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Re: early_retirement2 post# 2331

Wednesday, 03/01/2017 3:41:53 PM

Wednesday, March 01, 2017 3:41:53 PM

Post# of 3353
It's great that some patients will be able to try the product before full approval if they so desire.

BrainStorm Announces MOU with Tel Aviv Sourasky Medical Center to Make NurOwn® Available to Patients as a Hospital Exemption Product

http://www.prnewswire.com/news-releases/brainstorm-announces-mou-with-tel-aviv-sourasky-medical-center-to-make-nurown-available-to-patients-as-a-hospital-exemption-product-300415879.html


HACKENSACK, N.J. and PETACH TIKVAH, Israel, March 1, 2017 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that is has signed a Memorandum of Understanding (MOU) with The Medical Research, Infrastructure, and Health Services Fund of the Tel Aviv Sourasky Medical Center (Ichilov Hospital) to explore the possibility of making NurOwn® available to Amyotrophic Lateral Sclerosis (ALS) patients under the provisions of Hospital Exemption regulation. The MOU also covers the participation of Tel Aviv Sourasky Medical Center in the planned Phase 3 trial that will investigate NurOwn in ALS.

The MOU sets forth the basic terms under which Brainstorm and Tel Aviv Sourasky Medical Center would work together to submit an application to the Israeli Ministry of Health that will allow patient access to NurOwn and is subject to a definitive agreement. The agreement is expected to be formalized in the first half of 2017.

"We are pleased to be working with Tel Aviv Sourasky Medical Center and look forward to putting a definitive agreement in place," said Chaim Lebovits, President and CEO of BrainStorm. "We believe that NurOwn meets the requirements to be a Hospital Exempt product and, if our application is successful, we could potentially make the product available to patients prior to obtaining formal licensure."

"Tel Aviv Sourasky Medical Center and BrainStorm have a joint interest in developing a path to bring advanced therapies to patients," said Professor Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We hope our combined efforts will leverage BrainStorm's technology to provide a new and innovative treatment option for our ALS patients."







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