Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF)

Imagin Medical Inc. (CSE: IME) (OTCQB: IMEXF) is a surgical imaging company focused on establishing a new standard of care in visualizing cancer during minimally invasive procedures. Its initial focus is on bladder cancer.

The company’s first product is the i/Blue Imaging™ System, based on advanced optics and light sensors and employing patented ultrasensitive imaging technology. Imagin Medical believes the system can significantly improve surgeons’ ability to visualize and remove cancer cells.

Founded in 2016 and headquartered in Boston, Massachusetts, the company works to enhance its market potential by expanding its technology to multiple endoscopic indications, such as laparoscopic, colorectal and thoracic procedures, accommodating multiple contrast agents and illumination sources.

i/Blue Imaging™ System

The conventional method used for visualizing bladder cancer during surgery is an endoscopic procedure called a cystoscopy. This procedure uses white light to illuminate the bladder. White light has been used for decades and is the standard for more than 90% of the market. Blue light cystoscopy uses blue-filtered white light, which addresses the limitations of white light (such as detecting flat tumors and the fine edges that may result in cancerous cells being left behind during removal).

Blue light uses a contrast agent that causes cancer cells to fluoresce when illuminated. Surgeons are then able to more effectively visualize and resect the margins of bladder tumors to reduce the risk of recurrence. Notably, the use of the white light is still necessary during a blue-light procedure so that the surgeon can orient their position within the bladder.

Imagin Medical’s i/Blue Imaging System addresses the limitations of both white and blue light cystoscopies. The i/Blue System combines the white and blue light with an FDA-approved imaging agent and simultaneously displays side-by-side images in real-time, without the necessity to switch back and forth between the two images.

The i/Blue Imaging System is unlike other methods available on the market today. It is external to the body and can attach to almost any endoscope model currently in use. This way, hospitals adopting Imagin Medical’s technology have the ability to use their current endoscopes without the need to purchase new equipment.

Bladder Cancer Prevalence

The company’s initial focus is bladder cancer, which is the sixth most prevalent form of cancer in the United States. In 2020, the number of new bladder cancer cases is expected to total 81,400, accounting for 4.5 percent of all new cancers diagnosed. The death rate in 2020 for cancer deaths associated with the bladder is forecast at 17,980, or 3% of all cancer-related deaths (https://ibn.fm/qLi3l).

Bladder cancer also has one of the highest recurrence rates among all forms of cancer, leaving about 600,000 people in fear that their cancer will return, according to Imagin Medical. The company is committed to addressing this issue, and i/Blue demonstrations have indicated that the use of both white and blue light can enhance accuracy of detection and removal of cancer cells, potentially lowering recurrence rates.

Based on Verified Market Research, the global bladder cancer research market was valued at $3.43 billion in 2018. It is estimated to grow with a CAGR of 4.03% through 2026, resulting in a projected $4.71 billion market (https://ibn.fm/rI7G6).

Management Team

E. James Hutchens is the Chief Executive Officer of Imagin Medical Inc. He is a proven entrepreneur with over 30 years of experience in management in the medical technology industry. Hutchens served as a managing partner with Origin Partners, a $55 million early-stage venture capital fund. He was also the founder and CEO of both Microsurge Inc. (a venture-backed minimally invasive surgical company) and Choice Therapeutics (an advanced wound-care company). He is a former member of the Board of Directors of the Brigham and Women’s and Faulkner hospitals. Hutchins holds a BS in Business Administration from Boston University.

John Vacha is the company’s Chief Financial Officer. He has 20 years of experience in the health care industry. Prior to Medtronic’s acquisition of Intact Medical Corp. in 2017, Vacha was the company’s President, CEO and a board member for seven years. He is a licensed CPA in Massachusetts. Vacha has an MBA and an MS in Accounting from Northeastern University in Boston. He is also a serving member of the Board of Directors at the South Boston Health Center. He currently has two patents in electrosurgical instrumentation.

Michael G. Vergano is the Director of Operations of Imagin Medical. He has been the President of The Harvest Group Inc. since 1998, where he has provided consultant services for startups and major corporations. Vergano has over 30 years of experience in the medical device industry. He has held management positions at Microsurge Inc., Ciba Corning Diagnostics and Boston Scientific Corp. He is currently the holder of 11 medical device patents and holds a BS in Mechanical Engineering from Tufts University.

Pam Papineau is the company’s Director of Regulatory Affairs. She has over 30 years of experience in quality and regulatory affairs with Boston Scientific, Baxter and Cogentix. She has served as a consultant on various devices including imaging, endoscopy, orthopedic, GI/GU and cardiovascular applications. Papineau has successfully prepared dozens of FDA pre-market and EU submissions to support CE marking of a broad spectrum of medical devices. She is an ASQ Certified Quality Engineer, a Certified Biomedical Auditor, a Certified Quality Auditor and an ISO 13485:2016 Lead Auditor, and she is certified by the Regulatory Affairs Professional Society – U.S., EU and Canada. Papineau works with the company’s legal counsel to prepare pre-submission meetings with the FDA and activities through the regulatory approval process.

Investment Considerations
  • Imagin Medical Inc. uses the standard levels of care for bladder tumor resection and adds advanced technology combined with an FDA-approved imaging agent to display images side-by-side in real-time to provide better cancer visualization, potentially leading to less recurrence.
  • Hospitals can use their existing endoscopic equipment, as the company’s technology is compatible with almost every model on the market.
  • The i/Blue™ Imaging System can potentially be used for other minimally invasive procedures, accommodating multiple contrast agents and illumination sources.
  • Bladder cancer contributes to 4.5% of all new cancers diagnosed and 3% of all cancer-related deaths. It is the sixth most prevalent form of cancer in the United States, with a greater than 50% risk of recurrence.
  • The company is led by a management team with experience in this industry, including minimally invasive surgery and medical device implementation.
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