IZOTROPIC CORP IZO - CNX
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Latest Generation Of 3-D Breast Imaging
This medical device company's US
subsidiary Isotropic Imaging Corp, formed in
2016 has just begun commercializing the lastest version of its 360
degree 3D imaging process. With 2 patents in place and 5 pending patents
this company is at the forefront of breast imaging technologies. 3-D imaging technology breakthrough is now a reality , with the University of California - Davis licensing their technology under an exclusive license agreement . At a 52 week high this stock should be considered by serious investors and be placed on their Active BUY List . Any pullback should be used to accumulate shares. Website Imaging Management History Corp Video
IZOTRPOIC CORPORATION
MGMT
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October
2018
Izotropic
Corporation and its wholly owned U.S. operating subsidiary, Isotropic
Imaging Corp. were
established in 2016 to begin commercializing the next generation of
breast imaging technology for early diagnosis of breast cancer. The word
“isotropic” means “even in all directions.” The company’s imaging system
provides true 3-D imaging with 360° view acquisition, making it easier
to identify tumors in breast tissue and to determine the tumor size,
shape, and location. The company has an exclusive license with the
University of California, Davis (UC Davis) to commercialize the
technology invented by Drs. John M. Boone and Thomas R. Nelson. The
license includes all intellectual property, trade secrets, patents, and
patent-pending applications that are the foundation of the company’s
breast CT Imaging platform. The initial product will be known as the
“Isotropic Breast CT Imaging System.”
Over U.S. $19 million in research funding has been invested in
developing this groundbreaking breast CT[1]
imaging technology. Research to date includes thousands of images taken
on hundreds of patients using earlier versions of the Isotropic Breast
CT Imaging System. Results of these images show that the company’s
technology is superior to the current standard-of-care mammography for
early diagnosis of breast cancer in women. The company founders believe
that this technology will be a disruptive entry to the market,
overcoming many of the challenges faced by existing breast imaging
technologies.
Many meetings and focus sessions amongst the inventors, advisory board,
engineers and clinicians, has resulted in final decisions being made in
respect to component and functionality criteria required in the
fifth-generation offering. The company has also taken great care to
understand its market and how best to maximize marketing efforts by
understanding
needs and constraints that clinicians (customers) have in their hospital
and clinical settings. The design stage is close to completion for the
commercial product offering and additional key patents will be filed
around the new design. The
fifth-generation
breast CT unit will include several technical improvements over the
forth-generation unit and once constructed the new generation will be
used for final clinical trials, regulatory approvals, market launch and
other commercialization initiatives.
The new design of the commercial breast CT system draws on almost two
decades of research and development by inventors Drs. Boone and Nelson,
with many graduate students and senior academic collaborators, and most
recently by the company’s scientific advisory board. In addition to
clinical trials that totaled the imaging of 600 women, Dr. Boone at UC
Davis has recently secured $2.9 million in funding from the U.S.
National Institutes of Health to undertake further clinical
evaluation of breast CT on 400 women, comparing both screening and
diagnostic aspects of breast CT imaging systems. The company is the
beneficiary of the advancement of the technology, historic developments
and clinical trials.
Given the strong technical groundwork and extensive clinical testing
performed by Dr. Boone and his team of academic researchers, IIC expects
that regulatory approval for the commercial breast CT system to result
in a shorter than normal time frame. The company has engaged a senior
FDA consultant to manage the approval process in the US and other
specialists have been engaged for Europe and elsewhere.
The company’s founders, principals, directors, and advisors have
extensive scientific and medical expertise related to breast CT, and
medical imaging modalities in general. This team of engineers and
physicists, working with breast imaging radiologists and seasoned
business professionals has committed their considerable brain trusts and
skill sets to usher the fifth-generation commercial model through
development and approval processes, and bring a leading breast CT
technology to the market worldwide.
Robert (Bob) Thast,
Chief Executive Officer
In the past 30 years, Thast has served as board chairman, chief
executive officer, senior executive, and director of several publicly
traded companies. He has extensive knowledge of capital markets,
financing activities, and company management. Thast has a track record
of raising and attracting venture, early stage, and operating capital,
and has personally raised more than $200 million for companies he
directed, managed, or consulted for over the past 30 years. Through his
experience building and managing companies, Thast has also developed
expertise in strategic planning, business development, finance,
manufacturing, marketing and contract negotiations, as well as all
aspects of legal, accounting, corporate governance, and public and
regulatory compliance.
John M. Boone, Ph.D., Inventor, Chief Science Officer, Director
Boone is a medical physicist with 32 years of experience in academia,
with broad interests in medical imaging, computed tomography, and breast
computed tomography. He has been the principal investigator of the
Breast Tomography Project at University of California Davis for the past
18 years, and his laboratory has been at the forefront of the academic
development of breast CT technology. Boone is professor of radiology and
biomedical engineering, and recently served as president of the American
Association of Physicists in Medicine (AAPM), the principal medical
physics organization in the U.S. He is co-author of the medical imaging
textbook, Essential Physics of
Medical Imaging. Boone has also authored more than 200 peer-reviewed
papers and holds 13 U.S. patents.
Boone holds a Ph.D. in medical physics and is board certified by the
American Board of Radiology in diagnostic radiological imaging. He is a
fellow of the American Association of Physicists in Medicine, American
College of Radiology, Society of Breast Imaging, American Institute for
Medical and Biological Engineering (AIMBE), and SPIE (the international
society for optics and photonics). Boone is also a commissioner of the
International Commission on Radiation Units (ICRU).
Marshall (Terry) Severyn, Vice President of Marketing, Director
Severyn has more than 30 years’ experience in corporate sales and
marketing. He has successfully led teams from six to more than 1,000
employees
in the pharmaceutical and high-tech arenas. Severyn began his career in
a sales management position with Perdue Pharma, which led to a
director’s position with Norwich Eaton Pharmaceuticals, Proctor and
Gamble Pharma, and SISU.
His major focus was launching products globally in the areas of
gastroenterology, urogynecology, bone disease, and immunology.
Severyn has also held senior management positions with Telus, Bell
Canada, and Rogers Communications, where he led major sales
organizations and new product development.
Ali Sodagar – Legal Advisor, Director
Sodagar founded Sodagar & Company Law Corp. in 2005, a multidiscipline
law firm specializing in international business, project finance,
mergers and acquisition, corporate, real estate, intellectual property.
and trademark law. Sodagar specializes in business and commercial law,
intellectual property, trademark, copyright, and licensing law. In
addition to his background in law, Mr. Sodagar holds a bachelor’s degree
in medical & health physics and a master’s degree in medical biophysics.
As part of his master’s program Sodagar worked on a CT with a C-arm for
arterial and contrast enhanced imaging. Sodagar earned his LL.B. from
Western University in Ontario and an LL.B. in European law from the
University of Amsterdam. Mr. Sodagar has been a registered Trademark
Agent (License #14799) since January 2005.
Scientific Advisory Board (SAB)
The following advisors are recognized leaders in the field of breast
cancer research, imaging technology development, market approvals, and
business development. These industry experts and key thought leaders
have teamed up with Izotropic Corp. to provide guidance and assistance
with development and commercialization of breast CT. Additional
scientists interested in joining the SAB will add to the brain trust and
experience, and assist the company in demonstrating its commitment to
scientific excellence, going forward.
Martin Yaffe, Ph.D. – Senior Advisor
Dr. Yaffe is currently a senior scientist in physical sciences at Odette
Cancer Research Program, Sunnybrook Research Institute, Toronto,
Ontario, He is also a professor of medical imaging and medical
biophysics at University of Toronto.
His appointments include: (1) Tory Family Chair in cancer research,
Sunnybrook Health Sciences Centre; (2) director, smarter imaging
program, Ontario Institute for Cancer Research; (3) co-director, imaging
translation program, Ontario Institute for Cancer Research; (4) chief
scientific officer, Centre for Imaging Technology Commercialization of
Research; and, (5) member of the Order of Canada.
Yaffe’s research focus is digital imaging for medical diagnosis and
disease management. His research is directed toward developing and
improving imaging techniques for detecting, diagnosing, and treating
cancer, with a strong focus on breast cancer. His team is also
interested in methods for analyzing image patterns to predict breast
cancer risk and using these as tools to study the causes of breast
cancer and to help develop preventive measures. Activities in the lab
range from developing image processing strategies for assessing and
improving the quality of diagnostic images, to developing and evaluating
tomosynthesis imaging and contrast-enhanced imaging methods. His team
has established a comprehensive program in biomarker imaging research,
which includes developing new techniques for 3-D pathology. These
techniques will be used for validation of new in vivo imaging methods,
as well as for investigating approaches for improving accuracy of
pathology, and adding prognostic and predictive information in the
management of cancer.
Yaffe is a fellow of the American Association of Physicists in Medicine
and honorary fellow of the Society of Breast Imaging.
Karen Lindfors, M.D. – Senior Breast Imaging Radiologist and Clinical
Advisor
Dr. Lindfors is a leading expert in the field of breast cancer screening
and breast imaging and diagnostics, having specialized in cancer
radiology and breast imaging and diagnostic radiology for more than 30
years. She is highly published and a leading advocate for women's health
who works locally and nationally to promote patient and healthcare
professional education for early detection of breast cancer. Dr.
Lindfors has been the lead clinical researcher in developing new methods
to screen for breast cancer, including dedicated breast CT developed at
UC Davis and breast tomosynthesis.
Lindfors is a board-certified radiologist who began her career with an
internship and residency at Massachusetts General Hospital in Boston
from 1979 to 1983, followed by a fellowship at Harvard in 1984. She
joined the staff at UC Davis Medical Center in 1985 and retired in June
2017 as chief of breast imaging and professor of clinical radiology.
Lindfors is a fellow of the American College of Radiology. She is also a
member of the American Roentgen Ray Society, California Radiological
Society, Northern California Radiological Society, Radiological Society
of North America, and Society of Breast Imaging.
Norbert Pelc, Ph.D. – Senior Development and Technology Advisor
Pelc is a professor of bioengineering and radiology at Stanford
University. From 2012 to 2017, he was chair of the university’s
department of bioengineering. Prior to joining the Stanford faculty in
1990, Pelc was senior physicist and manager of the applied sciences
laboratory at GE Medical Systems where he developed technology for all
medical imaging modalities.
His primary research interests are in the physics, engineering, and
mathematics of diagnostic imaging, along with the development of
applications of this imaging technology. His current work focuses on
computed tomography, specifically in methods to improve information
content and image quality and to reduce the radiation dose from these
examinations.
Pelc is a member of the National Academy of Engineering and a fellow of
the American Association of Physicists in Medicine, the International
Society for Magnetic Resonance in Medicine, SPIE (the international
society for optics and photonics), and the American Institute of Medical
and Biological Engineering. Pelc served on the first National Advisory
Council of the National Institute of Biomedical Imaging and
Bioengineering of the National Institutes of Health.
Peymon Gazi, Ph.D. – Project Manager and Software Development Consultant
/ Advisor
Gazi received his master’s degree in electrical engineering from the
University of Texas in San Antonio, where he developed strong skills in
software development while working in the developing field of robotics.
His deep interest in applied physics led to his pursuit of a doctorate
in biomedical engineering, an interdisciplinary and emergent field at
the forefront of applied technologies in medicine, at the University of
California at Davis.
Gazi, mentored by Dr. John M. Boone, developed his expertise as a
medical physicist through the design, characterization and development
of two dedicated breast CT systems developed at UC Davis, both
predecessors to the system Izotropic seeks to commercialize. Gazi also
participated in clinical trials imaging 100 volunteer patients using
these breast CT imaging devices.
Before transitioning to industry, Gazi worked as a postdoctoral
researcher in the department of radiology at UC Davis, where he focused
on the application of neural networks and deep learning to breast CT. He
later worked as senior research and development engineer in the medical
applications division of Kawasaki Robotics in Silicon Valley, leading
the company’s efforts to incorporate medical imaging into its surgical
robotics platform.
Dr. Craig Shimasaki, Ph.D., MBA – Medical Device Business Consultant
Shimasaki is a scientist, businessperson and entrepreneur, having
co-founded three biotechnology companies. He is the president and CEO of
Moleculera Labs and BioSource Consulting. His personal career mission
has been to bring medically needed products from research, clinical
testing, and regulatory approval to the public so that more patients can
benefit from important new advances.
Shimasaki began his career at Genentech, working on the processes
required to develop an HIV vaccine. He has spent the past 31 years
developing diagnostic and therapeutic products, working with the FDA,
conducting clinical trials, manufacturing, and helping to develop
businesses.
Shimasaki has worked to bring five products through the FDA 510(k)
approval process and he has served in various roles at several
companies, from director of project planning, vice president of research
and development, chief operating officer, and chief executive officer.
Shimasaki is an inventor on multiple patents for diagnostic and clinical
testing products. He serves on numerous boards and teaches as an adjunct
professor at the University of Oklahoma in the entrepreneurship program
at the Price School of Business. He has written a book to train
scientists and physicians how to bring medically needed products to
market, titled The Business of
Bioscience: What Goes Into Making a Biotechnology Product. He
recently completed a second book titled
Biotechnology Entrepreneurship:
Starting, Managing and Leading Biotech Companies, to provide
curriculum for universities training future biotechnology entrepreneurs.
No true 3-D breast imaging technology is currently available to women.
Both traditional digital mammography and digital tomosynthesis, which is
sometimes marketed as 3-D mammography, are two-dimensional imaging
technologies. The
Isotropic Breast CT Imaging System
is very different; it delivers crystal-clear, true 3-D images.
The Isotropic Breast Imaging System is also unlike widely available
whole-body computed tomography systems that circle a patient’s body to
collect images of interest. Instead, breast CT makes use of cone-beam
computed tomography technology to scan only the breast of interest.
With
breast CT, the woman lays face down on the system table placing the
breast to be imaged in a hole in the table. The imaging hardware beneath
the table circles around the breast creating a series of raw-data
images. These raw images are processed through the computer to
reconstruct true three-dimensional images of the breast. The radiologist
can view the high-resolution 3-D images at any angle, but typically
looks at the images from three normal viewing planes.
In addition to producing two-dimensional images, traditional mammography
and tomosynthesis are lengthy processes requiring painful breast
compression and technicians repeated handling of the woman’s breast.
Breast CT requires no handling or compression and captures hundreds of
images in about 10 seconds. These benefits are especially important for
women with painful, inflammatory breast disease and women with breast
implants, for which mammography and tomosynthesis provide diminished
diagnostic accuracy.
Technology Development History
The academic development of breast CT by Dr. Boone and his extensive
team of investigators has led to the production of four prototype breast
CT systems, which have been used in studies imaging more than 600 women.
These studies of the scanner’s technical performance and computer
simulation of breast lesion (abnormalities) detection using the
extensive breast image database—with human observer validation of
simulation results—have demonstrated that breast CT significantly
outperforms mammography-like breast imaging for detecting tumor masses
and other lesions. In studies where X-ray dye was used during the
procedure (as it is with
contrast enhancement
in magnetic resonance imaging of the breast), almost perfect detection
performance was achieved in all types of breast lesions. It is likely
that contrast-enhanced breast CT has very similar cancer detection
performance as contrast-enhanced breast MRI, but at a fraction of the
cost. Furthermore, the breast CT scanner requires about 20 percent of
the floor space needed for an MRI system, making it an attractive option
for space-constrained facilities.
A Compelling Market Opportunity
About 1.7 million cases of breast cancer are diagnosed annually around
the world, and approximately 522,000 women die from the disease each
year, according to Global Cancer Facts & Figures, 3rd Edition from the
International Agency for Research on Cancer. In the U.S. alone, more
than 250,000 new cases of invasive breast cancer will be diagnosed in
women in 2017, and over 40,000 women will die from this disease. Early
detection is the key to reducing the chance that a woman who gets breast
cancer will die from the disease. Breast tumors detected early are
smaller and typically have not metastasized to other regions of the
body, which is a key factor in improving survival.
While much research focuses on breast cancer prevention, no major
advancements in early detection have been made in many years. Two-view
mammography is the current standard of care for breast cancer screening,
and approximately 39 million women undergo mammography screening each
year in the U.S.
While digital mammography is commonly used for breast cancer screening
in the U.S. and other developed nations, similar technology called
tomosynthesis (technically, limited-angle tomography) is also being used
to improve cancer detection, either alone or with mammography.
Despite the success of mammography in driving down breast cancer
mortality since its widespread introduction in the late 1980s, screening
mammography is not an ideal test for the following reasons:
·
Misses approximately one in five breast cancers, according to the
National Cancer Institute.
·
May fail to detect inflammatory breast cancer, the deadliest form of
breast cancer.
·
Commonly produces false positive results, a mammogram that looks
irregular when no cancer is present. According to the National Cancer
Institute, about 50 percent of women who get annual mammograms over a
10-year period will have a false-positive finding at least once.
·
Requires painful breast compression and technologist handling of the
woman’s breast.
·
Provides lower diagnostic accuracy and risks rupture in women with
breast implants.
For these reasons, the breast imaging community continues to look for a
cost-effective, true 3-D breast imaging technology that improves patient
comfort and delivers high diagnostic accuracy.
Advantages Over Existing Technologies
Mammography is the most commonly known screening modality for breast
cancer examination and is a 2-D technology. Tomosynthesis, sometimes
errantly referred to as 3-D mammography, improves only slightly on
mammography. Both provide good resolution for identifying
microcalcifications. While breast ultrasound examinations and MRI breast
imaging provide 3-D data sets, they are time intensive, which translates
into high costs. Although ultrasound and MRI do not require ionizing
radiation (contrast), neither can identify microcalcifications, a common
early warning sign in approximately 30% of breast cancers. Internal
breast CT test results to date demonstrate far superior resolution with
contrast than existing modalities in identifying lesions, and as good or
better resolution for micro-calcifications. The time required to image a
patient using breast CT developed by the company is approximately 10
seconds. During this time hundreds of pictures are taken that enables
company designed software to create true 360-degree 3D images in high
resolution. Greater resolution provides for more accurate, early stage
diagnosis, of lesions and microcalcifications, the two main indicators
for breast cancer. The company believes from test results to date that
its breast CT will be a next generation imaging device for clinicians
working to improve detection and treatment of breast cancers.
In the short term, breast CT is likely to emerge as an important tool
for diagnostic breast examinations, which are performed following a
concerning mammogram or when the presence of a tumor is suspected.
Longer term, breast CT is expected to partially or completely replace
mammography for breast cancer screening.
Given the circumstances the company is
launching at a time
when forces in the breast imaging market are driving the need for new
technologies. Two larger market trends are also contributing to market
demand:
·
The worldwide population is aging—and breast cancer incidence increases
with age. In 2015, 8.5 percent of the world population was age 65 or
older. By 2050, that percentage is projected to increase to 17 percent,
this according to a 2015 study commissioned by the U.S. National
Institute on Aging.
·
Healthcare costs are rising, causing increasing concern for governments,
insurers, and patients. Earlier detection of breast cancer saves lives
and lowers treatment related costs.
This combination of an aging population and rising healthcare costs has
led industry analysts to forecast increased demand and utilization of
cost-effective, accurate, early cancer detection and prevention
technologies. Next-generation imaging technologies such as breast CT,
which helps lower costs through more accurate early detection, with
reduced false-positive imaging tests and fewer unnecessary biopsies,
will be increasingly adopted.
Capitalization
(June 2018) Shares issued – approx. 23M
(fully diluted with Warrants and Stock Options issued – approx. 34M); Director / Management Control
– approx. 40%; $2.9M US (funded) - ongoing
clinical trial of 400 women using forth-generation unit; $500,000 CDN – approx. working
capital in Izotropic Corporation.
Funding Plan The Company plans to raise
approx. $6M to fund the next stage of development, the proceeds of which
will be allocated as follows: To complete design &
development; engage additional engineering consultants; file key (new)
patents and pursue broader protection in target markets; source
additional component suppliers and stock critical capital components;
establish manufacturing criteria and partnerships; purchase components
for two fifth-generation breast CT units; establish Sacramento CA based
facility; initiate market approval processes in the US, Europe and other
target markets; fund clinical trial on firth-generation unit; and for
early stage market related initiatives and commercial launch plans.
Note:
Customer Financing - for ISO breast CT imaging units will be secured
through a major US lender, based on long term contracts with hospitals
and clinics in the USA. The lender will also administer accounts for the
company.
[1]
Computed tomography (CT) is an imaging procedure that uses
special X-ray equipment to create detailed pictures, or scans,
of areas inside the body. It is also called computerized
tomography and computerized axial tomography (CAT). |