U.S. FDA Approves Cost Recovery for PLX-PAD under Expanded Access Program in the Treatment of Critical Limb Ischemia
Pluristem Therapeutics, Inc. (PSTI)
Last pluristem therapeutics, inc. earnings: 2/6 04:10 pm
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Source: GlobeNewswire
Pluristem enters into agreement with WideTrial Inc. to conduct the programWideTrial will purchase PLX-PAD cell products from PluristemProgram makes investigational treatment available to CLI patients who are unsuitable for inclusion in the Company’s ongoing multinational Phase 3 clinical study Allows for collection of real-world data concurrent with the Phase 3 study HAIFA, Israel and SAN FRANCISCO, Oct. 16, 2018 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, and WideTrial Inc., a privately-held third-party sponsor of authorized Expanded Access Programs (EAPs), today announced that the parties have entered into agreement to initiate an FDA-cleared EAP for Pluristem’s cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI). The parties further announced that the FDA has authorized WideTrial to charge payment for the PLX-PAD EAP treatment
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