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Latest Generation Of 3-D Breast Imaging

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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.

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IZOTRPOIC CORPORATION           MGMT COPY                                     October 2018

Introduction and Background

Text Box: Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012.
-World Cancer Research Fund International

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.  

Management Team

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.


Standard Imaging Technology

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.

Text Box: Each year, more than a half-million women die of breast cancer. A more accurate, affordable early detection tool could help significantly reduce that number.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. 

For breast CT, the woman lies on the table while the imaging hardware rotates around the breast under the table. No breast compression is needed, and total scan time is about 10 seconds.

High-resolution 3-D breast images are produced, allowing radiologists an exquisite view of the breast anatomy unhindered by structures that can obscure a tumor.

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. 


Market Outlook

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).