Neuralink Submits IPO Prospectus for Blindsight: FDA-Designated Breakthrough BCI Implant to Restore Vision

Oct 23, 2024 11:15 CST Updated 11:15

Neuralink

Brain-Computer Interface System Developer

Source: Eye Future; Editor: Felicia

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Recently, Elon Musk'sBrain-Computer Interface Company NeuralinkAnnounced its experimentalBrain-Implant Device “Blindsight”Has received the U.S. FDA's "Breakthrough Device" designation. This device is designed toHelp Patients Restore Vision。

It is reported that,Neuralink Has Implanted Brain-Computer Interface (BCI) Chips in Two Patients. BCI aims to help patients with neurological disorders control external devices, such as computers, using only their thoughts. Musk previously revealed that,Neuralink is expected to provide implants for eight additional patients this year。

Elon Musk has placed extremely high hopes on Neuralink’s Blindsight implant. He once stated on social media that this device ““will restore vision to those who have lost their eyes and optic nerves,” and if the visual cortex is intact, it could even enable those who have been blind since birth to regain their sight.。

The brain-computer interface (BCI) pioneer led by Elon Musk has once again pushed the boundaries of innovation,Bringing Hope for Restored Vision to Those Who Have Lost Their Sight. According to the information publicly released by Musk in April this year,The implantable device has already proven effective in monkeys.. This milestone achievement not only marks a significant leap forward in vision restoration technology, but also heralds a new way for humans to perceive the world in the future.

According to data from Precedence Statistics, the global brain-computer interface market size was $2.35 billion in 2023,It is projected to reach USD 10.89 billion by 2033, with a compound annual growth rate (CAGR) of 16.55% from 2024 to 2033.

From an industry perspective, the FDA’s “Breakthrough Device” designation for Neuralink representsThis not only recognizes the technological advancement and innovation of the “Blindsight” device, but also provides preliminary affirmation of its safety and efficacy.Upon receiving this designation, the “Blindsight” device will benefit from the FDA’s Priority Review, thereby accelerating its development and market launch.

# Core Technology Analysis

Generally speaking,The principle of ocular imaging is primarily：When light enters the eye, it first passes through the cornea and lens, which constitute the outer and middle layers of the eye. Upon reaching the retina at the back of the eye, specialized cells known as photoreceptors convert the light into electrical signals. These electrical signalsand then transmitted to the brain via the optic nerve,The brain interprets these electrical signals as visual images, andVisual ImpairmentPrimarily due to damage to the retina or optic nerve。

The core of the Blindsight technology lies in bypassing the damaged visual system and directly stimulating the brain’s visual cortex to simulate visual perception.。It is implanted into the brain through an invasive approach, directly stimulating the visual cortex via external electrical signals to induce light perception in blind individuals.(Perceiving the specific location of light within the visual field).

After the patient provides feedback on the perceived location of light sensation to the researchers, the researchers will again deliver the designed composite electrical stimulation signals, therebyForming an image within the patient's field of view。

According to Musk,This approach completely bypasses the eyes and optic nerve, sending information directly to the brain., so as long as the visual cortex is intact, even individuals with congenital blindness can be treated.

DespiteInitial visual experiences may have lower resolution., but Musk stated that with the continuous advancement of technology,The resolution of devices in future generations will continue to improve., and may even perceive parts of the electromagnetic spectrum beyond natural human perception, such as infrared and ultraviolet light.

Just like in "Star Trek"like Geordi La Forge (this character, by wearing a special device called VISOR, can see the electromagnetic spectrum invisible to ordinary people, thereby possessing visual abilities beyond those of normal humans).

Geordi La Forge Character Still

Using Blindsight technology,Physicians can tailor rehabilitation plans to each patient based on their neural feedback.. For example, two patients using the same device may respond differently to visual stimuli; physicians can tailor distinct rehabilitation plans based on these differences to achieve optimal outcomes.

Blindsight alsoProvides researchers with a window to directly observe how the brain processes visual information. This provides valuable data for scientists to gain a deeper understanding of the visual system, facilitating the future development of more precise and personalized treatment regimens.

However,Although Blindsight has received FDA designation, its future applications will still face many challenges., such as lower electrode density,resulting in “seen” images with no discernible pattern.Furthermore, some argue that individuals who are blind from birth do not develop the biological capacity for vision through the eyes, and therefore lack the visual concepts understood by those with normal sight.However, most people remain optimistic.

In addition,Any innovation in medical diagnosis and treatment may give rise to ethical and privacy concerns, especially when the technology involves the brain.。Does the patient understand how the device works?How is their data processed and protected?When using Blindsight, both physicians and patients will inevitably face these issues, ensuring that patients are fully informed and willing to assume the risks.

# Advances in Neuralink Technology

Before attempting to address vision problems,Neuralink has publicly disclosed the progress of two brain-computer interface implantation trials for a technology namedTelepathy (Mind Reading)，Blindsight will be the second technological product.。

On January 29, 2024, Musk stated on social media that,Neuralink Completes First Human Brain Implant Surgery。According to Musk, Neuralink’s first product is named “Telepathy.”After implantation of this product,Control smartphones or computers with mere thought, and through them, control virtually any device.。

The first recipient was Noland Arbaugh, who sustained injuries in a swimming accident in 2016 that resulted in quadriplegia, profoundly altering his life.Arbaugh was implanted with Neuralink’s N1 device, known as the Link.The device is equipped with 1,024 electrodes distributed across 64 wires.To ensure the successful implantation of these flexible wires into the brain, Neuralink has also developed a surgical robot.

With the support of Link,Arbaugh was able to control the mouse cursor with his thoughts shortly after surgery, allowing him to browse the internet, watch live streams, and play online games with friends—all while lying down.Prior to surgery, he relied on an assistive device known as a “mouth stick,” which not only required assistance from others for installation but also necessitated that he stand and operate it with his mouth. This significantly impaired his normal communication and caused discomforts such as muscle fatigue and pressure ulcers.

In July 2024, the second brain-computer interface chip implantation surgery was also successfully completed, with good progress in recovery.. The second participant is Alex, who worked as an automotive technician specializing in the maintenance of various vehicles and heavy machinery before his spinal cord injury.After the subject was implanted with the chip, they were able to control the cursor with their mind in under five minutes.. His ability to play video games has been continuously improving, and he has also begun learning how to use computer-aided design (CAD) software for 3D modeling.

However, according to Neuralink,Arbaugh: Some electrodes implanted in the brain tissue have retracted and detached, affecting data transmission rates, causing partial data loss, and resulting in device malfunction.。Neuralink later stated that the issues of wire retraction and detachment in the first patient had been resolved, and the subject’s current use of the brain-computer interface is very stable.Although partial functionality was restored through algorithm adjustments, this indicates that the technology still requires further research and improvement.。

It is undeniable that,These achievements validate the feasibility of Neuralink’s technology and provide valuable experience and data support for its subsequent research and development.With the “Blindsight” device receiving FDA Breakthrough Device designation, Neuralink is accelerating its expansion into broader medical applications.

# About Neuralink

Neuralink is a high-tech company founded by Elon Musk in 2016, headquartered in San Francisco, United States.Focused on the development of invasive brain-computer interface (BCI) technology. The company aims to connect the human brain with machine interfaces by manufacturing devices at the micron level,to achieve human brain-machine interaction. Since its establishment, the company has secured multiple rounds of financing. According to foreign media reports,As early as June 2023, Neuralink's valuation had already exceeded $5 billion.。

Neuralink’s technology involves implanting ultra-fine electrodes into the brain, which can read neural activity information; this information is then decoded and utilized via external devices.

In addition to the Blindsight project, Neuralink is conducting other research related to brain-computer interface (BCI) technology, such as leveraging BCIs to help paralyzed patients restore motor function. In animal experiments, Neuralink’s technology has already demonstrated positive results and is progressively advancing toward human clinical trials. The company’s research and product development have attracted widespread attention and are regarded as a significant breakthrough in the field of brain-computer interfaces.

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