Zinger Key Points
- Orion system completed a 6-year Early Feasibility Study in 2024 with positive safety and efficacy results.
- Spin-off is expected to be finalized by or before Q3 2025.
- Find out which stock just plummeted to the bottom of the new Benzinga Rankings. Updated daily—spot the biggest red flags before it’s too late.
On Wednesday, Vivani Medical, Inc. VANI said it intends to spin off Cortigent, Inc., a division that develops brain implant devices to help people recover critical body functions, as an independent publicly-traded company.
The company highlights a significant interest in neurostimulation technology, driven in part by companies like Elon Musk's Neuralink. The global neurostimulation market is experiencing substantial growth driven by the rising prevalence of chronic diseases and advancements in technology increasing regulatory approvals for neurostimulator devices.
Vivani believes it is in the best interest of shareholders to spin off Cortigent into an independently operated, publicly traded company, which would deliver enhanced value to Vivani and Cortigent shareholders.
The spin-off will allow Vivani to focus on developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration.
Cortigent is a precision neurostimulation technology that seeks to provide an artificial vision for blind people. Jonathan Adams has served as Cortigent's CEO since 2023 and will retain that position after the spin-off.
This involves implanting a micro-electrode array on the surface of the brain (cortex) to deliver finely tuned electrical pulses to neuron bundles to elicit spots of light called phosphenes.
The company proved its U.S. Food and Drug Administration (FDA) regulatory and CMS reimbursement capabilities when it commercialized, under a Humanitarian Device Exemption, the Argus II Retinal Prosthesis System, the first and only artificial vision device authorized by the FDA to treat a rare form of blindness called retinitis pigmentosa.
Cortigent's platform, the Orion Cortical Visual Prosthesis System, has been designed to treat blindness due to glaucoma, diabetic retinopathy, and other common causes.
Orion has received an FDA Breakthrough Device designation and, in 2024, completed a 6-year Early Feasibility Study with encouraging safety and efficacy results.
The company's core neurostimulation technology is being leveraged for other indications, including arm and hand motion recovery in paralysis due to stroke.
The spin-off is planned to be completed during or before Q3 2025.
Price Action: At the last check on Wednesday, VANI stock was down 1.85% to $1.03 during the premarket session.
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