Mr. Jim Hutchens reports

IMAGIN MEDICAL CONFIRMS FUNCTIONAL UNITS ON SCHEDULE FOR PRODUCT DESIGN VERIFICATION

Imagin Medical Inc. has made further progress toward verification of its i/Blue imaging system functional product.

The i/Blue system is currently in the design verification stage of the development process. Since Imagin's last progress update on July 15, 2019, the company has purchased and received components for the initial build of the functional units. Components have been purchased from established suppliers to meet Imagin's custom specifications.

The i/Blue system comprises five major subsystems. These include: (i) a controller that houses the light and energy sources; (ii) a dual-camera handpiece; (iii) optical light cables; (iv) a medical-grade equipment cart; and (v) a medical-grade printer. The system is used with a third party cystoscope not provided by Imagin.

Currently, components are being assembled for the control unit, which will integrate the dual-wavelength light source with the dual-camera handpiece, allowing simultaneous streaming of white-light and blue-light images to be projected side by side on the display monitor.

In-depth evaluation of this system will be performed by an independent testing lab to confirm electrical safety, radiated emission and susceptibility compliance, as well as other requirements. Data from these independent lab tests will be combined with data from internal testing performed by Imagin's opto-electronic design firm, Optel, engineering calculations, component suppliers and competitive device analysis, all of which will become the basis of the company's verification report. As previously forecasted, Imagin expects this work will be in process prior to the end of 2019.

Jim Hutchens, president and chief executive officer of Imagin, commented: "We're excited with the progress to date. The functional units are on schedule for design verification, leading the way to our pilot production runs. Throughout this process, we continue to work with the U.S. Food and Drug Administration (FDA) to determine the final requirements for obtaining marketing clearance."

About Imagin Medical Inc.

Imagin Medical is a surgical imaging company focused on establishing a new standard of care in visualizing cancer during minimally invasive surgeries. The company believes its first product, the i/Blue imaging system, will dramatically improve surgeons' ability to visualize cancerous cells by producing higher-quality images more quickly compared with current methods. Based on advanced optics and light sensors, the i/Blue imaging system employs patented ultrasensitive imaging technology and offers easy-to-use viewing options for more accurate resection. The company's initial focus is bladder cancer.

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