France's Pixium Vision reeled in $20.3 million in new financing to help further development of the company's retinal implant system designed to help people with certain degenerative eye conditions see better.
Bernard Gilly, the company's chairman and CEO, told FierceMedicalDevices via email that the Series A extension funding is "very important " for Paris-based Pixium because it will fuel development and launch of the company's IRIS system in Europe, plus the start of "the necessary regulatory trials in the U.S.A."
Sofinnova Partners led the round, which includes a syndicate of investors that encompasses new investor Bpifrance, Abingworth, Omnes Capital and others.
Pixium, which launched in 2011, will use the new investment to fuel further development of IRIS, which is designed specifically to help treat degenerative eye conditions such as retinitis pigmentosa and macular degeneration. There are several parts to IRIS, including an implant placed inside the eye and attached to the surface of the retina. As the company describes, a patient would then wear a special pair of glasses built with a minicamera and wireless transmitter, which is connected to a pocket computer.
As Pixium explains, the computer transforms the image taken by the camera into a signal transferred back to the glasses, and in turn, onto the retinal implant, where it stimulates the optic nerve and generates images. Over time and through a special rehabilitation program, the brain learns how to interpret the images.
Right now, Pixium's first implant system--known as IRIS1--is in the midst of clinical trials in Europe, at sites in Paris, Hamburg and Graz, Gilly said. Two additional centers will be added to the study in the coming months. Initial data is expected in 2014, and those results will form the basis of a CE mark submission, which will apply to the development of the company's next-generation IRIS2 device.
Gilly said that there is no development plan in place yet for the U.S., but the seeds are there, including a partnership with researchers at Stanford University. Also, he said that "because of the regulatory burden imposed by the FDA," approval of IRIS2 won't happen in the U.S. before late 2017.
A U.S. company has already beat Pixium to the punch in winning FDA approval for a similar device. In February 2013, California's Second Sight Medical Products gained the regulatory agency's OK for the Argus II Retinal Prosthesis System, the first-ever retinal implant in the U.S. designed to treat adults with a degenerative eye disease. It is designated as a humanitarian use device (limited to fewer than 4,000 people in the U.S. annually) and consists of a retinal implant, glasses with an attached video camera and a wireless processing unit worn on a belt. The camera converts video images into small electrical pulses, which are transmitted wirelessly to the retinal implant, where remaining light cells receive stimulation. At that point, the brain can see the light patterns and patients over time learn to interpret them and their new "sight."
Pixium is a spinout of the Vision Institute at the National Eye Hospital in Paris and Universite Pierre et Marie Curie.
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