A friend of mine was recently diagnosed with Stage 2 breast cancer. Up until that time, I hadn’t paid that much attention to breast cancer or to the statistics surrounding it. I was shocked to learn that 1 in 8 women worldwide will be diagnosed with breast cancer during her lifetime. For 1 in 33 women, it will be their cause of death.[1]
According to the World Health Organization, in 2020, 2.3 million women were diagnosed with breast cancer with 685,000 resulting deaths worldwide. In the 5 years previous to and including 2020, there were 7.8 million women who had been diagnosed with breast cancer during that period and had survived. There are more lost disability-adjusted years by women globally because of breast cancer than of any other cancer.[2]
Breast cancer is the most prevalent cancer in women after skin cancer.[3] Daunting statistics, to say the least.
As my friend went through her journey, I started to learn more about breast cancer and the procedures surrounding diagnosis and treatment.
I knew about mammograms, of course, and their purpose, but I really didn’t know much about the procedure. I started to ask questions and did some research.
I read that most breast cancer tumors have actually been growing for several years before they’re found. In order for the tumor to be detectable, the cells will need to divide as many as 30 times. Each division takes 1 to 2 months, so a tumor could be growing 2 to 5 years before it’s found.[4] On average, the size of tumor that can be detected by a first mammogram is about the size of a dime or around 1.5cm (15mm).[5]
As in all cancers, the earlier the cancer is detected the higher the chance for survival. When looking at the 5-year survival rate based on the Stage of diagnosis, the need for early detection becomes patently clear in reducing the mortality rate. Current rates of survival run from 100% for Stage 1 to 22% for Stage 4.[6]
As useful and valuable mammograms are, I was rather surprised to learn that they may not always be that effective and can be quite painful as they require the breast to be compressed by the machine. It also may be difficult to detect cancer if the breast tissue is denser than average. In addition, there is a risk of a false-positive. There may also be false-negative results which can lead to cancers being “missed.”[7]
From what I gathered, this could potentially mean more stress and unnecessary tests if the results are false-positive and conversely a false sense of good health if the results are false-negative. Either way, not a good case scenario.
This led me to look a bit more at the history of mammograms.
From the 1930s to the 1970s, breast cancer mortality rates remained virtually unchanged. Improvements in the survival rate didn’t begin until the 1980s following the introduction of early detection programs.[8]
A big part of this was the developing mammogram technology that occurred in the 1960s. Radiologists used general purpose X-ray tubes and no compression to perform breast exams. Low-contrast images were captured onto direct-exposure films, similar to chest X-rays. Over the next decade, mammography advanced through screen-film mammography, which made imaging faster, required a lower radiation dose, and provided greater contrast. Improvements continued throughout the 1980s and 1990s resulting in increasingly improved mammography images.[9]
There is no question that mammograms became vital in detecting breast cancer. A number of large and well-known companies have provided crucial technology and components such as Fujifilm Holdings (OTC US: FUJIY), General Electric (NYSE: GE), Siemens (OTC US: SIEGY) and Philips (NYSE: PHG), just to name a few.[10]
Fujifilm (OTC US: FUJIY) has developed a digital full-field mammography system called Aspire Cristalle. According to Fujifilm, the technology behind Aspire Cristalle is equipped with digital breast tomosynthesis (DBT), an advanced technique capable of providing 3D images and thus higher diagnostic capabilities to help physicians diagnose cancers earlier while striving to keep the radiation dose as low as possible. The system also includes a ‘comfort paddle’ which is designed to reduce pressure by conforming to the natural shape of the breast, thus ensuring adequate and even compression, which should somewhat lessen the discomfort. However, this system does still require a woman to stand upright while having her breast compressed in the machine. Therefore, while the technology seems to be more precise, the system still does require tissue compression and one would assume, still entail a certain level of discomfort.[11][12]
General Electric Healthcare (NYSE: GE) has also made advances in their mammography technology. Their system Senographe Pristina, as with Fujifilm, also incorporates DBT. The technology GE uses provides more clear, concise images. Breast compression is still required, although they have developed a compression device, Pristina Dueta, by which a patient can determine the compression level via a remote control. Presumably, this could lessen the pain normally associated with the standard mammography compression procedure.[13]
However, as I was reviewing all this information, I wondered if there was not a better, highly accurate and less painful way of detection, and perhaps a way where tumors could be detected at a smaller size than with conventional mammograms.
Izotropic Corporation (OTCQB: IZOZF / CSE: IZO / FSE: 1R3) is a company offering a new technology called IzoView breast CT system. IzoView is a technology that is expected to produce high-resolution breast images in true 3D with a radiation dose less comparable to 2D mammography. This is far more superior for imaging patients with dense breast tissue. A single 10-second scan acquires approximately 500 images without painful breast compression or continual technician breast handling, providing a more comfortable patient experience.[14][15]
In my opinion, the most important factor is that it may find cancer as early as possible. There are two factors that improve detection: excellent imaging and the ability to use contrast which enhances tumor localization. IzoView has both — you can use contrast, and their true 3D imagery helps give a complete view of objects in all dimensions. This is especially useful for women with dense breasts where it may be harder to identify tumors. When used with contrast in their planned clinical trials, the IzoView may be more accurate in detecting possible tumors than with today’s traditional mammograms. This translates to the possibility of earlier and more accurate detection.
Potentially, future trials may demonstrate a time span of 1–1.5 years earlier detection.[15] This is huge, and the significance of this is enormous as earlier detection could naturally translate into earlier stage diagnosis. This could then translate into shorter and less intensive treatment, saving time and money, and more importantly, potentially creating a less stressful situation for primarily the female patient.
Izotropic is unique to the market. As far as I know, it is the only publicly traded company commercializing a dedicated & advanced breast CT imaging platform. In addition, the developers hold a number of patents, and according to the company, they have already been in discussions with the FDA for the approval process.[16]
In some of the latest news, the company announced that they received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for their new 3D X-Ray Beam Filter patent. This 3D-Beam Modulation Filter is designed to tailor the shape of the IzoView X-ray beam to match the shape of the patient’s breast being scanned. It will maximize image quality while minimizing the dose of radiation to the breast tissue.[17]
In addition, Izotropic has recently partnered with John Hopkins School of Medicine to develop the latest image deep machine learning algorithms.[18]
In September, the top radiology website AuntMinnie.com nominated Izotropic as best new radiology device.[19] Quite remarkable and, in my opinion, a prime example of the astonishing progressive technology Izotropic is capable of producing with validation to work with world-class institutions and recognition by leading websites.
Another strong point is Izotropic’s leadership team with Dr. John McGraw as CEO. According to the Company’s website, his previous involvements included VP of Operations for Novadaq Technologies Inc., a medical device imaging company which was acquired by Stryker Corporation (NYSE: SYK) for US$701M in 2017. He was also Senior Vice President Business Development & Strategy for CML Healthcare which was acquired by LifeLabs (owned by OMERS/Borealis) for CA$1.2B in 2013.[20]
The company also recently announced the appointment of Dr. Younes Achkire as EVP of Product Engineering. Dr. Achkire stated, “As a medtech engineering executive with decades of experience, I know the potential IzoView has to disrupt the world of breast imaging and the power of having efficient and critical operating teams and structures during the integral growth stage Izotropic is currently in. I am aligned with Dr. McGraw’s vision for Izotropic and his aggressive plans to expedite patient access to Breast CT. I have founded startups and held COO and EVP roles with medical device companies where I was directly responsible for product designs and development, product marketing, and initiatives that built direct revenue increases as high as 30% for various companies including Foxconn, Zap Surgical, and Sotera Wireless Inc.”[21]
In my opinion, Izotropic is a very progressive company, and with all the positive aspects that it presents, one that will likely continue to grow in the future, expanding on what they have already developed. Therefore, possibilities abound. While the medical advancements this technology offers are astounding, the bottom line and the one that I think is the most crucial is that it could potentially help save many lives with the ability it has for earlier detection.
With the high statistics of breast cancer, most people know of someone who has been diagnosed with it, be it a family member, friend, or co-worker. Some have survived and unfortunately some others have not. Any company that can develop a technology that may lessen the number of those who do not is one that I feel is worth watching and definitely one worth applauding.
Izotropic (OTCQB: IZOZF / CSE: IZO / FSE: 1R3) has a timeline of Q2 2022 for shipment of the first clinical study units, with Q2 2022 as a target for a second clinical study with additional indications for use and platform products.[22] So better breast screening without the compression pain seems to be not too far in the future...
I asked my friend what she thought of Izotropic’s technology. What she told me confirmed my feeling that Izotropic could well be a game changer.
She said that had she been able to access equipment that led to more accurate detection when the lump was just a small spot, she may have had a Stage 1 diagnosis instead of Stage 2 as the cancer had spread to the lymph nodes. Once the cancer is in the lymph nodes, usually chemotherapy is a given. She would have been able to have less radical surgery, not had to deal with all the effects, both short and long-term, of the more extensive surgery and the ensuing chemo. She would have been able to get back to her regular life sooner and the medical costs would not have been so high. Her quality of life, both mentally and physically, would have been so much better during the months and months she battled the illness.
Now she has more regular breast screenings using the breast compression technology. Given that breast surgery can leave large, painful scars, she looks forward to the day when compression will be a thing of the past.
In the meantime, there will, unfortunately, be a lot more women who are diagnosed with breast cancer in the future. Based on everything I learned, I can’t even begin to say how valuable it would be able to detect the cancer earlier.
Fortunately, my friend made it through her treatment and is now in her first year of remission.
Imagine if we were able to say that for so many more women — perhaps we can soon based on the future of this new diagnostic technology.
Kal Kotecha, PhD
for Investors News Service
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DISCLAIMER: Investing in any securities is highly speculative. Please be sure to always do your own due diligence before making any investment decisions. Read our full disclaimer here.
DISCLOSURE: Izotropic Corporation is a Junior Gold Report (operated by Kal Kotecha) portfolio holding. Dr. Kotecha is currently engaged and paid by Izotropic for marketing services. This relationship with Izotropic should be deemed a potential conflict of interest.
[1] Government of Canada https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/breast-cancer.html
[2] World Health Organization (March 26, 2021) https://www.who.int/news-room/fact-sheets/detail/breast-cancer
[3] University of Kansas (August 21, 2020) Most Common Cancers in Women and How to Detect them Early https://www.kucancercenter.org/news-room/blog/2020/08/most-common-cancers-women-how-to-detect-them-early?reloadts=1628607395575
[4] Healthline: How Fast Does Cancer Spread https://www.healthline.com/health/metastatic-breast-cancer/how-fast-does-breast-cancer-spread
[5] Cancerquest: Mammography – Frequently Asked Questions https://www.cancerquest.org/sites/default/files/assets/pdf/breast-cancer/FAQMammography.pdf
[6] Breast Cancer Survival Rate – 0 to 4 stages of Cancer [2021 + Updated] (August 5, 2021) https://gohealthline.com/breast-cancer-survival-rate/
[7] American Cancer Society: Limitations of Mammograms https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/mammograms/limitations-of-mammograms.html
[8] Bonnie Joe, MD, PhD (July 7, 2015) Advances in Breast Imaging: Evolution and History of Mammography https://radiology.ucsf.edu/blog/advances-breast-imaging-evolution-history-mammography
[9] World Health Organization (March 26, 2021) https://www.who.int/news-room/fact-sheets/detail/breast-cancer
[10] Hospital Management (January 23, 2020) https://www.hospitalmanagement.net/features/featuremedical-imaging-technology-diagnostic-device-manufacturers/
[11] Fujifilm: Diagnostic Imaging https://www.fujifilm.com/us/en/healthcare/medical-imaging/about/diagnostic-imaging-business
[12] Fujifilm (July 23, 2019) Fujifilm announces release of tomosynthesis biopsy option for Aspire Cristalle Mammography System https://www.fujifilm.com/us/en/news/healthcare/fujifilm-release-tomosynthesis-biopsy-option-for-aspire-cristalle-mammography#
[13] General Electric Healthcare: Mammography https://www.gehealthcare.com/products/mammography
[14] Izotropic Corporation (February 9, 2021) Izotropic Unveils “IzoView” Branding for Breast CT Platform in Development and Files Trademark Application : https://izocorp.com/news-releases/izotropic-unveils-izoview-branding-for-breast-ct-platform-in-development-and-files-trademark-applications/
[15] Izotropic Corporation Fact Sheet https://izocorp.com/investors/fact-sheet/
[16] Izotropic Begins FDA Approval Process https://izocorp.com/news-releases/izotropic-begins-fda-approval-process/
[17] Izotropic Corporation (September 8, 2021) Izotropic Receives Notice of Allowance For New 3d X-Ray Beam Filter Patent From USPTO https://izocorp.com/news-releases/izotropic-receives-notice-of-allowance-for-new-3d-x-ray-beam-filter-patent-from-uspto/
[18] Izotropic Corporation (September 9, 2021) Izotropic Signs Agreement with John Hopkins University School of Medicine to Develop Deep Machine Learning Algorithms for IzoView Breast CT https://izocorp.com/news-releases/izotropic-signs-agreement-with-johns-hopkins-university-school-of-medicine-to-develop-deep-machine-learning-algorithms-for/
[19] Izotropic Corporation (September 9, 2021) Izotropic Nominated for Best New Radiology Device Award https://izocorp.com/news-releases/izotropic-nominated-for-best-new-radiology-device-award/
[20] Izotropic Management https://izocorp.com/investors/management/
[21] Izotropic Corporation (June 30, 2021) Izotropic Appoints Medical Device R&D Expert as Executive VP of Product Engineering https://izocorp.com/news-releases/izotropic-appoints-medical-device-r-d-expert-as-executive-vp-of-product-engineering/
[22] Izotropic Corporation Fact Sheet https://izocorp.com/investors/fact-sheet/