03:19:42 EDT Tue 16 Apr 2024
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Imagin Medical Inc
Symbol IME
Shares Issued 139,060,278
Close 2020-01-07 C$ 0.08
Market Cap C$ 11,124,822
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Imagin completes design verification of i/Blue

2020-01-07 16:41 ET - News Release

Mr. Stephen Kilmer reports

IMAGIN MEDICAL REPORTS SUCCESSFUL COMPLETION OF I/BLUE'S DESIGN VERIFICATION & ANNOUNCES PRIVATE PLACEMENT

Imagin Medical Inc. has completed design verification of its i/Blue imaging system functional unit on Dec. 31, 2019, as scheduled, and the company intends to undertake a non-brokered private placement offering to raise up to $1-million through the issuance of up to 20 million units.

Design verification successfully completed; pilot manufacturing run scheduled

Imagin's design partner, Optel Inc., confirmed that the key device performance characteristics have met technical design specifications using various testing techniques including, but not limited to, analytic design calculations, measurements of physical prototype characteristics and testing of prototypes by independent laboratories.

Jay Eastman, president of Optel, commented: "The verification process is about confirming that design outputs, or device performance, meet design inputs, the technical specifications. With the assistance of TUV Rheinland testing laboratory in Rochester, N.Y., we evaluated critical design characteristics related to radio frequency emissions, and mechanical and electrical safety. Verification reports and related documents will be included in the i/Blue system's design history file. Based on this success, Imagin is now poised to begin pilot manufacturing runs of the i/Blue imaging systems and refinement of the device validation protocols."

A subset of units from the pilot manufacturing runs will undergo appropriate additional testing, reprocessing, reliability and packaging integrity. The data from this will be submitted to the United States Food and Drug Administration to evaluate the i/Blue imaging system for market approval.

Jim Hutchens, president and chief executive officer of Imagin, commented: "I couldn't be more pleased about where the company is right now. We're starting off the new year having achieved our 2019 goal of i/Blue units built and verified. These units integrated our innovative design with invaluable feedback from leading urologists at the American Urology Association meeting last May in Chicago. Now in 2020, we're at a critical point to begin our pilot manufacturing runs and will continue to work with the FDA to determine the final requirements for the i/Blue's market approval."

Details of the private placement

Each unit will consist of one common share at a price of five cents per share and one share purchase warrant, each warrant entitling the holder to acquire one additional common share at 15 cents for a period of 24 months, provided that, in the event the closing price of the company's shares is equal to or greater than 25 cents per share for 10 consecutive trading days, the company may, by notice to the warrant holders (which notice may be by way of general news release), reduce the remaining exercise period of the warrants to not less than 30 days following the date of such notice.

The net proceeds of the offering will be used for the continued development of the i/Blue imaging system, management of the FDA approval process for i/Blue and general working capital.

Certain persons may assist the company by introducing potential subscribers for the offering and, subject to compliance with applicable legislation, may be entitled to receive a finder's fee in such amount as may be determined by the company.

Closing of the offering is expected to occur on or about Jan. 16, 2020.

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's first product, the i/Blue imaging system, is based on advanced optics and light sensors, and employs patented ultrasensitive imaging technology. The company believes the i/Blue system, with easy-to-use imaging options, will significantly improve surgeons' ability to visualize cancerous cells for more accurate resection.

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