Vivani Medical, Inc. - VANI STOCK NEWS

Vivani Medical's subsidiary, Cortigent, to present 5-year clinical trial results for Orion Visual Cortical Prosthesis System at research congress, showing no device malfunctions and potential for meaningful visual perception for blind individuals. Study extended to six years for further assessment. Positive potential for future pivotal study and FDA approval.

Vivani Medical reports Q2 financial results and business update. The company has completed the production of clinical trial materials and submitted an IND application for its lead therapeutic candidate, NPM-119. The FDA has placed the IND on clinical hold, but Vivani intends to respond and proceed with its Phase 2 clinical study. Vivani expects to commence enrollment in the study in the second half of 2023, with interim data available in H1 2024 and full results in H2 2024. The company also plans to move its headquarters to a new facility in Alameda, California.

Vivani Medical CEO, Dr. Adam Mendelsohn, will participate in a panel discussion at the Healthcare Virtual Conference Part II on June 20. The conference will focus on therapeutic categories and emerging technologies in the healthcare space.

Vivani Medical, Inc. (NASDAQ: VANI) announced the NIH's approval of year 5 funding for the Early Feasibility Clinical Study of the Orion Visual Cortical Prosthesis, amounting to $1 million, completing a $6.4 million five-year grant. This funding will support Cortigent, Inc., a subsidiary focusing on providing artificial vision to profoundly blind individuals. Approximately 82,000 Americans are estimated to be profoundly blind, and the results of the study are expected in mid-2023. The Orion device, designed to convert images into electrical pulses for the brain's visual cortex, has received FDA Breakthrough Device designation.

Vivani Medical (Nasdaq: VANI) reported its 2022 financial results, highlighting a cash balance of $45.1 million, up from $2.2 million in 2021. The company is focused on advancing its lead candidate, NPM-119, a GLP-1 implant for type 2 diabetes, with plans to submit an IND application in mid-2023 and initiate a Phase 2 clinical trial, LIBERATE-1, expected to yield results by first half of 2024. Despite operational challenges, including a 59% increase in operating expenses to $21.2 million and a net loss of $13.9 million, Vivani continues to prioritize growth through innovative therapies and strategic enhancements within its neuromodulation division.

Vivani Medical, Inc. (NASDAQ: VANI) announced the filing of a Registration Statement on Form S-1 with the SEC for the proposed initial public offering of its wholly-owned subsidiary Cortigent, Inc.. Cortigent aims to advance Vivani’s neuromodulation division and has an ongoing clinical trial for its ‘Orion’ device, which received FDA Breakthrough Device designation. ThinkEquity will act as the sole book-running manager for this IPO. The offering is subject to market conditions, and no securities can be sold until the registration is effective.

Vivani Medical, Inc. (Nasdaq: VANI) reported its Q3 2022 financial results and business updates. The merger with Second Sight Medical Products enabled operational growth, reflected by a net income of $1.4 million due to a net bargain purchase gain of $6.9 million. Operating expenses rose to $5.4 million, a 56% increase from the prior year, driven by heightened R&D and administrative costs. The company is on track to begin the LIBERATE-1 study for its NPM-119 implant in early 2023, with top-line results expected late 2023. Cash resources stand at $51.7 million, sufficient for operations through mid-2024.