partner institution’s technology is related to medical imaging
TRANSCRIPT
Proprietary and Confidential © [Client Name] Pte Ltd 2010
[Client Company Logo] Phase I Report
Title [Title] Partner Institution [Name of Partner Institution] Inventor(s) [Inventors] Likely Market [Geographical Locations] Date [Date of Delivery]
S
Summary PARTNER INSTITUTION’s technology is related to semiconductor based gamma ray detectors that include a Compton camera for detection. The technology is disclosed in the patent publications Patent No. 1, Patent No. 2, Patent No. 3 and Patent No. 4, which are assigned to PARTNER INSTITUTION. The disclosed technology has the following advantages:
• Position from where the gamma rays get emitted can be precisely estimated.
• Gamma rays with a wide energy range can be detected.
The technology domain appears to be niche and is populated with 79 patent publications. However, the number of patents filed has observed a surge in recent years because of increased R&D focus in this field. The technology domain is dominated by companies that are active in the field of medical imaging devices. The major application area of the technology is in the medical field, where diseases such as cancer can be detected at an early stage.
Gamma-ray detectors have potential applications in several areas such as medical imaging, homeland security and nuclear weapons verification. Gamma-ray sources are used for cancer treatment as well as diagnostic purposes. They are mainly utilized for breast cancers and tumors. With more than 10 million new cases every year, cancer has become one of the most devastating diseases worldwide. One of the techniques used for treating cancers is using nuclear medicines which can emit gamma rays.. According to Frost & Sullivan Global Gamma Camera Markets, this market generated $638.0 million of revenues in 2003. The market is expected to grow at a compound annual growth rate (CAGR) of 3.1% to $788.8 million in 2010. Philips, GE and Siemens are some of the leading companies in the domain with scanning technology for cancer treatment. PARTNER INSTITUTION’s gamma ray detector technology based on Compton camera can be commercialized through either of licensing, establishing a joint venture or establishing a standalone company.
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
Contents Description and Application ...................................................................................................................... 3
Novelty, Benefits, Solutions ...................................................................................................................... 3
Competitive Technologies ......................................................................................................................... 6
Patent Landscape ...................................................................................................................................... 9
Technology Landscape ........................................................................................................................... 11
Technology Bundling Opportunities ...................................................................................................... 13
Market Opportunities ............................................................................................................................... 14
Market Potential ........................................................................................................................................ 16
Regulatory Environment .......................................................................................................................... 17
Geographic Description of Likely Markets ............................................................................................ 18
Potential Licensees/Partners/Customers ............................................................................................. 18
Commercialization Strategy .................................................................................................................... 19
SWOT Analysis for Commercialization ................................................................................................. 20
Go/No Go Recommendation .................................................................................................................. 20
Keywords and Phrases Used in Searches ........................................................................................... 20
Technology Triage Form Input .................................................................. Error! Bookmark not defined.
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
Description and Application PARTNER INSTITUTION’s technology is related to medical imaging for the detection of diseases such as cancer, through non-invasive techniques. A radiopharmaceutical such as fludeoxyglucose (F-FDG) is administered to a patient suspected to be suffering from a disease. The radiopharmaceuticals are capable of emitting gamma rays, and accumulate in the organs or tissues with cancerous growth. Gamma ray detectors detect the radiation emitted by the radiopharmaceuticals and can capture images of different parts (such as tissues and organs) of the human body. The tissues or organs with accumulated radiopharmaceuticals are detected and identified as being possibly diseased.
Gamma rays are detected using a Compton scatter camera. Compton cameras include two detector systems. The first detector system receives incoming gamma rays and scatters them. The second detector in the camera absorbs scattered gamma rays, and measures the position in the human body from where the gamma rays were emitted. The location of the gamma ray sources can thus be estimated. Further, the technology measures the energy of the received gamma rays. The gamma ray detector used in the technology has a high energy resolution. This enables accurate energy measurement. Furthermore, the technology is capable of simultaneously detecting more than one source of gamma ray emissions. Moreover, gamma rays over a wide energy range can be detected.
One of the important areas of application of the technology is diagnosing human diseases. The technology is especially helpful for the detection of abnormal growth in body tissue or the growth of lymph nodes. Tumor growth or cancer, such as breast cancer, in human body can be detected by this technology.
The following patents are related to the technology:
Patent Publications Title Inventors Publication
Date Family Members
[Patent No.] [Title] [Inventors] [Date] [Families]
… … … … …
… … … … …
… … … … …
Novelty, Benefits, Solutions Patent No. [No.] (Family Member of [Patent No.])
Gamma Ray Detection Technology (Prior Art)
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
X-rays and gamma rays are detected by semiconductor detectors on interaction between the incident rays and a semiconductor crystal. This interaction results in creation of an electron-hole pair in the crystal. Interactions include, but are not limited to photoelectric effect, Compton scattering, and electron pair creation. The detectors include a pair of electrodes provided on the opposite sides of the semiconductor crystal. A bias voltage is applied between the electrodes and a charge created in the crystal is measured as signal by the electrodes. The position at which an interaction occurs is detected based on the detected signals. The detected signal that has the largest amplitude corresponds to the interaction position.
In the aforementioned method for detecting the interaction position, detection accuracy is directly proportional to the size of the electrodes.
The aforementioned problem is overcome by the semiconductor detector disclosed in the Japanese Patent Application No. [No.] assigned to PARTNER INSTITUTION. The patent application discloses a detector that detects the interaction position of the gamma rays with high accuracy compared to the prior art. The patent discloses a cross strip detector that estimates a difference in the rise times of signals between the anode and cathode closest to the interaction point. The estimation is used to determine the interaction position with respect to depth.
The publication “[Publication Title]” by [Author Name], et. al., discloses a technology for detecting the position of a gamma ray interaction. According to the disclosed technology, interactions that occur at specific positions are measured and stored as reference signal waveforms. The detected signal waveforms are compared with the reference waveforms and a corresponding position is determined. The position where the difference between the signal and the reference waveforms is the minimum is the interaction position.
The aforementioned methods suffer from the drawback of superposition of signal waveforms during the detection of multiple waveforms.
PARTNER INSTITUTION’s Technology
The patent discloses a semiconductor radiation detector that can detect the position of each interaction in cases of multiple interactions. Various embodiments of the technology are as follows:
First Embodiment
The semiconductor detector stores signal waveforms obtained from the electrodes for each interaction occurring at different positions in the semiconductor crystal. Subsequently, energy corresponding to the interaction positions is calculated based on signals obtained from segmented electrodes. Further, signal waveforms are calculated by superposing reference waveforms (obtained for a single interaction). Interaction positions are roughly estimated from signal waveforms obtained from a segmented electrode. Furthermore, synthesis of reference waveforms may be performed for points in an estimated region. The synthesized waveforms are compared with waveforms obtained from the segmented electrode. Synthesis of reference waveforms can be made redundant by reducing the size of the region in which the interaction point exists. Moreover, comparison between synthesized and signal waveforms (for all
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
combinations of two arbitrary points in the crystal), may also be redundant. Consequently, faster processing times can be achieved.
Second Embodiment
The second embodiment can be used for efficient detection of the position of the interaction. The detector estimates the interaction region for calculating the interaction position from a signal waveform.
Third Embodiment
In the third embodiment of the invention, interaction position in a plane parallel to the segmented electrodes is determined, based on the sum of the difference in the absolute values of the signal values of the segmented electrodes. As a result, the interaction position can be determined efficiently with high accuracy.
Fourth Embodiment
In this embodiment, an interaction position calculation section analytically calculates the position of an interaction from measurement signals. This enhances the measurement accuracy of the semiconductor detector.
Advantages
The position of gamma rays can be precisely detected when silicon or cadmium telluride crystals are used.
Disadvantages
The semiconductors used in the gamma ray detectors may require cooling.
Patent Publication No [No.] (Family member of [Patent No.])
Gamma Ray Detection Technology (Prior Art)
The Japanese patent publications no. [No.] assigned to PARTNER INSTITUTION discloses a gamma ray detector that works on the principle of Compton scattering without the use of a collimator. The gamma ray detector includes two germanium elements. Gamma rays undergo Compton scattering from the first germanium element, and get absorbed by the second element. Thus, the position, direction and energy of incident gamma rays can be detected.
The publication “[Publication Title]” by [Author’s Name], et al. from the Proceedings of [Conference Name] discloses a gamma ray detector that uses silicon and cadmium telluride elements.
PARTNER INSTITUTION’s Technology
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
The patent discloses a gamma ray detector having two detector elements made of germanium for detecting gamma rays. The detector elements are used for estimating the position and energy of high-and low-energy gamma rays. This results in detection of a wider energy range. The detecting elements for high-energy gamma rays include germanium crystals, and the detecting elements for low-energy gamma rays include silicon crystals. The following are the embodiments of the invention.
First Embodiment
The detector includes a silicon detecting element added in front of two germanium detecting elements. Low-energy gamma rays undergo Compton scattering at the silicon element, and high-energy gamma rays undergo scattering at the first germanium element. Thus, both low-and high-energy gamma rays can be efficiently detected.
The gamma ray detector includes detecting elements aligned in parallel in three stages. The first stage includes a silicon semiconductor for low energy detection. The second and third stages include germanium semiconductors for high energy detection. Further, the first stage may include a diamond element and the third stage detecting element can be made of CdTe or CdZnTe. At least one detecting element among the three stages is a scattering detector. Similarly, at least one of the detecting elements is an absorption detector.
Second Embodiment
According to the second embodiment, high-energy gamma rays can be efficiently detected by using a silicon element at the first stage and a germanium or cadmium telluride element at the second stage.
Advantages
Gamma rays can be sufficiently detected over a wide energy range. The technology is capable of detecting gamma rays in an energy range of 100 keV to 2 MeV.
Disadvantages
The semiconductors used in the gamma ray detectors may require cooling.
Competitive Technologies Various imaging technologies used for detection of cancer are as follows.
1. Single Photon Emission Computed Tomography1
1 http://en.wikipedia.org/wiki/Single_photon_emission_computed_tomography
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
Single Photon Emission Computed Tomography (SPECT) is a tomographic technique. Radioactive gamma rays are emitted from the human body by the administered radiopharmaceuticals. A gamma ray detection camera captures two-dimensional images from more than one angle. The tomographic reconstruction algorithm is applied to the two-dimensional images to form a three-dimensional image. The final image can be manipulated to view images of the human body along a desired axis.
Advantages
1. Three-dimensional images can be obtained.
Disadvantages2
1. Because of use of the collimator, a higher amount of radiopharmaceutical is needed to detect its position in the body3. This is substantiated by the half life of radiopharmaceuticals used in SPECT. SPECT radiopharmaceuticals usually include Iodine-123 (half life of 13.3 hours) and Technetium-99m (half life of 6.0 hours4)
2. Positron Emission Tomography5
Positron emission tomography (PET) is used for capturing abnormalities such as rapidly growing tissues, tumors, metastases and infections. The image detection process includes collimation of photons and their subsequent detection by a crystal. The crystal emits a light signal, which is amplified and converted into data.
Advantages6
1. Metabolism in tissues can be detected.
Disadvantages7
2http://ieeexplore.ieee.org/Xplore/login.jsp?url=http%3A%2F%2Fieeexplore.ieee.org%2Fiel5%2F4436263%2F4436808%2F04436865.pdf%3Farnumber%3D4436865&authDecision=-203
3http://www.rsna.org/Publications/rsnanews/upload/RSNA_News_June2010.pdf
4http://books.google.co.in/books?id=mojjQG5iUu0C&pg=PA444&lpg=PA444&dq=nuclear+medicine+half+life+spect+imaging&source=bl&ots=45SzATlmU2&sig=Jp9ErbsqDVEhxs0ntnDwqJJkm6s&hl=en&ei=pTD_TLuGCYrOvQOsjuG_Bw&sa=X&oi=book_result&ct=result&resnum=9&ved=0CD8Q6AEwCDgK#v=onepage&q=nuclear%20medicine%20half%20life%20spect%20imaging&f=false
5 http://en.wikipedia.org/wiki/Medical_imaging
6 http://www.bmi2.bmt.tue.nl/image-analysis/Research/techniques/final/A5%20final.%20Single%20Photon%20Emission%20Computed%20Tomography.pdf
7http://ieeexplore.ieee.org/Xplore/login.jsp?url=http%3A%2F%2Fieeexplore.ieee.org%2Fiel5%2F4436263%2F4436808%2F04436865.pdf%3Farnumber%3D4436865&authDecision=-203
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
1. Expensive synchrotron facilities are required to make the positron-emitting pharmaca (active pharmaceutical ingredient (API) in drugs)8.
2. PET scanners are very expensive (~ $2 million)
3. Magnetic resonance imaging (MRI)
MRI visualizes body tissues for use in detecting diseases such as cancer. A magnetic field is used to align the magnetization of atoms of the human body. Subsequently, radiofrequency fields are used to change the alignment of the magnetization. As a result, the atomic nuclei produce a rotating magnetic field that can be detected by the scanner. The information is recorded and an image of the scanned body part is constructed.
Advantages9
1. MRI discriminates among tissues using their physical and biochemical properties such as water, iron, fat, and extra vascular blood. Hence, better detection of diseases is possible as compared to other contemporary techniques.
Disadvantages10
1. Patients with pacemakers and certain ferromagnetic appliances cannot be studied.
2. MRI equipment is expensive to purchase, maintain, and operate. The cost of MRI machines ranges from US $1 million to US $3 million11.
4. Diffuse Optical Spectroscopy12
Diffuse Optical Spectroscopy (DOS) uses laser breast scanners for non-invasive detection of breast cancer. DOS uses a probe that can capture cancerous areas by scanning the cancerous lesions externally. Measurements can be made based on the scan. The probe uses lasers that have a power of 10 to 20 mW. Absorption and scattering spectra is used for the detection.
Advantages13
1. Use of non-ionizing radiation
8http://www.google.co.in/search?hl=en&rlz=1W1GFRG_en-GB&q=define%3A+pharmaca&aq=f&aqi=&aql=&oq=&gs_rfai=
9 http://dir.nhlbi.nih.gov/labs/lce/cmri/mri-advantages-limitation.asp
10 http://dir.nhlbi.nih.gov/labs/lce/cmri/mri-advantages-limitation.asp
11 http://www.ehow.com/about_4731161_much-do-mri-machines-cost.html
12 http://breast-cancer-research.com/content/7/6/279
13 http://www.expert-reviews.com/doi/abs/10.1586/17434440.4.1.83?journalCode=erd
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
2. Lower cost
3. Portability
5. Diffuse Optical Imaging14
Diffuse Optical Imaging (DOI) is a technique used for medical imaging based on inverse tomographic reconstruction technique. Data from a large number of source-detector views is combined. DOI can be used to measure absorption and scattering from 650 to 1000nm range.
Advantages15
1. High temporal resolution. DOI offers a high precision in measurement, with respect to time16.
Patent Landscape A focused patent search related to gamma ray detection using semiconductor Compton camera resulted in approximately 79 patent publications. Further, the US jurisdiction has the highest patent filing activity in this domain. Patent publications that disclose technologies which are related to the technology are as follows:
Sr. No. Patent Publications Title Assignee/ Inventor(s)
1 WO2006107727A2 Edge-On Sar Scintillator Devices And Systems For Enhanced Spect, Pet, And Compton Gamma Cameras
Univ State San Diego; Nelson Robert Sigurd
2 US20100096555A1
Edge-on SAR scintillator devices and systems for enhanced SPECT, PET, and Compton gamma cameras
Nelson Robert Sigurd
3 WO2010074325A1
Labeling Composition For Intraocular Tissue, Labeling Method Of Intraocular Tissue, And Screening Method
Canon Kk; Watanabe Kohei; Shinto Taichi; Nomoto Tsuyoshi; Miyazaki Takeshi; Tanaka Toshio;
14 http://breast-cancer-research.com/content/7/6/279
15 http://www.nmr.mgh.harvard.edu/PMI/PDF/bruk-diss/Bruk-Ch3.pdf
16 http://en.wikipedia.org/wiki/Temporal_resolution
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
Nishimura Yuhei; Shimada Yasuhito; Nishimura Norihiro
4 US7291841B2
Device and system for enhanced SPECT, PET, and Compton scatter imaging in nuclear medicine
Nelson Robert Sigurd; Nelson William Bert
5 US20090134334A1
Edge-On Sar Scintillator Devices And Systems For Enhanced Spect, Pet, And Compton Gamma Cameras
San Diego State University Res
6 US6169287B1
X-ray detector method and apparatus for obtaining spatial, energy, and/or timing information using signals from neighboring electrodes in an electrode array
Warburton William K
7 US20040021083A1
Device and system for improved Compton scatter imaging in nuclear medicine {and mammography}
Nelson Robert Sigurd; Nelson William Bert
8 US20100270462A1
Slit and slot scan, SAR, and compton devices and systems for radiation imaging
Nelson Robert Sigurd; Nelson William Bert
9 US20100090116A1
Edge-on SAR scintillator devices and systems for enhanced SPECT, PET, and Compton gamma cameras
Nelson Robert Sigurd
10 US7635848B2
Edge-on SAR scintillator devices and systems for enhanced SPECT, PET, and compton gamma cameras
San Diego State University Res
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
11 US20030205675A1
Device and system for improved [compton scatter] imaging in nuclear medicine {and mammography}
Nelson Robert Sigurd; Nelson William Bert
12 US20030209662A1
Device and system for improved imaging in nuclear medicine {and mammography}
Nelson Willaim Bert; Nelson Robert Sigurd
13 US20040251419A1
Device and system for enhanced SPECT, PET, and Compton scatter imaging in nuclear medicine
Nelson Robert Sigurd; Nelson William Bert
14 US20100090117A1
Edge-on SAR scintillator devices and systems for enhanced SPECT, PET, and Compton gamma cameras
Nelson Robert Sigurd
Technology Landscape Medical imaging using nuclear medicine is a widely used technology. Use of semiconductor Compton cameras for medical imaging using radiopharmaceuticals is an evolving technology domain. Some technology trends are illustrated below:
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
Ideas ASA is the most active company in the domain of medical imaging using Compton camera. It can be observed that the Universities of Washington and California are actively researching this domain. The patent publications assigned to these universities can be licensed to other parties.
The following chart illustrates the patent filing trend in the technology domain of “Gamma Ray Detection”.
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
The aforementioned chart illustrates that the gamma ray detection technology has been steadily growing for the past 50 years and also indicates the maturity of the gamma ray imaging instruments market. The technology domain includes gamma ray detection by using detectors such as Anger cameras. However, Compton cameras have recently found application as detectors.
The following chart illustrates the patent filing trend specifically for the gamma ray detection by using Compton scattering.
It can be observed from the above chart that the technology domain for gamma ray detectors using Compton phenomena has witnessed significant increase in R&D since 2002. Hence, it can be established that the technology for gamma ray detection using Compton cameras is in growth phase and has not matured yet. There is ongoing research and development in this field.
Technology Bundling Opportunities PARTNER INSTITUTION’s technology focuses on the Compton scattering phenomena for gamma ray detection. Medical imaging involves the use of image processing algorithms along with the detection of gamma rays. Hence, PARTNER INSTITUTION’s technology can be bundled with technologies that process the detected gamma rays by using image processing algorithms. Some of the patent publications with technologies that can be bundled with PARTNER INSTITUTION’s technology are as follows:
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
Sr. No
Patent Publications Title Assignee/
Inventor(s) Rationale/Value Addition
1 US6881959B2
Method and system for generating an image of the radiation density of a source of photons located in an object
UNIV MICHIGAN
The patent discloses a method for generating an image of the radiation density of detected rays using Compton or non-Compton scattering.
2 US6541763B2 Semiconductor gamma-ray camera and medical imaging system
DIGIRAD CORP
The patent discloses a system and method that detects the incident rays and processes them to form images based on them.
3 US5847398A Gamma-ray imaging with sub-pixel resolution
MARAD IMAGING SYSTEMS LTD
The patent publication discloses a gamma ray imaging system that provides high resolution images.
Market Opportunities Gamma-Ray Detectors have potential applications in several areas such as medical imaging, homeland security and nuclear weapons verification17.
Medical imaging: A high-resolution gamma-ray camera offers efficient mapping of radiation in the body, enabling physicians to use lower doses of nuclear medicines. Real-time “movies” depicting the way nuclear medicines are absorbed may be possible.
Homeland security: A gamma-ray camera is used to scan containers, other objects and people for radiation. This kind of position sensitivity conveys the presence of radiation somewhere inside, as well as the type of source by way of the material’s configuration and the energy of gamma rays.
Nuclear weapons verification: A gamma-ray camera scans nuclear warheads to verify the presence or absence of fissile material. The camera can be set to some agreed-to resolution, enough to confirm the presence of fissile material but not reveal details of the warhead’s construction. This would eliminate the need to actually open up the warhead, which could make such inspections more acceptable. 17 http://www.anl.gov/Media_Center/News/2003/031031gammacam.htm
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
The applications of gamma radiation are similar to X rays, both in medicine and industry18.
Gamma-ray sources are used for cancer treatment as well as diagnostic purposes. They are mainly utilized for the detection of cancer such as breast cancer.
With more than 10 million new cases every year worldwide, cancer has become one of the most devastating diseases. The global burden of cancer continues to increase. In the year 2000, 5.3 million men and 4.7 million women developed a malignant tumor and 6.2 million died from the disease. The number of new cases is expected to grow by 50% over the next 20 years to reach 16 million by 202019.
More than 30% of cancer could be prevented by modifying or avoiding key risk factors, according to a study by international cancer collaborators20..
Various other technologies such as scintigraphy, SPECT and PET compete with gamma ray detectors However, the gamma ray detector in PARTNER INSTITUTION’s technology has an added advantage because of its feature of simultaneous detection of different types of abnormal cell growth (such as cancer) in the human body. Radiopharmaceuticals with different isotopes can be administered to a patient. The different radiopharmaceuticals emit different frequency of gamma radiations and are simultaneously detected by the Compton detector. The figure below illustrates the phenomenon of simultaneous detection of iodinated (131I) methylnorcholestenol (131I-Adosterol), and zinc chloride (65ZnCl2).
In the US, gamma-ray detectors are beginning to be employed as part of the Container Security Initiative (CSI). These US$5 million machines are advertised to scan 30 containers per hour.
18http://webcache.googleusercontent.com/search?q=cache:YokpkhPLiEIJ:encyclopedia2.thefreedictionary.com/Gamma%2BRadiation+gamma+rays+detectors+industrial+applications&cd=27&hl=en&ct=clnk&gl=in
19 http://apps.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1&codcol=76&codcch=16
20 http://www.who.int/mediacentre/factsheets/fs297/en/index.html
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
The objective of this technique is to screen merchant ship containers before they enter US ports21.
Although this technology was originally intended primarily to detect drugs, analysis has shown it might function more effectively as a bomb detector. It possesses the required resolution to detect thin sheets of explosive, and can also create three-dimensional images of a container, which would reveal explosives hidden behind other objects.
Market Potential According to Frost & Sullivan, Global Gamma Camera Market (for medical applications only) generated $638.0 million of revenues in 2003. The market is expected to increase at a compound annual growth rate (CAGR) of 3.1% to $788.8 million in 2010. The chart below depicts the market for gamma cameras from 2003 to 201022.
638 658 678 699 721 743 766 790
0
100
200
300
400
500
600
700
800
900
2003 2004 2005 2006 2007 2008 2009 2010
(Milli
on $)
The long-term outlook for this market is immensely favorable; however, as compared with PET imaging, the nuclear gamma camera’s key competitive advantages lie in its much larger worldwide installed base and the availability of longer half-life radioisotopes. According to Monali Patel, industry manager with Frost & Sullivan, “the long-term outlook for the gamma camera market is very favorable”. “However, the exact timing for accelerated growth for the market is harder to pinpoint. This is very much dependent on the availability of new diagnostic and therapeutic agents, as well as product introduction and clinical acceptance of hybrid SPECT/CT systems, such as GE’s Infinia Hawkeye”, commented the manager. One of the reasons for the favorable outlook for growth in the gamma camera market is that the SPECT gamma camera is less expensive than a PET scanner. The SPECT gamma camera 21 http://www.enotes.com/topic/Gamma_Ray
22 http://www.allbusiness.com/medicine-health/diagnostics-screening/5622680-1.html
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
costs around $400,000 to $600,000, while a PET-CT scanner cost around $2 million23. Further, diagnostic costs are also high; a typical PET scans generally costs anywhere from $2,000 to $5,000 per sitting24.
Regulatory Environment Under the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1976, all Emission Computed Tomography (ECT) and their accessory devices may be cleared by the 510(k) process, when the device shows substantial equivalence to the legally marketed predicate devices. All ECT devices and accessories are currently classified as Class II devices with a 90-KPS Product Code. Nuclear Tomography Systems are categorized Class II with a JWM product code25. Japan26 In April 2005, new regulations, known as Japanese Pharmaceutical Affairs Law (JPAL), came into effect covering the manufacture and distribution of medical devices, in vitro diagnostic medical device (IVDs), cosmetics and pharmaceuticals for the Japanese market. New rules presented the opportunity to bring Japanese regulations in line with recent global practice as set out in the Global Harmonization Task Force (GHTF) Guidelines and the ISO 13485 standard. Main Components of JPAL:
• Establishes Market Authorization Holders (MAHs) – who must be established in Japan – as the only organizations that can release medical devices into the Japanese market;
• Regulates foreign and domestic manufacturers and domestic MAHs, repairers and distributors;
• Puts devices into three classes: Class I extremely low risk devices; Class II low risk devices; and Class III & IV medium to high risk devices.
• Establishes different approval routes for the different classes of devices; • Establishes a role for Japanese established third party Registered Certification Bodies
(RCBs) to undertake certification of certain Class II medical devices; • Defines a Japanese Quality Management System (QMS) in MHLW Ordinance#169
similar to ISO 13485:2003; and • Regulates clinical trials and the acceptance of clinical data
Certain Class II devices have been defined as Designated Controlled Medical Devices and these are approved by Registered Certification Bodies (RCBs) rather than by the Japanese
23 http://www.dicardiology.net/node/28668/
24 http://www.scandirectory.com/content/pet-scan.asp
25 http://www.semi.org/en/About/index.htm
26 http://www.us.sgs.com/regulatory_certification_-_jpal?serviceId=10052112&lobId=18866
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
Pharmaceuticals and Medical Devices Agency (PMDA). There are 22 product groups within the category of Designated Controlled Medical Devices. Radiation/diagnostic imaging systems are covered under Categories 20 & 21and include Radiography, fluoroscopy, gamma, MRI, UT imaging equipment and accessories;
Geographic Description of Likely Markets From a geographic perspective, the likely markets for gamma ray cameras in medical imaging are arguably reasoned to be correlated with the number of cancer patients. A higher number of cancer patients would require an increased number of diagnostic labs, effectively a higher count of imaging devices27.
a. United States – Number of visits (to physician offices, hospital outpatient and emergency departments) with a primary diagnosis of cancer: 24.6 million
b. Europe – With more than 3 million new cases and 1.7 million deaths each year, cancer represents the second most important cause of death and morbidity in Europe
c. India – 2.5 million cancer patients registered in 2008 d. Japan – In 2008 the number of cancer patients in Japan was up 95,000 from 2005 and
up 238,000 from 2002 e. China – Cancer causes more than 1.5 million deaths every year in China. In China’s
developed coastal areas, one out of every 1,000 women has the disease, and it develops sharply at a rate of 3 to 4% a year, experts said. In addition, the fatality rate of breast cancer is rising 6.9% every year
Potential Licensees/Partners/Customers The potential licensees for PARTNER INSTITUTION’s technology include:
Barco Medical Imaging, Cedaron, GE Healthcare, Konica Minolta Medical Imaging, Siemens Medical, Toshiba, Positron, Philips, Hitachi Medical Systems, etc.
Company Products PET and SPECT Description
Barco Medical Imaging Link NO PARTNER INSTITUTION’s technology can
expand product portfolio
Cedaron Link NO PARTNER INSTITUTION’s technology can expand product portfolio
GE Healthcare Link YES GE’s products under the categories of computed tomography and nuclear medicine can use PARTNER INSTITUTION’s
27 http://www.cdc.gov/nchs/fastats/cancer.htm
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
technology.
Konica Minolta Medical Imaging Link NO PARTNER INSTITUTION’s technology can
increase product portfolio
Siemens Medical Link YES
Siemens’s products under the categories of computed tomography and nuclear medicine can use PARTNER INSTITUTION’s technology.
Toshiba Link YES Toshiba’s products under the category of computed tomography can use PARTNER INSTITUTION’s technology.
Positron Link YES
Positron’s products that are related to computed tomography and nuclear medicine can use PARTNER INSTITUTION’s technology.
Philips Link YES
Philips’ products that fall under the categories of computed tomography and nuclear medicine can use PARTNER INSTITUTION’s technology.
Hitachi Medical Systems Link YES
Hitachi’s computed tomography solutions can use PARTNER INSTITUTION’s technology.
Siemens, General Electric and Philips Electronics are among the major makers of scanning technology. The industry has drawn some criticism in the United States where use of expensive scans has risen sharply in recent years.
The same companies would also serve as prospective partners for joint venture creation and technology development.
Commercialization Strategy Gamma ray detectors with Compton cameras can be used for the detection of cancer such as breast cancer. The technology has certain advantages as compared to competing technologies such as PET and SPECT. At present, few big players such as Philips, GE and Siemens, are the market leaders and have established imaging centers as customer base. The market seems to be growing at a CAGR of 3.1% which presents a small opportunity of growth in sales for the existing players as well as for any new market entrant. In such as scenario, licensing or partnering with existing leading company appears to be a better option for commercialization
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
over manufacturing. However, [The Client] can adopt any of the following three paths for commercializing its technology.
1. Licensing: [The Client] can license the patented technology to a leading imaging device manufacturer not having Compton camera based technology. The advantage of such an approach will be to capitalize on the existing business set-up of the licensee without paying up for heavy initial investment.
2. Setting up a joint venture – [The Client] can get into a joint venture kind of arrangement and partner with an existing market leader. The joint venture will enable [The Client] to enter into a new market with the goodwill and customer reach of the partner.
3. Setting up a manufacturing plant – [The Client] can start its own company. However, this would require reasonable amount of investment for setting up a manufacturing plant.
SWOT Analysis for Commercialization
Strengths Weakness
Wider energy coverage range
Simultaneous detection of multiple body areas
The semiconductor in the Compton camera may require regular cooling
Opportunities Threats
Continuous increase in cancer patients
Diverse application areas
Unproven technology in the market w.r.t its
current competitors
Go/No Go Recommendation PARTNER INSTITUTION’s technology finds application in the detection of cancer such as breast cancer. The technology seems to have advantage over existing ones such as wider energy coverage range and simultaneous imaging of more than one body part. The imaging market at present is dominated by SPECT and PET technology with a small compound annual growth of 3.1% in market size. In order to better understand the market potential of the PARTNER INSTITUTION’s technology further due-diligence needs to be carried out.
Recommendation: Proceed to Phase II --
Keywords and Phrases Used in Searches Following are the search strategies that are used conduct the landscape.
Sr. No. Search Strings Results
Phase I Report Gamma Ray Detector
Proprietary and Confidential © [Client Name] 2010
1 DSC=((gamma NEAR1 ray) AND (detect*3 AND semiconduct*3 AND "Compton" NEAR1 camera)) AND AD>=(18360101);
79
2 ALL=((gamma NEAR1 ray) AND (detect*3 AND semiconduct*3 AND "Compton")) AND AD>=(18360101);
768
3 CTB=((gamma NEAR1 ray) AND (detect*3)) AND AD>=(18360101); 6688
4 [Removed from the Sample] [Removed from the Sample]
5 [Removed from the Sample] [Removed from the Sample]