Dallas, TX, United States
Dallas, TX, United States

InSightec Ltd. , founded in 1999, is a privately held company owned by Elbit Medical Imaging, GE Healthcare, private investors and employees. InSightec was founded specifically to develop MR guided Focused Ultrasound technology. Headquartered in Tirat Carmel near Haifa, Israel, with US headquarters in Dallas Texas, the company has over 160 employees. Wikipedia.

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News Article | August 16, 2017
Site: www.prnewswire.com

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." 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 usa.essential-tremor.com.


Exablate Neuro uses focused ultrasound waves to target and ablate the Vim nucleus of the thalamus with no surgical incisions or implants. The treatment is done under MRI guidance for real-time treatment monitoring. In July 2016, INSIGHTEC received FDA approval for the Exablate Neuro for use with 3.0T MRI systems. This approval for a new MR head coil significantly opens new potential markets for INSIGHTEC'S Exablate Neuro as 1.5T systems are the most common MRI systems in use today. Essential tremor is the most common movement disorder, affecting more than 42 million people worldwide. For patients suffering from essential tremor, performing everyday tasks presents a challenge and impacts their quality of life. "Being able to bring MR-guided focused ultrasound to hospitals that have 1.5T MRIs will enable more essential tremor patients to have access to this non-invasive treatment option using INSIGHTEC's ground-breaking technology," stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. To read more about the Exablate Neuro, please visit: http://www.insightec.com/us/clinical/neurosurgery INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive therapy 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 .


Der Gemeinsame Bundesausschuss (G‑BA) hat am 15.12.2016 seine erste Richtlinie zur Erprobung einer neuen Behandlungsmethode auf Antrag eines Medizinprodukteherstellers beschlossen. Nach positiver Überprüfung durch das Bundesministerium für Gesundheit und Veröffentlichung im Bundesanzeiger tritt diese Richtlinie nun im März 2017 in Kraft. Gegenstand der Verfahrenserprobung ist die Magnetresonanztomographie (MRT)-gesteuerte hochfokussierte Ultraschalltherapie zur Behandlung des Uterusmyoms (gutartige Tumoren der Gebärmutter). Der G-BA stellte dazu fest, dass die MRT gesteuerte Ultraschalltherapie das Potenzial für eine für Patientinnen weniger belastende und aufwendige Behandlungsalternative besitzt. Mit Hilfe der nun vom G-BA angestoßenen Erprobungsstudie sollen die möglichen Vorteile gegenüber einer operativen Myomentfernung genauer identifiziert werden. Bereits im Juni 2015 hatte der G-BA grundsätzlich entschieden, dass die operationsersetzende Behandlungsmethode "MRT-gestützter Einsatz von hochfokussiertem Ultraschall" (MRgFUS) hinreichendes Potenzial für einen Patientennutzen bietet und ein entsprechendes Beratungsverfahren eingeleitet. Zum Hintergrund: Für Untersuchungs- und Behandlungsmethoden, deren Nutzen in der Vergangenheit noch nicht hinreichend belegt war, die jedoch das Potenzial einer erforderlichen Behandlungsalternative erkennen lassen, kann der G-BA Richtlinien zur Erprobung beschließen. Diese Möglichkeit hat der Gesetzgeber mit dem GKV-Versorgungsstrukturgesetz (GKV-VStG) im Jahr 2012 neu geschaffen. Bislang mussten sich Frauen, die unter Uterusmyomen leiden, einem operativen Eingriff unterziehen. Dabei kann es zur vollständigen oder teilweisen Uterusentfernung (Hysterektomie bzw. Myomektomie) kommen, in seltenen Fällen auch zu einer strahlenbelasteten radiologischen Intervention, zur Uterusarterienembolisation. Bei der Ultraschalltherapie werden Uterusmyome durch gebündelten (hochfokussierten) Ultraschall erhitzt und zerstört. Die MRT-Bilder ermöglichen dabei ein gezieltes Steuern des Ultraschalls. Dies geschieht ohne operativen Eingriff. Durch die G-BA-Richtlinie zur Erprobung besteht nunmehr die Chance, dass das schonende, Gebärmutter-erhaltende Verfahren, wie es von INSIGHTEC angeboten wird, in den Leistungskatalog der gesetzlichen Krankenversicherung (GKV) aufgenommen wird und zukünftig vielen Frauen zur Verfügung stehen kann. Myome der Gebärmutter (Uterus myomatosus) gehören zu den häufigsten gutartigen Tumoren der der weiblichen Geschlechtsorgane: Etwa ein bis zwei von zehn Frauen über 30 Jahre haben Myome. 20 Prozent davon müssen behandelt werden. Rund 35 Prozent aller gynäkologischen Krankenhauseinweisungen gehen auf Myomerkrankungen zurück. Einem innovativen, nicht-invasiven Verfahren für ihre Behandlung als Alternative zur Operation kommt daher eine große Bedeutung zu. Der Medizinproduktehersteller INSIGHTEC bietet diese Technologie unter dem Namen ExAblate® O.R. an. Für das schonende Verfahren zur Behandlung von Uterus-Myomen übernahmen einige Krankenkassen die Kosten bereits im Rahmen von Selektivverträgen. Der jetzt gefasste Beschluss geht auf einen Antrag von INSIGHTEC bei G-BA zurück, der in Zusammenarbeit mit Experten des IGES Instituts (Berlin) entstand. Er legt die Grundlage für einen verbesserten Zugang von Frauen mit Myomerkrankungen zu schonender Behandlung. INSIGHTEC definiert Chirurgie neu:  mit nicht-invasiven MR-gesteuerten fokussierten Ultraschallbehandlungen. Fokussierter Ultraschall minimiert das Risiko von chirurgischen Komplikationen wie Infektion, reduziert Krankenhausaufenthalte und eröffnet Patienten die Möglichkeit, schnell zu ihren täglichen Aktivitäten zurückkehren zu können. Derzeit besitzt diese revolutionäre Technologie neben der Zulassung für die Behandlung von Uterusmyom bereits die CE-Kennzeichnungen für die Behandlung von Patienten, die unter essentiellem Tremor, Tremor-dominanter Parkinson-Krankheit, neuropathischen Schmerzen, Prostatakrebs, schmerzhaften Knochenmetastasen, Osteoidosteom leiden oder eine Denervationsbehandlung der kleinen. Wirbelgelenke (Facettenrhizotomie) benötigen. Mit nachgewiesenen positiven klinischen Ergebnissen fühlt sich das Unternehmen verpflichtet, sich mit Pionierforschung für weitere und neue klinische Anwendungen zu engagieren, um weiteres Potential zu erschließen, das Leben von Millionen von Patienten auf der ganzen Welt zu ändern. Weiterführende Informationen zu den verschiedenen Behandlungsmöglichkeiten von Myomen  u.a.: von Schroeders N, Matzko M: Dem Markt voraus.in: führen & wirtschaften 4/2013 (http://www.dlmc.de/fileadmin/dlmc/pdf/fuw_04_2013_Dem_Markt_voraus.pdf)


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ICT-2013.5.2 | Award Amount: 5.62M | Year: 2014

MR-guided Focused Ultrasound Surgery (MRgFUS) combines high intensity focused ultrasound for thermal ablation of diseased tissue with MR imaging to visualise the tumour and surrounding anatomy and to provide MR thermal feedback.\nHowever, MRgFUS treatment of the liver and other abdominal organs present tremendous technological challenges, including motion due to breathing and shielding of the target by the rib cage.\nTo tackle these challenges, the VPH project FUSIMO has set out to develop a planning system for MRgFUS capable to deal with moving abdominal organs.\nTRANS-FUSIMO will translate the FUSIMO demonstrator into a clinically applicable system spanning the full clinical workflow of planning, conduction and assessment as well as learning from the procedure:\n1) Extension of the FUSIMO demonstrator to support conduction and assessment of the intervention under breathing motion\n2) Interfacing state-of-the-art FUS hardware and imaging devices to build an integrated real-time-capable system for liver FUS\n3) Improving model components for optimized clinical workflow, real-time applicability and validated outcome prediction\n4) Allowing training and learning using the FUSIMO software system by building a case and result database\n5) Conduction of pre-clinical (phantoms, cadaver, animal) experiments of the FUSIMO system\nIn a clinical trial, the feasibility of using the integrated system for neoadjuvant MRgFUS to achieve prolonged survival will be investigated.\nAs a final project result, the integrated system will be close to certification status and subsequent commercialization. With such an integrated real-time system, FUS can become a commercially and clinically competitive alternative to current surgical and minimal-invasive oncological interventions, thus providing a non-invasive treatment, reducing side-effects, and healthcare costs.


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ICT-2009.5.3 | Award Amount: 4.68M | Year: 2011

In recent years, High-Intensity Focused Ultrasound and Focused Ultrasound (FUS) have become frequent tools for non-invasive benign tumour therapy. Applications in the treatment of fibroadenoma of uterus has become commercial and passed FDA clearance in 2004 and sonication of bone metastasis has obtained a CE mark. Other tumours are under preclinical (prostate, kidney) and clinical (breast, brain and liver) evaluation. However, treating tumours with focused ultrasound is still challenging in terms of reliable therapy planning, monitoring and outcome prediction especially in moving organs with a complex blood supply. It is important to understand that the processes involved in FUS therapy are multi-level ranging from organ morphology, perfusion and motion, down to microscopic and cellular level. The relation within and between these levels is not well understood.\nFUSIMO will develop, implement and validate a multi-level model for moving abdominal organs for use with FUS and Magnetic resonance-guided focused ultrasound surgery. The overall model will consist of several sub-models, which interact and describe aspects in a hierarchical manner. The integrated model will consist of;\n- Abdominal organ model to simulate motion and the influence on ultrasound application\n- Target organ/tumour model to capture organ/tumour physiology, and organ/tumour reaction to therapy\n- Microscopic tissue model to simulate direct heat ablation, model energy distribution, tissue heating and cooling\n- Model to evaluate first steps to simulate drug delivery, microbubble distribution and dynamics\nThe FUSIMO developments in the field of hardware and software will be combined into an integrated system, which will allow both abdominal FUS application to moving organs, and also other treatment modalities such as radio frequency, laser or cryotherapy or other types of interventions based on particles or fields in radiation therapy.


Grant
Agency: European Commission | Branch: FP7 | Program: MC-IAPP | Phase: FP7-PEOPLE-IAPP-2008 | Award Amount: 2.07M | Year: 2009

Clinical drug delivery (DD) remains a problem of heightened industrial and academic interest. The proposed partnership seeks to embrace the problem by exploiting the unique expertise-base spanning the industrial research and academic pratners. We will provide inter-sectoral training of mulit-disciplinary researchers and create a novel new DD modality that addresses the key critical needs for non-invasive therapy via intelligent generic targeting and with intrinsic flexibility in drug choice. An essential simplicity to the present approach is that it takes strands of intrinsically safe technologies, and marries these into a powerful amalgam that offers true power and enhanced versatility. Chief amongst the areas of research are: (i) A generic encapsulating technology [CapsuTech - industrial partner] that will vector active anti-cancer drugs to a tumour target; (ii) Remotely triggered drug release on demand by externally focused ultrasound energy [development by industrial partner Insightec](iii) Enhanced drug uptake through the parallel disruption of cell membranes by the action of ultrasound on commercially available microscopic bubbles [sonoporation - University of Dundee]. The Dundee Group, who will lead this partnership, has made significant inroads to fundamental understanding with this latter strand. Moreover, the partners have gone to great lengths to factor in a level of training that also embraces existing trends for image guided intervention: in particular with magnetic resonance imaging (MRI). The project objectives we have realized are fully compatible with MRI technology and indeed, this prescience endows the overall scheme with significant added value. We anticipate that this synergistic and intra-sectoral multi-disciplinary research partnership will create significant momentum, enduring relationships, visionary researchers and a roadmap towards significant European market share, as well as delivering on truly excellent scientific objectives.


During a focused-ultrasound or other non-invasive treatment procedure, the motion of the treatment target or other object(s) of interest can be tracked in real time based on the comparison of treatment images against a reference library of images that have been acquired prior to treatment for the anticipated range of motion and have been processed to identify the location of the target or other object(s) therein.


Patent
InSightec | Date: 2014-01-29

A focused-ultrasound or other procedure for treating a target within a tissue region can be planned iteratively by creating a treatment plan specifying a treatment location pattern and stimuli applied thereto, simulating the treatment, computationally predicting an effect of the simulated treatment, comparing the predicted effect against one or more treatment constraints (such as efficacy and/or safety thresholds), and, if a constraint is violated, repeating the simulation for an adjusted treatment plan.


Patent
InSightec | Date: 2014-03-06

In ultrasound therapy, the frequency of sonications can be optimized, within a certain frequency range, to maximize the absorption or the acoustic intensity at the target in a manner specific to the patient.


HAIFA, Israel, March 3, 2017 /PRNewswire/ -- Der Gemeinsame Bundesausschuss (G‑BA) hat am 15.12.2016 seine erste Richtlinie zur Erprobung einer neuen Behandlungsmethode auf Antrag eines Medizinprodukteherstellers beschlossen. Nach positiver Überprüfung durch das Bundesministerium für...

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