EDMONTON, Alberta, Dec. 14, 2018 /PRNewswire-PRWeb/ -- NOVA
OCULUS PARTNERS, LLC, and its Canadian partner, the Eye Machine
Canada Inc., have been given the green light to immediately begin a
clinical patient trial in Edmonton
using their pioneering technology for treating Age-Related Macular
Degeneration (AMD).
The medical devices bureau of Health Canada has granted what is
called an Investigational Testing Authorization for the trial,
while approval of the protocol and the study's investigator has
been given by the clinical trials committee of the Health Research
Ethics Board of Alberta.
Recruitment of the trial participants will begin immediately.
The clinical trial will be conducted independently in
Edmonton by optometrist Dr.
Brent Saik using the company's Nova
Oculus II device. Serving as investigator for the trial will be Dr.
Michael Fielden, an ophthalmologist
with the Calgary Retina Institute. The trial will be double-blind
study involving 50 patients. A double-blind study is one in which
neither the participants nor those administering the tests know
whether the patient is receiving the actual treatment or a placebo.
This procedure is utilized to prevent bias in research results.
How long the study will take is unknown. "We will conduct the
trial as quickly as possible, but it is a complex trial with a
challenging patient population," said Walter O'Rourke, the Fergus, Ontario-based chief operating officer
for Nova Oculus. "Our priority is the care of the trial
participants and the production of good data."
Results from the trial will play a key role in gaining
regulatory approval in Canada for
the Nova Oculus II device. It was designed and engineered to use
microcurrent electro-therapy technology to treat the dry version of
AMD.
ABOUT AMD
AGE-RELATED Macular Degeneration has no cure. It is the No. 1
cause of severe vision loss and legal blindness in adults over 60
in North America. More than 15
million North Americans suffer from this affliction — a figure that
is expected to double as baby boomers age.
ABOUT NOVA OCULUS
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-American company that
created it.
The Nova Oculus II device could revolutionize the treatment
protocols for dry AMD and offer hope to millions of North Americans
who might otherwise going blind without it. Though dry AMD is an
affliction without a cure, the Nova Oculus company's patented
microcurrent electro-therapy technology can help mitigate its
symptoms.
Nova Oculus Partners boasts a blue-ribbon team of highly
experienced engineering professionals leading its efforts to bring
Nova Oculus to market. The company has also assembled a medical
advisory board that includes some of the leading optometric
professionals in the United States
who are assisting in developing a plan to earn FDA approval for the
Nova Oculus II device and gain its widespread commercialization in
the U.S. Efforts toward regulatory approval are also underway in
Canada and Mexico.
The Nova Oculus II 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 global certifications will help pave the way for
regulatory approvals for Nova Oculus in Europe and elsewhere.
For more information:
Walter O'Rourke,
519-829-8587.
SOURCE Nova Oculus