Imaging and Monitoring Tools 2016 - Sheba · Imaging and Monitoring Tools 2016 Contact : ......
Transcript of Imaging and Monitoring Tools 2016 - Sheba · Imaging and Monitoring Tools 2016 Contact : ......
Tel Hashomer Medical Research
Infrastructure and Services Ltd.
Imaging and Monitoring Tools
2016
Contact : Sylvie Luria PhD., CEO
Technology Transfer Company
Tel Hashomer Medical Research, Infrastructure and Services Ltd.
Tel: +972-3-5305998 Fax: +972-3-5305944 Cell: 052-6667277
[email protected] http://research.sheba.co.il/e/
Sheba Medical Center - Technology Transfer Company
Tel Hashomer Medical Research, Infrastructure and Services Ltd.
http://rnd.sheba.co.il/
Business:
Tel Hashomer Medical Research, Infrastructure and Services Ltd. (THM) the technology
transfer arm of Sheba Medical Center, is responsible for managing the intellectual property
assets of Sheba Medical Center and to promote the transfer of technologies, innovation and
professional know-how for society's use and benefit, and for the development of the medical and
health care delivery fields. Sheba Medical Center facilities, experience, human resources and
regulations enable the development of a novel idea from its basic science to its product
development and prototype, thus rapidly generating value to its IP for commercialization.
Main Activities:
Scientific insights and academic breakthroughs often translate into inventions for the benefit of
the marketplace. THM bridges the gap between Academia Research and Industry Needs, since
the industry is product-based, business-oriented, and focused on time-framed missions, THM
helps turn scientific progress into tangible products, while returning income to the inventor and
to Sheba Medical Center to support further research.
THM receives invention disclosures from faculty, staff and students. We evaluate the innovations
for patent applications and develop licensing strategy, consider the technical and market risks.
Patentable inventions constitute the majority of THM's licensing activities; however, we also
handle collaborations with industrial partners and Tangible Research Property (TRP) such as
Tissue Bank, Genomics and Bio-Markers, Cell Therapy, Computational Imaging and more.
THM builds a well-structured and organized “value creation” model, as well as several business
models pending on industry: (Health IT, Medical Devices, Bio-Medical, ) and on entity (start-
up, SME and Big Entity/ Pharma).
THM has several strategic support plans such as the “Micro Fund" and strategic collaboration
with other research institutes and industry to facilitate invention development.
IP strategy and managemnt
Commercialization and
licensing management
Royalties Streaming
THM Strategic Principles to the Success of our Tech Transfer
► We bridge basic research to commercial Value
► We develop close interaction with researchers and industry
► We Build Strategic Capabilities
► We are a “Learning Organization” and Flexible Organization
► We understand the stakeholders need and Value creation
► We Build Collaboration & Alliances
► Our stream: Identify Need from the bedside, Basic and applicable Research-
► We develop broad and Multi-national view
THM Intellectual property's portfolio spans over therapeutics, diagnostics, medical devices
and medical tools in the fields of Onco-Genetics, Hemato-Oncology, Epidemiology of
Malignant Diseases and Trauma, Lipids, Diabetes, Hypertension, Onco-Surgery , including
research in Breast and Colon Cancer, Regenerative medicine, Immunology, Neuro-Immunology,
Alzheimer's Disease, Multiple Sclerosis and Psychiatry.
Contact:
Sylvie Luria Ph.D. Technology Transfer and Business & Development Manager
Tel Hashomer Medical Research, Infrastructure and Services Ltd.
Tel: +972-3-5305998 Fax: +972-3-5305944 Cell: +972-052-6667277
[email protected] http://rnd.sheba.co.il/e/
Innovations from Sheba Medical Center - Technologies for Licensing:
1. MRI- TRANS RECTAL ULTRASOUND FUSION FOR IMPROVED PROSTATE CANCER THERAPY Zvi Simon and Arlando Mayer
2. FUSION BETWEEN PRE-OPERATIVE AND INTRA-OPERATIVE BRAIN MRI FOR NEUROSURGICAL NAVIGATION
Moshe Hadani and Arlando Mayer
3. METHOD AND SYSTEM TO CONFIRM INTRAVENOUS CATHETER PLACEMENT AND POSITIONING Ilan Keidan and Arlando Mayer
4. SMARTI-SMART IMMOBILZATION FOR ADVANCED RADIATION THERAPY AND IMAGING. A
CONTROLLED PLATFORM FOR ASSESSING AND OBTAINING TARGET LESION IMMOBILIZATION
THROUGH INTEGRATED USE OF CPAP, BIOFEEDBACK AND OTHER MODALITIES. Zvi Symon, Jeff Goldstein, and Yaacov Lawrence
5 THE APPLICATION OF MRI FOR DETERMINING BBB ABNORMALITIES Yael Mardor
MRI- TRANS RECTAL ULTRASOUND FUSION FOR IMPROVED PROSTATE CANCER THERAPY
Dr. Zvi Simon and Dr. Arlando Mayer, Sheba Medical Center
Categories Image Processing , Medical Algorithm, Medical Navigation, Prostate Cancer
Development Stage Clinical Stage
Patent Status WO2015/008279 – "MRI Image Fusion Methods and uses Thereof"- Pending
Background of the Invent ion
We develop a complete framework for focal therapy of the prostate guided by TRUS-MRI image fusion.
In image guided prostate biopsy, we distinguish between the first biopsy and the recurring follow-up. In
the first biopsy it is necessary to ensure that the lesion(s) will be sampled to provide informative tissue for
the pathologist and accurate diagnosis. The accurate position of the area sampled inside the lesion is less
important by itself.
In the recurring follow up it is required to sample the prostate at the locations that were sampled at
previous biopsies in order to enable temporal evolution monitoring. Here again it is important to ensure
that the needle re-samples an area sufficiently close the previous biopsy location to provide comparable
pathology results over time. For example, if the area sampled at first biopsy was inside a lesion, it is
important that the corresponding area sampled in the recurring biopsies be inside the same lesion.
On the other hand, prostate focal therapy has much more stringent requirements in terms of accuracy.
Fusion accuracy must enable to mark the whole volume of the targeted lesion up to a predefined resection
margin. The acceptable resection margin will usually be much smaller (1-2 mm) than the tolerable biopsy
positioning error. According to Seifabadi, the maximum tolerable error in biopsy is 5 about mm, which is
the radius of a clinically significant tumor assuming that it has a spherical shape .
The technologies that are developed these days for TRUS-MRI fusion in prostate imaging are dedicated to
biopsy applications and are not designed to cope with the stringent accuracy requirements of focal therapy
that we address in this project.
Our innovation revealed that software to register and merge data from magnetic resonance imaging (MRI)
and ultrasound (US) images enables intraoperative visualization of tumors, not typically seen in a US
image. It is possible that this technology may be essential for the efficient implementation of focal
therapy techniques in which individual tumors are treated within an appropriate and safe surgical margin.
The Need
Prostate cancer is the most common cause of cancer in men in many countries. It is the second leading
cause of death from cancer in American man.
Over the last decade, more accurate localization
of cancers within the prostate
Growing interest in focal therapy
Less radical approach.
Image-guided radiation therapy (IGRT) is the process of frequent two and three-dimensional imaging,
during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of
the actual radiation treatment plan.
IGRT and Precise radiation therapy offers several advantages:
1. Reduce severity and risk of therapy-induced complications.
2. Increase both quality and probability of success.
3. Broaden application of proven therapies.
4. Permit new therapies that are intolerant to geometric imprecision.
Co-localization of the target and
therapeutic dose distribution within the
human body is a significant technical
challenge.
P otent ia l Appl icat ions
parametric MRI is a powerful tool for any guided prostate cancer -Fusion between TRUS and multi
ct the sampling/treatment needle intervention whether diagnostic or therapeutic and could be used to dire
to suspicious lesions on MRI not clearly visible on TRUS alone.
therapy, photodynamic therapy, gene -high intensity focused ultrasound, cryo-These modalities include:
therapy and guided biopsies.
This fusion technology can be easily adapted to CT-MRI fusion. Thereby, it has the potential of
significantly improving the accuracy of CT-MRI fusion routinely performed in external beam
radiotherapy (EBRT). Current fusion solutions for CT-MRI fusion in EBRT are not accurate enough and
usually require much manual tweaking. The number of EBRT procedures is even larger than
brachytherapy
In Addition the automatic contouring technology we developed is also very useful in EBRT planning as ,
manual contouring takes a significant amount of time and is difficult to realize on CT scans due to poor
contrast in soft tissues. Actually, the contouring technology may be applied to other organs, leading to
additional products.
The Market
The Global market for Radiation Therapy Equipment is projected to reach US$6.8 billion by 2018, driven
by the increasing incidence of cancer around the world and by the development of Image-guided
radiation therapy tools. Additionally, technological advancements are driving the market for Radiation
Therapy Equipment, owing to the development of sophisticated screening methods that facilitate early
cancer detection.
Brachytherapy is increasingly been accepted as standard treatment for prostate cancer and gynecological
cancers including ovarian cancers, cervical cancer, and endometrial cancer among others. Brachytherapy
offers several benefits to cancer sufferers who are increasingly adopting this non-invasive alternative, and
this is predicted to continue to drive the future demand for brachytherapy. Extending applications of
brachytherapy to other locations within the body to include gliomas and intraocular melanomas, which are
a kind of brain tumor would assist in propelling the market for temporary brachytherapy devices in the
future.
Approximately 70 percent of all the cancer patients globally undergo radiation therapy. But almost 20
percent of malignant tumors are radiation-resistant. The radiation can be delivered via external-beam
radiation therapy, internal radiation therapy or systemic radiation therapy.
The market is also segmented by various technologies like intensity-modulated radiation therapy (IMRT),
image-guided radiation therapy (IGRT), cyber knife, gamma knife, proton / neutron therapy and dynamic
multi-leaf collimator (DMLC), among others, though External-beam radiation therapy (EBRT) continues
to represent the largest segment.
P atent
WO2015/008279 – "MRI Image Fusion Methods and uses Thereof"- Pending
T e c h T r a n s f e r Of f i c er
Dr. Sylvie Luria
Tel Hashomer Medical Research, Infrastructure and Services
Tel: +972-3-5305998 Fax: +972-3-5305944 ; [email protected]
FUSION BETWEEN PRE-OPERATIVE AND INTRA-OPERATIVE BRAIN MRI FOR NEUROSURGICAL NAVIGATION
Moshe Hadani, Arlando Mayer and Eli Konen – Sheba Medical Center, Israel
Nahum Kiryati, Ori Weber – Tel Aviv University, Israel
Categories Image Processing , Medical Algorithm, Medical Navigation, Neurosergury
Development Stage Clinical Stage
Patent StatusC156-P1374-USP- "Fusion between Intraoperative and Low Field MRI and
Preoperative MRI for Improved Neurosurgical Navigation" - pending
Background of the Invent ion
Preoperative high-resolution MRI is commonly used as anatomical reference for navigation during open-
brain surgery. It can be enhanced by overlaid preoperative Functional MRI (fMRI) and diffusion tensor
imaging (DTI) data that localize critical grey and white matter areas in the vicinity of the targeted lesion.
The use of preoperative images implicitly assumes that the brain remains immobile with regard to the
skull during the entire procedure. In practice, this assumption has only a limited validity in time.
When the skull is opened (craniotomy) at the brain drift progressively with regard to the skull. This well-
known effect is called brain shift. As surgery progresses, local deformations caused by ongoing tissue
resection further increase the discrepancy between preoperative MRI and the actual brain anatomy.
Intraoperative MRI slices: Left-before surgery; Middle-during surgery; Right-overlay before
(grayscale) / during (purple) surgery. In the middle image, the yellow arrow through the skull opening
indicates the area that has been resected (black). Note in the right image the local misalignment
(yellow contour) between before and during surgery corresponding to brainshift effect and resection
induced deformations.
Pre-operative planning and intra-operative guidance in neurosurgery require detailed information
about the location of functional areas and their anatomo-functional connectivity. In particular,
regarding the language system, post-operative deficits such as aphasia can be avoided.
During the last decade, low field (~0.15 Tesla) interventional MRIs (iMRI) has been developed to
provide updated MR images during surgery, thereby helping to compensate for brain shift. It has been
shown that iMRI guided Glioma surgery helps surgeons provide the optimum extent of tumor resection.
In practice, however, due to magnetic field and physical size limitations, intra-operative MRI cannot
provide images comparable to the pre-surgical images obtained on a full size, high field scanner. The field
of view is limited to an ellipsoidal window that is usually too small to contain the whole brain and whose
position and orientation are unknown a-priori, and it is not possible to acquire functional MRI (fMRI) or
diffusion tensor imaging (DTI) intra-operatively.
Preoperative high field image (left); intraoperative low field and SNR image (right)
Currently, no existing solution gives the neurosurgeon an image quality comparable to pre-operative
MRI with the compactness, ease of use and low cost of low field MRI.
We developed and validated an algorithmic framework to perform accurate and robust registration
between high quality pre-surgical MRI and noisy intra-operative MRI images. On completion of
successful registration, pre-operative anatomical, functional and DTI tractography maps shall be projected
onto the intraoperative MRI images, thereby providing fusion between preoperative (anatomical, DTI
tractography and fMRI) and intra-operative MRI.
The Need
There is major need for Precision guidance system for surgeon with real-time updated information of
target condition . Computer Assisted Surgery based on Intraoperative Information and Navigation
Technology is in great demand for several reasons:
1. Patient safety
2. Evaluation of performance of surgeon/procedure/device
–Record, Analyze, Visualize
–By human: hard task, long time, high cost, error
–Do not disturb surgical procedure 3. Demand for Automatic Recording/Analysis/Visualization
–Quantitative digital data for computer processing
–No effect on surgical procedure and environment
Automatic analysis using navigation information4 .
Advantages:
Platform technology for accurate medical image Fusion.
Improved patient safety and procedure outcome.
The technology can be applied to MRI and iMRI images generated by equipment
produced by different vendor.
The software can be standalone and load standard DICOM images dirtectly from the
imaging devices or from a picture archiving and communication system (PACS).
The software can be fully integrated to existing iMRI navigation systems in collaboration
with the vendor.
P otent ia l Appl icat ions
The developed deformable registration between modalities with different field-of-view, such as
iMRI-MRI fusion application - is applicable to other scenarios in image guided interventions.
For example, the registration between preoperative MRI images and intraoperative optical
microscope or endoscope images can benefit of our ability to deal with partial field-of-views
(here for the microscope).
The resulting product may prove particularly useful as the intrasurgical microscope provides real-
time updates while iMRI can only provide snaphots at a given time.This is applicable not only for
Brain but virtually to any form of micro-surgery performed under microscope or endoscope.
The developed technology can be applied to the registration between MRI and CT required
for the accurate planning of image guided cancer radiotherapy. The potential use of this
application is very widespread since image guided radiotherapy is performed on a multitude of
organs affected by cancer. Accuracy is a critical factor in radiotherapy as it ensures proper
delivery of radiation to the target while sparing surrounding healthy tissues.
The developed technology can also be applied to PET-CT or PET-MRI fusion. The significant
difference in SNR between these modalities is similar to the iMRI – MRI problem addressed
specifically in our research. Here again, the potential use is very important as PET-CT / MRI is
the method of choice for cancer metabollic imaging
The Market
Neurosurgery is a complex surgical procedure that involves diagnosis, treatment, and
rehabilitation of disorders affecting any region of the nervous system. Some of the common
neurosurgeries are endovascular neurosurgery, stereotactic neurosurgery, oncological
neurosurgery, craniotomy, and neuroendoscopy. In all neurosurgery procedures, Image navigation
in real time is mandatory with millimeter accuracy. Advanced imaging maps of the brain structure
and function, using intraoperative MRI with This allows our surgeons to perform brain surgery
with precision and real-time imaging information, helps surgeons identify vital areas of the
brain, and these are key success factors. Brain Tumors pose particular challenges because of
edema, displacement effects on brain tissue and infiltration of white matter. Under these
conditions, standard fiber tracking methods reconstruct pathways of insufficient quality.
Therefore, robust global or probabilistic approaches are required.
The global MRI market is currently valued in the region of US$5.5 billion (2010) and is estimated
to rise to US$7.5 billion by the year 2015. Of this the US market is estimated at US4.5 million
(2010) rising to US$5.8 million by 2015 (GIA, 2010; Reportlinker 2010). The leading MRI
producers are GE (Signa brand), Siemens (Magnetom), Philips (Achieva, Intera, Panorama),
Hitachi (Aaltaire, Airis) and Toshiba (Vantage, Opart, Ultra). Products range from Low Field
systems (<0.5T) through Mid Field (0.5-1T) High Field (usually 1.5T) to Very High Field
(usually 3T).
Procedure Types Currently the greatest demand for MRI procedures in the US is for Brain, Head and Neck scans
with spine and extremity scans running a close second. The following chart shows a breakdown
of procedure types in the years 2010 and 2007.
Procedure types 2010, 2007
MRI Procedure Type
2010 2007
Procedure
numbers
(millions)
% of all
procedure
s
% of sites
performin
g
Procedure
numbers
(millions)
% of all
procedure
s
% of sites
performin
g
Spine 7.5 25% 97% 7.1 27% 100%
Brain Head and Neck 8.7 29% 89% 8.5 32% 94%
Extremity 7.3 24% 99.5% 5.3 20% 99%
Vascular (MRA) 2.3 8% 99% 2.4 9% 88%
Pelvic & Abdominal 2 7% 91% 1.9 7% 91%
Breast 1.1 4% 55% 0.5 2% 26%
Chest, other cardiac 1.1 4% 19% 0.8 3% 34%
Other (inc
interventional) 0.2 1% 5% 0.2 1% 5%
Total 30.2
26.7
Our technology will have an impact to other procedures that require real time imaging for
precision procedures.
P atent
"Fusion between Intraoperative and Low Field MRI and Preoperative MRI for Improved Neurosurgical
Navigation" 61/984,988, pending
Method and System to Confirm Intravenous Catheter Placement and Positioning
Dr. Ilan Keidan, Sheba Medical Center, Israel
Categories Method and Algorithm
Development Stage Clinical Stage
Patent Status
PCT/IB2012/052288 :
"PROVIDING EVIDENCE WHETHER AN INTRAVASCULAR
CONDUIT ISCORRECTLY POSITIONED"
Background and Technology
INFILTRATION AND EXTRAVASATION are common complications of intravenous (I.V.) infusion
therapy. Extravasation can cause accidental administration of intravenously infused medicinal drugs into
the surrounding tissue, either by leakage (e.g., because of brittle veins in very elderly patients), or direct
exposure (e.g. because the needle has punctured the vein and the infusion goes directly into the arm
tissue). For example, Extravasation of medicinal drugs highly irritating solutions, such as those containing
calcium, potassium, contrast media, some antibiotics, vasopressors, or chemotherapeutic agents.during
intravenous therapy is a side effect that should be avoided. In mild cases, extravasation can cause pain,
reddening, or irritation on the arm with the infusion needle. Severe damage may include tissue necrosis. In
extreme cases, it even can lead to loss of an arm. The best "treatment" of extravasation is prevention.
While there is no real treatment per se, there are some techniques that can be applied in case of
extravasation, though their efficacy is modest. We have developed a simple method and system to
monitor intravenous position of catheters via periodically administration of a simple composition and a
monitoring device. (Sodium bicarbonate solution and end-tidal carbon dioxide monitor). The rationale for
using bicarbonate is based on the well-known phenomenon of increased exhaled carbon dioxide (CO2)
after its IV administration.
The Need
Extravasation is a serious condition that warrants special attention from the healthcare professionals
involved in administering intravenous medications. Over 100,000 doses of chemotherapy and in excess of
1,000,000 intravenous (IV) infusions given every day around the world, keeping adverse events and
complications of these procedures to a minimum is important both for the patients receiving them and the
healthcare systems in which they take place. It is critical that an extravasation is recognized and diagnosed
early. The tools available today to recognize and detect extravasation in its early stages are mainly
subjective and awareness to all relevant signs and symptoms. Infiltration rates were reported to be high,
with as many as 20-30% of IV catheters in adults resulting in infiltration, with higher rates seen in
children. Analysis of the American Society of Anesthesiologists Closed Claims database revealed 2% of
all claims were related to peripheral IV catheterization and over half of these were due to extravasation,
and higher rates could be expected with other health care providers given the presumed expertise of
anesthesiologists in IV cannulation.
Development Stage and Technology
We developed a novel technique that can differentiate between an infiltrated and a correctly sited IV
catheter in both anesthetized ventilated and spontaneously breathing volunteers. We have demonstrated
the efficacy of the novel method as very useful in providing information to monitor and assist in
determining whether or not an intravenous conduit is in a correct position. The method is simple to
integrate in various monitoring systems in the hospital set-up. We have initiated clinical studies that
demonstrate the efficacy and specificity of the concept and system in patients from age 2-35 years old.
Currently we are expending the study to the general patient's population. We target those patients which
extravasations/ infiltration rate is high and the consequences are grave.
Advantages
The technology relates to a specific tool to be implemented in clinical monitors. Our technology is simple
to integrate into existing monitoring devices, Capnometers and monitoring systems with critical added
value of CO2 monitoring..
The Market
The market is add on capnometry devices for the determination of the end-tidal partial pressure of carbon
dioxideThe carbon dioxide (CO2) monitors market is witnessing an increasing trend over the last few
years, primarily driven by enhanced requirements in patient monitoring for safety and disease
management. Although majority of capnography applications are in the operating rooms for detecting and
identifying the end-tidal CO2 levels, new and emerging applications including critical care units, recovery
rooms, labor and delivery rooms, emergency rooms, post-anesthesia care units, intensive care units and
daily care units in Oncology and autoimmune diseases are instigating the use of capnography equipment.
Capnography market worldwide is presently considered a segment with rich opportunities, increasing
simultaneously with the continuously evolving ways and methods of patient care. Our new feature to be
incorporated into an existing commercial end-tidal CO2 monitor may contribute the market growth, with
the rise of aging population as well as increasing IV bio-pharmaceutical therapies and the augmented
safety regulations.
The worldwide markets for Carbon Dioxide (CO2) Monitors include the following Product Segments:
End-tidal Carbon Dioxide (EtCO2) Monitors, and Transcutaneous Carbon Dioxide (tcpCO2) Monitors.
There are 40 companies including many key and niche players such as B. Braun Melsungen AG, CAS
Medical Systems, Inc., Criticare Systems, Inc., Dräger Medical AG & Co. KG, GE Healthcare Life
Support Solutions, Heinen + Löwenstein GmbH, Invivo Corporation, Ivy Biomedical Systems, Inc.,
Mindray North America, Nellcor Puritan Bennett, LLC, Nihon Kohden Corporation, Nonin Medical, Inc.,
Oridion Systems, Ltd., OSI Systems, Inc., Philips Healthcare, Physio-Control, Inc., Radiometer Basel AG,
Radiometer Medical ApS, Respironics, Smiths Medical, Thames Medical, Weinmann Geräte Für Medizin
GmbH + Co. KG, and Welch Allyn Inc.
The global market for intravenous therapy and vein access was $19.3 billion in 2013. The market reached
$20.3 billion in 2014 and is expected to reach about $27.2 billion in 2019, registering a compound annual
growth (CAGR) of 6.0% over the next five years.
The next generation market for capnometry devices will be at each bed station in the hospitals.
P atent
METHODS AND DEVICES USEFUL FOR DETERMINING CORRECT PLACEMENT OF INTRA-VASCULARTURE "
CONDUIT "
A controlled platform for assessing and obtaining target lesion immobilization through
integrated use of CPAP, biofeedback and other modalities.
Zvi Symon, Jeff Goldstein and Yaacov Lawrence, Sheba Medical Center
Categories Radiotherapy, Target Lesion Immobilization, Imaging, Medical
Device
Development Stage First prototype
Patent Status Pending
BACKGROUND AND TECHNOLOGY
Organ movement is troublesome in many areas of interventional and diagnostic medicine where
precision is vital to success. The concept ‘motion management’ has especially been developed in
radiation oncology in order to avoid missing the target (e.g. a lung tumor) and to minimize
radiation exposure of normal tissues. Currently various strategies of motion management exist
(e.g. abdominal compression, gating of the X ray beam, breath hold) and are employed
empirically depending upon physician preference and availability. No predictive algorithms exist
that predict what the optimal motion management should be employed.
We have developed a novel approach and Smart iMmobilzation device that incorporate multiple
inputs for measuring organ movement / respiratory phase and have the ability to control multiple
interventions to minimize organ movement. The device is an individualized ‘organ-stabilization’
strategy based upon 1) a preliminary dummy run testing how each individual patient/tumor reacts
to each intervention and 2) an inbuilt algorithm that predicts the impact of respiration based upon
tumor location and body habitus.
The multiple interventions that are used to decrease tidal volume include: CPAP, Air Pressure for
delivering CPAP will be under computer control (or other respiratory mode, biofeedback of size
of tidal volume supplementary oxygen, abdominal compression under computer control,
breathing control, and use of pharmaceutical agents .
The device will incorporate number of sensors to probe the depth of respiration, and tumor
movement as well as other parameters: respiratory rate, pulse oximeter, spirometer including
pressure volume measurement, lung compliance and volume, mechanical measure of chest
expansion using wearable sensors a mechanism for distinguishing different patterns of breathing
(e.g. thoracic vs abdominal breathing), blood pressure and pulse, panic button, and ultrasound.
The device will be able to control/trigger LINAC gating (or other device e.g. PET scan). The
patient will have a hand control that will enable manual adjustment of pressure (and measure
pulse oximtery), incorporating a panic button.
A control station can adjust CPAP volume, oxygen concentration, visual feedback and
abdominal pressure in order to help the patient minimize tidal volume. The system includes an
algorithm that optimizes the above interventions based upon real-time feedback , e.g. of chest
movement. The algorithm predicts the optimal strategy for organ mobilization based upon
clinical and anatomical parameters, previously collected clinical data. The machine will also be
used during delivery to ensure consistent care.
This device will employ allow assessment and use of both widely used (e.g. abdominal
compression, breath hold) and novel (e.g. CPAP) methods of motion management. Further more
it will provide a platform for further development.
DEVELOPMENT STAGE:
CPAP as an individual modality is already being developed and is protected by a patent
pending registered by Sheba.
We are performing on-going clinical studies to understand the optimal duration and
pressure for CPAP use and these will form the basis of the algorithm, which will be
implemented within the device.
We are submitting an IRB proposal to investigate the effect of CPAP and abdominal
compression on tidal volume and respiratory rate.
THE NEED
Radiation therapy uses controlled high-energy rays to treat tumors and other diseases. The goal
of radiation therapy is to maximize the dose to the target lesion within the organ with the
following general principles
Precisely locate the target
Hold the target still - Patient and Machine alignment
Accurately aim the radiation beam
Shape the radiation beam to the target
Deliver a radiation dose that damages abnormal cells yet spares normal cells
Immobilization devices are needed for precise treatments:
Stereotactic
Radiosurgery (SRS)
Fractionated Stereotactic
Radiotherapy (FSR)
Conventional
Radiotherapy
Locate target Uses stereotactic
localization
Uses stereotactic localization Uses standard diagnostic
scans
Immobilization
device
Uses a rigid
stereotactic head or
body frame
Uses a repositionable stereotactic
mask or body mold
May use a mask or body
mold
Accurately aim
radiation beam
Most precise
Uses laser, infrared and
x-ray body tracking
Very precise, Uses laser, infrared
and x-ray body tracking
Larger target area that
includes normal brain
margin
Immobilization devices need to be improved to control for precise treatments in real time. Smart
immobilization devices will affect treatment efficacy and safety. Our novel system and general
platform will address the need in every radiotherapy clinic and for every patient in the clinic.
The need for smart immobilization devices will grow with market growth of proton therapy.
Additional possible applications: radiology for improving contrast between lesions and normal
lung tissue, screening for lung cancer, invasive radiology- performing biopsies (e.g. kidney,
liver biopsy), urology (lithotripsy) and to optimize imaging e.g. PET (which is degraded through
organ movement)or MRI.
ADVANTAGES
Current strategies of motion management are ‘dumb’, e.g. abdominal compression used to limit
breath size consists of a simple belt or plastic paddle that is adjusted by hand prior to treatment
and not connected to any electronic device. Our ‘smart’ device will both measure movement and
intervene to minimize breath size before and during treatment, allowing real-time monitoring,
and inform a self-learning algorithms to the benefit of subsequent subjects.
THE MARKET
Radiation therapy is one of the advanced treatment and diagnostic procedures to kill tumor cells
using focused energy with an intension to limiting harmful effects to the neighboring healthy
cells. Radiotherapy is generally applied either alone or along with the combination of surgery or
chemotherapy.
The global radiotherapy devices market is classified into external radiotherapy, internal
radiotherapy (brachytherapy) and systemic radiotherapy. The radiation therapy market is
expected to grow at a faster rate with a CAGR of 5.3% from 2013 to 2018.
The global radiotherapy market has seen challenging and dynamic market conditions, but still
remains strong, with a size of approximately $4.4 billion in 2011, at an estimated annual growth
rate of 5.3% over the next five years.
Major players in the market include Varian Medical System (U.S.), Elekta AB (Sweden) and
Accuray (U.S.), IBA Group (Belgium), Eckert & Ziegler BEBIG (Belgium), iCAD, Inc. (U.S.),
GE Healthcare (U.K.), Covidien, PLC (Ireland), C.R. Bard, Inc. (U.S.), Nordion, Inc. (Canada),
Theragenics Corporation (U.S.), Oncura, Inc. (U.S.) among others.
The market for treatment solutions to support radiotherapy include software and hardware,
including immobilization devices.
Beam shaping IMRT or 3D conformal IMRT or 3D conformal IMRT or 3D conformal
Optimal dose Very high dose
delivered during one
treatment session
Moderate “fractions” of the
complete high dose delivered over
multiple treatment sessions
Moderate “fractions” of
the complete dose
delivered over multiple
treatment sessions
The successful clinical implementation of radiotherapy modalities requires precise positioning of
the target to avoid a geographical miss. Effective reduction in target positional inaccuracies can
be achieved with the proper use of immobilization devices.
Immobilization devices are applicable to any interventional procedures in the chest and abdomen
where respiration-induced organ movement is detrimental, e.g. Optimization of internal patient
anatomy for radiation treatment planning and delivery, other ablative modalities ( Focused
ultrasound, radiofrequency ablation, nano-knife and other ablative modalities), interventional
radiology for performing biopsies (e.g. kidney, liver biopsy), urology (lithotripsy) and to
optimize imaging e.g. PET (which is degraded through organ movement)or MRI.
The immobilization device market includes stereotactic frame, Talon system, thermoplastic
molds, Alpha Cradles, and Vac-Lok system. Main players are VARIAN, Elekta, Orfit Industries,
Bionix Radiation Therapy , Kobold , Qfix and others. The overall market reaches over 430 M
USD during 2013. The driving force of this market will be precise treatment and proton therapy
using immobilization with real time controlled operation systems.
FUTURE OUTLOOK
New therapeutic approaches to disease are increasingly minimally invasive and non-operative.
All require precision, and if located within the chest or abdomen, they are negatively affected by
respiratory motion. Hence there is a growing need for “organ stabilization” techniques.
IP STATUS- NEW APPLICATION , PENDING
AUTOMATIC DECISION SUPPORT SYSTEM FOR CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
Dr. Miri SklairLevy and Dr. Arnaldo Mayer , Sheba Medical Center
Categories Digital Mammography, Breast Cancer, Imaging, Medical Device
Development Stage First prototype
Patent Status Pending
BACKGROUND AND TECHNOLOGY
Mammography is a well-established, cost-effective imaging technique for breast cancer
detection that has been clinically available since 1970. It is the only screening technology that
was proved to reduce mortality and the only one with FDA clearance.
In the last decade, full-field digital mammography has progressively replaced the film-based
mammogram. Solid-state detectors, directly converts X-rays into a high resolution digital
image.
The lack of visibility in dense breasts remains a major limitation of mammography even in its
digital form. 40 to 50% of women below 50 years have dense breasts as well as a significant
proportion of women older than 50 years. The overall sensitivity range of mammography is
63%-98% and drops to 30%-58% for dense breast.
MRI proved to be a very sensitive tool in breast cancer detection even with dense breast by
leveraging the complementary information provided by contrast administration. In particular,
contrast-enhanced MRI is extremely sensitive to angiogenesis. Unfortunately, breast MRI
remains very expensive in comparison to digital mammography and with limited availability.
Contrast enhanced digital mammography (CEDM) was developed in the very recent years as
a low cost technique for the detection of abnormal focal areas with increased micro vessel
density.
We have developed an automatic decision support system that will help the radiologist reach
a confident classification of CEDM breast lesions as benign or malignant. Our goal is to
increase the radiologist diagnostic specificity so that a significant amount of unnecessary
biopsies will be avoided without compromising sensitivity. In a unique approach, the
developed system will integrate both visual data (pixels) and patient background information
(risk stratification system )into a joint supervised learning scheme.
The developed technology can be applied to other breast imaging techniques such as MRI
that would also benefit from the contextual patient information in obtaining a higher
diagnostic confidence and potentially reduce the amount of unnecessary biopsies.
Also, the developed technology may be applied to other organs where contrast enhancement
MRI is performed for the detection of malignant lesions such as the prostate.
We propose imaging tools for Contrast-enhanced digital mammography (CEDM) and contrast-
enhanced tomosynthesis (CET). CET and CEDM may be considered as an alternative modality to
MRI for following up women with abnormal mammography. .
DEVELOPMENT STAGE
1) Development of a lesion classification system in CEDM images: The algorithm developed
is enhanced to include additional visual features into the learning and classification process.
The enhanced algorithm is validated on retrospective set of at least 200 CEDM lesions for
which manual contour will be provided by an expert breast radiologist and lesion
classification available from prior biopsy.
2) Enhanced classification by joint visual and contextual features learning : Contextual
information describing the patient medical background such as age, genetically background
(BRCA gene), previous/family history of disease, lesion palpability, etc is included to
complement the "pixel" based information in the classification system. For this purpose,
contextual information will be collected for each of the 200 CEDM of point 1.
3) Development of an Online learning capability architecture for continuous performance
improvement: Online learning enables the incremental update of a learning system model
parameters each time new training data is available. We leverage the routine reading work of
breast radiologists on CEDM to add automatically new cases to the training set and update
the classifier parameters to account for the newly available data. For this purpose incremental
learning techniques is investigated and compared to standard batch re-training of the
classifier.
4) Integration of the developed system with the radiologist workflow: The developed system
is implemented on a virtual machine. .
5) Clinical validation of the integrated system in Sheba: Using the integrated workflow
described above, the developed system is evaluated on a set over 100 new CEDM lesion for
which ground truth is available. The automatic classification results is compared to ground
truth (biopsy) and statistical analysis will be performed.
THE NEED
The main problem with mammography is its unacceptably high rate of false positives.
If a mammogram detects an abnormal spot in a woman's breast, the next step is typically a
biopsy. In addition, early stage cancer like ductal carcinoma in situ, or D.C.I.S., can be very
hard to diagnose. Many of the tests that produce false positives, lead to many unnecessary
biopsies and other invasive medical procedures. Vast research demonstrate that biopsies
performed for 70% to 80% of all positive mammograms do not show any presence of cancer.
According to some estimates, 90% of these call backs are because of unclear readings due to
dense overlying breast tissue.
Estrogen replacement therapy (ERT) obscures mammogram results. According to a study of
8,800 postmenopausal women aged 50 and older, the use of ERT leads to a 71% increased
chance of receiving a false positive from a mammogram. It was also found that women on ERT
were more likely to get more false-negative readings.
Safer methods of breast cancer screening is needed, and some technologies are becoming
available, however more studies are needed to enable these technologies as a screening tests.
ADVANTAGES OF OUR NOVEL APPROAC H:
Our Innovation enables several advantages for the patient, for radiologists and for clinics:
We have demonstrated very high sensitivity. This low cost CEDM technology has an excellent
growth potential that will benefit to any decision support systems relying on it.
Using an "online" learning approach, the performances will benefit from the increasing number of
processed cases over time.
The technology is easily applied to the characterization of MRI lesions.
The technology developed in this project is purely software based and therefore "vendor
agnostic". Alternatively, the software can be integrated to existing CEDM systems in
collaboration with the vendor.
The developed technology can be applied to other breast imaging techniques such as MRI that
would also benefit from the contextual patient information in obtaining a higher diagnostic
confidence and potentially reduce the amount of unnecessary biopsies.
The developed technology may be applied to other organs where contrast enhancement MRI is
performed for the detection of malignant lesions such as the prostate.
THE MARKET
Breast Imaging Market worth 4.14 Billion USD by 2021 at a CAGR of 8.5% from 2016 to 2021.
Based on type, the global breast imaging market is segmented into ionizing breast imaging
technologies and non-ionizing breast imaging technologies. The ionizing breast imaging
technologies segment is subsegmented into analog mammography, full-field digital
mammography (FFDM), 3D breast tomosynthesis, positron emission tomography/computed
tomography (PET/CT), molecular breast imaging/breast-specific gamma imaging (MBI/BSGI),
cone-beam computed tomography (CBCT), positron emission mammography (PEM), and
electric impedance tomography. The non-ionizing breast imaging technologies segment includes
breast MRI, breast ultrasound, optical imaging, automated whole-breast ultrasound (AWBU),
and breast thermography.
Growth in the breast imaging market is driven by factors such as the rising incidence of breast
cancer globally; growing government investments and funding for breast cancer treatment and
related research; increasing awareness about early detection of breast cancer; rising geriatric
population; technological advancements in breast imaging modalities; and launch of advanced
breast imaging systems capable of detecting cancer in women with dense breast tissues. In
addition, the growing demand for breast imaging in emerging Asian countries, and technological
advancements in breast cancer detection are expected to offer high growth opportunities for
market players. However, factors such as high installation cost of breast imaging systems, side-
effects of radiation exposure, and errors in breast cancer screening and diagnosis are restricting
the growth of the global breast imaging market.
North America is estimated to be the largest regional segment in the global breast imaging
market in 2016, followed by Europe. However, the Asia-Pacific market is expected to grow at
the highest CAGR of 9.5% from 2016 to 2021. A number of factors, such as the growing patient
population, increasing healthcare expenditure, improving healthcare infrastructure, growing
government spending on breast cancer research studies, and implementation of several initiatives
to create awareness about the early detection of breast cancer are expected to drive the market in
the Asia-Pacific region.
Hologic, Inc. (U.S.), GE Healthcare (U.K.), Siemens Healthcare (Germany), Philips Healthcare
(Netherlands), Fujifilm Holdings Corporation (Japan), Gamma Medica, Inc. (U.S.), Toshiba
Corporation (Japan), Sonocine, Inc. (U.S.), Aurora Imaging Technology, Inc. (U.S.),
Technologies, Inc. (U.S.) , and Toshiba are some of the key players operating in the global breast
imaging market.
FUTURE OUTLOOK
Breast cancer is identified by the WHO as the leading cause of cancer in women.
According to the estimates of WHO (World Health Organization), approximately 1.5 million
cases of breast cancer were diagnosed in 2010 and this number is expected to double by 2030.
Such rapidly rising incidence rates of breast cancer will serve the global mammography
equipment market as a significant growth rendering driver.
The history of breast imaging continues to evolve with the introduction of new applications, such
as computed tomography, breast-specific gamma imaging, and positron emission mammography.
However, the higher radiation doses associated with these new technologies deserves close
attention as the relative benefits and risks of these modalities are evaluated in the clinical setting.
The 3D mammography equipment is identified as the fastest growing market. Better image
clarity aiding in accurate diagnosis and the implementation of PACS (Picture Archiving and
Communication Systems) eliminating costs associated with the usage and storage of X-ray fimls
are some of the factors attributing to its high growth rates.
North America is expected to dominate the market throughout the forecast period. The presence
of sophisticated reimbursement frameworks and high patient awareness levels account for the
aforementioned conclusion. The European mammography equipment market follows North
America in terms of market share on account of the presence of high breast cancer prevalence in
countries such as Belgium, Denmark and France coupled with high per capita healthcare
expenditures in this region.
IP STATUS- NEW APPLICATION , PENDING