Vancouver, B.C. and Boston, MA, September 26, 2019 – Imagin Medical (CSE: IME) (OTCQB: IMEXF) (Frankfurt & Stuttgart Symbol: DPD2) (“Imagin” or the “Company”) today announced it recently met with the U.S. Food and Drug Administration (“FDA” or the “Agency”) to discuss its premarket approval regulatory pathway for marketing authorization.
Based on the Company’s continued collaborative discussions with the Agency, Imagin anticipates pursing approval for the i/BlueTM Imaging System through a regulatory pathway that demonstrates safety and effectiveness but that is also the least burdensome approach for the Company. The initial i/Blue functional products, along with the necessary documentation to support them, are on schedule to be verified late this year.
“We are pleased with the feedback we received from the FDA during our second meeting to discuss i/Blue’s regulatory path,”
said Jim Hutchens, Imagin’s President and CEO.
“We will continue to collaborate with the Agency as we move closer to our our submission package.”
About Imagin Medical
Imagin Medical is a surgical imaging company focused on establishing a new standard of care in visualizing cancer during minimally invasive surgeries (MIS). 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’s initial focus is bladder cancer. Learn more at www.imaginmedical.com.
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.
President & CEO
Email: [email protected]