Nova Oculus Recruits Emergo to Assist with Global Compliance

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Job One is to help achieve regulatory approvals in Canada

Nova Oculus Partners has forged another key alliance in our ongoing endeavors to bring to market a pioneering medical device for the treatment of Age-Related Macular Degeneration.

The company’s chief operating officer, Walter O’Rourke, has signed an engagement contract with Emergo, a global regulatory consultancy that helps companies like ours secure government approvals for their medical devices. O’Rourke says Emergo will play a key role for licensing the Nova Oculus device and our patented micro-current therapy in Japan, Australia, Britain and the European Union, Argentina, Colombia and Cuba.

“We have undertaken an extremely aggressive certification program and Emergo is key to meeting our goals,” said O’Rourke. “This is an ideal structure for us because it gives management the ability to control costs and manage market priorities as we expand globally.”

O’Rourke says Canada will be the initial focus for the joint Nova Oculus/Emergo undertaking. Working with our Canadian subsidiary, Emergo is performing an in-house audit of the work done by the Nova Oculus development team in accordance with ISO (International Organization of Standardization) criteria. That will set the stage for a third-party audit of our device’s development process that is sanctioned by the ISO. Emergo will also assist in identifying a company to conduct that audit, relative to cost, timing and that firm’s international credibility.

In addition, Emergo will assist Nova Oculus in obtaining a Medical Device License from the Canadian government. “Canada has a globally recognized regulatory review process and it’s also a meaningful commercial opportunity for us,” O’Rourke said. “Once we commercialize in Canada, Emergo will then assist us in registering our products with regulatory authorities in multiple other international markets.”

Emergo CEO Rene van de Zande says complying with complex regulations in multiple markets can be daunting for companies developing innovative medical devices and seeking opportunities internationally. “They quickly come to realize we’ve become their in-house regulatory resource,” he said.

Emergo is based in Austin, Texas, and has offices staffed with local regulatory professionals in Canada and 24 other countries that serve 95 percent of the global marketplace for medical devices. In addition to regulatory strategies and device registrations, the services they offer include quality management system compliance, clinical trial consulting, and in-country regulatory representation.

Van de Zande, who founded Emergo in 1997, holds master’s and post-graduate degrees from Radboud University in the Netherlands, and Johns Hopkins University School of International Studies. Emergo’s client base includes more than 2,800 medical device and in-vitro device companies in 55 countries around the world.

It is estimated that more than 40 million people in the U.S., Canada, Britain, the EU, Japan and Australia are afflicted with AMD, and are either blind or at risk for becoming blind. According to the company’s calculations, as many as four million of those could be treated by the Nova Oculus device within the first five years after commercialization.

About Nova Oculus Partners:
Nova Oculus Partners, LLC was formed to develop, manufacture, and lease to medical professionals an electrotherapeutic medical device to treat visual disease, providing a pulsed micro-current output delivered to the retina by way of a closed eyelid. This treatment method can help mitigate the effects of age-related macular degeneration and diabetic retinopathy.

The Nova Oculus company’s pulsed micro-current therapy represents a new, non-invasive treatment for all forms of macular degeneration. The device output signal is structured to provide a range and pattern of frequencies to stimulate the desired physiologic response at the retinal level. This low current has been shown by studies to stimulate the production of the active transport enzyme, adenosine triphosphate (“ATP”), which facilitates the movement of nutrition from the blood to the cell.

According to recent studies, this treatment improves permeability of the blood vessel membranes and cells, allows better oxygen and nutrition delivery to the cells, metabolism, and removal of by-products from the cells. Through these mechanisms, pulsed micro-current therapy improves retinal pigment epithelium (“RPE”) efficiency and in so doing may restore and/or improve retinal function.

For more information contact:
Walter O'Rourke,
Chief Operating Officer

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Terry McConnell

Walter O'Rourke
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