- Bladder cancer is the fourth most common cancer in men andexpected to cause more than 17,000 deaths in the United States this year
- Imagin Medical is advancing its patented bladder cancer visualization technology toward commercialization and FDA approval, expecting the technology to revolutionize blue light cystoscopy procedures and improve patient outcomes in the process
- Imagin is funding its efforts with $2.165 million raised towards its convertible note offering
- Rollout of the company’s manufacturing process was delayed about nine months as a result of the COVID-19 pandemic.but Imagin and its production partner remain on its revised schedule
- The company expects to expand its product line once the bladder cancer technology rolls out, adapting its IP for use with other contrast dyes so the technology can be used in additional endoscopic procedures
Imagin Medical (CSE: IME) (OTCQB: IMEXF) announced on March 16 that its product development partner, ISO 13485:2016-certified manufacturer, Lighthouse Imaging, is making progress towards commercial-stage manufacturing capability of the novel, state-of-the-art bladder i/Blue Imaging System (TM) for use in bladder cancer visualization procedures.
“Prior to Imagin’s selection of Lighthouse as its contract manufacturer for the i/Blue Imaging System (TM) in October 2020, the Company received multiple fully functional feasibility units from its original design partner, Optel, Inc.,” the news release states (https://ibn.fm/34rXB). “Lighthouse’s development program has since focused on further refining the design to support Imagin’s submissions to the U.S. Food and Drug Administration and to ensure final device performance, compliance with all applicable regulatory standards, and optimal manufacturability to meet both cost targets and anticipated user demand.”
The i/Blue Imaging System will improve the ability of surgeons to view bladder tumors during cystoscopy procedures. Bladder cancer is the sixth most prevalent cancer in the US and the fourth most common cancer in men and was expected to directly result in more than 17,000 deaths during the past year in the United States, with similar statistics anticipated for 2021 (https://ibn.fm/wcmFw).
The challenge for surgeons is to get a full view of any tumors on the bladder wall so they can be removed in their entirety. The existing technique of using blue light in cystoscopies to view tumors stained with a pink contrast dye makes it possible for them to view all the contours of the tumors and ensure they are completely removed, potentially reducing the rate of recurrence in a cancer renowned for its repeat incidence rate.
Blue light cystoscopy is still an emerging technique, despite its reported rate of success and cost-effectiveness in medical studies (https://ibn.fm/66wE3). Two primary obstacles to wider adoption identified by Imagin include a reluctance by hospitals and clinics to upgrade existing equipment, and the technological imposition of blue light procedures that require surgeons to repeatedly switch back and forth between standard white light camera images and blue light camera images as they visualize the patient’s internal landscape.
Imagin’s patented system responds to both concerns, first by developing a device that can easily be adapted to nearly all existing cystoscopes, eliminating the need to replace surgical tools they already own, and second, by establishing a camera system that delivers white and blue light images side-by-side on a single screen so they can be viewed simultaneously.
The advent of the COVID-19 pandemic set the transition from development to manufacturing back by about nine months, meaning the system will be available for commercial production in 2022. In the meantime, Lighthouse continues laying the groundwork for meeting the FDA’s rigorous standards for surgical devices.
The good news is that Lighthouse’s program has stayed on schedule and we expect it to remain on target going forward,” Imagin CEO and President Jim Hutchens stated.
The project is primarily being funded by a $3 million convertible note Imagin undertook late last year (https://ibn.fm/yKZHJ).
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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