reports
Pluristem Provides 28-Day Follow Up for Ventilator-Dependent COVID-19 ...
Pluristem Provides 28-Day Follow Up for Ventilator-Dependent COVID-19 Patients under Compassionate Use Program in Israel and U.S. Update is provided in advance of the company’s recruitment of first patient for its phase II Covid-19 study 87.5% survival rate of patients on invasive mechanical ventilation injected with PLX cells75% of patients no longer in need of any mechanical ventilation 62.5% of the patients discharged alive from the hospitalA 28-day study period is also the primary endpoint timeline for Pluristem’s recently announced FDA Phase II study HAIFA, Israel, May 14, 2020 ...
U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 St...
U.S. FDA Clears Pluristem’s IND Application for Phase II COVID-19 Study 140 patients with severe COVID-19 and ARDS to be treatedPrimary endpoint: ventilator free days during the main 28-day study period, secondary endpoint includes survival rate and ICU free days HAIFA, Israel, May 08, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a Phase II s...
Pluristem Announces Pricing of Its Registered Direct Offering for Aggr...
Pluristem Announces Pricing of Its Registered Direct Offering for Aggregate Proceeds of $15 Million HAIFA, Israel, May 05, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has entered into definitive agreements with two institutional investors in connection with a registered direct offering, providing for the issuance of an aggregate of 1,587,302 shares of its common stock at a price of $9.45 per share. The net proceeds from the offering are expected to be a...
Pluristem Recaps Investor & Analyst Call Reviewing European Investment...
Pluristem Recaps Investor & Analyst Call Reviewing European Investment Bank’s €50 Million Financing • Elaborating on agreement terms and tranches schedule• Provides update on cash position and clinical program HAIFA, Israel, April 30, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today provided a summary of an Investor & Analyst Call (the “Call”) conducted on April 30, 2020, in conjunction with the European Investment Bank (“EIB”) and kENUP Foundation. The purpos...
EIB signs collaboration with Israel Innovation Authority and €50 mil...
EIB signs collaboration with Israel Innovation Authority and €50 million financing agreement with Pluristem to develop therapies for COVID-19 and other unmet medical needs HAIFA, Israel, April 30, 2020 (GLOBE NEWSWIRE) -- European Investment Bank (EIB) backs Pluristem with €50 million of financing, which will help the company to advance the clinical development of its cell therapies and address a number of severe medical conditionsThe deal is the first Israeli-European project guaranteed by the European Fund for Strategic Investments, the financial pillar of the Investment Plan f...
The European Investment Bank (EIB), EU Delegation to Israel, the Israe...
The European Investment Bank (EIB), EU Delegation to Israel, the Israel Innovation Authority, and Pluristem Cordially Invite the Public to an Online Signing Ceremony on April 30, 2020 EIB, kENUP Foundation and Pluristem Will Host Investor & Analyst Call HAIFA, Israel, April 27, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, cordially invites investors, the media, and the public to join a signing ceremony and analyst & investor call on Thursday, April 30, 2020. Signing Cer...
Pluristem Secures €50 Million Non-Dilutive Financing from the Europe...
Pluristem Secures €50 Million Non-Dilutive Financing from the European Investment Bank to Support its COVID-19 Project and Phase III Studies EXPECTED ONLINE SIGNING CEREMONY ON APRIL 30, 2020 HAIFA, Israel, April 24, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the European Investment Bank (“EIB”) has approved a €50 million non-dilutive financing for the Company (the “Approved Financing”). This Approved Financing, once received, will support Pluristem’s r...
Pluristem Expands its Compassionate Use Program: Treated First COVID-1...
Pluristem Expands its Compassionate Use Program: Treated First COVID-19 Patient in U.S. Under FDA Single Patient Expanded Access Program Cleared by FDA to proceed with the treatment in U.S. under Coronavirus Treatment Acceleration Program (CTAP)Pluristem’s main focus: multinational clinical trial of PLX cells for treatment of complications associated with COVID-19 HAIFA, Israel, April 13, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of ...
Pluristem Reports Preliminary Data from its COVID-19 Compassionate Use...
Pluristem Reports Preliminary Data from its COVID-19 Compassionate Use Program, Treating Seven Patients with Acute Respiratory Failure All treated patients were in Intensive Care Units (ICU) on ventilators and suffered from Acute Respiratory Distress Syndrome (ARDS)100% survival rate for all seven patients6 patients completed 1 week follow up; the seventh patient was treated on April 5 20204 of the 6 (66%) patients that completed 1 week follow up demonstrated improvement in respiratory parameters 3 of the 6 (50%) patients that completed 1 week follow up are in advanced stages of weaning fro...
Pluristem Treated First Three COVID-19 Patients in Israel under Compas...
Pluristem Treated First Three COVID-19 Patients in Israel under Compassionate Use Expects to treat more patients in Israel in the coming daysCompany is in discussions with regulators in the U.S. and Europe to define its clinical strategy for COVID-19 HAIFA, Israel, March 30, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that since its , it has dosed three patients in two different hospitals in Israel under a compassionate use program for the treatment of COVID-19...
Pluristem Provides Update on COVID-19:Â Preparedness, Current Phase I...
Pluristem Provides Update on COVID-19: Preparedness, Current Phase III Clinical Trials Status and Treatment Development Activity HAIFA, Israel, March 26, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today issued an update to its shareholders from its Chief Executive Officer and President, Yaky Yanay. Dear Fellow Shareholders, In light of the novel coronavirus pandemic (COVID-19), today we wanted to provide an update on the impact of the coronavirus pandemic on our business and on our ong...
Israeli Ministry of Health Clears a Path to Allow Per Patient Compassi...
Israeli Ministry of Health Clears a Path to Allow Per Patient Compassionate Use Treatment of Covid-19 Patients with Pluristem’s PLX Cells HAIFA, Israel, March 17, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that the Israeli Ministry of Health has approved Pluristem’s request to seek approvals to treat COVID-19 coronavirus patients under the per-patient compassionate use framework in Israel. The Israeli Ministry of Health may approve proposed treatments on a per-patient basi...
Pluristem and Charité University of Medicine Berlin Join Forces Targe...
Pluristem and Charité University of Medicine Berlin Join Forces Targeting Potential Treatment for Respiratory and Inflammatory Intratissue Complications Caused by COVID-19 HAIFA, Israel, March 12, 2020 (GLOBE NEWSWIRE) -- HAIFA, Israel, March 12, 2020 - (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced it has signed a collaborative agreement with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin to expand its exis...
Pluristem Receives Response from U.S. BARDA for Acute Radiation Syndro...
Pluristem Receives Response from U.S. BARDA for Acute Radiation Syndrome Research Proposal HAIFA, Israel, March 03, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced it received a response to the proposal it submitted to the U.S. Biomedical Advanced Research and Development Authority (BARDA) for funding a study designed to demonstrate the superiority of PLX-R18 therapy versus current standard of care in the treatment of Acute Radiation Syndrome (ARS). At this time, BARDA has chos...
Pluristem Therapeutics CEO Issues Shareholder Update
Pluristem Therapeutics CEO Issues Shareholder Update HAIFA, Israel, Feb. 10, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel cell therapy products, today issued an update to its shareholders from its Chief Executive Officer and President, Yaky Yanay. Dear Fellow Shareholders, Today we announce Pluristem’s update for the second quarter of fiscal 2020, including recent achievements and our next short-term milestones. Recently, Pluristem’s management attended the annual J.P. Morgan Healthcare Conference in San Fran...
In Its Path Towards Marketing, Pluristem Provides Highly Favorable Mar...
In Its Path Towards Marketing, Pluristem Provides Highly Favorable Market Access Data Regarding the Critical Limb Ischemia Market in U.S. HAIFA, Israel, Feb. 03, 2020 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced results from a market access comprehensive research study conducted by Marwood Group, a healthcare advisory firm, for the critical limb ischemia (CLI) market in the U.S. The report included data from published literature as well as direct interviews regarding Pluristem’s ...
Pluristem Completes 75% Enrollment in its Pivotal Phase III CLI Clinic...
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 HAIFA, Israel, Dec. 17, 2019 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has enrolled 75% of the 246 patients planned for its Phase III clinical study of PLX-PAD in the treatment of Critical Li...
Pluristem Reaches Milestone in its Phase III Muscle Injury Study, Comp...
Pluristem Reaches Milestone in its Phase III Muscle Injury Study, Completes 50% Enrollment Multinational study in the U.S., Israel and Europe targeting to be the first product candidate supporting muscle regeneration after significant trauma such as hip fracture HAIFA, Israel, Dec. 03, 2019 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has completed enrollment of 50% of the 240 patients planned for its ongoing Phase III PLX-PAD study of muscle regeneration. There a...
Pluristem Therapeutics CEO Issues Shareholder Update
Pluristem Therapeutics CEO Issues Shareholder Update HAIFA, Israel, Nov. 12, 2019 (GLOBE NEWSWIRE) -- (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today issued an update to its shareholders from its Chief Executive Officer, Yaky Yanay. Dear Fellow Shareholders, Today we announce Pluristem’s update for the first fiscal quarter of 2020, as we are entering a very important period as we are in preparation towards the interim readout expected from our CLI phase III study. We continued to develop our robust clinical...
RESTORE Consortium to Host the 1st Advanced Therapies Science Meeting,...
RESTORE Consortium to Host the 1st Advanced Therapies Science Meeting, Aiming to Translate Promising Research into a Game Changer in Healthcare RESTORE Consortium, of which Pluristem is a leading member, is competing for up to a €1 billion award by the European CommissionWinner announcement is expected in May 2020 HAIFA, Israel, Nov. 04, 2019 (GLOBE NEWSWIRE) -- . (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the RESTORE Consortium is hosting its 1st Advanced Therapies Science Meeting (...
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