VANCOUVER, BC and BOSTON, MA / ACCESSWIRE / January 23, 2020 / Imagin Medical (CSE:IME) (OTCQB:IMEXF) (Frankfurt & Stuttgart Symbol:DPD2) ("Imagin" or the "Company") today provided a corporate update to shareholders.
"2019 was a momentous year for the Company as we advanced our deep understanding of the i/Blue System™ and moved into the final stages of development. Our unique value proposition is well positioned for a very promising 2020 with the goal to provide patients suffering from bladder cancer potentially better outcomes," said Jim Hutchens, President and CEO of Imagin.
2019 Development Achievements
Throughout 2019, Imagin achieved significant progress in the i/Blue Imaging System's development. After completing the first functional unit in April, the Company was able to gather and incorporate significant feedback from a select group of urologists at the American Urological Association's ("AUA") Annual Meeting in May. Imagin concluded the year with the assembly and design verification of additional functional units, as well as the initiation of independent lab testing to confirm electrical safety and other compliance requirements.
Mr. Hutchens commented, "Among our many 2019 activities, I consider our meetings at the AUA to be the most important. We were able to introduce the i/Blue technology to North America's top urologists, who helped us define user needs and further refine the system. We were very encouraged by their overwhelmingly positive feedback on the i/Blue Imaging System's key features - simultaneous dual images and adaptability to almost any endoscope - to advance the use of blue light in treating bladder cancer."
From a regulatory perspective, the Company met with the U.S. Food and Drug Administration ("FDA") on two occasions to discuss the i/Blue 's approval pathway and the need for clinical studies. The content and feedback from the meetings continue to be instrumental in refining Imagin's regulatory strategy.
Goals for 2020 and Beyond
As reported on January 21, 2020, Imagin achieved a significant milestone by closing an oversubscribed, non-brokered private placement for $1,914,000 in gross proceeds.
"We're pleased with investors' confidence in the Company. The recent financing will provide the needed funds for Imagin to finalize development of the i/Blue Imaging System, move forward with the FDA approval process, and expand our exposure in the marketplace," commented Mr. Hutchens.
In the coming months, Imagin plans to initiate pilot production runs of i/Blue Imaging System, which are scheduled to be completed and validated by mid-year. The Company will then submit its application to the FDA for market approval.
To prepare for commercialization, Imagin will continue to build awareness in the urology marketplace via trade shows and relationships with key opinion leaders. The Company will also continue to build on its intellectual property portfolio and develop distribution channels in the urology marketplace.
With i/Blue development completed, the technology can be readily adapted to accommodate additional FDA-approved contrast agents, such as Indocyanine green (ICG) used in laparoscopic surgeries, significantly expanding Imagin's market potential.
In summary, Mr. Hutchens said, "We are excited to enter 2020 closer to delivering the benefits of the i/Blue System to the medical community to help cancer patients and increasing the visibility of Imagin Medical. Our ongoing goal is to become a resource to physicians and their patients as we progress, and to continue building shareholder value."
About Imagin Medical
Imagin Medical is a surgical imaging company focused on advancing new methods of visualizing cancer during minimally invasive procedures. The Company believes its first product, the i/Blue™ Imaging System, with its proprietary optics and light sensors, will greatly increase the efficiency and accuracy of detecting cancer for removal, helping to reduce recurrence rates. The Company's initial focus is bladder cancer. Learn more at www.imaginmedical.com.
Forward-Looking Statements
Information set forth in this news release contains forward-looking statements. These statements reflect management's current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company's control. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Specifically, there is no assurance the Company's imaging system will work in the manner expected. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. The CSE has neither approved nor disapproved the information contained herein and does not accept responsibility for the adequacy or accuracy of this news release.
Contacts:
Stephen Kilmer, Investor Relations
Telephone: 647-872-4849
Email: [email protected]
Jim Hutchens, President & CEO
Telephone: 833-246-2446
SOURCE: Imagin Medical