Wednesday, September 27, 2017 6:38:06 PM
IMAGIN MEDICAL RECEIVES APPROVAL FOR 1ST IN-HUMAN RESEARCH STUDY
The University of Rochester (UR) Research Study Review Board (RSRB) has approved the first in-human study using Imagin Medical Inc.'s i/Blue imaging system. Recruitment of subjects will begin immediately and continue until the study is completed, which is expected to be a three-month process. More information can be found on the Clinical Trials website.
The pilot study, entitled "Near Infrared Fluorescence Imaging for Bladder Cancer Detection," is sponsored by Dr. Edward Messing, chair of urology at the University of Rochester Medical Center and the study's principal investigator. The primary purpose of the study is to determine the minimal dwell time needed for adequate detection of hexaminolevinulate HCL avid tumours using protoporphyrin IX (PpIX) near infrared fluorescence (NIRF).
The company has expressed confidence that the 10-patient study will validate previous bench-testing results that have shown: (1) physicians will be able to see the cancer in 10 minutes versus the full hour required by today's technology; and (2) the white and fluorescence images will blend into one to put the cancer into context within the bladder.
"We're very excited to receive the approval. It's a major milestone for Imagin and we're eager to see the study begin," said Jim Hutchens, Imagin's president and chief executive officer. "Based on previous testing, we anticipate positive results that will bring us closer to delivering this life-saving technology to the marketplace."
About Imagin Medical Inc.
Imagin Medical is developing imaging solutions for minimally invasive surgical procedures where endoscopes are used. The company believes it will radically improve the way physicians detect cancer and view the surgical field. Imagin's initial target market is bladder cancer, a major cancer around the world, the sixth-most prevalent in the United States and the most costly cancer to treat due to a greater-than-50-per-cent recurrence rate. The ultrasensitive imaging technology is based upon improved optical designs and advanced light sensors.
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