A Statement from Nova Oculus Concerning Clinical Trials for AMD in Canada

Thursday, March 14, 2019 Clinical Trials News
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Clarification and apology offered over earlier press release announcing approval of testing using Nova Oculus device

PALM DESERT, Calif., March 14, 2019 /PRNewswire-PRWeb/ -- ON NOVEMBER 27, 2018, Nova Oculus

Partners, LLC, issued a press release announcing that its Canadian partner, the Eye Machine Canada Inc., had been given approval to begin a clinical patient trial in Edmonton, Canada, using Nova Oculus's pioneering technology for treating Age-Related Macular Degeneration (AMD).

The previous month, the medical devices bureau of Health Canada had granted an Investigational Testing Authorization for that trial. In making that announcement, the press release also reported that approval of the trial's protocol and its investigator has been given by the clinical trials committee of the Health Research Ethics Board of Alberta (HREBA).

However, the press release's assertion that approval of the protocol and the study's investigator by the clinical trials committee was in error. It was the result of a misunderstanding based on a communication from HREBA that was assumed to be granting such approval. As of today's date, the Eye Machine Canada Inc. is still awaiting the committee's approval to proceed with the study.

Nova Oculus Partners, LLC, did not intend to suggest there was approval that at the time it did not believe had actually been granted. Moreover, upon learning of the actual status of the application, Nova Oculus made it clear in subsequent direct communications with its investors that the Eye Machine Canada is still awaiting approval from HREBA of its protocol.

Nova Oculus Partners, LLC, unreservedly apologizes to the members of HREBA, to its clinical trials committee, to the Eye Machine Canada Inc., and to the trial's investigators for this misunderstanding.

 

SOURCE Nova Oculus



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