Surgical imaging company Imagin Medical (CSE: IME) (OTCQB: IMEXF) is continuing progress with the commercial-stage manufacturing of its patented i/Blue Imaging System, an innovative technology that the company believes will revolutionize the way surgeons visualize the bladder and identify cancers during minimally invasive surgery. The company has been working with contract manufacturer, Lighthouse Imaging, to complete the system for commercialization.
In a company press release, Imagin Medical’s President and CEO, Jim Hutchens, said the COVID-19 pandemic impacted the company’s production timeline by approximately nine months, which moved product completion into 2022. “The good news is that Lighthouse’s program has stayed on schedule and we expect it to remain on target going forward,” Hutchens added (https://ibn.fm/rHZFl).
Lighthouse Imaging’s development program is focused on refining the i/Blue System’s design after Imagin Medical received multiple fully functional feasibility units from original design partner, Optel, Inc. The patented, ultrasensitive imaging technology behind i/Blue employs advanced light sensors and optics to enhance visibility and aid in the removal bladder cancer, the sixth most prevalent form of cancer in the United States and, the most expensive to treat because of high recurrence rates.
Surgeons traditionally perform cystoscopies to visualize and diagnose bladder cancer during surgery. Most cystoscopies use white light to illuminate the bladder, a technique that has been used for decades and is the standard for 90 percent of the market. For its many benefits, white light has the disadvantage of only highlighting cancerous tumors that protrude above the bladder wall. This makes it difficult to identify flat tumors because of the inability to distinguish between healthy tissue and tumors.
This drawback has been addressed with the introduction of blue light with a contrast imaging agent that highlights the cancer to detect flat tumors, but blue light images are not in real time, which makes it impossible to operate using blue light images alone. For the surgery to be effective, surgeons need to manually switch back and forth from white to blue light images, requiring the surgeon to resect the tumor from memory when they switch back to the white light.
Imagin Medical’s i/Blue System can correct the limitations of today’s white and blue light cystoscopy procedures. Combining the same FDA-approved imaging agent with white and blue light, the innovative technology allows surgeons to view both white and blue light images side-by-side simultaneously on the monitor during the procedure, which means they do not have to switch back and forth. Additionally, the technology is highly versatile and can be attached to most endoscopes on the market, which means hospitals would be able to adopt the visualization system without having to replace their current instruments, resulting in significant cost savings.
The company believes this technology has the potential to revolutionize the current standard of care for bladder cancer patients by advancing the efficiency and accuracy of cancer detection and removal, and potentially reducing recurrence rates. Imagin plans to build on the i/Blue technology to expand its use in multiple endoscopic procedures, including laparoscopic, colorectal and thoracic procedures that use a variety of contrast dye agents and illumination sources.
Imagin’s FDA approval process is supported by certified manufacturer Lighthouse Imaging’s manufacturing program, which aims to ensure i/Blue System’s compliance with all applicable regulatory standards, as well as final device performance and manufacturability to meet anticipated demands and cost targets.
Director of Engineering and Quality, Mike Vergano, voiced appreciation for the Lighthouse team’s expertise and exceptional work to date and added “We chose Lighthouse because of its accomplished history of taking innovative products like our i/Blue System and applying its cross-functional expertise in optics, electronics, software and mechanical design to move into commercial manufacturing,” he explained, underlining that the results so far have not been disappointing and expects the same going forward.
For more information, visit the company’s website at www.ImaginMedical.com.
NOTE TO INVESTORS: The latest news and updates relating to IMEXF are available in the company’s newsroom at https://ibn.fm/IMEXF
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