In a sign that women’s health may be about to see the biggest technological boost in a century, an upstart medical device company is establishing a new R&D facility in Sacramento, California, after entering into an agreement with Johns Hopkins University School of Medicine (JHU) to revolutionize how women undergo breast diagnostic imaging.
The development could be a major breakthrough for women’s health – and has the potential to make early investors substantial profits. Based on reports of early design proposals alone, shares of the company involved — Izotropic Corporation (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO) — soared 428 percent1 over 21 months before settling back into the under $1 range.
The need for new technology like this is obvious.
According to the American Cancer Society, approximately 1 in 8 women (13%) will be diagnosed with invasive breast cancer at some point in their lifetime. In raw numbers, every year in the United States, 268,0002 women get the bad news – and 42,0002 die from the disease.
Yet now, Izotropic Corporation (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO) is developing a revolutionary technology that is a possible game-changer and could potentially improve and even save the lives of thousands of women every year.
And with the help of Johns Hopkins’ sophisticated machine learning algorithms, this new 3D imaging technology could soon provide more accurate detection and diagnosis of breast cancers.
Working with an award-winning research team at the University of California, Davis (UC Davis), and other top specialists in the U.S. and Canada, Izotropic’s engineers, medical physicists, and designers are developing what they believe is the most important major advancement in breast imaging and diagnostics in perhaps a century.
More than $25 million has been invested across all aspects of this unique breast CT diagnostic system, with the majority of this capital spent on research and clinical studies at UC Davis Medical Center, funded primarily by the National Institutes of Health.
Now, Izotropic Corporation (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO) has completed noteworthy milestones, and is proceeding as planned to fabricate the IzoView system.2 They recently announced that engineering teams have successfully built and assembled IzoView’s radiation imaging subsystem, which has been formally certified as safe to operate. This milestone enables the subsystem, which is now taking static images, to be characterized and optimized for 360-degree image acquisition.3
At Last, a Breast Imaging Technology for the 21st Century!
The IzoView platform is unlike any other breast imaging technology currently on the market – and its potential as a platform is far greater than merely that of a diagnostic device.
Instead of women standing in front of an old-fashioned x-ray machine that requires uncomfortable, vice-like breast compression, they lie on a comfortable tabletop and place their own breast in an opening in the table.
Beneath the bed-like table, an advanced computed tomography (CT) camera moves around the breast in a 360-degree circle, taking approximately 500 images in just 10 seconds.
Proprietary AI computer software then takes these 500 raw image slices of the non-compressed breast and reconstructs the slices into full 3D images of the entire breast.
Comparable to High-Resolution MRI Images, But at a Fraction of the Cost
Recent technological advancements allow the IzoView platform to generate clear, true 3D images.
These high-resolution 3D images of the breast are comparable in quality to images created by ultra-expensive Magnetic Resonance Imaging (MRI) scanners – yet for a fraction of the cost.
And here’s the good news for investors looking to get in on the “next big thing” in medical device technology: Izotropic Corporation (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO) is now moving from the design phase to the clinical study prototype and FDA submission stage, which is where early investors can quickly see if they’ve struck a winner or not. It plans on having fully-functional test devices ready in a matter of months, not years as previously thought.
Four successive working breast CT models have been built and tested at UC Davis Medical Center, each incorporating efficiencies and new cutting-edge technological advancements as they became available.
The advancements include superior breast positioning design, ergonomic tabletop modifications, positioning aids, specialized x-ray detector and x-ray tube technologies, new x-ray beam shaping filters, and many other subtleties that improved the imaging system’s clinical performance and contributed to the current, very high-resolution imaging capability.
Plus, in late November the company also announced that it was implementing a Quality Management System (QMS) for regulatory and manufacturing purposes. In addition to being a requirement for submission for market authorization, a QMS implemented during the product development phase can reduce the time to market between completion of development and market authorization.4
The Advantages of High-Resolution 3D Imaging Over Traditional Mammograms
There are many potential advantages of the 3D imaging system that Izotropic is developing over diagnostic x-ray mammograms as they are currently used. The greater comfort and privacy are of paramount importance, but they are merely two of the many benefits of IzoView CT imaging for breast diagnostics.
A traditional diagnostic x-ray mammogram can require up to 12 individual “views,” with each view taking up to 20 seconds of painful, sometimes agonizing compression to complete. Between each view, a technician has to handle the patient’s breast as it is repositioned in the compression plates. As a result, an x-ray mammogram can take between 20 and 45 minutes to complete.
What’s more, the images produced are often not ideal. Anatomical structures can be distorted, and there is no differentiation between macro-and micro-calcifications in the breast tissue – crucial for identifying potential tumors.
In addition, traditional diagnostic x-ray mammograms do not use contrast for tumor visualization. That’s one reason why mammograms are only rated 73% sensitive in detecting tumors and only 44% sensitive for patients with dense breast tissue.
Worse yet, 40% of women over age 40 have dense breast tissue.7 That means x-ray mammograms can and often do miss a substantial number of abnormalities.
According to one recent study, old-fashioned mammograms can miss up to 15 percent6 of cancer tumors, and follow-up ultrasounds miss 2.3 percent, often because of dense breast tissue.
Izotropic’s 3D Imaging System Seeks to Overcome These Disadvantages
Natural breast orientation is preserved with the patient placing her own breast in the imaging cup, so there is no embarrassing handling by a technician. This also ensures that there is excellent visualization with contrast.
Further, the imaging procedure is over in a flash. The system takes 500 high-resolution images in approximately 10 seconds with about the same level of radiation from just two traditional mammogram views.
What’s more, Izotropic is developing new image reconstruction software utilizing the latest machine learning algorithms to deliver both high resolution and low noise images at low radiation dose levels. Aside from improved detection capabilities, IzoView is a potential solution for more precise margin analysis (viewing edges of a tumor), better “lesion characterization” (the detailed description of an abnormality), and higher spatial resolution, allowing radiologists to better differentiate internal breast structures.
Women and Doctors Eager for the “Next Stage” in Breast Health
As a result, the “buzz” is substantial around this potentially breakthrough technology in women’s health – and it’s not just investors that are so excited about the IzoView 3D imaging platform.
Patients are already asking when the technology will be available and for a good reason!
The IzoView 3D imaging platform is…
- A solution for Patients: Patients enjoy a pain-free, comfortable, and more private procedure that is over in seconds rather than in 20 to 45 minutes.
- A solution for Doctors: Doctors benefit because the 3D visualization and contrast expand use cases and can aid diagnosis
- A solution for Hospitals & Clinics: The 3D imaging system can improve patient throughput and attract more customers
- A solution for Insurers: Could lower costs by lowering the number of false positives that lead to unnecessary (and costly) biopsies
Half of Women Will Likely Get a Devastating False Breast Cancer Diagnosis
False positives are common in breast imaging: False positives are when old-fashioned mammograms reveal abnormalities in the breast tissue that later tests and biopsies reveal are actually benign and not cancerous tumors. About 50 percent of women who get annual mammograms over a ten-year period will have a false-positive finding at least once.
The problem is, these false positives cause tremendous stress and worry for thousands of women, not to mention unnecessary biopsy procedures – and the follow-up imaging exams and biopsies can cost tens of thousands of dollars per patient.
The market for Breast Imaging to Soar to $5.4 Billion by 2025
The market for Izotropic Corporation’s (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO) new breast imaging platform is potentially enormous. It’s estimated that the market for breast imaging technology will grow from $3.7 billion in 2020 to $5.4 billion by 202513.
What’s more, 40 million women receive a mammogram each year in the United States. Of these, about 10 percent – or 4 million — are called back for expensive follow-up tests, such as diagnostic mammograms, tomosynthesis, ultrasound, MRI, and biopsies.
An advanced breast imaging technology like the one Izotropic is designing and submitting to the FDA could potentially save America’s struggling health care systems billions of dollars – and would be extremely attractive for hospitals and health care managers.
A recent study found that the cost of follow-up imaging and diagnostic procedures after initial mammograms was more than $8 billion annually, just in the United States alone.
Fully Functioning Research Prototypes Now Being Tested
Izotropic Corporation’s breast CT imaging platform could allow radiologists to view 3D images comparable to MRI as part of the initial, low-cost, low-dose routine breast cancer imaging in the future– as many as 40 million per year – and not have to order and then wait for expensive follow-up tests.
Right now, Izotropic Corporation (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO) is the only public Company developing an advanced breast CT imaging platform for diagnostic use based on clinically validated research prototypes. This alone is a reason why many investors are excited by this Company’s potential.
U.S. Government Funding and Patents
In addition to investor funds, approximately $20 million in U.S. government grants has been invested to develop this ground-breaking, potentially life-saving technology at the UC Davis Medical Center in Sacramento, California. Izotropic is well-funded to advance important initiatives, with news flow expected to be strong in the months ahead.
The researchers developing the IzoView platform have 10 unique U.S. patents and patent-pending applications, including for using breast CT to measure breast density, to perform robotic guided biopsies, and to incorporate a 3D-beam modulation filter that shapes IzoView’s x-ray beam to match the shape of the patient’s breast and further reducing the radiation dose.
The patent for biopsies is particularly noteworthy. 71 percent of the 1.6 million breast biopsies performed in the U.S. are found to be negative at the cost of $2.2 billion.14
Looking to the Future
Izotropic is setting up its long-term platform strategy to increase customer appeal with more add-ons and building in additional revenue streams. After market entrance as a diagnostic device, the Company plans to offer solutions across the gamut of breast health care, including screening and diagnosis in radiology, treatment planning and monitoring in surgical oncology, and breast reconstruction and implant monitoring in plastic and reconstruction surgery.
Dr. John McGraw, CEO
- Senior VP of Business Development & Strategy, CML Healthcare (TSX: CLC) Canada’s largest provider of medical imaging services acquired by Lifelabs for C$1.2B.
- VP Operations for Novadaq Technologies Inc. (NASDAQ: NCVQ), a medical device imaging company acquired by Styker Corporation for USD $701M.
Dr. John Boone, Principal Founder of Breast CT Technology & Director
- Editor-In-Chief of Medical Physics, the official journal of the American Association of Physicists in Medicine (AAPM).
- Commissioner of the International Commission of Radiation Units & Measurements (ICRU)
- Co-author of “The Essential Physics of Medical Imaging,” the leading textbook for radiology residents
Dr. Andrew M. Hernandez, Head of Imaging Technology.
- 8 years experience in the design, development, and optimization of breast CT at the University of California, Davis, under the mentorship of Dr. John M. Boone, principal breast CT Founder and Company Director.
- Ph.D. in Biomedical Engineering and Assistant Professor, University of California, Davis, with focus on computer simulations and design of novel imaging modalities.5
As a publicly-traded company only founded in 2016, shares of Izotropic Corporation (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO) are currently selling for around a dollar – but likely not for long.
Only about 40 million shares are outstanding, meaning the current market capitalization is tiny given the “disruptive” nature of Izotropic’s technology and the fact it’s the only publicly traded Company developing this kind of platform to address the growing problem of breast cancer.
Making Lemonade Out of Lemons with Covid-19
Izotropic Corporation is a company that figured out a way to use the economic disruptions of the Covid-19 pandemic to its advantage.
As Covid-19 set in, the Company took advantage of the delays in performing clinical studies and supply chain disruptions to design an even better product.
As newer, next-generation components became available, the Company incorporated these improvements in its imaging system. The Company spent the past two years making additional investments and expanding its engineering capabilities, onboarding personnel, and investigating and finalizing the IzoView platform strategy.
That means, as the Company enters the clinical study phase and FDA submission phases of its product development, it expects to deliver a better performing technology with a broader product offering and a more competitively priced Breast CT system.
Getting Ready to Launch
The Company is completing the final design for the development of its IzoView platform – and is preparing for a clinical study to collect data that it will use for an FDA application for approval of an indication for use as a diagnostic device.
When FDA approval has been awarded, the Company will ramp up marketing of its revolutionary IzoView platform to the thousands of hospitals and clinics throughout the United States. The Company is already participating in the FDA’s Center for Devices & Radiological Health Payor Communication Task Force program and can use historical trial data in discussions with insurance payers to demonstrate patient benefits for insurance coverage of the Company’s new IzoView platform.
Hundreds of Millions of Women Will Demand This Technology
Women worldwide have already begun hearing about a brand-new, easy, and compression-free way to do breast imaging – lying comfortably for a few seconds on an imaging table rather than standing in front of an x-ray machine while their breasts are compressed between metal plates.
Once word gets out, even more, the demand for this disruptive new technology will likely be intense – and all bets are off for shares in Izotropic Corporation (OTCQB: IZOZF | CSE: IZOOTCQB: IZOZF | CSE: IZO).
The time to investigate this Company is now, before it submits to the FDA, with a major breakthrough in breast imaging technology that could potentially change the lives of millions of women and their families.
415% x 40 million mammograms = 6 million. That seems high. 15% of 4 million follow-up exams = 600,000
14Corporate Presentation, September 2020, p. 10.
15Ibid., p. 15
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