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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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: Cordis | 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: Cordis | 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.


Un uomo su sei contrae nel corso della sua vita il tumore della prostata. Per molti pazienti la diagnosi è di una patologia circoscritta con un rischio di avanzamento intermedio o basso. In questi casi, i pazienti possono optare per la sorveglianza attiva o per un intervento. Attualmente, le terapie disponibili inclusa la prostatectomia, ovvero la rimozione chirurgica di tutta la prostata, e la radioterapia mirata a tutta la prostata dimostrano un buon controllo del tumore, ma presentano un rischio elevato di impotenza e incontinenza. Il sistema Exablate Prostate si basa sulla tecnologia INSIGHTEC a ultrasuoni focalizzati guidati da risonanza magnetica. Gli ultrasuoni focalizzati vengono utilizzati per individuare e asportare con precisione il tessuto di prostata specifico riducendo al minimo i danni alle strutture adiacenti. Il trattamento viene eseguito sotto la guida della risonanza magnetica (MRI) per una visualizzazione ad alta risoluzione dell'anatomia del paziente e per monitorare in tempo reale la temperatura. Il trattamento non richiede incisioni e viene eseguito in un'unica sessione, consentendo al paziente di riprendere al più presto le sue normali attività. "Il trattamento focalizzato a ultrasuoni per il cancro della prostata potrebbe offrire un nuovo approccio alla gestione del tumore prostatico circoscritto in determinati pazienti," ha dichiarato Behfar Ehdaie, MD, MPH chirurgo presso il Memorial Sloan Kettering Cancer Center. "La risonanza magnetica consente ai chirurghi la visualizzazione e il feedback di temperatura in tempo reale per permettere la massima precisione nell'asportazione del tessuto preservando i tessuti sani" ha concluso il medico. "INSIGHTEC ha raggiunto un'altra importante tappa strategica. Continuiamo a lavorare sull'espansione della piattaforma tecnologica Exablate per rispondere alle varie indicazioni cliniche e trattiamo sempre più pazienti in tutto il mondo" ha dichiarato Maurice R. Ferré MD, CEO di INSIGHTEC e Presidente del consiglio di amministrazione. Il sistema Exablate Prostate include una sonda endo-rettale integrata in un lettino per trattamento compatibile con GE MRI 1.5 e 3T. L'energia ultrasonora è fornita da un trasduttore phased array da 1.000 elementi ad altra frequenza che fornisce una terapia focale sotto la guida della RM e un feedback di temperatura in tempo reale. Ciò consente al medico di gestire e personalizzare la terapia. INSIGHTEC è leader mondiale per gli ultrasuoni focalizzati a guida RM (MRgFUS). Il suo sistema non invasivo Exablate sta trasformando le modalità di trattamento in numerosi campi della neurochirurgia, dell'oncologia e della ginecologia. Un numero sempre maggiore di medici in tutto il mondo si sta accorgendo della validità clinica ed economica del trattamento MRgFUS.  Per ulteriori informazioni, visitare il sito web http://www.crytek.com.


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...


Grant
Agency: Cordis | 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.


Medical guidance systems often employ several data sources using different coordinate systems. In order to map positions from one coordinate system to the other, these guidance systems usually employ rigid-body point-based registration, using pairs of fiducial points: pairs which describe the same physical positions, but in different coordinate systems. The customary test for the quality of the registration is the fiducial registration error (FRE), which is the root-mean-square of the mismatch between the fiducials in each pair (after the registration). The FRE, however, does not give an answer to the question which is usually of interest, and that is the accuracy at a " target" point which is not part of the set of fiducial points.The statistics of the target registration error (TRE) have been studied before and approximate expressions were derived, but those expressions require as input the unknown true fiducial positions. In the present paper, it is proven that by replacing these unknowable true positions with the known measured positions in the expression for mean-square TRE, a higher order approximation is achieved. In other words, it is shown that more accurate estimates are obtained by using less accurate, but available, inputs. Furthermore, in previous approximations FRE and TRE were shown to be statistically independent, whereas here, due to the higher approximation level, it is shown that a slight dependence exists. Thus, the knowledge of FRE can in fact be employed to improve predictions of the TRE statistics. These results are supported by simulations and hold even for fiducial localization error (FLE) distributions with large standard deviations. © 2011 Elsevier B.V.


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.

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