Press releases

 

December 2020 · Pluristem
Pluristem Announces DMC Recommendation Following Interim Analysis of its Phase III CLI Study
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February 2020 · Pluristem
In Its Path Towards Marketing, Pluristem Provides Highly Favorable Market Access Data Regarding the Critical Limb Ischemia Market in U.S.
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December 2019 · Pluristem
Pluristem Completes 75% Enrollment in its Pivotal Phase III CLI Clinical Study
Patients unsuitable for revascularization surgery currently have no alternative treatments, leading to high risk of leg amputation and death; PLX-PAD may become the first drug approved to treat CLI.
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October 2019 · NJ Spotlight News
Holy Name clinical trial tests the healing power of stem cells
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May 2019 · Pluristem
Lead Physicians in Pluristem’s Pivotal Study in Critical Limb Ischemia Publish Peer-Reviewed Paper
Paper appears in the European Journal of Vascular and Endovascular Surgery and highlights the study’s design rationale and the potential impact of PLX cells in the treatment of CLI.
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April 2019 · Pluristem
Pluristem Therapeutics (PSTI) Stock: Gaining On Clinical Update
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April 2019 · Pluristem
Pluristem Completes Interim Enrollment in Pivotal CLI Study, Targeting Potential Conditional Marketing Approval in Europe
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December 2018 · Pluristem
Pluristem Therapeutics Recaps Key Opinion Leader Meeting on Peripheral Artery Disease (PAD)
Presentations underscore significant need for new PAD treatment approaches and the potential of cell therapy to improve patient outcomes while reducing healthcare costs.
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December 2018 · Pluristem
U.S. FDA Approves Cost Recovery for PLX-PAD under Expanded Access Program in the Treatment of Critical Limb Ischemia
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September 2018 · Pluristem
U.S. FDA Grants Fast Track Designation to Pluristem's PLX-PAD for the Treatment of Critical Limb Ischemia (CLI)
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August 2018 · Pluristem
Pluristem Initiates Two Pivotal Phase III Studies in Israel
Numerous Clinical Sites in Israel to join sites in the U.S. and Europe for Pivotal Phase III Studies of PLX-PAD Cell Therapy in the Treatment of Critical Limb Ischemia and Muscle Injury Following Hip Fracture.
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June 2018 · NJ Spotlight News
Clinical trial at Holy Name aims to save limbs and lives
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June 2018 · Pluristem
Pluristem Reports Positive Top-Line Results from Its Multinational Phase II Intermittent Claudication Study
The IC study validates the design of our ongoing PACE phase III trial on Critical Limb Ischemia (CLI). Best results in the IC trial were obtain with two times administration of 300 million PLX-PAD cells. The same dosing is foreseen within PACE clinical study. Besides Pluristem, also other partners of the PACE consortium were involved in the IC trial as scientists: Sigrid Nikol (Asklepios) and Norbert Weiss (TUD) as lead principal investigator.
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February 2018 · Jerusalem Post · Sigrid Nikol
Smart cells that heal
Innovative Israeli cell therapy could step up treatment of CLI.
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February 2018 · LINC TODAY · Sigrid Nikol
Stem cell angiogenesis: showing promise
Pioneering techniques for critical limb ischaemia and "no option patients".
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January 2018 · Pluristem
FDA Clears Pluristem’s Expanded Access Program to Initiate Treatments of Critical Limb Ischemia Outside of Ongoing Phase III Study
Pioneering techniques for critical limb ischaemia and "no option patients".
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July 2017 · Pluristem
Pluristem Advances its Multinational Phase III Critical Limb Ischemia Study, Targeting Initiation at 40 Active Sites
by the End of 2017
Austria’s regulatory health agency clears CLI study and joins the U.S., U.K., and Germany in conducting the 250-patient Phase III trial.
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January 2017 · Pluristem
Pluristem Receives Clearance from Germany to Initiate its Multinational Phase III Trial in Critical Limb Ischemia Targeting Early Conditional Marketing Approval
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January 2017 · Pluristem
Pluristem’s Phase III Study of PLX-PAD Cells for the Treatment of Critical Limb Ischemia Cleared by U.S. FDA
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November 2016 · Pluristem
Pluristem’s Pivotal Phase III Critical Limb Ischemia Trial Approved by UK Regulatory Agency
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August 2016 · Pluristem
Pluristem’s Phase III Critical Limb Ischemia Study Wins $8 Million Grant from Europe’s Horizon 2020 Program
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August 2016 · Pluristem
Pluristem Receives Positive Feedback from FDA and Gears Up for Phase III Trial of PLX-PAD in Critical Limb Ischemia
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March 2016 · Reuters
Israel's Pluristem sees positive results from leg pain study
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