Vivani Medical to Spin Out Neurostimulation Subsidiary Cortigent via Merger with Nasdaq-Listed ClearOne
核心洞察
Vivani Medical has entered a definitive merger agreement to combine its wholly owned subsidiary Cortigent with ClearOne, creating a new publicly traded entity focused on brain-computer interface devices.
The transaction will see ClearOne renamed Cortigent Holdings, trading under the ticker "CRGT," with Vivani retaining 59.4% to 67.5% ownership of the combined company.
Cortigent's lead program, the Orion cortical stimulation system (搜索) for blindness, has FDA Breakthrough Device Designation and completed a six-year early feasibility study in 2025 with promising results.
Vivani Medical, Inc. (Nasdaq: VANI), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced on July 2, 2026 that it has entered into a definitive agreement and plan of merger among its wholly owned subsidiary Cortigent, Inc. (搜索), ClearOne, Inc. (搜索) (Nasdaq: CLRO), and a wholly owned subsidiary of ClearOne. Upon consummation, Cortigent will become a wholly owned subsidiary of ClearOne, which will be renamed Cortigent Holdings, Inc. and trade under the Nasdaq ticker symbol "CRGT."
The transaction represents the culmination of years of work to establish the neurostimulation technology acquired from Second Sight Medical Products (搜索) as a separate publicly listed company, according to Vivani CEO Adam Mendelsohn, PhD.
"We continue to have high confidence in our subsidiary's cutting-edge neurostimulation technology," Mendelsohn said. "In addition to providing meaningful funding for Cortigent to pursue development of its product portfolio, this transaction is expected to provide additional benefits, including: 1) reducing Vivani's direct expenditures relating to Cortigent; 2) enabling our team to fully focus on advancing our portfolio of miniature, ultra long-acting drug implants; and 3) achieving Nasdaq-listing of Cortigent."
Cortigent's Technology Pipeline
Cortigent is a developer of brain-computer interface (BCI) devices based on precision neurostimulation technology. Its predecessor, Second Sight Medical Products (搜索), previously marketed the Argus II (搜索), the first and only medical device to obtain FDA approval to treat a rare form of blindness. That device helped hundreds of profoundly blind patients achieve meaningful visual perception.
The company's next-generation investigational system, the Orion cortical stimulation system (搜索), has been designed to treat blindness caused by common conditions including glaucoma (搜索) and diabetic retinopathy (搜索). Orion has been awarded FDA Breakthrough Device Designation and completed a six-year early feasibility study in 2025, demonstrating promising tolerability and clinical activity results. The system is covered by an extensive intellectual property portfolio.
Cortigent is also applying its core technology to a new device intended to speed recovery of arm and hand mobility following partial paralysis due to stroke (搜索).
"The planned financing will enable accelerated development of our innovative technology, including the Orion artificial vision device, which completed a successful Early Feasibility Study last year and a new device intended to speed recovery of arm and hand mobility following partial paralysis due to stroke (搜索)," said Cortigent CEO Jonathan Adams.
Transaction Structure and Financing
Under the terms of the agreement, Vivani will receive 12,500,000 shares of ClearOne common stock as consideration for all issued and outstanding shares of Cortigent common stock. Vivani is anticipated to own between 59.4% and 67.5% of the outstanding equity in the combined company, while former ClearOne shareholders will own between 12.7% and 14.4%.
In connection with the transaction, ClearOne has agreed to file a registration statement on Form S-1 to raise a minimum of $10,000,000 and a maximum of $15,000,000, with the financing expected to occur concurrently with the closing.
Upon closing, the combined company will be majority-owned by Vivani and will operate independently under the oversight of a reconstituted board of directors. The transaction has been unanimously approved by the boards of directors of both Vivani and ClearOne.
Path to Closing
The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions, including receipt of required stockholder approvals, closing of the financing, meeting minimum net cash requirements set forth in the agreement, and the continued listing of the combined company's common stock on Nasdaq.
ThinkEquity acted as the sole financial advisor to Vivani for the transaction.
For Vivani, the separation allows the company to fully focus on advancing its portfolio of miniature, ultra long-acting drug implants utilizing its proprietary NanoPortal technology. Vivani is the only company in clinical-stage development with a portfolio of GLP-1 (搜索) based implants targeting the treatment of metabolic diseases including obesity (搜索) and type-2 diabetes (搜索).