Imagin Medical’s (CSE:IME; OTC:IMEXF) i/Blue Imaging System is expected to improve physicians’ ability to detect bladder cancer with minimally invasive endoscopes and reduce recurrence by dramatically improving the urologist’s ability to visualize, identify and remove cancerous cells.
“We have completed development of our prototype, an advanced optical and light sensor technology that, in conjunction with white light and near-infrared fluorescence, is expected to deliver superior images in less than 15 minutes, instead of the full hour required by conventional systems prior to use in the operating room,” Jim Hutchens, president and CEO, says in an interview with BioTuesdays.
“We believe the time savings will increase the efficiency of the operating room and reduce healthcare costs by potentially enabling procedures to be performed in the less expensive setting of a physician’s office,” he adds.
And as the i/Blue Imaging System becomes established in the urology market, Mr. Hutchens says Imagin plans to complete development of the i/Vision Imaging System technology, which combines multiple illumination sources into one system.
“The i/Vision will accommodate the most commonly used fluorescing contrast agents, such as indocyanine green (ICG), and would potentially enable Imagin to expand into additional specialties such as, general surgery, gynecology, colorectal and thoracic procedures,” he contends.
The current standard of care using endoscopes with white light has been used for decades and is ripe for innovation, Mr. Hutchens suggests. “White light is highly effective for visualizing cancerous tumors that protrude above the bladder wall, but is not as effective in visualizing their margins or tumors that lie flay on the bladder surface.”
There is a newer endoscopic technique using contrast agents with white light and a blue filter to induce fluorescence. While it improves the ability to visualize cancer, he says it requires surgeons to toggle back and forth between different images in order to detect flat cancers and visualize the margins of the tumors. And that’s in addition to the inconvenience of waiting an hour for the contrast agents to be visible in the bladder before being able to begin surgery.
“Endoscopes with our i/Blue Imaging System have the potential to see bladder cancer in less than 15 minutes, with optics that are 100 times more sensitive,” Mr. Hutchens points out. Premalignant lesions and tumor tissue along the margins would be highlighted and identified for removal, potentially reducing the chances of recurrence, he adds.
Mr. Hutchens explains there is no toggling back and forth with i/Blue, which blends white light and fluorescence images into one image, putting cancerous tissue into context within the bladder, and allowing surgeons to better visualize and resect the cancer. And the i/Blue technology adapts seamlessly to most types of endoscopes on the market, he points out.
“We believe this is a disruptive imaging technology for a significant unmet medical need,” he adds.
The company’s IP is protected by three U.S. patents licensed from Lawrence Livermore National Laboratory, a federal research lab, and as “our product is redesigned for commercialization, we’re looking to add three-to-five new pieces of IP,” Mr. Hutchens notes.
Bladder cancer is the sixth most common cancer in the U.S., yet is the most expensive to treat. There is a more than 50% recurrence rate in the more common non-muscle type of bladder cancer, along with 81,000 new cases a year in the U.S. and 17,000 deaths, according to the American Cancer Society.
“Bladder cancer is a hot-button urology issue looking for innovation,” Mr. Hutchens suggests. “Our prototype product has been completed, so our R&D risk has been mitigated. This is in large part an execution play, addressing a $750-million-plus global market.”
Dr. Edward Messing, chair of Urology at the University of Rochester Medical Center and a member of Imagin’s SAB, is currently conducting a first-in-human research study with the i/Blue Imaging System. The 10-patient project, which is designed to show that the system can detect bladder cancer within 15 minutes, is expected to conclude within the next few months.
“The study will help us prepare our submission to meet with the FDA late in the summer to discuss the clinical and regulatory pathway for an i/Blue product redesigned for commercialization,” Mr. Hutchens says. The company will likely seek premarket approval of i/Blue through a clinical study that compares its performance to other devices currently on the market.
Imagin expects to conduct its clinical programs at the University of Rochester and University of California at Davis, as well as with private physician groups, where patients can be enrolled quickly, he adds.
“If all goes according to plan, we hope to launch our product or at least demonstrate its effectiveness at the American Urology Association meeting in Chicago in May 2019,” Mr. Hutchens says. The company’s 2019 program also includes continued development of the next generation i/Vision Imaging System.
Mr. Hutchens says Imagin’s growth strategy begins with installing i/Blue in the operating room and then expanding into physician’s offices where diagnosis of bladder cancer is performed. “Establishing up to four Centers of Excellence would immediately create credibility in the market.”
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