Canadian company confident it has the answer for treating disease that blinds millions
Pioneering medical device offers hope to AMD sufferers
FERGUS, ON (February 4, 2022) — The completion of an investigative clinical trial for a pioneering medical device that treats Age-Related Macular Degeneration has officials for the Canadian company that developed the device optimistic for its approval by federal regulators.
The Nova Oculus medical device holds the potential to revolutionize the treatment protocols for the dry version of AMD and offer hope to the two million Canadians over the age of 50 who are going blind without treatment. Dry AMD is an affliction without a cure, yet independent assessments of that investigative trial affirm the Nova Oculus medical device’s microcurrent electro-therapy technology was successful in mitigating AMD’s symptoms in those trial participants treated with the device.
“The clinical trial exceeded the expectations of all those involved,” said Walter O’Rourke, president of Nova Oculus Canada Manufacturing, the company that developed the device. “We are confident that 2022 will be the year we can bring a non-invasive life-improving solution to so many Canadians.”
Results from the 50 participating patients in the trial, completed in Vancouver last year, were reviewed by an independent statistical analysis group that has worked before with Canadian health regulators. That report and the formal application were submitted to Health Canada at the end of August. O’Rourke is confident the trial offers a significant prospect of approval by the federal regulators. Should that happen, commercialization of the device to the Canadian market could happen sometime before the end of the year.
The trial was conducted by the Canadian licensee for the Nova Oculus medical device, MacuMira Medical Devices (formerly EMC Inc.) and supervised by the Western Institutional Review Board, a regulatory panel based in Washington state that ensures the protocol approved by the Canadian government is being implemented correctly.
February is Age-related Macular Degeneration Awareness Month. The Canadian Ophthalmology Society states AMD is the leading cause of vision loss and blindness.
ABOUT NOVA OCULUS CANADA
NOVA OCULUS is the name of the pioneering new medical device engineered and developed to treat the dry form of Age-Related Macular Degeneration—and for the Canadian company of innovative people that created it. The Nova Oculus medical device has been certified as complying with the quality management standard set by the International Organization of Standardization (ISO) and the electrical safety standard set by the International Electrotechnical Commission (IEC). These certifications make future global regulatory approvals possible for the Nova Oculus medical device.
Age-related Macular Degeneration has no cure. It is the leading cause of blindness in Canada. More than two million Canadians suffer from this affliction — a figure expected to double as baby boomers age.