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 bladder cancer.
Imagin's first product, the i/Blue™ Imaging System, is based on advanced optics and light sensors and employs patented ultrasensitive imaging technology. The company believes the system, currently in the manufacturing stage, will significantly improve surgeons' ability to visualize and remove cancer cells.
Run by a Boston-based management team, the company will work to enhance its market potential in the future by expanding its technology to multiple endoscopic procedures, such as laparoscopic and thoracic procedures, accommodating multiple contrast agents and illumination sources.
Current Technology
The conventional method of detecting bladder cancer uses white light during minimally invasive surgery to illuminate the bladder during a procedure called a cystoscopy. White light has been used for decades and is the standard for more than 90% of the market, yet inadequate if tumors do not protrude above the bladder wall or when trying to differentiate between flat tumors and normal tissue. This limitation may result in cancerous cells being left behind, leading to a 50% recurrence rate.
Introduced in 2010, blue light cystoscopy (BLC) addresses this limitation by using a proprietary, blue-filtered cystoscope and an FDA approved contrast agent that is inserted into the bladder, causing cancerous cells to fluoresce when exposed to the blue light. Surgeons are then able to more effectively visualize the margins of tumors for removal, reducing the risk of recurrence. While blue light produces a sharper image of the cancer, surgeons still need to view the white light images during the procedure to orient their position within the bladder. Current blue light technology requires them to switch back and forth between the white and blue light images to resect.
The i/Blue Imaging System
Imagin Medical's i/Blue Imaging System addresses the limitations of both white and blue light methods by going one step further. Combining the same FDA-approved contrast agent with advanced technology, the i/Blue simultaneously displays white and blue light images side-by-side on the same monitor in real-time, eliminating the need to switch back and forth between the two images. The i/Blue system also eliminates the need to purchase new proprietary blue light cystoscopes at considerable cost because its DualView Camera Head is external to the body and attaches to most cystoscopes on the market, allowing hospitals to use equipment they already own while still offering patients the latest technology.
Bladder Cancer Prevalence
The company's initial focus is bladder cancer, the sixth most prevalent form of cancer in the United States, the third most common in men and the most expensive to treat over the lifetime of a patient. In 2021, the number of new bladder cancer cases is expected to total more than 81,000, and deaths more than 18,000 (https://ibn.fm/qLi3l).
Bladder cancer also has the highest recurrence rates among all forms of cancer, leaving almost 600,000 people living in fear that their cancer will return. Studies have proven blue light cystoscopy as a clinical and cost-effective means of reducing the recurrence of bladder cancer as well as reducing the burden of disease for patients and the health care system (https://ibn.fm/G6tJv). Imagin Medical is committed to addressing this issue.
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.
