August 2023 issue
August 31, 2023 | The quest to restore sight to those blinded by retinal diseases has been one of the most technologically challenging applications of neuromodulation over the past few decades. Retinal stimulation devices, developed to assist those affected by retinitis pigmentosa or macular degeneration, translate visual data into electrical impulses. These signals, either initiated from mounted cameras or directly from microchips in the retina, are conveyed to the brain, helping patients discern patterns of light and darkness, which with training, translates into meaningful imagery.
The neuromodulation journey for sight restoration began in earnest in the 1990s, led by pioneers like Second Sight, founded by the famed late neurotech entrepreneur, Alfred Mann. Yet, commercial challenges, primarily the staggering costs and long development timelines (often spanning 10 to 20 years), along with technical hiccups, hindered many in their pursuit. Many promising startups, such as Optobionics, IIP Technologies, and Retina Implant, met untimely demises despite their revolutionary approaches. Second Sight almost followed a similar demise, but merged with another company, Vivani Medical, which recently announced their plans for an IPO of the technology through a newly established company, Cortigent, Inc.
Other implantable solutions have a brighter future than the Al Mann-founded venture, specifically, Bionic Vision Technologies, an Australian company bringing to market the world’s first suprachoroidal visual implant to restore functional vision to blind people suffering from inherited retinal diseases. The company has recently completed initial human testing in seven patients demonstrating safety and efficacy with positive outcomes in patient mobility and device stability/durability. Also, Pixium Vision, a French publicly-traded company listed on Euronext Paris since 2014 (ticker: ALPIX).
While the legacy of these trailblazers is undeniably significant, non-invasive solutions are emerging which offer a more immediate path to commercialization. i-Lumen Scientific is a Minneapolis-based retinal biotech company that was founded in 2015 and led by John VeLure, a seasoned neurotech executive. i-Lumen is focusing on improving vision for patients with nonexudative (dry) age-related macular degeneration—a condition that, until now, had no approved treatments in the U.S.
Unlike implantable devices, the i-LUMEN system relies on software-driven, non-invasive pulsed microcurrent stimulation. This approach targets the retinal pigment epithelium and Muller cells, essential for processing light and crafting images in our brains. Clinical data from i-Lumen shows promising results with 86.4% of treated eyes demonstrating improved visual acuity. Their device, backed by 11 issued U.S. patents, is undergoing clinical trials and is projected to receive FDA clearance by 2026.
While highly compelling as an alternative to implantable devices, non-invasive approaches have their own challenges, particularly around reimbursement. Few non-invasive neuromodulation devices to date have succeeded commercially, and there has yet to be a unicorn compared to implantable companies where billion dollar exits and valuations are common. Perhaps i-Lumen, with its compelling value proposition, will succeed where others have not.
