Imagin Medical releases i/Blue research study results!!![url=https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aIME-2634674&symbol=IME®ion=C]https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aIME-2634674&symbol=IME®ion=C[/url]
2018-07-17 16:43 ET - News Release
Mr. Jim Hutchens reports
IMAGIN MEDICAL REPORTS RESEARCH STUDY PROGRESS
Imagin Medical Inc. has released favourable results in the 10-subject investigator-sponsored research study being conducted at the University of Rochester Medical Center using the i/Blue imaging system (the URMC research study), 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 will potentially allow physicians to see bladder cancer significantly faster than the full hour or more required by currently available imaging technology.
"While a backorder on certain component parts needed to make system adjustments during the URMC research study caused some delay, we are obviously very pleased with the outcome," said Jim Hutchens, Imagin's president and chief executive officer. "This is an exciting time. 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. To that end, we look forward to updating our stakeholders as we progress."
Information gathered from the URMC research study is being used to help optimize Imagin's i/Blue technology to further the development of a commercially viable device system in preparation for the company's planned clinical trials to support its application to the U.S. Food and Drug Administration (FDA) for approval to market the i/Blue imaging system in the United States.
"Imagin is grateful to the University of Rochester Medical Center for initiating and conducting this investigator-sponsored human research study," commented Pam Papineau, Imagin's director of regulatory and clinical affairs. "Imagin was pleased to provide early prototype equipment to assist the investigators in testing the underlying hypothesis that the i/Blue imaging system can potentially identify protoporphyrin IX (PpIX) fluorescence associated with bladder cancer lesions in the presence of the contrasting agent, hexaminolevulinate hydrochloride. This project was undertaken prior to the commencement of an FDA application and provides important insights that will help guide the company in an FDA-compliant process. Imagin anticipates initiating preliminary discussions with the FDA regarding the i/Blue imaging system as soon as possible."
Running parallel to the URMC research study, the i/Blue imaging system design and development have moved forward, incorporating feedback from the study into the system's opto-electronic functions and features. As previously reported, Optel Inc., Imagin's opto-electronic design firm, is working against three phases of development: proof of concept, functional unit and verified unit. Of the three phases, the proof-of-concept phase has now been completed, verifying the performance of the two critical optical modules of the i/Blue imaging system -- the light source module and the imaging module.
Dr. Jay Eastman, PhD, chief executive officer of Optel, stated: "The lessons learned from 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. All of this information continues to increase our confidence that the miniaturization, imaging quality and cost reduction goals for the i/Blue system important to surgeons performing bladder cancer procedures."
About Imagin Medical Inc.
Imagin is developing powerful new imaging solutions for the detection and visualization of cancer. The company believes its technology will radically improve physicians' ability to detect cancer with minimally invasive endoscopes, improving their ability to visualize, identify and remove cancerous cells. Imagin's initial target market is bladder cancer, the sixth-most common cancer in the United States and the costliest cancer to treat due to a greater-than-50-per-cent recurrence rate.