The Retinal Implant Market Emerges
The market for retinal prostheses, once thought to be a far-off possibility, is now a reality. Industry pioneer Second Sight Medical Products, a spinoff from the Alfred Mann Foundation, has achieved its first $1 million in product revenue in Europe and may well be on the market in the U.S. in a matter of months if its HDE application is approved by the FDA [see vendor profile, p6]. Though we’ve learned never to take FDA approval for granted, we’d be surprised to see the agency delay this application, given that blind people in Europe already have this device and given CDRH’s recent commitment to a more reasonable approval process.
The HDE route should work well for Second Sight, now that previous restrictions on profitability of HDE-approved devices have been removed. There’s still a 4,000 device limit in place but at $100,000 per unit, reaching that limit would be a good problem for Second Sight to have. In the meantime, the company can pursue a PMA for their device for the long term.
Although there are several other retinal implant ventures underway, it’s likely that Second Sight will have the market to itself for at least a couple years and maybe longer. One potential competitor, Intelligent Medical Implants in Germany, has reportedly run into technical and financial problems and is undergoing reorganization. Another German firm, Retina Implant AG in Hamburg, is further along, having implanted several patients this year with its 1,500-element subretinal prosthesis. But this system evidently has its problems and one of its first users, British music producer Robin Millar, complained publicly about the failure of his device and the light sensation it produced. “So because of the advance of all my other senses and my expertise in using them, this tiny light source on a scale of 1 to 100 is about a 0.2 on the usefulness Richter scale. I wouldn’t give up so much as a little finger for it,” Millar wrote on his blog.
Perhaps more promising is a consortium called Bionic Vision Australia, which received about $40 million from the Australian government. That effort involves a 1024-element sensor made up of diamond electrodes. Two prototype devices are under development there.
In preparing for the development of the commercial retinal implant market, vendors such as Second Sight have been examining the early days of the cochlear implant market as a potential model. Indeed, many of the same components and issues come into play with both types of devices, although retinal implants, with far more channels, are certainly more complex.
Though we expect much more technology development and commercial activity in coming years, we congratulate Second Sight on its achievements and we’ll be watching with interest as this market develops.
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