery. The disease occurs after the 20th week of pregnancy, and is characterized by high blood pressure and significant amounts of protein in the urine or other signs of organ dysfunction. According to the American Society of Hypertension, preeclampsia costs the U.S. alone more than $7 billion annually, and globally it causes between 50-70,000 maternal and approximately 500,000 infant deaths each year.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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 potential of Pluristem’s cells to treat preeclampsia. 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 surgical 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Trial now active in 13 clinical centers in 4 countries
HAIFA, ISRAEL, July 8, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced the initiation of South Korean sites in the Phase II study assessing PLacental eXpanded (PLX) cells in the treatment of intermittent claudication (IC). Patient screening is now underway at three clinical centers, making South Korea the fourth country to participate in this randomized, double-blind, placebo-controlled Phase II trial. The trial has been ongoing at clinical sites in the U.S., Israel and Germany with an enrollment target of 150 patients.
The South Korean part of the study is being conducted by CHA Bio & Diostech (Kosdaq: CHA) under an exclusive licensing agreement for the use of PLX cells for peripheral artery disease (PAD) in South Korea. Under the terms of Pluristem’s licensing agreement with CHA, if there is regulatory approval for a PLX product in South Korea Pluristem and CHA will establish a joint venture (JV) co-owned by the parties; they will share the revenues and income generated through sales of PLX cell therapies in the South Korean market. It is estimated that one million people in South Korea suffer from PAD and this number is expected to grow.
“We have a very productive partnership with CHA, as evidenced by our joint clinical program. Initiating our first trial in South Korea is a major milestone. We look forward to reporting further progress on our Phase II IC trial in the South Korean market,” stated Pluristem CEO Zami Aberman.
In May, Pluristem received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) to use PLX cells in South Korean trials.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammatory or ischemic conditions. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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 receiving regulatory approval for PLX products in South Korea, or when we discuss reporting further progress on our Phase II IC trial in the South Korean 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 surgical 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Pluristem to share insights on emerging markets and its industry-leading cell manufacturing methods with audience of bio-manufacturing experts
HAIFA, ISRAEL, June 30, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced its VP of Development & Manufacturing, Ohad Karnieli, Ph.D., will give a plenary talk at the Bio-Process Systems Alliance’s (BPSA) 4th Annual International Single-Use Summit (ISUS 2014), which will be held on July 9-11, 2014 in Washington, D.C.
Speakers at this year’s ISUS 2014 event will offer insight on building bio-manufacturing venues tailored to single-use technologies, new markets for single-use (disposable) biopharmaceutical manufacturing equipment, and a host of other technical topics facing this fast-evolving industry.
On Thursday, July 10th from 11:45 a.m. to 12:30 p.m., during his presentation on behalf of the ISCT titled, “Emerging Markets for Single-Use: Cell Therapy and Regenerative Medicine,” Dr. Karnieli will speak about process and product development and innovation in single-use manufacturing of cell therapy and regenerative medicine products.
Pluristem is currently the only company manufacturing large quantities of homogeneous, clinical-grade, placenta-based cell products using a 3D bioreactor. Driving this achievement are research, development and manufacturing teams dedicated to shaping the future of placenta-based cell therapies.
The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led trade association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies for the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its members.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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. 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 surgical 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
PLX cells offer potential as first off-the-shelf product for muscle and tendon regeneration
HAIFA, ISRAEL, June 25, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has selected rotator cuff repair as the second indication in its orthopedic clinical program. The Company’s PLacental eXpanded (PLX) cells offer potential as the first off-the-shelf cell therapy product for muscle and tendon regeneration that can be used to enhance repair after rotator cuff surgery. There are currently no FDA-approved therapies using engineered cells for the treatment of rotator cuff injuries.
According to the American Academy of Orthopaedic Surgeons (AAOS), nearly 2 million patients in the U.S. seek help for their rotator cuff injuries. The incidence of these injuries increases with age, so as the U.S. population ages the prevalence and potential cost burden is likely to grow.
“Following the favorable results of our Phase I/II trial in our first orthopedic indication, the treatment of injured gluteal muscle after total hip replacement, we, together with Key Opinion Leaders in orthopedic surgery, selected rotator cuff repair as an important indication in need of a novel cell therapy solution. We are progressing with our study design, and are considering the addition of a third orthopedic indication,” stated Pluristem CEO Zami Aberman.
“There is a clear and unmet need for a new kind of therapy that can improve the outcome of orthopedic surgery for rotator cuff tears. Our PLX cells can be administered as a simple office procedure. The team of Key Opinion Leaders advising us is particularly excited by the potential of a non-invasive, effective cell therapy for orthopedic indications,” added Aberman.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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 plan to enter into clinical trials for rotator cuff repair indication, or that our PLX cells offer potential as the first off-the- shelf cell therapy product for muscle and tendon regeneration that can be used to enhance repair after rotator cuff surgery, or that we are considering the addition of a third orthopedic indication, or when we discuss the potential of a non-invasive, effective cell therapy for orthopedic indications . 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 surgical 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
PLX cells shown to be a potentially effective treatment
HAIFA, ISRAEL, June 19, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that Russia’s Federal Service for Intellectual Property has granted to Pluristem Patent No. 2515156 titled, “Methods of Treating Inflammatory Colon Diseases”. The patent covers methods for treating ulcerative colitis or Crohn’s disease using placenta-derived cells. This patent has already been issued to Pluristem in South Africa and is currently pending in several other jurisdictions.
“Pre-clinical studies have demonstrated that PLX cells are potentially effective in treating inflammatory bowel disease, and we may consider advancing into clinical trials with this indication in future,” stated Pluristem CEO Zami Aberman. “This patent issued in Russia is the latest in a series of patents we’ve been granted across the globe for the use of placenta-derived cell therapies in a variety of different indications.”
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic conditions. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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 that PLX cells are potentially effective in treating inflammatory bowel disease and that we may consider advancing inflammatory bowel disease and Crohn’s disease indications into clinical trials in future.
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 surgical 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.
Contact:
Pluristem Therapeutics
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, June 16, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has been granted Patent No. 261087 from India’s Office of the Controller General of Patents, Designs & Trade Marks for a patent titled, “Methods for Cell Expansion and Conditioned Media Produced Thereby for Therapy.”
The patent, which has also been granted to Pluristem in Australia, Russia and South Africa, covers the Company’s key technology platform, its method for 3-dimensional expansion of placental and adipose (fat) derived cells. It also covers the composition of cells derived using this method.
“We believe Pluristem is the global leader in the commercial-scale production of placenta-derived cells. In our manufacturing facility, we use proprietary 3-dimensional cell expansion technology that gives us the ability to precisely control cell growth based on the intended indication to be treated. Our ability to do this on a large scale is one of our key assets,” stated Pluristem CEO Zami Aberman.
“This patent issued by India is an important part of our global IP strategy to protect our breakthrough cell production methods in high-value and emerging healthcare markets where we see future potential for growth,” Aberman added.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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 being a global leader in the commercial-scale production of placenta-derived cells, or our ability to precisely control cell growth based on the intended indication to be treated and do it on a large scale. 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 surgical 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.
Contact:
Pluristem Therapeutics Inc.:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, June 10, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced that it will exhibit at the BIO International Convention from June 23-26, 2014 in San Diego, California. Pluristem will exhibit at the Israeli National Pavilion, booth 611. BIO International is one of the leading events for the biotechnology industry.
The BIO International Convention is a global event that offers key networking and partnering opportunities, and provides insights on the major trends affecting the global biotechnology industry. The event features keynotes and sessions from key policymakers, scientists and CEOs, the BIO Business Forum (One-on-One Partnering), and the biotechnology exhibition.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are protein delivery platforms that release a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are produced using the Company’s proprietary 3D technology, which creates a micro-environment to optimize their growth. The cells are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions, and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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. 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 surgical 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.
Contact:
Pluristem Therapeutics Karine Kleinhaus, MD, MPH
Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, May 29, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, today announced it has enhanced its activity in the orthopedic indications for its PLacental eXpanded (PLX) cell therapies. In January, Pluristem announced positive results from its Phase I/II clinical trial for the treatment of injured gluteal muscle after total hip arthroplasty (THA). “This is a great result for a long path from a first idea to such a success in a first-in-men study in orthopedics with an off-the-shelf product to allow muscle regeneration” states Dr. Georg Duda, the Director of the Julius Wolff Institute and Berlin-Brandenburg Center for Regenerative Therapies at the Charité, Berlin. “This is the first hope for muscle regeneration with virtually no clinical therapy presently available to treat injuries or defects in shoulder or lower leg muscles.” added Dr. Carsten Perka, Head of Orthopedics at the Center for Musculoskeletal Surgery at the Charité, Berlin.
In addition, the Company has reported strong preclinical data from studies of PLX-PAD cells in the treatment of tendon injuries. Among the additional Key Opinion Leaders that are advising Pluristem, Dr. Scott Rodeo, who conducted the preclinical study of PLX- PAD cells in tendon injuries, commented, “One aspect that makes PLX cells unique and beneficial as a potential cell therapy is that they are adherent stromal cells derived from placentas, as compared to autologous cells which are sourced from the patient. Beyond the potential promise of PLX cells’ efficacy, the abundant commercial supplies of PLX- PAD cells produced by Pluristem eliminate the need for patients to go through an additional procedure to extract the cells from their own bodies.”
“We have strong clinical and preclinical data on several orthopedic indications for our PLX-PAD cells. With the guidance and expertise offered by Key Opinion Leaders, we are developing and prioritizing our orthopedic clinical indications pipeline,” stated Pluristem Chairman and CEO Zami Aberman.
Key Opinion Leaders supporting Pluristem’s orthopedic program: Doctor Shaul Beyth, M.D., Ph.D.
Orthopedic surgeon Hebrew University Medical School and Hadassah Medical Center, Jerusalem, Israel
Professor Andrew Carr, M.D. University of Oxford
Professor, Orthopaedics and Head of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Professor Georg Duda, Ph.D.
Charité Hospital, University of Berlin, Germany
Julius Wolff Institute and Center for Musculoskeletal Surgery Berlin-Brandenburg Center for Regenerative Therapies
Professor Thomas A. Einhorn, M.D. Boston University
Chairman of the Department of Orthopaedic Surgery and Professor of Orthopaedic Surgery, Biochemistry and Biomedical Engineering
Doctor Ron Noy, M.D.
Founder, Prestige Orthopaedics & Sports Medicine, NY
Orthopaedic Surgeon and Sports Medicine Specialist, Mount Sinai Beth Israel/Lenox Hill Hospital, NY
Professor Carsten Perka, M.D.
Charité Hospital, University of Berlin, Germany, Deputy Director of the Center for Musculoskeletal Surgery and Chairman of the Orthopaedic Department
Professor Scott Rodeo, M.D.
Co-Chief, Sports Medicine and Shoulder Service
Co-Director, Tissue Engineering, Regeneration, and Repair Program Professor, Orthopaedic Surgery, Weill Medical College of Cornell University Attending Orthopaedic Surgeon, The Hospital for Special Surgery
Associate Team Physician, New York Giants Football
Doctor Tobias Winkler, M.D., Ph.D.
Charité Hospital, University of Berlin, Germany
Orthopedic surgeon at the Center for Musculoskeletal Surgery
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to an inflammatory or ischemic process. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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 developing and prioritizing our orthopedic clinical indications pipeline or when the potential efficacy and benefits of our PLX cells, and the hope they may bring for muscle regeneration, are discussed. 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 surgical 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.
Pluristem Therapeutics
Karine Kleinhaus, M.D., M.P.H. Divisional VP, North America
1-914-512-4109
HAIFA, ISRAEL, May 27, 2014 — Pluristem Therapeutics Inc. (NasdaqCM:PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, announced today that the Company’s COO, Yaky Yanay, and the Divisional VP for North America, Dr. Karine Kleinhaus, will participate in three upcoming financial conferences.
Israel 2014 Roadmap in the Biotech Sector Date: May 28, 2014
Location: Airport City, Israel
Format: Yaky Yanay to present from 1:15 pm – 2:15 pm
Barclays Select Series 2014: Israel Biotech/Medtech Corporate Day Date: May 29, 2014
Location: New York, New York
Format: Karine Kleinhaus to participate in one-on-one meetings
Jefferies 2014 Global Healthcare Conference Date: June 2 – 5, 2014
Location: New York, New York
Format: Karine Kleinhaus to present on Wednesday, June 4, 2014 from 3:30 pm – 4:00 pm
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.
Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
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. 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 surgical 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.
Contact:
Pluristem Therapeutics Karine Kleinhaus, MD, MPH
Divisional VP, North America 1-914-512-4109
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