Izotropic Hits Key Milestones on Path to FDA Approval

The Problem

Breast cancer is one of the deadliest diseases worldwide affecting more than 1.7M women every year. Over 500,000 of women die from the disease annually. The earlier that breast cancer can be detected, the greater the probability that a treatment plan will be effective. The financial burden on the global economy cannot be underestimated, and the market is expected to grow from C$5B in 2020 to over C$7B in 2025. Several factors contribute to this market growth include an aging population, increased obesity rates, and rising health care costs. The following chart shows the market for breast imaging modalities, which can be broadly grouped into “ionizing” (such as Izotropic’s imaging system) and “non-ionizing” (such as ultrasound). Cost-efficient, early detection of breast cancer is critical to combating these excessive expenses and improving patient outcome.

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Current Limitations

Current breast cancer detection methods are low resolution, 2-dimensional (or “quasi” 3-dimensional), and often require painful compression of the breast. Ultrasound and MRI imaging do provide a 3-dimensional view of the breast but are largely used to assess abnormalities found in other imaging modalities (such as mammography and tomosynthesis, both of which only produce 2-dimensional images). Typically, a patient will undergo a mammography to detect any breast abnormalities, followed by an ultrasound to determine if the abnormality is solid or liquid. Afterward, a biopsy may be performed with the help of additional ultrasound or a MRI. The patient may undergo multiple rounds of imaging to accurately determine the location of the tumor before a biopsy can be performed. This process is long, costly (follow up screening in the US alone was over C$10B), and fraught with error (20% of mammograms are false negatives). There remains a large unmet need for a high-resolution, 3-dimensional imaging system that can accurately detect breast cancer in its early stages and provide a platform for efficient biopsy of potential cancerous abnormalities.

The Solution

Izotropic Corporation (CSE:IZO, OTC: IZOZF, FRA:1R3) has developed a disruptive solution to the shortcomings of current imaging methods and has carved a new path for early breast cancer detection and biopsy. The company’s imaging platform, the Izotropic Breast CT Imaging System, produces true 3-dimensional images that are high resolution at incredible speed, taking 500 images in 10 seconds per breast. This technology requires no painful compression of the breast and delivers a small dose of radiation that is isolated to the area of interest (unlike whole-body computed tomography).

With the Izotropic Breast CT Imaging System, the patient 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 and creates a series of raw-data images. The platform computer processes these raw images to reconstruct true 3-dimensional, high-resolution images, allowing radiologists to view the breast anatomy from any angle. This is an impressive technologic feat, which you can see in the images below. The Izotropic Breast CT Imaging System can detect lesions and tumors in the 3-5mm range, a vast improvement from the low-resolution scans of mammography that detect tumors with an average size of 11mm. This technologic leap cannot be overstated – the ability to detect tumors as small as 3-5mm could result in 1.5-year earlier detection time and significantly improve the efficacy of treatment.

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The Izotropic Breast Imaging System offers significant advantages over current imaging modalities:

• The Izotropic Breast Imaging System delivers true 3-D images
• The Izotropic Breast Imaging System delivers high resolution images that are top quality and crystal clear
• Fast imaging (500 uncompressed images every 10 seconds per breast imaged)
• No discomfort from painful breast compression

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The Team

Dr. John Boone of University of California at Davis has been working with a team to develop the Izotropic Breast Imaging System for the last twenty years. Over US$20 million has been invested to date in developing this revolutionary technology, which simplifies breast imaging for both patients and medical providers in addition to reducing costs. 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 is a professor of radiology and biomedical engineering, and recently served as president of the principal medical physics organization in the U.S., The American Association of Physicists in Medicine (AAPM). Boone is co-author of the medical imaging textbook, Essential Physics of Medical Imaging, has also authored more than 200 peer-reviewed papers, and holds 13 U.S. patents. He has been the principal investigator of the Breast Tomography Project at the 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.

I recommend investing eight minutes to hear Dr. Boone discuss the Izotropic System in his own words.

Another key person in the Izotropic story is the CEO, Bob Thast. Over the past 35 years, Thast has served as chairman of the board, chief executive officer, senior executive, and director of several publicly listed companies. He has extensive knowledge of capital markets, financing activities, company management, and a track record of raising and attracting venture, early stage, and operating capital for companies he has directed and managed. Thast has expertise in strategic planning, business development, marketing, recruiting, product distribution, contract negotiation, legal, accounting, corporate governance, and regulatory requirements associated with public companies.

My first conversation with Thast left me with the impression that the Izotropic team had been meticulously constructed to bring expertise to all facets of the medical imaging development process: basic research, regulatory approval, and commercialization/exit. Since that conversation in October 2019, the following key additions to the team have been made:

• Ralph Proceviat, a CPA, CA, and C-level executive with over 35 years’ experience in managing public companies in tech, manufacturing, and the life sciences, has been added to the Board of Directors.

• John McGraw, MSc, PhD, with 20 years’ experience in business development of medical device and imaging companies, has been added to the Advisory Board. The addition of Dr. McGraw brings market sector expertise and executive-level advisory experience.

• George Burkett, M. Eng, an expert in Breast Computed Tomography (BCT) who designed and maintained four successive BCT imaging systems, has been added to the Advisory Board. Mr. Burkett’s specialized knowledge in the evolutionary nature of BCT brings an edge to the Izotropic team as they seek to develop the next iteration of the technology.

• Anita Nosratieh, PhD, a lead reviewer at the FDA for breast cancer imaging technologies, has been added to the Advisory Board. Dr. Nostratieh’s extensive experience in the regulatory aspect of medical imaging development brings key knowledge to the company’s already strong scientific and medical Advisory Board.

The Investment Opportunity

A competent, top notch management team and Advisory Board filled with key opinion leaders is the first thing I look for when researching an investment opportunity in early-stage biotech. I also look for:

• The ability to disrupt a growing market segment
• Tight share structure and ownership by insiders/management (skin in the game is crucial regardless of market sector)
• Well-defined milestones with a clear plan to accomplish them over the next 6 to 12 months
• A defensible patent portfolio and other barriers to duplication
• The stock has not gained the market’s attention and is flying under the radar

Izotropic fits all these criteria. The company has achieved key milestones since Q3 2019 that could trigger significant upward revaluations in IZO shares when the market returns its attention to this undervalued company:

• Two patents were granted allowance by the USPTO for Izotropic’s robotic guidance biopsy system (U. S. Patent No. 11/913494) and CT imaging technology (U. S. Patent No. 10,548,549)
• Izotropic has engaged Starfish Medical, a project management group, in May 2020 to complete final engineering requirements for the commercial Breast CT Imaging model, with completion scheduled for early Q3, 2020
• Izotropic has appointed Anita Nosratieh, PhD, an FDA consultant and reviewer of medical imaging technology to setup a pre-submission meeting with FDA before the end of Q3, 2020 and guide the team through the FDA regulatory process
• Izotropic expects to construct and demonstrate its first commercial Breast CT imaging model by the end of Q4, 2020
• Izotropic expects to begin the FDA approval process (Pre-Market Approval, “PMA”) for its imaging technology in early Q1 2021

Timeline to Exit

Izotropic expects to begin its clinical study by Q2 2021 and submit the application for FDA approval by Q3 2022. The company will then look for a licensing partner to begin commercialization.

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The Risk

‍It is important to note that Izotropic will need to raise money over the next few months to achieve its commercialization objectives. This financing risk is the main reason IZO is currently trading at a C$5M market cap. The market opportunity in breast imaging is enormous, and in my estimation IZO’s patents alone more than support its current market valuation. Rapid progress in demonstrating commercial viability for Izotropic’s Breast Imaging Platform is where the big upside exists for IZO shareholders. An acquisition or licensing deal could occur as early as 2022 if Izotropic hits its milestones.

The Cap Structure

I have purchased IZO shares on the open market and intend to add to my position over the coming weeks. I believe that anything under C$0.30 per share is extremely attractive and IZO has the potential to be a 10-bagger from current levels over the next 12 months. The key will be achieving the regulatory milestones and finalizing IZO’s first commercial Breast CT imaging model by the end of 2020. Izotropic CEO, Bob Thast, has an extensive track record of nurturing early-stage biotech companies to maturity, and his expertise and commitment to bringing the Izotropic Breast CT Imaging technology to market is a strong predictor of IZO’s enormous upside potential. He personally welcomes any questions from investors at info@izocorp.com.

Izotropic Corporation (CSE:IZO)

Common Shares Outstanding: 29,965,499

Options

2,900,000 x $.20 (average price) = C$580,000

Warrants

6,509,000 x C$0.20 (average price) = C$1,301,800

Fully Diluted Share Count = 39,374,998

Fully diluted market cap at C$.16 per share = C$5.8 million

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Disclosure

Author is long IZO shares at the time of publishing and may choose to buy or sell at any time without notice. Author has been compensated for marketing and promotional services by Izotropic Corporation.