Vivani Medical to Spin Off Neurostimulation Business as Cortigent

Vivani Medical, formerly known as Second Sight Medical Products, has announced plans to spin off its neurostimulation business into an independent, publicly traded company named Cortigent. The move, expected to be completed in the third quarter of 2025, will allow Vivani to focus on its GLP-1 implant technology while enabling shareholders to participate directly in Cortigent's future endeavors in brain implant development.

Cortigent's Neurostimulation Pipeline

Cortigent will continue to advance brain implant technologies aimed at helping patients recover body functions such as vision and movement. The company's development pipeline includes two primary projects:

1. The Orion Cortical Visual Prosthesis System: Designed to treat blindness caused by glaucoma and other conditions, Orion recently completed a six-year feasibility study. However, the study revealed mixed results, with three out of six patients requesting device removal and one patient experiencing a seizure.

2. Stroke Recovery System: Initiated in 2022, this project focuses on helping patients recover arm and hand motion after stroke. The company conducted cadaver studies in 2023 but faced setbacks when the National Institutes of Health rejected a grant funding request. Cortigent plans to reapply for funding and has also applied for FDA breakthrough designation, pending clinical data submission.

Challenges and Setbacks

The road to Cortigent's formation has been marked by significant challenges. Second Sight, the predecessor to Vivani, faced commercial difficulties with its Argus II vision implant, leading to a cessation of production and marketing in 2019. The company subsequently underwent multiple rounds of layoffs, citing financial constraints and the impact of COVID-19.

These business struggles had far-reaching consequences, leaving some patients with defective or obsolete implanted devices and others without necessary support or software upgrades. Cortigent has acknowledged the difficulties in supporting existing users and implant centers following the initial layoffs.

Looking Ahead

As Cortigent prepares for its independence, the company faces several challenges. With only seven employees reported in its most recent financial update, the firm must navigate the complexities of advancing cutting-edge neurostimulation technologies while addressing the needs of existing patients and rebuilding trust within the medical community.

The spinoff strategy represents Vivani's attempt to create value for shareholders while allowing each entity to focus on its core competencies. As the pharmaceutical and medical device industries continue to evolve, the success of Cortigent will likely depend on its ability to overcome past setbacks, secure funding, and demonstrate clinical efficacy in its ongoing and future trials.