Mr. Jim Hutchens reports

IMAGIN'S i/BLUE IMAGING SYTEM PROTOTYPE REDESIGN BEGINS

Imagin Medical Inc.'s optical product-design firm, Optel Inc., will begin the redesign of the i/Blue imaging system prototype for manufacturability and commercialization. The redesign will be concurrent with the first in-human research study using the i/Blue prototype that is anticipated to begin shortly at the University of Rochester Medical Center.

With its unique expertise in the manufacture and miniaturization of optical systems, Optel integrates optics, mechanics, electronics, and software into user-friendly, cost-effective products. Optel will work with Imagin to bring the alpha prototype of its state-of-the-art, optics-based i/Blue imaging system through three phases of development: proof of concept, functional unit, and the redesigned verified unit ready for manufacturing.

The i/Blue system will be a mobile device, 70 per cent smaller than the current prototype that can be easily moved between operating rooms and physicians' offices. First proof-of-concept product samples are expected to be available late in the calendar first quarter of 2018. The device will be highly manufacturable and cost effective, with a modular design that will be the basic platform for Imagin's i/Blue imaging system to expand from bladder cancer detection to other minimally invasive surgical procedures requiring improved visualization.

The i/Blue imaging system is highly sensitive and is estimated to be greater than 100 times more precise than currently available systems. It is expected to highlight cancer lesions and put the cancer in context in less than 10 minutes, compared with the current standard of one hour. It is anticipated this procedure will be more comprehensive, improve outcomes, and expand the market. Early detection may reduce the recurrence of bladder cancer.

Jay Eastman, Optel's founder, received his BS and PhD at the Institute of Optics at the University of Rochester. He previously held positions as the Omega laser system project manager, and director of the Laboratory of Laser Energetics (LLE), where development of the i/Blue imaging system alpha prototype was completed. Dr. Eastman commented, "Combining our electronics-design expertise with the fact that the i/Blue prototype was developed at Rochester's LLE and will be tested in the operating rooms at the University of Rochester Medical Center will greatly facilitate rapid product development."

Critical to Imagin Medical, Optel will ensure that the i/Blue imaging system will be in compliance with the requirements of the Food and Drug Administration, good manufacturing practices (GMP), European medical device standard ISO 13485, and other international compliance requirements.

"With the urology community looking for improved bladder-cancer detection, this is an exciting time as the human research study begins and the product redesign is underway," said Jim Hutchens, Imagin's president and chief executive officer.

About Imagin Medical Inc.

Imagin Medical is developing imaging solutions for minimally invasive surgical procedures where endoscopes are used. The company believes it will radically improve the way physicians detect cancer and view the surgical field. Imagin's initial target market is bladder cancer, a major cancer worldwide, the sixth-most prevalent in the United States, and the most costly cancer to treat due to a greater than 50-per-cent recurrence rate. The ultrasensitive imaging technology is based upon improved optical designs and advanced light sensors.

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