Imagin Medical (CSE:IME; OTCQB:IMEXF) reported favorable results in a 10-subject investigator-sponsored research study at the University of Rochester Medical Center (URMC) using the i/Blue Imaging System, an important step in the development of a commercially-viable product.
In the URMC research study, fluorescence was successfully demonstrated in 15 minutes, confirming that the i/Blue Imaging System potentially will allow physicians to “see” bladder cancer significantly faster than the full hour or more required by currently available imaging technology.
“We believe that the i/Blue Imaging System holds great promise for improving physicians’ ability to detect cancer and visualize the surgical field where endoscopes are used,” Jim Hutchens, Imagin’s president and CEO, said in a statement.
Information gathered from the URMC research study is being used to help optimize Imagin’s i/Blue technology to further development of a commercially-viable device system in preparation for planned clinical trials to support Imagin’s application to the FDA for approval to market i/Blue in the U.S.
Pam Papineau, Imagin’s director of regulatory and clinical affairs, said the company provided early prototype equipment to assist investigators in testing the underlying hypothesis that i/Blue can potentially identify protoporphyrin IX fluorescence associated with bladder cancer lesions in the presence of the contrasting agent, hexaminolevulinate hydrochloride.
Imagin anticipates initiating preliminary discussions with the FDA regarding the i/Blue Imaging System as soon as possible, she added.
Jay Eastman, CEO of Optel, Imagin’s opto-electronic design firm, said the URMC research study has provided valuable technical data, clinical insight and physician feedback that is significantly influencing the design of the i/Blue system.
