Cortigent's Brain Implant Device Receives FDA Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 20h ago
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Source: Newsfilter
- Clinical Study Results: Cortigent presented the results of a 6-year Early Feasibility Study of the Orion Visual Cortical Prosthesis System at the North American Neuromodulation Society annual meeting, demonstrating good safety and reliability, with plans for a larger pivotal trial to seek FDA marketing approval.
- Device Performance: Among the six subjects implanted between 2018 and 2019, all showed significant improvement in visual function tests, with final Functional Low-vision Observer Rated Assessment (FLORA) scores being positive or mildly positive, indicating a beneficial impact of the Orion system on their quality of life.
- Electrode Stability: Throughout the study, all devices remained functional with a functionality loss rate of less than 4%, indicating the reliability of the Orion system for long-term use and laying a foundation for future market introduction.
- Strategic Development Plans: Cortigent CEO Jonathan Adams stated that the company will collaborate with the FDA and world-leading experts to advance the Orion system, aiming to provide meaningful visual perception for the blind, showcasing the company's strategic vision in neurostimulation technology.
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Analyst Views on VANI
Wall Street analysts forecast VANI stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for VANI is 4.00 USD with a low forecast of 4.00 USD and a high forecast of 4.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.490
Low
4.00
Averages
4.00
High
4.00
Current: 1.490
Low
4.00
Averages
4.00
High
4.00
About VANI
Vivani Medical, Inc. is a clinical-stage biopharmaceutical company, developing miniature, ultra-long-acting drug implants. Leveraging its NanoPortal platform, it develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and to improve patient tolerance to their medication. Its lead program, NPM-115, is a six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in overweight individuals. Its pipeline includes NPM-139 (semaglutide implant), which is also under development for chronic weight management. NPM-119 refers to its six-month, subdermal, GLP-1 (exenatide) implant under development for the treatment of type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cortigent's Brain Implant Device Receives FDA Approval
- Clinical Study Results: Cortigent presented the results of a 6-year Early Feasibility Study of the Orion Visual Cortical Prosthesis System at the North American Neuromodulation Society annual meeting, demonstrating good safety and reliability, with plans for a larger pivotal trial to seek FDA marketing approval.
- Device Performance: Among the six subjects implanted between 2018 and 2019, all showed significant improvement in visual function tests, with final Functional Low-vision Observer Rated Assessment (FLORA) scores being positive or mildly positive, indicating a beneficial impact of the Orion system on their quality of life.
- Electrode Stability: Throughout the study, all devices remained functional with a functionality loss rate of less than 4%, indicating the reliability of the Orion system for long-term use and laying a foundation for future market introduction.
- Strategic Development Plans: Cortigent CEO Jonathan Adams stated that the company will collaborate with the FDA and world-leading experts to advance the Orion system, aiming to provide meaningful visual perception for the blind, showcasing the company's strategic vision in neurostimulation technology.
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Vivani Medical Prices $4.5M Offering for Growth Initiatives
- Offering Size: Vivani Medical has priced 1,689,200 common shares at $1.48 each, alongside a concurrent private placement of 1,351,351 shares purchased by Chairman Gregg Williams, raising a total of $4.5 million, indicating strong market interest in the company.
- Use of Proceeds: The net proceeds from this offering will fund ongoing research and clinical development of the company's product candidates, as well as provide working capital and general corporate purposes, ensuring sustained growth in a competitive healthcare landscape.
- Transaction Timeline: The registered offering and private placement are expected to close around January 27, providing the company with a swift influx of capital that will accelerate its research and development efforts.
- Market Reaction: The successful pricing of this offering reflects investor confidence in Vivani Medical's growth potential, which may positively impact the company's stock price and strengthen its market position in the healthcare sector.
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