Nova Oculus Canada Manufacturing was incorporated in Canada in 2018 and was established to develop, manufacture, and lease to medical professionals, primarily optometrists, a medical device to treat Age-Related Macular Degeneration (AMD) by delivering a proprietary microcurrent waveform directly to the retina, mitigating the effects of AMD.
Each procedure takes approximately 32 minutes, and consists of a 40-cycle treatment of microcurrent stimulation applied to four sites around the eyes (upper left lid, lower left lid, upper right lid and lower right lid) for 40 seconds at each location, simultaneously.
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 global certifications pave the way for clinical trials and regulatory approvals globally.
A technician can be trained to apply the treatments under the supervision of the optometrist or ophthalmologist.
Clinical studies involving electro-therapy procedures reported in scientific literature have not indicated any evidence of a tolerance forming to repeated treatments with microcurrent.
In the recently completed Health Care clinical trial, participants were treated for 32 minutes, on four consecutive days during the first week. Most participants saw an immediate improvement in their ability to watch television, recognize faces and function within their environment. Not only did the trial show significant improvement in the treatment group, but the control group of participants who were treated with a placebo device experienced a decline in their vision, which would be expected with a progressive disease like AMD.
Patients usually require subsequent treatments as the effects of each treatment wears off over time. After the initial four consecutive treatments, patients are treated at 30-day intervals for approximately six months to maintain the effects of the initial treatment.
No. The Nova Oculus medical device will vastly improve the patient’s eyesight. People are treated as required to maintain their best visual acuity.
One of the Canadian trial’s objectives was to confirm our mechanism of action theory: that is, treatment with the Nova Oculus medical device improves the permeability of the blood vessel membranes and cells and allows better oxygen and nutrition delivery to the cells. In other words, pulsed microcurrent electro-therapy can re-awaken hibernating cells that impair vision.
Our Canadian clinical trial was conducted in Vancouver, by MacuMira Medical Devices. Kevin Parkinson, MD, FRCSC an ophthalmologist in Coquitlam, B.C., was the primary investigator leading the trial.