Rambam Health Care Campus

Haifa, Israel

Rambam Health Care Campus

Haifa, Israel

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News Article | November 18, 2016
Site: marketersmedia.com

— The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Minimally Invasive Surgical (MIS) Devices pipeline products. Get Sample Report @ https://www.wiseguyreports.com/sample-request/729487-minimally-invasive-surgical-mis-devices-medical-devices-pipeline-assessment-2016 Scope - Extensive coverage of the Minimally Invasive Surgical (MIS) Devices under development - The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities - The report reviews the major players involved in the development of Minimally Invasive Surgical (MIS) Devices and list all their pipeline projects - The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage - The report provides key clinical trial data of ongoing trials specific to pipeline products - Recent developments in the segment / industry The report enables you to - - Formulate significant competitor information, analysis, and insights to improve R&D strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Identify and understand important and diverse types of Minimally Invasive Surgical (MIS) Devices under development - Develop market-entry and market expansion strategies - Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline - In-depth analysis of the product’s current stage of development, territory and estimated launch date 1 Table of Contents 2 1.1 List of Tables 6 1.2 List of Figures 8 2 Introduction 9 2.1 Minimally Invasive Surgical (MIS) Devices Overview 9 3 Products under Development 10 3.1 Minimally Invasive Surgical (MIS) Devices - Pipeline Products by Stage of Development 10 3.2 Minimally Invasive Surgical (MIS) Devices - Pipeline Products by Territory 11 3.3 Minimally Invasive Surgical (MIS) Devices - Pipeline Products by Regulatory Path 12 3.4 Minimally Invasive Surgical (MIS) Devices - Pipeline Products by Estimated Approval Date 13 3.5 Minimally Invasive Surgical (MIS) Devices - Ongoing Clinical Trials 14 4 Minimally Invasive Surgical (MIS) Devices - Pipeline Products under Development by Companies 15 4.1 Minimally Invasive Surgical (MIS) Devices Companies - Pipeline Products by Stage of Development 15 4.2 Minimally Invasive Surgical (MIS) Devices - Pipeline Products by Stage of Development 17 5 Minimally Invasive Surgical (MIS) Devices Companies and Product Overview 18 5.1 Actuated Medical, Inc. Company Overview 18 5.1.1 Actuated Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18 5.2 BriteSeed Company Overview 20 5.2.1 BriteSeed Pipeline Products & Ongoing Clinical Trials Overview 20 5.3 Delft University of Technology Company Overview 21 5.3.1 Delft University of Technology Pipeline Products & Ongoing Clinical Trials Overview 21 5.4 DistalMotion Company Overview 24 5.4.1 DistalMotion Pipeline Products & Ongoing Clinical Trials Overview 24 5.5 ES Vascular Ltd. Company Overview 26 5.5.1 ES Vascular Ltd. Pipeline Products & Ongoing Clinical Trials Overview 26 5.6 Ethicon Endo-Surgery, Inc. Company Overview 27 5.6.1 Ethicon Endo-Surgery, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27 5.7 Eximis Company Overview 28 5.7.1 Eximis Pipeline Products & Ongoing Clinical Trials Overview 28 5.8 FlexDex Company Overview 29 5.8.1 FlexDex Pipeline Products & Ongoing Clinical Trials Overview 29 5.9 Fortimedix B.V. Company Overview 31 5.9.1 Fortimedix B.V. Pipeline Products & Ongoing Clinical Trials Overview 31 5.10 Hadassah Medical Center Company Overview 32 5.10.1 Hadassah Medical Center Pipeline Products & Ongoing Clinical Trials Overview 32 5.11 Human Extensions LTD Company Overview 33 5.11.1 Human Extensions LTD Pipeline Products & Ongoing Clinical Trials Overview 33 5.12 Imperial College London Company Overview 34 5.12.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 34 5.13 John Hopkins University Company Overview 35 5.13.1 John Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 35 5.14 Osaka University Company Overview 36 5.14.1 Osaka University Pipeline Products & Ongoing Clinical Trials Overview 36 5.15 Rambam Health Care Campus Company Overview 37 5.15.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 37 5.16 Signum Surgical Ltd Company Overview 38 5.16.1 Signum Surgical Ltd Pipeline Products & Ongoing Clinical Trials Overview 38 5.17 Technische Universiteit Eindhoven Company Overview 39 5.17.1 Technische Universiteit Eindhoven Pipeline Products & Ongoing Clinical Trials Overview 39 5.18 UltraSurge Technologies Ltd. Company Overview 40 5.18.1 UltraSurge Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 40 5.19 University of California, San Francisco Company Overview 41 5.19.1 University of California, San Francisco Pipeline Products & Ongoing Clinical Trials Overview 41 5.20 University of Wisconsin Madison Company Overview 45 5.20.1 University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 45 5.21 Varada Innovations Inc. Company Overview 47 5.21.1 Varada Innovations Inc. Pipeline Products & Ongoing Clinical Trials Overview 47 5.22 VenX Medical LLC Company Overview 48 5.22.1 VenX Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 48 5.23 XACT Robotics Ltd. Company Overview 51 5.23.1 XACT Robotics Ltd. Pipeline Products & Ongoing Clinical Trials Overview 51 6 Minimally Invasive Surgical (MIS) Devices- Recent Developments 52 6.1 Oct 26, 2016: LeMaitre Q3 2016 Record Sales $23.2 mm (+22%), Record Op. Income $5.3 mm (+61%) 52 6.2 Oct 26, 2016: Life Spine Achieves 32% Sales Growth and Announces Industry’s Largest Post-Packing Capabilities for Lateral Fusion 52 6.3 Oct 18, 2016: Intuitive Surgical Announces Third Quarter Earnings 53 6.4 Oct 17, 2016: Fortimedix Surgical Announces the U.S. Launch of symphonX Surgical Platform, the World’s Lowest Profile Single-Port Surgery Solution, During American College of Surgeons Clinical Congress 2016 54 6.5 Oct 17, 2016: Syneron Medical Strengthens Senior Management Team 54 6.6 Oct 17, 2016: Syneron Medical Announces Preliminary Third Quarter 2016 Revenue 55 6.7 Oct 10, 2016: Fortimedix Surgical Announces Successful Completion of First-In-Man Laparoscopic Cholecystectomy with FMX314, the World’s Lowest Profile Single-Port Surgery Solution, in the United States 55 6.8 Oct 03, 2016: Fortimedix Surgical Announces CE Mark Approval for FMX314, the World’s Lowest Profile Single-Port Surgery Solution 56 6.9 Oct 03, 2016: miVIP Reveals Robot-Assisted Gynecological Techniques to Surgeons Worldwide 56 6.10 Sep 30, 2016: MagForce Publishes Financial Results for the First Half of 2016 and Operative Highlights 57 For more information, please visit http://www.wiseguyreports.com


Kaidar-Person O.,Rambam Health Care Campus | Roach III M.,University of California at San Francisco | Crehange G.,Georges Francois Leclerc Cancer Center
International Journal of Radiation Oncology Biology Physics | Year: 2013

Given the low α/β ratio of prostate cancer, prostate hypofractionation has been tested through numerous clinical studies. There is a growing body of literature suggesting that with high conformal radiation therapy and even with more sophisticated radiation techniques, such as high-dose-rate brachytherapy or image-guided intensity modulated radiation therapy, morbidity associated with shortening overall treatment time with higher doses per fraction remains low when compared with protracted conventional radiation therapy to the prostate only. In high-risk prostate cancer patients, there is accumulating evidence that either dose escalation to the prostate or hypofractionation may improve outcome. Nevertheless, selected patients who have a high risk of lymph node involvement may benefit from whole-pelvic radiation therapy (WPRT). Although combining WPRT with hypofractionated prostate radiation therapy is feasible, it remains investigational. By combining modern advances in radiation oncology (high-dose-rate prostate brachytherapy, intensity modulated radiation therapy with an improved image guidance for soft-tissue sparing), it is hypothesized that WPRT could take advantage of recent results from hypofractionation trials. Moreover, the results from hypofractionation trials raise questions as to whether hypofractionation to pelvic lymph nodes with a high risk of occult involvement might improve the outcomes in WPRT. Although investigational, this review discusses the challenging idea of WPRT in the context of hypofractionation for patients with high-risk prostate cancer. © 2013 Elsevier Inc.


Bar-Sela G.,Rambam Health Care Campus | Epelbaum R.,Rambam Health Care Campus | Schaffer M.,Rambam Health Care Campus
Current Medicinal Chemistry | Year: 2010

Curcumin, commonly called diferuloyl methane, is a hydrophobic polyphenol derived from rhizome (turmeric) of the herb Curcuma longa. Extensive research over the last half century has revealed important functions of curcumin. In vitro and in vivo research has shown various activities, such as anti-inflammatory, cytokines release, antioxidant, immunomodulatory, enhancing of the apoptotic process, and anti-angiogenic properties. Curcumin has also been shown to be a mediator of chemo-resistance and radio-resistance. The anti-cancer effect has been seen in a few clinical trials, mainly as a native chemoprevention agent in colon and pancreatic cancer, cervical neoplasia and Barrets metaplasia. Some clinical studies with healthy volunteers revealed a low bioavailability of curcumin, casting doubt on the use of curcumin only as food additive. Our clinical experience with curcumin, along with the anti-metabolite gemcitabine in the treatment of patients with advanced pancreatic carcinoma, produced an objective response in less than 10% of patients, with a minor effect on survival. However, the safety of this combination was proved. Curcumin's potent anti-proliferative activity interacting with several intracellular signal transduction pathways may potentiate the anti-tumor effect of gemcitabine. The preclinical data lead to various, but still scarce, clinical studies (some on-going) that demonstrated the possible efficacy of this treatment as a chemopreventive or chemotherapeutic agent. This review will focus on the clinical evidence, including our experience with curcumin as a chemopreventive and therapeutic agent and the in vitro background results. © 2010 Bentham Science Publishers Ltd.


Nevelsky A.,Rambam Health Care Campus
Journal of applied clinical medical physics / American College of Medical Physics | Year: 2013

The purpose of this study was to evaluate the feasibility of hippocampal-sparing whole-brain radiotherapy (HS WBRT) using the Elekta Infinity linear accelerator and Monaco treatment planning system (TPS). Ten treatment plans were created for HS-WBRT to a dose of 30 Gy (10 fractions). RTOG 0933 recommendations were applied for treatment planning. Intensity-modulated radiotherapy (IMRT) plans for the Elekta Infinity linear accelerator were created using Monaco 3.1 TPS-based on a nine-field arrangement and step-and-shoot delivery method. Plan evaluation was performed using D2% and D98% for the whole-brain PTV (defined as whole brain excluding hippocampus avoidance region), D100% and maximum dose to the hippocampus, and maximum dose to optic nerves and chiasm. Homogeneity index (HI) defined as (D2%-D98%)/Dmedian was used to quantify dose homogeneity in the PTV. The whole-brain PTV D2% mean value was 37.28 Gy (range 36.95-37.49Gy), and D98% mean value was 25.37 Gy (range 25.40-25.89 Gy). The hippocampus D100% mean value was 8.37 Gy (range 7.48-8.97 Gy) and the hippocampus maximum dose mean value was 14.35 Gy (range 13.48-15.40 Gy). The maximum dose to optic nerves and optic chiasm for all patients did not exceed 37.50 Gy. HI mean value was 0.36 (range 0.34-0.37). Mean number of segments was 105 (range 88-122) and mean number of monitor units was 1724 (range 1622-1914). Gamma evaluation showed that all plans passed 3%, 3 mm criteria with more than 99% of the measured points. These results indicate that Elekta equipment (Elekta Infinity linac and Monaco TPS) can be used for HS WBRT planning according to compliance criteria defined by the RTOG 0933 protocol.


Brenner B.,Rambam Health Care Campus | Brenner B.,Technion - Israel Institute of Technology | Avivi I.,Rambam Health Care Campus | Avivi I.,Technion - Israel Institute of Technology | And 2 more authors.
The Lancet | Year: 2012

Haematological cancer in pregnancy, although rare, poses a substantial risk to both mother and fetus. Hodgkin's lymphoma is the most common, followed by non-Hodgkin lymphoma and acute leukaemia. Diagnosis of haematological cancers is challenged by an overlap of the disease and gestation-related symptoms and limitations of imaging studies in pregnancy. Data for safety and effectiveness of therapy are scarce and mostly retrospective. This report provides updated guidance for management, focusing on chemotherapy and biological agents. The primary goal of treatment is to preserve the mother's health; hence, pregnancy termination is often advisable at early stages, allowing delivery of adequate therapy. However, at later gestational stages treatment is often feasible. Pregnancy-related hypercoagulability, augmented by cancer, often necessitates thromboprophylaxis. The consequences and complex management of haematological cancer during pregnancy emphasise the need for collaborative research, focusing on basic mechanisms of disease and prospective epidemiological studies. © 2012 Elsevier Ltd.


Skorecki K.L.,Technion - Israel Institute of Technology | Wasser W.G.,Rambam Health Care Campus
Kidney International | Year: 2013

Lipkowitz et al. extend the African American Study of Kidney Disease and Hypertension to the level of genetic epidemiology, in a case-control study design. Analysis of genotypes at the APOL1 kidney disease risk region supports a paradigm shift in which genetic risk is proximate to both kidney disease and hypertension. The findings mandate urgency in clarifying mechanisms whereby APOL1 region risk variants interact with environmental triggers to cause progressive kidney disease accompanied by dangerous hypertension. © 2012 International Society of Nephrology.


Gralnek I.M.,Rambam Health Care Campus | Suissa A.,Rambam Health Care Campus | Domanov S.,Elisha Hospital
Endoscopy | Year: 2014

BACKGROUND AND STUDY AIMS: Although colonoscopy is the gold standard for detecting colorectal cancer (CRC), adenomas and cancers are missed. We aimed to establish the safety and feasibility of use of a novel balloon-colonoscope.PATIENTS AND METHODS: Patients (40 - 75 years) referred for CRC screening, polyp surveillance, or diagnostic evaluation were enrolled in a prospective pilot cohort study whose primary endpoint was device safety. Additional endpoints included success of and time to cecal intubation, withdrawal and total procedure times, polyp detection rate (PDR), adenoma detection rate (ADR), and success of polypectomies.RESULTS: Among 50 patients (mean age 59.0 years, 27 women [54 %]), three were excluded (inadequate colon preparation, technical problem, abdominal hernia) and 47 were analyzed. Two patients experienced minor adverse events (diarrhea, abdominal pain). Cecal intubation rate was 47 /47 (100 %). Mean times, to reach cecum, withdrawal, and total procedure, were 4.3, 7.4, and 16.5 minutes, respectively. We identified 44 polyps (all successfully removed) in 25 /47 patients (PDR 53.2 %), 35 polyps (79.5 %) were 1 - 5 mm, 4 (9.1 %) 6 - 9 mm, and 5 (11.4 %) ≥ 10 mm. Of 44 polyps, 36 (81.8 %) were "adenomas"; 21/47 patients had ≥ 1 adenoma (ADR 44.7 %).CONCLUSIONS: The NaviAid G-EYE balloon-colonoscope appears safe and feasible to use. Comparative human studies are underway.Clinicaltrials.gov identifier: NCT01749722. © Georg Thieme Verlag KG Stuttgart · New York.


Weissman A.,Rambam Health Care Campus
Pflügers Archiv : European journal of physiology | Year: 2012

Autonomic nervous system modulation of heart rate is significantly altered during painful procedures in newborns. Most studies investigating pain employed only linear-based analysis methods, thus ignoring the complex, non-linear nature of heart rate control mechanisms. The emergences of dynamic, nonlinear analysis methods enable us to uncover information embedded in the fluctuations of heart rate not otherwise noticeable. Our objective was to examine how cardiac dynamics change in newborns who undergo heel lancing by analyzing linear and nonlinear characteristics of heart rate fluctuations. We used dynamic nonlinear analyses methods to reveal heart rate variability and complexity alterations during painful stimulus in newborns. Poincaré plots were applied to examine the dynamics of the system, sample entropy to investigate the complexity of the system, and detrended fluctuation analysis, to reveal the fractal properties of the system. Heart rate significantly increased (165 vs.123 beats per minute, p < 0.001) while variability decreased. Sample entropy and the quantitative measures of the Poincaré plots (SD1 and SD2) significantly decreased during heel lancing (0.75 vs. 1.0, p < 0.01; 6.4 vs. 12.8, p < 0.001; and 30.4 vs. 50.5, p < 0.01, respectively). Detrended fluctuation analysis showed a significant decrease in the short-term scaling exponent α1 (1.06 vs. 1.3, p < 0.001), and an increase in the long-term scaling exponent α2 (1.5 vs. 1.1, p < 0.001). Our results indicate altered complexity of heart rate variability during painful stimulus in newborns and disruption of the mechanisms that regularly control it. Such alterations resemble certain pathological conditions and may represent stress reaction.


Klil-Drori A.J.,Rambam Health Care Campus
Prostaglandins & other lipid mediators | Year: 2013

Among the lipoxygenases, a diverse family of fatty acid dioxygenases with varying tissue-specific expression, 15-lipoxygenase (15-LOX) was found to be involved in many aspects of human cancer, such as angiogenesis, chronic inflammation, metastasis formation, and direct and indirect tumor suppression. Herein, evidence for the expression and action of 15-LOX and its orthologs in various neoplasms, including solid tumors and hematologic malignancies, is reviewed. The debate surrounding the impact of 15-LOX as either a tumor-promoting or a tumor-suppressing enzyme is highlighted and discussed in the context of its role in other biological systems. Copyright © 2013 Elsevier Inc. All rights reserved.


Networking is the name of the game In May 2017, MIXiii-BIOMED, the leading event of Israel’s life science industry, will mark its 16th anniversary. Throughout the years, this conference emerged as the main annual meeting place for representatives of Israel’s healthcare industry with colleagues from around the globe. Anyone looking for innovation in the life sciences should definitely attend this meeting! Visitors from around the world come to explore the various innovations and experience firsthand the entrepreneurial spirit which is a basis of Israel’s vibrant life science community. Previous successful conferences hosted over 6,000 senior executives, scientists, engineers and investors, including approximately 1,000 participants from over 45 countries. This year, aging and age-related diseases are the central themes of the conference, which will be dedicated to diseases affecting the elderly population such as chronic diseases, cancer, neuro-degenerative diseases, diabetes and more. Looking at the future of the healthcare system, participants will address ways to monitor, diagnose and treat elderly patients by utilizing new methods and innovations in fields such as precision medicine, genetics, personal diagnostics and more, as well as explore how digital health and health IT address these fields. In addition, issues of cybersecurity will be raised in association with the use of new age-related technologies. Additional fields that will play a crucial role in aging individuals are medical robotics, regenerative and cell therapies and longevity. All these and more will be presented and discussed as part of the growing interest and resources invested by healthcare systems in addressing issues of aging populations. If your company is active in the one of the following age-related fields, you are invited to submit an abstract to be reviewed for an oral presentation: This year the conference’s group of organizers has been expanded to include various leading international healthcare institutions such as the Cleveland Clinic and the Mayo Clinic, with the objective of enhancing the exposure of the Israeli industry to key global opinion leaders and experts, and allowing local and global attendees to mix and exchange knowledge and ideas. Israel’s leading medical centers, including Tel Aviv Sourasky Medical Center, Sheba Medical Center at Tel Hashomer, Hadassah Medical Center and Rambam Health Care Campus, have also joined the effort. In addition to IATI and Kenes Exhibitions, and with the aim of continuing to increase the flow of investors in the Israeli biomed industry, OurCrowd, whose sole “raison d’etre” is facilitating financial and joint venture interactions between Israeli and global healthcare players, has also been added as a co-organizer. And finally, Start-Up Nation Central, which connects between global entities and companies and Israeli innovation, has also joined the team.

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