Vancouver, B.C. and Boston, MA, February 26, 2018 – Imagin Medical (CSE: IME) (OTC PINK: IMEXF) (Frankfurt & Stuttgart Symbol: DPD2) (the “Company”), announced today the Company has hired Pam Papineau as the Director of Regulatory Affairs.
Ms. Papineau has over 30 years’ experience in quality and regulatory affairs with Baxter, Boston Scientific and Cogentix (Vision-Sciences), and has served as a consultant on a wide variety of devices that includes endoscopy, imaging, GI/GU, orthopedic and cardiovascular. Pam has successfully prepared dozens of FDA premarket submissions and European Union (EU) technical files to support CE marking of a broad spectrum of medical devices and has overseen numerous clinical studies entailing protocol development, reporting and management of Clinical Research Organization (CRO) services. Pam is an ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and Certified Biomedical Auditor (CBA), an ISO 13485:2016 Lead Auditor, and holds Regulatory Affairs Professional Society (RAPS) certifications for the US, EU, CAN. Pam will work with Hogan Lovells, the Company’s legal Counsel, preparing for a pre-submission meeting with the FDA and follow-on activities through the regulatory approval process.
“As the project progresses, we continue to put the needed talent in place to bring the i/Blue Imaging System to market,” said Jim Hutchens, Imagin’s President and CEO. “We have worked with Pam in the past and we’re excited to have her expertise on our team.”
For further information on the current i/Blue Imaging System research study, visit, Near Infrared Fluorescence Imaging for Bladder Cancer Detection on www.clinicaltrials.gov.
About Imagin Medical
Imagin Medical is developing imaging solutions for the early detection of cancer during minimally invasive surgeries. The Company believes it will radically improve the way physicians detect cancer where endoscopes are used. Imagin’s initial target market is bladder cancer, a major cancer worldwide, the sixth most prevalent in the U.S., and the most costly cancer to treat due to a greater than 50% recurrence rate. Developed at the Lawrence Livermore National Laboratory, this advanced, ultrasensitive imaging technology is based upon improved optical designs and advanced light sensors. Learn more at www.imagindev.wpengine.com.
For further information, contact:
Jim Hutchens, President & CEO
Email: [email protected]
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.
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