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Elbit Imaging Announces That Its Subsidiary, Elbit Medical Technologies Ltd., Has Appointed A Chief Executive Officer And Chief Financial Officer
TEL AVIV, ISRAEL / ACCESSWIRE / December 18, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, that its subsidiary, Elbit Medical Technologies Ltd. ("Elbit Medical") has appointed a new Chief Executive Officer (CEO) and Chief Financial Officer (CFO), as following:
Ms. Yael Naftali will cease to serve as Elbit Medical's CFO and will be appointed as Elbit Medical's CEO.
Ms. Yael Naftali will replace the current Elbit Medical's CEO, Mr. Doron Moshe.
Ms. Tsipi Siani will be appointed as Elbit Medical's CFO.
Both appointments will be effective as of January 1, 2018.
Treatment for Alzheimer’s, Parkinson’s gets a boost. There’s a Miami connection.
BY JANE WOOLDRIDGE
jwooldridge@miamiherald.com
DECEMBER 15, 2017 12:24 PM
UPDATED DECEMBER 15, 2017 03:43 PM
Potential new treatments for Alzheimer’s and Parkinson’s patients just got a boost.
INSIGHTEC, a medical device company led by Miami’s Dr. Maurice Ferre, has received $150 million in funding from Koch Disruptive Technologies, a subsidiary of Koch Industries.
The money will enable INSIGHTEC to expand studies of its current FDA-cleared ultrasound device to Alzheimer’s and Parkinson’s patients. The company currently is conducting a Phase 1 trial into Alzheimer’s treataments and beginning at Phase 3 trial in uses for Parkinson’s Disease.
The non-invasive device uses Magnetic Resonance Imaging and focused ultrasound to target specific tissues in a procedure called Exablate Neuro. It is now used for uncontrollable tremors, called essential tremor, at 40 medical centers worldwide, including two in South Florida. The underlying technology can also be used to treat uterine fibroids and bone cancer non-invasively.
INSIGHTEC is based in Israel, with U.S. offices in Miami. Ferre, a serial entrepreneur, co-founded MAKO Surgical Corp., a leader in robotic orthopedic surgery. His father, Maurice Ferre, was a long-time mayor of Miami.
An avalanche of PRs today, here
are #3 and #4
https://finance.yahoo.com/news/elbit-imaging-announces-regarding-dispute-165400504.html
https://finance.yahoo.com/news/elbit-imaging-announces-availability-investor-174000116.html
Elbit Imaging Ltd. Announces That The CMS Has Updated The Reimbursement Code For Insightec's Exablate Neuro Treatment For Essential Tremor
TEL AVIV, ISRAEL / ACCESSWIRE / December 14, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today, further to its previous announcement dated November 16, 2016, that it was informed by Insightec Ltd. ("Insightec"), that the Centers for Medicare and Medicaid Services (the "CMS") updated the reimbursement code for Exablate Neuro treatment for essential tremor, as follows:
On November 2016 the CMS has decided to associate Insightec's Exablate Neuro system (for essential tremor treatment), a reimbursement code with a payment level of USD9,751.
Beginning January 1, 2018, the primary procedure code for Movement Disorders (essential tremor) is assigned to new technology level and will be paid at USD17,500.50 for Medicare beneficiaries (if deemed medically appropriate).
The CMS decision is one of several steps toward gaining appropriate reimbursement for MRgFUS for essential tremor. This needs to be followed by CMS regional offices approval to the reimbursement for the Exablate Neuro treatment, for their patients.
The CMS's regional offices are yet to adopt the CMS decision and as of the date of this report, Insightec is unable to assess whether, when and in what manner the CMS's regional offices will adopt the CMS decision. Therefore, at this stage, Insightec is unable to assess the impact of the CMS recommendation on its business.
About Insightec
The Company holds approximately 89.6% of Elbit Medical Ltd.'s outstanding share capital (86.6% on a fully diluted basis), which in turn holds 31% of the outstanding share capital of Insightec (25% fully diluted basis) which is a private company.
Insightec's Exablate Neuro platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to lesion the targeted tissue deep in the brain, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcomes.
Essential tremor is the most common movement disorder, affecting millions of people worldwide. It is a progressive and debilitating neurological condition that causes a rhythmic trembling of the hands, head, voice, legs or trunk.
Insightec Signed An Agreement With An Investor Who Will Invest Up To USD150 Million In Insightec
TEL AVIV, ISRAEL / ACCESSWIRE / December 14, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today that InSightec Ltd. ("Insightec"), has signed a Share Purchase Agreement with Koch Disruptive Technologies (a subsidiary of Koch Industries, Inc.) ("Koch Disruptive Technologies"), pursuant to which Koch Disruptive Technologies together with other investors (the "Additional Investors") will invest in Insightec a total amount of between US$75 million and US$150 million, in consideration for the issuance of a new series of preferred stock of Insightec (the "Transaction").
The main terms of the Transaction are as follows:
At the initial closing of the Transaction, Koch Disruptive Technologies shall purchase new Series E Preferred Shares of Insightec (the "Preferred Stock") in consideration for a total amount of USD75 million. The Preferred Stock will represent, immediately following the issuance, approximately 17% of the outstanding share capital (14% on a fully-diluted basis) of Insightec. The initial closing is scheduled to be held, subject to fulfillment of all conditions precedent described in Section 6 below, no later than January 31, 2018.
The transaction documents grant Koch Disruptive Technologies and the Additional Investors (some of which are existing shareholders of Insightec) the right to invest in additional closings (to be held by no later than January 31, 2018) an additional amount of up to USD75 million in consideration for the issuance of additional Preferred Stock, provided that Koch Disruptive Technologies will hold at least 66% of the Preferred Stock after each closing.
The Transaction reflects a pre-money valuation for Insightec of approximately USD460 million (on a fully-diluted basis).
Holders of Preferred Stock shall have preferred rights in the event of a dividend distribution and certain material events as set forth in the transaction documents.
The transaction documents also set forth the rights of Koch Disruptive Technologies and other major shareholders of Insightec (in an amended Securityholders Agreement and amended Articles of Association), including, that following the consummation of the Transaction, Insightec's board of directors shall consist of a maximum of nine (9) board members. Each of the four major shareholders in Insightec (including Elbit Medical) will be entitled to appoint one director for as long as each of them holds at least 5% of the outstanding share capital of Insightec. The directors appointed by three of the major shareholders (including the one appointed by Elbit Medical) may together appoint up to four (4) additional directors. The CEO of Insightec will also serve as the director.
The completion of the Transaction is subject to the terms and conditions stipulated in the transaction documents, including the approvals of the shareholders' meetings of Insightec. Elbit Medical has undertaken to support the Transaction in Insightec's shareholders' meetings.
Following the consummation of the Transaction, Elbit Medical will hold approximately 26% (22% on a fully-diluted basis) of Insightec's share capital, assuming a total investment of US $75 million, and 22% (19% on a fully-diluted basis) in the event of an investment of the total amount of US $150 million.
Gamida Cell reports positive cancer drug trial
cancer
The company is preparing for an IPO next year, after recently raising money at a $160 million company value.
A few weeks after Dr. Julian Adams was appointed chairperson and CEO of cancer treatment company Gamida Cell, the company published the results of its Phase I/II clinical trial for its NiCord product. The leading shareholders in the company are Clal Biotechnology Industries Ltd. (TASE: CBI), and Elbit Medical Technologies Ltd. (TASE:EMTC), each of which has an 18% stake. Clal Biotechnology's market cap is NIS 521 million, and Elbit Medical's is NIS 262 million.
Although the trial included only 36 patients, it is considered important in this sector, because Gamida is on a fast track for approval by the US Food and Drug Administration (FDA), which significantly reduces the number of trials required in order to reach the market (provided that the trials are successful, of course). Gamida Cell has developed a method for improving the density of stem cells in a blood sample in a way designed to bolster the effectiveness of treatment that utilizes implants of these stem cells. NiCord is a product based on upgrading the density of umbilical blood units designated for implants in the treatment of blood cancer.
Shortening the engraftment time
The principle measure for the trial was how long it took to engraft the cells. The cells in the trial were engrafted within 21 days, while the scientific literature reported twice as much time for engraftment of umbilical blood that did not undergo the treatment. The engraftment time is the same as for bone marrow implants, which is the usual alternative treatment if a donor is found (usually, however, no donor is found).
In the first year following the implant, only 9.8% of the patients suffered from moderate or severe chronic graft vs. host disease (cGvHD) (the figures from medical literature mention 15%), and during 100 days after the implant, 20.2% of the patients experienced grade 2-3 bacterial or grade 3 fungal infections, a figure regarding as compliant with the safety rules.
Gamida Cell is already conducting a Phase III trial of the product, and expects results in 2019. The company wants to hold an IPO in 2018, and hopes that the results from the smaller trial will help it in this task. Several months ago, the company raised $40 million at a company value of $160 million, after money.
In recent days, Gamida Cell also presented results from a number of preclinical trials indicating that the NAM technology it is developing, which makes it possible to enrich blood cells taken from the patient, could be relevant to improving the effectiveness of natural killer cells in immunotherapy for various types of cancer. The company has begun a clinical trial in this area.
Published by Globes [online], Israel Business News - www.globes-online.com - on December 13, 2017
Gamida Cell Presents Data from Two Key Development Programs at the 2017 ASH Annual Meeting
Dec 11, 2017
— Final results from the company’s phase I/II study of NiCord® demonstrate important potential as a universal transplantation solution for patients with high-risk blood cancers —
— Preclinical study of NAM-NK Cells supports utility as an immunotherapeutic modality for treating cancer —
JERUSALEM and CAMBRIDGE, Mass., December 11, 2017 – Gamida Cell, a leading cellular and immune therapeutics company, today announced final results from the phase I/II trial evaluating NiCord, a product derived from cord blood stem cells, as a stand-alone graft to treat patients with high-risk hematologic malignancies. The study met its primary endpoint, demonstrating rapid neutrophil engraftment with manageable side effects. The company also presented preclinical data for the advancement of natural killer cells (NK cells) as an immunotherapeutic modality for patients with cancer. Both studies were presented today at the annual meeting of the American Society of Hematology (ASH) in Atlanta, GA.
“We are enthusiastic about the data presented today at ASH, including the final results of our NiCord phase I/II study, which support the basis for our global phase III trial of NiCord versus standard unmanipulated cord blood transplantation (UCBT), currently enrolling patients with hematologic malignancies,” said Julian Adams, Ph.D., chairman and chief executive officer of Gamida Cell. “We look forward to further evaluating the potential of NiCord to serve as the graft of choice for the thousands of patients with no matched donor in need of a transplant every year, as well as continuing to progress our other pipeline programs.”
Final Data from Phase I/II Trial of NiCord.
The multicenter phase I/II study evaluated the safety and efficacy of NiCord as a stand-alone graft in 36 patients with high-risk hematologic malignancies, with a primary endpoint of time to neutrophil engraftment following transplantation. Despite varying blood cancer diagnoses and preparative conditioning regimens across patients across centers, improved results were seen in the majority of study participants treated with NiCord.
Final results of the study include the following:
Participants transplanted with NiCord had rapid and durable engraftment of neutrophils and platelets, as well as prompt immune reconstitution:
Median time to neutrophil engraftment was 11 days (95% CI: 9-13 days);
Median time to platelet engraftment was 34 days (95% CI: 32-42 days).
Results from the study participants were compared to a database of matched patients from the Center for International Blood and Marrow Transplant Research (CIBMTR). According to the CIBMTR data, patients who received UCBT had a median time to neutrophil engraftment of 21 days and a median time to platelet engraftment of 46 days.
NiCord demonstrated an acceptable safety profile, with moderate/severe chronic graft vs. host disease (cGvHD) in 9.8% of patients at one year following transplantation. By day 100, 20.2% of participants experienced grade 2-3 bacterial or grade 3 fungal infections.
“Historically, transplantation with cord blood has been limited due to slow engraftment time in patients. We are looking to address this gap, and this study demonstrated rapid and sustained engraftment in study participants by utilizing technology to expand the number of stem cord blood cells in a culture,” said Mitchell Horwitz, M.D., principal investigator, co-study chair and professor of medicine at the Duke Cancer Institute. “These phase I/II data demonstrate the potential to make stem cell transplants accessible to a greater number of patients who do not have a matched donor.”
Preclinical Data from NAM-NK Cell Program
Proof-of-concept data on the application of the company’s proprietary NAM technology to healthy donor natural killer cells (NK cells) as a potential immunotherapeutic approach to treating cancer were highlighted in an oral presentation.
“The use of NK cells as a modality for immunotherapy has been limited by impaired functionality of adoptively transferred NK cells in patients,” said Ronit Simantov, M.D., chief medical officer at Gamida Cell. “We are encouraged by the study results, which demonstrated persistence and proliferation of NAM-NK cells in pre-clinical in vivo models and describe a reliable, scalable culture model for the expansion of functional donor NK cells aimed at clinical use.”
The analysis, which combines data from multiple preclinical studies, validates the approach and is the basis for an investigator-sponsored, phase I clinical trial of NAM-NK Cells in patients with relapsed/refractory multiple myeloma or CD20-positive non-Hodgkin lymphoma.
About NiCord
NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has demonstrated improved efficacy over unmanipulated cord blood, including fewer bacterial and fungal infections and a reduction in duration of hospital stays. NiCord has been granted breakthrough status by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. The ongoing phase III study is evaluating NiCord as a curative treatment for patients with leukemia and lymphoma who have been indicated for an allogeneic stem cell transplant. For more information on NiCord clinical trials, please visit www.clinicaltrials.gov.
About NAM-NK Cells
Gamida Cell expanded the capabilities of its NAM technology to utilize NK cells to create an immunotherapy to treat patients with refractor blood cancers and solid tumors. Through expansion of highly functional NK cells using NAM technology, NAM-NK Cells can be used to harness the immune system to attack cancer. NAM-NK Cell is under phase I development (NCT03019666) in patients with relapsed or refractory B-cell lymphoma and multiple myeloma.
About Gamida Cell
Gamida Cell is a leader in cellular and immune therapeutics dedicated to treating patients with cancer and rare genetic diseases. The company is building a diverse pipeline based on its proprietary NAM technology platform to deliver transformative medicines to patients in need of new treatment options. To learn more about Gamida Cell, including current clinical studies, please visit www.gamida-cell.com and on Twitter, LinkedIn and Facebook.
Elbit Imaging Signs a Definitive Agreement for the Sale of its Rights in the Radisson Hotel Complex in Bucharest, Romania
TEL AVIV, ISRAEL / ACCESSWIRE / November 29, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF, NASDAQ: EMITF) announced today, further to its previous announcements dated November 23, 2017, November 8, 2017 and August 18, 2017 respectively, that its wholly owned indirect subsidiary (the "Vendor") has signed a definitive sale and purchase agreement (the "Agreement") for the sale of its entire shareholding (comprising approx. 98.2% of the outstanding share capital) in the company (the "SPV") which owns the Radisson Hotel Complex in Bucharest, Romania, based on a property value of €169.2 million (the "Transaction"). The Agreement has been signed with an acquisition vehicle jointly owned by two international investment funds (the "Purchaser").
The consummation of the Transaction, which is expected to occur during the month of December 2017, is subject to the fulfillment of a conditions precedent, namely the obtaining by the Purchaser of externally sourced financing.
The estimated net proceeds to be derived from the Transaction (after offsetting the SPV's senior bank loan, working capital and other adjustments, as well as transaction expenses) is expected to be approximately €81 million. Part of the net proceeds equal to €8 million will be used to finance a vendor loan which has been granted for a period of 3 years, bearing interest at the rate of 5% per annum (the "Vendor Loan").
The Vendor Loan will act as collateral for customary post-closing liabilities of the SPV, whereby the Purchaser may offset adjudicated losses which may be incurred by it as a result of a breach of warranties or in respect of certain indemnities given by the Vendor in terms of the Agreement. Additionally, the Company has granted a letter of guarantee in favour of the Purchaser pursuant to which it has undertaken to fulfill the Vendor's undertakings and obligations under the Agreement (if and to the extent that the Vendor fails to do so). At this stage, there can be no certainty that the condition precedent will be met in a timely manner, or that the Transaction will be successfully consummated.
The Company is being exclusively advised by JLL's Hotels & Hospitality Group in London and JLL in Bucharest.
Elbit Imaging Announces Signing an Amendment to the Loan Agreement with Bank Hapoalim
ACCESSWIRE ACCESSWIRENovember 28, 2017
TEL AVIV, ISRAEL / ACCESSWIRE / November 28, 2017 / Elbit Imaging Ltd. (the "Company") (TASE: EMITF, NASDAQ: EMITF) announced today, further to its announcements dated on November 14, 2013, December 30, 2013 and March 22, 2016, regarding the loan agreement with Bank Hapoalim B.M. (the "Bank" and "Loan agreement"), that it has signed an amendment to the Loan Agreement So that the repayment date of the loan will be postponed as detailed below (the "Amendment" and the "Loan").
The balance of the debt as of November 22, 2017 is approximately 12.65 million EURO which were due on November 30, 2017. Upon signing the Amendment, the Company will pay €1,050,000 to the Bank, so that the balance of the Loan will be €11.6 million ("Updated Balance"). The Updated Balance will be repaid to the Bank in monthly installments, according to the following payment schedule:
€1,000,000 will be repaid on December 27, 2017.
The remaining balance of the Loan will be paid no later than January 31, 2018.
The Loan will bear interest at the rate of LIBOR + 4.65%, to be paid by the Company in monthly installments beginning December 27, 2017.
Any funds that the Company will receive from the sale of the Radisson Blu Hotel in Bucharest Romania, and/or from any other sources, will be used for early repayment on account of, or full repayment, as the case may be, of the Loan.
FDA Approves First Study of INSIGHTEC's Exablate Neuro to Open the Blood-Brain Barrier in Glioblastoma Patients
HAIFA, Israel, November 27, 2017 /PRNewswire/ --
INSIGHTEC, the world leader of MR-guided Focused Ultrasound announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a study to evaluate the safety and feasibility of the Exablate Neuro for disrupting the blood brain barrier (BBB) in patients with Glioblastoma.
The blood brain barrier restricts the passage of substances from the bloodstream into the brain, protecting it from toxins. This barrier also prevents the effective delivery of agents, such as medications from reaching their target.
In the current trial, the research team will inject a commonly used sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor. Ultrasound waves will then be delivered to oscillate the microbubbles causing temporary disruption of the blood brain barrier. The trial will include up to 15 subjects with suspected glioblastoma who are scheduled to undergo tumor resection. The Principal Investigator is Graeme F. Woodworth, MD, FACS, Associate Professor of Neurosurgery and Director of The Brain Tumor Treatment & Research Center at the University of Maryland School of Medicine, and Attending Neurosurgeon at the University of Maryland Medical Center in Baltimore, Maryland.
"Clinical research is critical for pushing the boundaries of MR-guided focused ultrasound technology," said Maurice R. Ferré MD, INSIGHTEC's CEO and Chairman of the Board. "INSIGHTEC continues to collaborate with leading researchers to trial new clinical applications that may have significant impact where it matters most - patient lives."
Elbit Imaging Update Regarding The Sale Of The Radisson Hotel Complex In Bucharest, Romania
ACCESSWIRE ACCESSWIRENovember 24, 2017
TEL AVIV, ISRAEL / ACCESSWIRE / November 24, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, further to its announcement dated November 8, 2017, that the Company and the proposed purchaser agreed that the exclusivity period regarding the conduct of negotiations for the sale of its entire indirect shareholdings (98.2%) in the subsidiary company owning the Radisson Hotel Complex in Bucharest, Romania (the "Transaction"), will be extended until November 29, 2017, which the Company anticipates will be the signing and execution date of a definitive Share Purchase Agreement.
The closing and consummation of the Transaction, which is expected to take place during the course of the month of December 2017, is subject to the execution of definitive agreements and the fulfillment of certain conditions precedent to be specified in the definitive agreement. At this stage, there can be no certainty that the conditions precedent will be met in a timely manner, or that the Transaction will be successfully completed.
Elbit Imaging Ltd. Announces The Taiwanese Food And Drug Administration (TFDA) Approved Insightec's Exablate Neuro For The Treatment Of Essential Tremor
TEL AVIV, ISRAEL / ACCESSWIRE / November 24, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today, that Insightec Ltd. ("Insightec") informed that the Taiwanese Food and Drug Administration (TFDA) has approved its Exablate Neuro system for the treatment of essential tremor in patients who do not respond to medication.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions. The treatment is done under Magnetic Resonance Imaging (MRI) guidance which provides real-time imaging and temperature monitoring. Due to its non-invasive nature, the treatment carries minimal risk of surgical complications such as infections or bleeding. The treatment is performed in a single session with no anesthesia, allowing patients to experience immediate tremor improvement.
The approval was based on data from a randomized, double-blind clinical study conducted in eight medical centers in North America and Asia. The study demonstrated the safety and efficacy of Exablate Neuro.
The Company holds approximately 89.64% of the share capital of Elbit Medical Technologies Ltd. (TASE: EMTC-M) (86.64% on a fully diluted basis) which, in turn, holds approximately 31% of the share capital in Insightec (25% on a fully diluted basis).
Elbit Imaging Announces Completion of the Sale of Torun Plaza Shopping and Entertainment Center in Poland
TEL AVIV, ISRAEL / ACCESSWIRE / November 21, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF; NASDAQ: EMITF) announced today, further to its announcements dated June 21, 2017, August 30, 2017, October 25, 2017, and November 6, 2017, that its subsidiary, Plaza Centers N.V. ("Plaza"), has completed the sale of the Torun Plaza shopping and entertainment center in Poland (the "Project") to a private investment fund for a purchase price reflecting a total forecasted value for the Project of Euro 70.6 million, including approximately Euro 1.1 million which may be due as an earn out payment.
Plaza has now received a payment of approximately Euro 14.6 million, while additional Euro 13.7 million shall be paid within 7 days.
The net cash proceeds to Plaza is after taking into account the deduction of the bank loan (approximately Euro 43.3 million), and other working capital adjustments in accordance with the balance sheet of the SPV through which Plaza held the Project. The cash proceeds does not include an additional expected payment of approximately Euro 1.1 million at the end of May 2018 (the "Future Payment") on account of new leases signed by the end of April 2018.
The information regarding the Future Payment is forward-looking information based on Plaza's forecasts and there is no absolute certainty that the said amount will be actually paid to Plaza.
Biotech veteran Julian Adams takes top job at Gamida Cell
by Phil Taylor | Nov 20, 2017 9:00am
Adams is currently chair at Gamida and CSO at Clal Biotech.
Novartis-backed biotech Gamida Cell has named Julian Adams, Ph.D.—its current chair and chief scientific officer of Clal Biotech—as its new CEO.
Adams joins Jerusalem, Israel-based Gamida as the company is in the midst of a phase 3 trial of lead product NiCord, in development as a universal bone marrow transplant option for patients unable to find a suitable matched donor derived from umbilical cord blood, that it hopes to bring to market in 2020.
Adams is making the transition from chair at Gamida—a position he has held for a little over a year—to replace long-serving CEO Yael Margolin, Ph.D., who is staying on as president of the biotech as it tries to bring the lead program to market. To help that process, Adams will drive the expansion of the company into the U.S., with Margolin continuing to lead the firm’s Israeli operations.
The new CEO is a 30-year veteran of the biotech industry, most recently serving as president and chief scientific officer at Clal. He previously held positions at Millennium Pharmaceuticals, where he was a key figure in driving the development of myeloma blockbuster Velcade, as well as Infinity Pharma, Boehringer Ingelheim, LeukoSite and ProScript.
“Julian is one of the most respected leaders in the biotechnology industry and has successfully led the global development and registration of multiple clinical programs,” says Margolin. “This is a dynamic time at Gamida Cell and as we advance the pipeline including our lead candidate, NiCord, we are excited to have Julian join us and support our objectives of expanding Gamida Cell’s global presence in the U.S. market.”
The Israeli company has made no secret of its intention to get a bigger presence in the U.S., which it sees as the first market for its products, saying in the summer that it intended to make multiple senior hires and open an East Coast office. It will be hoping Adams can replicate earlier successes with Velcade and other projects such as Boehringer’s antiviral Viramune.
Gamida started enrolling patients into its pivotal trial of NiCord in the summer and has already picked up breakthrough and orphan drug designations for the therapy, which aims to make BMT more accessible as a treatment option for patients with high-risk blood cancers by doing away with the need to find a matched donor. That is thought to be a challenge for around 70% of the 70,000 patients around the world per year who could be helped by the procedure.
The company will present phase 2 results from its NiCord program at the American Society for Hematology in December, and according to Adams the treatment has “unprecedented potential to create curative cellular and immune therapeutics for a diverse population of patients in need.”
Gamida raised $40 million in June to help it progress the phase 3 trial and bring forward other candidates such as CordIn for diseases such as sickle cell anemia and thalassemia.
Elbit Imaging Announces Release of Plaza Centers N.V.'S Reviewed Interim Condensed Consolidated Financial Statements for the Six Month Period That Ended On June 30, 2017
ACCESSWIRE ACCESSWIRENovember 17, 2017
TEL AVIV, ISRAEL / ACCESSWIRE / November 17, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF; NASDAQ: EMITF) announced, further to its announcement dated October 2, 2017, that Plaza Centers N.V. ("Plaza") (LSE: PLAZ), its subsidiary, announced that Ernst & Young Israel (the auditor of Plaza's consolidated financial statements in accordance with IFRS) has concluded their review of the interim condensed consolidated financial statements of Plaza for the six month period that ended on June 30, 2017 (the "Reviewed Interim Financial Statements").
The Reviewed Interim Financial Statements are available for review on Plaza's website at: http://www.plazacenters.com/index.php?p=financial_reports_2017.
Elbit Imaging Updates Its Previous Announcements Regarding The Terms For The Sale Of The Radisson Hotel Complex In Bucharest, Romania
TEL AVIV, ISRAEL / ACCESSWIRE / November 8, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF, NASDAQ: EMITF) announced today that , further to its announcement dated August 18, 2017 (regarding the conduct of negotiations for the sale of its entire indirect shareholding in the subsidiary company ("SPV") owning the Radisson Hotel Complex in Bucharest, Romania (the "Asset")) after the completion by the proposed purchaser ("Purchaser") of its due diligence investigations, agreement has been reached with the Purchaser so that the estimated net proceeds to the Company deriving from the sale of its holding in the SPV is anticipated to be approximately Euro 80 million, of which a certain amount will be granted as an interest bearing Vendor Loan to the Purchaser.
In addition, the Company and the Purchaser agreed that the signing and execution of the Share Purchase Agreement between the parties shall take place not by later than November 23, 2017 and that the exclusivity period will be extended till that date. The Company anticipates that the closing and consummation of the transaction will take place during the course of the month of December 2017.
The consummation of the transaction is subject to the execution of definitive agreements, the fulfillment of certain conditions precedent to be specified in the definitive agreement, and the successful closing of the transaction. At this stage there can be no certainty that the definitive agreements will be signed on the terms indicated above, that the conditions precedent will be fulfilled in a timely manner, or that transaction will be successfully completed.
Elbit Imaging Announces Update Regarding The Sale Of The Torun Plaza Shopping Center In Poland
TEL AVIV, ISRAEL / ACCESSWIRE / November 6, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, in further to its announcements dated June 21, 2017, August 30, 2017 and October 25, 2017 that its subsidiary, Plaza Centers N.V. ("Plaza") has signed a definitive Share Purchase Agreement regarding the sale of shares in the SPV holding of the Torun Plaza shopping center in Poland to an investment fund. Plaza anticipates that the closing and settlement of the transaction will take place by the end of November.
Gamida Cell to Present New Data from Key Programs at 2017 ASH Annual Meeting
Phase 2 NiCord Data in Allogeneic Bone Marrow Transplant and Preclinical Data for NK Cells to be Presented in Oral Presentations
November 01, 2017 09:00 AM Eastern Daylight Time
JERUSELUM--(BUSINESS WIRE)--Gamida Cell, a leading cellular and immune therapeutics company, today announced that two oral presentations on new data from the company’s pipeline programs will be presented during the 59th Annual Meeting of the American Society for Hematology (ASH).
The oral presentations will highlight safety and efficacy data for a completed phase 2 study of the company’s lead clinical asset, NiCord, as a single cord blood graft, and proof-of-concept data for the advancement of natural killer cells (NK cells) as an immunotherapeutic modality for patients with cancer. These abstracts are now available on the ASH conference website.
Oral Presentations
NiCord Single Unit Expanded Umbilical Cord Blood Transplantation (UCBT): Final Results of a Multicenter Phase I/ II Trial
Date & Time: Monday, December 11, 2017 at 4:30 p.m. ET
Session Name: Clinical Allogeneic Transplantation: Results: Donor Selection in the Haplo Transplant Era
Abstract Number: 847
Location: Georgia World Congress Center, Building C, Level 2, Room C202-204
Enhanced In Vivo Persistence and Proliferation of NK Cells Expanded in Culture with the Small Molecule Nicotinamide: Development of a Clinical-Applicable Method for NK Expansion
Date & Time: Monday, December 11, 2017 at 11:00 a.m. ET
Session Name: Cell Collection and Processing: Optimization of Hematopoietic Graft Using Small Molecules in Culture
Abstract Number: 657
Location: Georgia World Congress Center, Building B, Level 2, Room B216-217
Elbit Imaging Announces Release of Plaza Centers N.V.'s Audited Consolidated Financial Statements for the Year 2016
TEL AVIV, ISRAEL / ACCESSWIRE / October 30, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF; NASDAQ: EMITF) announced, further to its announcement dated May 15, 2017, that Plaza Centers N.V. ("Plaza") (LSE:PLAZ), its subsidiary, published its audited consolidated financial statements for the year 2016 (the "Financial Statements").
The audited consolidated financial statements are available for review on Plaza's website at: http://www.plazacenters.com/index.php?p=financial_reports_2017.
INSIGHTEC's Exablate Neuro Named Best Medical Technology at Esteemed Prix Galien Awards 2017
HAIFA, Israel, Oct. 27, 2017 /CNW/ - INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS), has been awarded Best Medical Technology for Exablate Neuro by The Galien Foundation. Exablate Neuro is an innovative medical technology that uses focused ultrasound coupled with MR imaging (MRgFUS), to precisely target and treat areas deep within the brain through an intact skull.
The prestigious Prix Galien awards recognize excellence in scientific innovations that improve the state of human health. The Best Medical Technology award confirms INSIGHTEC's vision of transformative healthcare and the company's determination to improve the daily lives of patients living with essential tremor.
"It's a great honor to receive this award, which recognizes our dedication to researching and developing a non-invasive medical treatment," said INSIGHTEC's CEO and Chairman of the Board, Maurice R. Ferré MD. "Our pursuit of innovation is not only driven by our founder Kobi Vortman, but also by the leading neurosurgery centers which have adopted the Exablate Neuro around the world. This is an exciting time for INSIGHTEC and spurs on our commitment to supporting healthcare professionals, deliver treatments which truly improve the lives of people worldwide."
Having accepted the award at The American Museum of Natural History in New York City, INSIGHTEC's Vice President of Marketing, Xen Mendelsohn Aderka added "To be seen as an innovator whilst in the presence of so many renowned figures in the pharmaceutical, biomedical and medical technology industry, is a great accolade. We thank the judges for acknowledging the hard work and dedication of our team."
The U.S. Food and Drug Administration (FDA) approved Exablate Neuro in July 2016 for the non-invasive treatment of patients with essential tremor who had not responded to medication. Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom and for these patients, performing everyday tasks can seem nearly impossible and greatly impacts on their quality of life.
About INSIGHTEC
INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world. For more information, please visit: http://www.insightec.com The Neuravive website for essential tremor patients is http://usa.essential-tremor.com.
Elbit Imaging Announces Update Regarding the Sale of the Torun Plaza Shopping Center in Poland
TEL AVIV, ISRAEL / ACCESSWIRE / October 25, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF, NASDAQ: EMITF) announced today, in further to its announcements dated June 21, 2017 and August 30, 2017, that its subsidiary, Plaza Centers N.V. ("Plaza"), has concluded the final terms regarding the sale of shares in the SPV holding of the Torun Plaza shopping center in Poland ("Asset") to an investment fund.
The signing of the transaction has been set for the beginning of November 2017, with final closing and settlement expected by the end of November, conditional on the buyer receiving bank financing, which was already approved and is expected to be concluded during November 2017.
The agreement reflects an estimated value for the Asset of €70.6 million including an additional forecasted payment at the end of May 2018 for new leases signed by the end of April 2018 (if and to the extent that such agreements will be signed) ("earn out period").
The total expected net proceeds to Plaza, following the deduction of the related bank loan, earn out period, and other working capital adjustments in accordance with the balance sheet of the SPV, are estimated to be approximately €29.4 million.
The transaction is subject to the actual signing of a definitive agreement, the fulfillment of all conditions precedent that will be determined in the definitive agreement and the closing of the transaction.
About Elbit Imaging Ltd.
Elbit Imaging Ltd. Announces FDA Approval to Initiate Phase III Pivotal Study of Insightec's Exablate Neuro for the Treatment of Patients with Parkinson's Disease
TEL AVIV, ISRAEL / ACCESSWIRE / October 24, 2017 / Elbit Imaging Ltd. (TASE: EMITF; NASDAQ: EMITF) ("Elbit" or the "Company") announced today that Insightec Ltd. ("Insightec") has received approval from the U.S. Food and Drug Administration (FDA) to initiate a Phase III clinical trial (pivotal study) of the Exablate Neuro for treating dyskinesia symptoms or motor fluctuations of advanced Parkinson's disease patients who have not responded to medication. The principal investigator is Howard Eisenberg, MD, from the University of Maryland.
Insightec estimates that Parkinson's disease afflicts millions of people worldwide, including approximately one million in the United States alone, with 60,000 additional diagnoses each year. Treatment with the Exablate Neuro is intended to improve motor function and reduce dyskinesia, one debilitating symptom that presents as uncontrolled, involuntary movement of the arms and/or legs.
Exablate Neuro uses focused ultrasound to target and ablate tissue deep in the brain with no surgical incisions. MR imaging guides the treatment planning and delivers thermal feedback for real-time monitoring. In the current clinical trial, the target is to burn a point in the GPI area, which is known to be involved in the regulation of voluntary movement.
The Company holds approximately 89.68% of the share capital of Elbit Medical Technologies Ltd. (TASE: EMTC-M) (86.5% on a fully diluted basis) which, in turn, holds approximately 31% of the share capital in Insightec (25% on a fully diluted basis).
Elbit Imaging Announces Release Of Plaza Centers N.V.'S Financial Statements (Not Reviewed) For The Six Month Period That Ended On June 30, 2017
TEL AVIV, ISRAEL / ACCESSWIRE / October 2, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced that Plaza Centers N.V. ("Plaza") ( LSE: PLAZ), its subsidiary, published its financial statements (not reviewed) for the six-month period that ended on June 30, 2017 (the "Financial Statements").
Plaza's Financial Statements (not reviewed) are available on the website of the London Stock Exchange at the following link:
http://www.londonstockexchange.com/exchange/news/market-news/market-news-detail/PLAZ/13381029.html
Elbit Imaging Announces Consumation Of Two Transactions By Plaza's Centers N.V.
TEL AVIV, ISRAEL / ACCESSWIRE / October 2, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today that its subsidiary, Plaza Centers N.V. ("Plaza"), announced the consummation of two transactions, as follows:
Plaza has received the final payment of €1,000,000 for the sale of the MUP plot in Belgrade, Serbia. The final payment comprises the €400,000 purchase price for the asset, together with an additional €600,000 which had been conditional upon the purchaser receiving development rights for the plot of at least 69,000 sqm above ground.
Plaza has also concluded the transaction with an international investor, NEPI Rockcastle (the "Buyer"), on the termination of land use right registered in favour of Kerepesi 5 Irodaépület Kft, Plaza subsidiary ("K5") in respect of a ca. 21,788 sqm plot in Budapest, Hungary. Simultaneous with the termination of the land use right, the parties also terminated the preliminary easement agreement which created certain easement rights in favour of K5 over the Arena Plaza plot. The termination of the land use right and the termination of the easement became effective from 28 September 2017. In consideration for termination of the land use right and the preliminary easement agreement, K5 received the net sum of €2,500,000.
Elbit Imaging Announces Receipt Of Further Payment Following The Sale Of Belgrade Plaza (Visnjicka) By Its Subsidiary, Plaza Centers
TEL AVIV, ISRAEL / ACCESSWIRE / September 14, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, in further to its announcements dated on March 2, 2017, regarding the completion of the sale of Belgrade Plaza, that Plaza Centers N.V. ("Plaza") (LSE:PLAZ), an indirect subsidiary (45%) of the Company, has received a further payment of €13.4 million from the Purchaser, having met certain pre-agreed milestones.
About Elbit Imaging Ltd.
Elbit Imaging Ltd. operates in the following principal fields of business: (i) Commercial centers - initiation, construction, and sale of commercial centers and other mixed-use property projects, predominantly in the retail sector, located in Central and Eastern Europe. In certain circumstances and depending on market conditions, the Group operates and manages commercial centers prior to their sale. (ii) Hotel - operation and management of the Radisson hotel complex in Bucharest, Romania. (iii) Medical industries and devices - (a) research and development, production and marketing of magnetic resonance imaging guided focused ultrasound treatment equipment, and (b) development of stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. (iv) Plots in India - plots designated for sale initially designated to residential projects.
Elbit Imaging Announces Update Regarding the Sale of Torun Plaza Shopping and Entertainment Center in Poland, by its Subsidiary, Plaza Centers
TEL AVIV, ISRAEL / ACCESSWIRE / August 31, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, in further to its announcement dated June 21, 2017, regarding the sale of Torun Plaza commercial center in Poland, that the completion of the transaction has been postponed and is now expected to conclude in the fourth quarter of this year.
Gamida Cell Announces First Patient Transplanted in Phase 1/2 Study of CordIn for Severe Aplastic Anemia and Hypoplastic MDS
This investigator initiated study is being conducted in collaboration with the U.S. National Heart, Lung and Blood Institute (NHLBI)
JERUSALEM, Aug. 21, 2017 /PRNewswire/ -- The first subject has been transplanted in an investigator-initiated study of Cordin™ for patients with severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS) who have no available matched donor. CordIn™ is produced by Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases.
The study is being conducted by Dr. Richard W. Childs, Clinical Director of the National Heart, Lung, and Blood Institute's (NHLBI) Division of Intramural Research in the National Institutes of Health (NIH) and Assistant United States Surgeon General.
"Severe aplastic anemia and myelodysplastic syndrome are life-threatening bone marrow disorders with few optimal treatment options. Many patients with these diseases fail conventional therapy. Amongst those with severe AA who respond to conventional treatment, up to 30% will suffer relapse or evolve to myelodysplastic syndrome or leukemia which is often fatal," said Dr. Childs. "Promising preclinical and clinical data have shown the efficacy of Gamida Cell's ex-vivo hematopoietic stem cell technology. Based upon exciting prior data, we are now conducting a clinical trial at the NHLBI testing whether umbilical cord blood transplantation using CordIn can be used to improve the results of conventional cord blood transplantation for patients with these life-threatening conditions who lack an available matched donor," said Dr. Childs.
"The study, announced today, represents a significant milestone for Gamida Cell, as we continue our important mission of expanding access to curative transplantation in patients for which engraftment has been historically difficult," said Gamida Cell President and CEO Dr. Yael Margolin. "We highly value our collaboration with the NIH and with Dr. Childs, who is one of the world experts in the field, and we look forward to evaluating the potential of CordIn in patients with life-threatening hematologic diseases."
The study is titled Unrelated Umbilical Cord Blood Transplantation for Severe Aplastic Anemia and Hypo-plastic MDS Using CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells to Expedite Engraftment and Improve Transplant Outcome. The primary endpoint of the Phase 1/2 trial is prompt and durable cord engraftment in patients transplanted with CordIn. Additional information can be accessed here on the Clinicaltrials.gov website.
About CordIn
CordIn is in development for patients with rare genetic diseases where bone marrow transplantation is clinically established as a potential cure but no fully matched donors are available. CordIn is also currently being evaluated in a Phase 1/2 study in patients with sickle cell disease, a rare genetic disease of red blood cells.
Nice market reaction to PR in TASE
http://www.tase.co.il/Eng/Management/GeneralPages/Pages/SimpleSearchResult.aspx?objectId=&objectType=&securityType=&searchTerm=EMITF
Should the deal be finalised i bet the
share price will zoom another 30%.
Fingers crossed!!!
A Subsidiary Of Elbit Imaging Has Signed A Non-Binding Letter Of Intent With An International Investment Fund To Sell Its Shareholdings In The Radisson Complex In Bucharest, Romania
TEL AVIV, ISRAEL / ACCESSWIRE / August 18, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today, that a Company's wholly owned indirect subsidiary ("Seller") has signed a non-binding letter of intent ("LOI") with an international investment fund (the "Purchaser") to sell its entire shareholding (approximately 98.2%) in a company owning the Radisson Complex in Bucharest, Romania ("Target Shares"), based on a Property Value of approximately Euro 177.5 million (the "Transaction").
The consummation of the Transaction, which expected to occur within three to four months from the signing of the LOI, is subject to the fulfillment of certain conditions, including inter alia: (i) the successful conclusion by the Purchaser of its due diligence investigations; (ii) the signing of a binding share purchase agreement ("SPA"); and (iii) the fulfillment of certain conditions precedent as will be finally determined in the SPA, including obtaining the approval of the Romanian Competition Council, and the obtaining of externally sourced financing by the Purchaser.
The net proceed to the Company will be calculated following the repayment of the secured bank loan, customary working capital adjustments and other agreed adjustments as of the closing date.
During the period starting on the date of the signing of the LOI and terminating on the earlier to occur of the date of the execution of the SPA, or the date of the termination of the LOI by either party (the "Exclusivity Period"), the Seller and its representatives have undertaken to refrain from negotiating with any other third party other than the Purchaser for the purpose of selling the Target Shares or the Radisson Complex.
As of the date hereof, there can be no certainty that the SPA will be signed and/or that the Transaction will be consummated.
About the Radisson Complex
The Radisson Complex is located in the heart of Bucharest, Romania with 763 rooms. The Complex includes the Radisson Blu hotel which is the leading five stars hotel in Romania, with a capacity of 487 rooms, the newly renovated four star Park Inn Hotel with a capacity of 276 rooms and 7,200 sqm of commercial area that includes the biggest Casino in Bucharest, a fitness center and fashion shops.
The Radisson Blu hotel and the Park Inn hotel are managed by Rezidor, which is part of Carlson Rezidor Hotel Group.
About Elbit Imaging Ltd.
Cell therapy firm in flurry of activity as hope nears for bone marrow patients.
Jerusalem-based biotech pioneer Gamida hopes to launch its first product for blood cancer patients in 2020
BY SHOSHANNA SOLOMON August 1, 2017,
http://www.timesofisrael.com/gamida-in-flurry-of-activity-as-hope-nears-for-bone-marrow-patients/
The excitement at Jerusalem-based Gamida Cell, a maker of cell and immune therapy technologies, is palpable.
The biotechnology company has started enrolling patients for a last-stage clinical trial for a drug it believes will help increase the success of bone marrow transplants in blood cancer patients, and help them better withstand the ordeal of the lifesaving procedure.
The patients are being enrolled in the US, Spain, The Netherlands and Singapore. Should the results of the trial, as hoped, be positive, that would lead to the launch of a commercially available product in 2020, Gamida Cell’s CEO Yael Margolin said in an interview with The Times of Israel.
“We are at an exciting transition point, and moving from being a research and development firm, based in Israel, to an international commercial firm,” said Margolin — who has headed the company for the past 12 years — in her sun-drenched office at the biotech firm’s headquarters in Jerusalem. “We need to prepare to commercialize the product. We are now looking at various sites in Israel for a new manufacturing facility and looking to employ some 100 people.” These workers will be added to the 40 already employed in Jerusalem.
Preliminary clinical data has already revealed that the risk of their leading product for blood cancers, NiCord, not meeting its targets in the Phase 3 trial, “is low,” added Margolin.
The drug has already received a breakthrough therapy designation by the US Food and Drug Administration (FDA). The designation is given to a drug that is meant to treat a serious or life-threatening condition, and where preliminary clinical evidence indicates that it may demonstrate a substantial improvement on at least one clinically significant target (endpoint) over other available therapies. The designation also entitles the company to get more and closer FDA guidance to help bring the treatment faster to patients.
The combination of the low clinical risk — based on the previous trial results — and the lower regulatory risk, because the drug is being developed in close collaboration with the FDA, has spurred the company into a flurry of activity that is aimed at scaling up its production facilities to get ready for the day NiCord hits the markets.
The company said last month it raised $40 million from investors including Novartis, which is already a major shareholder in the firm. The funds will support the ongoing Phase 3 stage for NiCord. The company also announced, on July 20, that it received a $3.5-million grant from the Israeli government that will support the further development of NiCord and other drugs that the company is developing, including therapies for sickle cell disease and for blood and solid cancers. Gamida has also appointed a new chief medical officer, Ronit Simantov, who will be based in the US.
“The first market for our drug will be the US,” Margolin said.
NiCord, which would be the first drug developed by Gamida to hit the market — if the trial goes well — is believed to increase the chances of a successful bone marrow transplantation process for patients who do not have a rapidly available, fully matched, bone marrow donor.
Today some high-risk blood cancers cannot be cured unless patients undergo a bone marrow graft. For that purpose, a perfect — 100-percent — match needs to be found, a process that in the US takes an average of three to four months, if the patient is lucky. Sometimes, no match is found.
“There are 70,000 patients a year globally with blood cancers who need a bone marrow transplant,” Margolin said. “It is a rare condition. But for that transplant, you need a donor with full tissue matching. As many as 50% don’t get to the transplant phase, because they haven’t found a matching donor in time.”
Umbilical cord blood — collected from newborn babies — contains stem cells, which can be used to treat diseases. Today cord-blood banks around the world store the cord blood. It great advantage is that because it is so “young,” there is no need for a full tissue matching.
“The big advantage with umbilical blood is that you don’t need full tissue matching; a partial match is enough,” Margolin continued. “Most patients generally find at least one unit of cord blood that partially matches them.”
The problem is that the quantity of cells in each unit is not huge, and it is the number of stem cells in the cord blood that is critical to the success of transplantation.
“Our idea is to leverage the advantages of the cord blood and overcome the limitations of the cell number by applying our own platform technology, called NAM Technology,” added Margolin. “This technology allows us to take one unit of umbilical cord blood and expand the number of stem cells within it and enhance their performance.”
Gamida Cell selects the stem cells from the unit and puts them in a culture together with a molecule called Nicotinamide (NAM) — a form of Vitamin B3 — and adds other ingredients. This culture, to which the firm holds intellectual property rights, increases the number of stem cells, and enhances their functionality, Margolin said.
The cells are then harvested from the culture, frozen in a small blood-bag in a final formulation that is ready for infusion, and then shipped to hospitals via couriers. Doctors thaw the product by the bedside of the patients and infuse the fluid into them.
A three-week process
“From start to finish, our process takes three weeks,” Margolin said. “The average search for a bone marrow match takes three to four months.”
The clinical trial underway is enrolling patients aged 16 years and older.
An earlier trial of the drug showed that patients transplanted with NiCord showed a more rapid engraftment — the amount of time needed for the development of a minimal amount of white blood cells, or neutrophils, in the blood. That minimum amount indicates the patient is now less vulnerable to infections and bleeding following the transplant, and is an indication of success.
In the pilot phase clinical trials, the median time to neutrophil engraftment with NiCord was 11 days, compared to three to four weeks in patients who received standard umbilical cord blood. The results in a study conducted at Duke University also showed a lower rate of infection – 22% vs 54%; and a lower duration of hospitalization compared to standard umbilical cord engraftment, Margolin said.
Now the company is enrolling patients for its larger, Phase 3 multi-national, randomized controlled registration study. And in February it said it had already transplanted its first patient, as part of the trial.
“We hope to publish positive topline data from the Phase3 study in the first half of 2019 and launch the product on the market in 2020,” she said.
A metal barrel — within which was a frozen bag of umbilical cord stem cells — was waiting to be picked by a courier in the lobby of the Gamida Cell offices, ready to be thawed and injected into a patient somewhere around the world.
“We have a sophisticated infrastructure that coordinates everything between the cord bank blood and our manufacturing site and the hospital where the patient is to be treated,” Margolin continued. “This infrastructure is 100% robust, but we plan to scale this up toward commercialization.”
The $40 million in funds the company raised last month is expected to last until late 2019. After that, she added, “all options” are on the table: an IPO, or teaming up with a strategic partner, are both possibilities for the future.
INSIGHTEC ANNOUNCES EXPANDED REACH OF MR-GUIDED FOCUSED ULTRASOUND
August 16, 2017
INSIGHTEC announced today that worldwide adoption of MR-guided focused ultrasound continues to gain momentum as Exablate Neuro patient treatment numbers surpass the 1000 mark. Medical facilities are ramping up their MR-guided focused ultrasound service and essential tremor patients are now being treated on a weekly basis at many sites.
Exablate Neuro delivers focused ultrasound beams without any surgical incisionto ablate, or destroy, the Vim of the thalamus, the tiny area of the brain thought to be responsible for causing tremors.
Regulatory approvals in the USA, Canada, Japan, Europe, Israel and Korea contributed to the accelerated adoption of focused ultrasound treatments worldwide. One year ago, on July 11, 2016, the U.S. Food and Drug Administration approved Exablate Neuro as the first focused ultrasound device to treat essential tremor in patients who have not responded to medication.
“Having this newly established treatment at Weill Cornell Medical Center allows us to offer a safe and effective, incisionless treatment for patients with disabling tremor,” said Dr. M. Kaplitt, Neurosurgeon at Weill Cornell Medical Center.
Essential tremor is a very common neurological condition that causes shaking of the hands, as well as other parts of the body. For most people, the severity of the tremor increases over time to the point where performing everyday tasks is impossible. This can have a significant impact on a person’s quality of life. If medications fail to control symptoms, it may also be treated with radiation or invasive surgical procedures including traditional thalamotomy or deep brain stimulation.
Focused ultrasound is an incision-less treatment option that minimizes risk of complications such as infection and bleeding, reduces time spent recovering and rapidly returns patients to their lives.
“This past year, since having the focused ultrasound treatment, has simply been life-changing for me and my entire family”, commented Gregg Ley. Gregg was treated one year ago at Swedish Medical Center in Seattle, Washington during the FDA pivotal study designed to evaluate the safety and efficacy of Exablate Neuro for the treatment of essential tremor in subjects for whom medications were not effective.
Over 30 Exablate Neuro systems are now actively treating patients for essential tremor as well as various research protocols for additional indications in 10 countries.
“We are well on our way to changing the lives of millions of people living with essential tremor in the US and around the world”, said Maurice R. Ferré MD, INSIGHTEC’S CEO and Chairman of the Board. Ferré is looking ahead to what the future holds for INSIGHTEC. “We are seeing significant demand from both the neurosurgery and patient communities for focused ultrasound. Physicians are excited by the cutting edge technology, while patients are getting their lives back without a single cut.”
About INSIGHTEC
INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company’s non-invasive platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world. For more information, please visit: www.insightec.com. The Neuravive website for essential tremor patients is www.essential-tremor.com.
EMITF has to sell all properties
in order to serve its huge debts to the
bondholders.
Myself i have no interest in the
company itself but in its two
granddaughter companies InsighTec and
Gamida Cell. In fact i am mostly
invested in EMTC traded in TASE
only, the parent company of both:
ELBIT MEDICAL TECHNOLOGIES LTD
http://www.tase.co.il/Eng/Management/GeneralPages/Pages/SimpleSearchResult.aspx?objectId=&objectType=&securityType=&searchTerm=Emtc
BTW, EMITF is traded in TASE as
well as in the Naz
http://www.tase.co.il/Eng/Management/GeneralPages/Pages/SimpleSearchResult.aspx?objectId=&objectType=&securityType=&searchTerm=EMITF
It seems like they are going to sell off everything but the medical side.
In my quick reads, it is the real estate stuff with all the debts.
A debt-free company with ownership in medical should prove more valuable IMHO.
Elbit Imaging Announces Completing the Sale of Plots in Timisoara and Constanta, Romania, by its Subsidiary, Plaza Centers
TEL AVIV, ISRAEL / ACCESSWIRE / August 7, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF, NASDAQ: EMITF) announced today, that Plaza Centers N.V. ("Plaza") (PLAZ.L), an indirect subsidiary of the Company, has completed the sale of a plot totaling approximately 32,000 sqm in Timisoara, Romania, for Euro7.25 million and a plot totaling approximately 30,000 sqm in Constanta, Romania, for Euro 1.3 million.
Posted in Medical Device Business
by mthibault on August 4, 2017
http://www.mddionline.com/blog/devicetalk/exablate-neuro
Elbit Imaging Ltd. Announces Cessation of Doron Moshe as CEO
TEL AVIV, ISRAEL / ACCESSWIRE / July 31, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, that Mr. Doron Moshe will cease to serve as the Company's Chief Executive Officer (CEO) effective as of January 1, 2018.
Mr. Moshe and the Company have reached a mutual understanding regarding Mr. Moshe termination of office, considering the Company's business status and its future objectives.
Mr. Moshe serves as the Company's CEO since April 1, 2016 and served as the Company's acting CEO from April 1, 2015.
Gamida Cell Announces $3.5 Million Grant from the Israeli Government
Non-dilutive funding follows the recent closing of a $40 million round
Combined financing will support further development and commercialization of NiCord®, a breakthrough designation product for blood cancers
JERUSALEM, July 20, 2017 /PRNewswire/ -- Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that it has been awarded a grant of $3.5 million from the Israel Innovation Authority (IIA) of the Israeli Ministry of Economy and Industry. The mission of the IIA is to encourage innovation and entrepreneurship in various industries, including science and technology, while stimulating economic growth.
The grant follows the recent closing of a $40 million financing round by the Company and its recent establishment of an executive presence in the U.S. http://www.gamida-cell.com/press_release/gamida-cell-inc-names-ronit-simantov-m-d-as-chief-medical-officer/
The non-dilutive funding, combined with the $40 million financing round, will support Gamida Cell's ongoing research and development efforts, including its Phase 3 registration study of NiCord® for hematological malignancies, such as leukemia and lymphoma, its clinical trials of CordIn® for sickle cell disease and thalassemia, and its NK cell therapy for blood and solid cancers.
"We are very pleased with the Israeli government's ongoing contributions and support in helping to bring Gamida Cell's very important products to market," said Dr. Yael Margolin, Gamida Cell's president and CEO. "The grant provides additional funding for the development and commercialization of NiCord®, as well as our additional pipeline programs."
About Gamida Cell
Gamida Cell is a world leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company's pipeline of products are in development to treat a wide range of conditions including cancer, genetic hematological diseases such as sickle cell disease and thalassemia, bone marrow failure syndromes such as aplastic anemia, genetic metabolic diseases and refractory autoimmune diseases. Gamida Cell's shareholders include Novartis, Clal Biotechnology Industries, Elbit Imaging, Israel Healthcare Ventures, Shavit Capital Fund, VMS Investment Group, Denali Ventures, Auriga Ventures and Israel Biotech Fund. For more information please visit www.gamida-cell.com.
Press Contact:
Marjie Hadad
MH Communications
+972-54-536-5220
marjierhadad@gmail.com
Elbit Imaging Announces Results of its Bondholders Meeting Held on July 10, 2017
TEL AVIV, ISRAEL / ACCESSWIRE / July 13, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE: EMITF, NASDAQ: EMITF) announced today, in further to its announcement dated on July 3, 2017, that at its bondholders meeting held on July 10, 2017, the resolution to approve an extension to submit the Company's annual financial statements for the year of 2016 until the December 31, 2017 and to waive the bondholders' immediate repayment right, pursuant to the delay in publications of the financial statements (the "Resolution"), was approved by the required majority of the series "I" bondholders.
Series "H" bondholders already approved the Resolution by the required majority in the meeting held on July 3, 2017. Therefore, their approval became valid as result of the series "I" bondholders Resolution.
Why we getting some action today? Anyone knows?
A lost case. I promised myself to
never reply again to his queries.
He has been answering you all along. Why not actually read the items he is posting, and then you will know what is happening with the company too!
VC-backed Gamida Cell hires chief medical officer
July 10, 2017 By Iris Dorbian
Jerusalem-based Gamida Cell, a provider of cellular and immune therapies that treat cancer and orphan genetic diseases, has appointed Dr. Ronit Simantov as its new chief medical officer. Previously, Simantov was vice president and head of global medical affairs at Pfizer Oncology. Gamida’s backers include Novartis, Clal Biotechnology Industries, Elbit Imaging, Israel Healthcare Ventures, Shavit Capital Fund, VMS Investment Group, Denali Ventures, Auriga Ventures and Israel Biotech Fund.
JERUSALEM, Israel and NEW YORK, July 10, 2017 /PRNewswire/ — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that Ronit Simantov, M.D. will join the Company as its new Chief Medical Officer (CMO) based in the U.S.
“We are delighted to welcome Dr. Simantov to Gamida Cell. We are now enrolling patients to the Phase 3 registration study of our FDA Breakthrough Designation product, NiCord®. Dr. Simantov will play a central role in the late stage development program and associated activities geared towards commercialization of NiCord, backed by the recently announced $40 million financing,” said Gamida Cell president and CEO Yael Margolin, PhD.
Gamida Cell Chairman of the Board Julian Adams, PhD said, “We are certain that Dr. Simantov’s background and experience in the industry will be a valuable addition to Gamida Cell. This is also the first step we are taking towards establishing a U.S. executive presence and transitioning Gamida Cell into a global commercial organization.”
“Gamida Cell has an innovative pipeline of cellular and immune therapies with the potential to address significant patient needs in cancer and hematologic disease,” said Dr. Simantov. “I look forward to leading the clinical development and regulatory path to approval of NiCord, a novel graft modality for patients undergoing bone marrow transplantation.”
Dr. Simantov brings more than 20 years of experience in research, development, registration, and launch of hematology and oncology drugs. Prior to joining Gamida Cell, Dr. Simantov was Vice President and Head of Global Medical Affairs at Pfizer Oncology. Previous roles included Vice President, Head of Clinical Development at OSI Pharmaceuticals, Chief Medical Officer at CuraGen Corporation, and Global Clinical Leader in Oncology at Bayer HealthCare Pharmaceuticals. Dr. Simantov holds a B.A. from Johns Hopkins University in Baltimore, Maryland, and received her MD from New York University School of Medicine. She completed a residency in Internal Medicine and a Fellowship in Hematology and Oncology at New York-Presbyterian Hospital/Weill Cornell Medical College, where she served on the academic faculty for seven years before joining the pharmaceutical industry. Dr. Simantov has co-authored more than 40 peer-reviewed journal manuscripts.
About NiCord
NiCord is a stand-alone graft derived from a single umbilical cord blood unit which has been expanded in culture and enriched with stem and progenitor cells using Gamida Cell’s proprietary NAM technology. NiCord leverages the advantages of umbilical cord blood, which does not need full tissue matching to the patient and can therefore be available to practically all patients in need. It also aims to address the major barrier of umbilical cord blood transplantation – delayed hematopoietic recovery – by demonstrating an advantage with a primary endpoint that is clinically meaningful.
Results from the Phase 1 and Phase 2 studies of NiCord were published in the April 2017 edition of the Journal of Biology of Blood and Marrow Transplantation (BBMT, the official publication of the American Society for Blood and Marrow Transplantation) entitled “Transplantation of Ex Vivo Expanded Umbilical Cord Blood (NiCord) Decreases Early Infection and Hospitalization”.
Gamida Cell is currently enrolling patients in an international, multi-center, Phase 3 registration study of NiCord as a graft for bone marrow transplantation for patients with blood cancer who do not have a rapidly available fully matched donor. The Company announced in February 2017 that the first patient in the study had been transplanted. NiCord has an FDA Breakthrough Therapy Designation as well asFDA and EMA orphan drug designations, the most recent granted in March 2017. For more information on enrolling transplantation centers and study inclusion and exclusion criteria please click here.
About Gamida Cell
Gamida Cell is a world leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases. The company’s pipeline of products are in development to treat a wide range of conditions including cancer, genetic hematological diseases such as sickle cell disease and thalassemia, bone marrow failure syndromes such as aplastic anemia, genetic metabolic diseases and refractory autoimmune diseases. Gamida Cell’s shareholders include Novartis, Clal Biotechnology Industries, Elbit Imaging, Israel Healthcare Ventures, Shavit Capital Fund, VMS Investment Group, Denali Ventures, Auriga Ventures and Israel Biotech Fund. For more information please visit www.gamida-cell.com.
Midas..can you answer my question from my previous post? TIA
Elbit Imaging Announces That Gamida Cell's has Completed a $40m Private Financing
TEL AVIV, ISRAEL / ACCESSWIRE / July 10 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today, in further to its announcements dated March 8 and June 19, 2017, that it was informed by Gamida Cell Ltd. ("Gamida"), an indirect associate of the Company, regarding the following:
An approximately $40 million private financing investment has been completed ("the Investment").
The Investment was led by Shavit Capital Fund joined by the pharmaceutical company Novartis and additional investors, including VMS Investment Group, Israel Biotech Fund, IHCV and Clal Biotechnology Industries (the "Investors").
Following the Investment, preferred shares were allotted to the Investors, based on $120 million pre-money valuation to Gamida Cell (the "Allotted Shares").
In addition, the investors received options to preferred shares in the amount of 60% of the Allotted Shares. The exercise price of the options is 120% of the shares price which has been paid on the Investment closing date. The options will expire 5 years after the Investment closing date.
The Company's subsidiary, Elbit Medical Technologies Ltd. (TASE:EMTC-M) (89.7% and 86.1% on a fully diluted basis), ("Elbit Medical") didn't take part in the Investment. Following the closing of the Investment, Elbit Medical holds approximately 17.87% of the share capital in Gamida (13.63% on a fully diluted basis). As of the date herein, there is no certainty that the Investors will exercise their options.
Gamida informed the Company that the Investment proceeds will be used to complete Nicord ©'s Phase III clinical trial and to prepare for product commercialization by expanding its in-house manufacturing capacity, expanding Gamida's presence in the US, as well as continuing to develop additional pipeline products.
Gamida Cell has commenced Phase III trial of NiCord© for patients with blood cancer and Lymphoma Cancer. NiCord© has an FDA Breakthrough Therapy Designation as well as FDA and EMA orphan drug designations. In addition, Gamida Cell is conducting a Phase II trial for patients with hematological diseases such as sickle cell disease.
As of today, NiCord© is in a clinical stage of development and there is no certainty that it will be marketed on a commercial basis.
Hey Midas..so what's next for EMITF? Bankruptcy? Israel juggernaut? Any ideas buddy?
Elbit Imaging Announces Results of Its Bondholders Meetings Held on June 27, 2017
TEL AVIV, ISRAEL / ACCESSWIRE / July 3, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (EMITF) (EMITF) announced today that at its bondholders meetings (one meeting for series "H" bondholders and second meeting for series "I" bondholders) held on June 27, 2017, the resolution to approve an extension to submit the Company's annual financial statements for the year of 2016 until December 31, 2017 and to waive the bondholders' immediate repayment right, pursuant to the delay in publications of the financial statements (the "Resolution"), was not approved by the required majority of the series "I" bondholders.
Series "H" bondholders did approve the Resolution by the required majority. However, their approval is not valid so long as the series "I" bondholders do not approve the Resolution. The trustee for the series "H" bonds informed the Company that the approval will become valid if the series "I" bondholders will approve the Resolution by July 13, 2017. The trustee for the Series "I" bonds has called for an additional bondholders meeting to again request the approval of the Resolution to be held on July 10, 2017 (the "Additional Meeting"). The trustee for the series "I" bonds has notified the Company that if the Additional Meeting will not approve the Resolution, the trustee for the series "I" bonds will convene an additional meeting for the series "I" bondholders to decide whether or not to request an immediate repayment of the Series "I" bonds.
Elbit Imaging Announces End of the Engagement with the Former Auditor and Appointment of New Auditor
TEL AVIV, ISRAEL / ACCESSWIRE / June 29, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today, that On June 28, 2017, following approval by the audit committee and board of directors of the Company, the Company and Brightman Almagor Zohar & Co., a Member Firm of Deloitte Touche Tohmatsu (the "Former Auditor"), reached an understanding to end the engagement of the Former Auditor as the independent accountants of the Company effective immediately.
This understanding resulted from the previously announced notification by the Company's Former Auditor that it was unable to provide an unqualified audit opinion regarding the Company's financial statements for 2016 as a result of matters underlying the disclaimer made by KPMG Hungaria Kft., the former auditor of Plaza Centers N.V. ("Plaza") (LSE: PLAZ), an indirect subsidiary (45%) of the Company, in its report relating to Plaza's annual financial statements for 2016, which report expresses no opinion with regard to Plaza's financial statements.
In addition, on June 28, 2017, following approval by the audit committee and board of directors of the Company, the Company approved the engagement with KOST FORER GABBAY & KASIERER (A Member of EY Global) ("EY Israel") as the Company's new independent Auditor, subject to shareholders' approval. EY Israel has also been retained by Plaza to serve as the independent accountants of Plaza.
Midas..with all the good news the company putting out how come the stock price keep going down? I just don't get it !!!! ????????
Medical technology pioneer INSIGHTEC goes
global with the lorries
By Hannah Patel in News
On June 26, 2017
After a competitive pitch, medical technology pioneer INSIGHTEC hired us as its US retained agency, expanding the already existing partnership in the UK.
Xen Mendelsohn Aderka, vice president of marketing at INSIGHTEC, said: “We’ve already been working successfully with the lorries’ UK team over the last year, and have been very impressed with their can-do attitude, creative thinking and results. When we first met the US team, we got the same feeling – it’s clear that the same culture spans the company. We’re looking forward to working with the global lorry team to develop and tell the amazing INSIGHTEC story to a much wider audience.”
Founded in Israel, INSIGHTEC is a world leader in focused ultrasound technology, a non-invasive therapy platform that is redefining surgery and transforming patients’ lives by providing effective treatment for conditions such as essential tremor, uterine fibroids, prostate and bone cancer. With high success rates and minimal side effects, INSIGHTEC technology has been embraced successfully by world-renowned physicians in 130 medical facilities, including Stanford University Medical School and Brigham, Women’s Hospital – Harvard Medical School, and Imperial College.
http://www.rlyl.com/insightec-chooses-rlyl-as-global-pr-agency/
Elbit Imaging Ltd. Announces FDA Approval of Insightec's Phase I Clinical Trial for the Treatment of Neuropathic Pain
TEL AVIV, ISRAEL / ACCESSWIRE / June 26, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today that the FDA has approved the commencement of Phase I clinical trial for the treatment of neuropathic pain by INSIGHTEC's Exablate Neuro system (the "Trial"). The Trial will include 10 patients and will be fund by the Focused Ultrasound Foundation. INSIGHTEC is the regulatory sponsor of the clinical Trial. The purpose of the Trial is to examine the safety and the efficiency of the treatment.
INSIGHTEC cannot estimate at this stage when the Trial will actually commence and when the first patient will be recruited.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under MRI guidance for real time treatment monitoring.
The Company holds approximately 89.7% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (86.1% on a fully diluted basis) which, in turn, holds approximately 31.3% of the share capital in INSIGHTEC (26.6% on a fully diluted basis).
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