Craig Mermel, the president and chief product officer at Precision Neuroscience, found himself missing a momentous event due to its rapid occurrence. While present in a bustling operating room in West Virginia, he awaited the moment when a surgeon would place Precision’s neural implant system onto a conscious patient’s brain for the very first time. However, Mermel briefly looked away, and when he turned his gaze back, he discovered that the company’s ultra-thin electrode array had already been positioned.
In a matter of seconds, a real-time, high-resolution visualization of the patient’s brain activity appeared on a screen. Precision claims that their system has achieved the highest level of resolution ever recorded, providing an unprecedented insight into human thought.
The observation made by Mermel marked the inaugural in-human clinical study conducted by the company.
Established in 2021 by one of the co-founders of Neuralink, Elon Musk‘s brain-computer interface (BCI) venture, Precision is a competitive player in the industry, aiming to assist individuals with paralysis in operating digital devices by decoding their neural signals. BCIs are systems designed to interpret brain signals and convert them into commands for external technologies. Other companies such as Synchron, Paradromics, and Blackrock Neurotech have also developed devices with similar capabilities. In January, Precision made headlines with the announcement of a successful $41 million Series B funding round.
Neuralink, led by Elon Musk, has obtained FDA approval to commence its “first-in-human clinical study.” This significant milestone brings the company closer to its goal of creating a direct connection between the human brain and computers.
Revolutionizing Brain-Computer Interfaces
Precision’s leading brain-computer interface (BCI) system, known as the Layer 7 Cortical Interface, consists of an electrode array that closely resembles a strip of adhesive tape. Remarkably thin, measuring thinner than a human hair, Precision asserts that it can seamlessly conform to the brain’s surface without causing any tissue damage. In the study conducted, Precision temporarily placed the system onto the brains of three patients who were already undergoing neurosurgery for tumor removal.
Given the success of the technology in these initial trials, Mermel expressed the intention to explore its applications in various clinical and behavioral contexts. Precision aims to conduct further studies to expand the potential use cases. According to their plan, if the trials proceed as anticipated, individuals afflicted with severe degenerative diseases like ALS may eventually regain some capacity to communicate with their loved ones. This could be achieved through cursor movement, typing, and even accessing social media, all accomplished solely with the power of their minds.
While the in-human study represents a significant milestone, the path to bringing this type of technology to market is a lengthy one. Precision has not yet obtained approval from the U.S. Food and Drug Administration (FDA) for its device, and the company will need to closely collaborate with regulatory authorities to successfully navigate multiple rounds of comprehensive testing and meticulous data collection to ensure safety.
Advancing BCI Technology
As of June, no BCI company has managed to secure the FDA’s final approval.
Mermel commented, “The objective is to provide a device that can assist individuals living with permanent disabilities, so this marks the initial step. Now, the real work lies ahead.”
Dr. Benjamin Rapoport, co-founder and chief science officer at Precision, revealed that several academic medical centers expressed interest in supporting the company’s pilot clinical study. After careful consideration, Precision formed a partnership with West Virginia University’s Rockefeller Neuroscience Institute. The collaboration between the two entities involved extensive preparations spanning over a year in advance, as stated by Rapoport.
Having dedicated more than two decades to the development of BCI technology, Rapoport expressed immense satisfaction at witnessing Precision’s technology being applied to a human patient’s brain for the very first time. He described this achievement as an “incredibly gratifying” milestone.
Describing the experience, he expressed, “Emotionally, it’s difficult to put into words. It was an extraordinary moment.”
Dr. Peter Konrad, the Chairman of the Department of Neurosurgery at the Rockefeller Neuroscience Institute, took on the role of surgeon, physically implanting Precision’s system onto the patients’ brains during the procedures.
According to Konrad, the process was straightforward and felt akin to gently placing a piece of tissue paper on the brain.
The patients underwent a 15-minute procedure with Precision’s system implanted on their brains. One patient remained asleep throughout the process, while two patients were awakened to allow the Layer 7 system to record their brain activity while speaking.
Dr. Peter Konrad, described the experience, stating, “I have never witnessed such an extensive amount of real-time data, with 1,000 channels of electrical activity cascading over the brain as someone was speaking. It was as if you were observing someone’s thoughts in action. Truly remarkable.”
Enhancing Clarity Beyond Standard Electrodes
In current medical practice, electrodes are utilized to monitor brain activity during neurosurgical procedures. However, the resolution offered by conventional systems is limited. Dr. Konrad explained that standard electrodes have a size of approximately 4 mm, whereas Precision’s array can accommodate 500 to 1,000 contacts within the same space.
He likened the disparity to viewing the world through an outdated black and white camera versus experiencing it in high definition.
Dr. Konrad noted that it is premature for the patients in this study to directly witness the advantages of this technology.
Precision has a long-term vision of eliminating the need for open brain surgery with its technology. According to co-founder and CEO Michael Mager, in January, the company envisions a surgeon being able to implant the array by creating a narrow incision in the skull and inserting the device like a letter into a letterbox. The incision would be less than a millimeter thick, making it so small that patients would not require their hair to be shaved for the procedure.
Precision deliberately adopts a minimally invasive approach, distinguishing itself from competing BCI companies like Paradromics and Neuralink, which have developed systems intended for direct insertion into brain tissue.
Precision’s Trade-Off for Functionality and Scalability
According to Rapoport, the co-founder and chief science officer at Precision, directly inserting a BCI into the brain would offer a comprehensive understanding of each neuron’s activity. However, this approach carries the risk of tissue damage and presents challenges in scalability. He emphasized that such a level of detail is not essential for decoding speech or achieving the desired functions pursued by Precision. Therefore, it was a trade-off the company was willing to accept.
As part of its pilot clinical study, Precision plans to repeat the procedure with two additional patients in the upcoming weeks. Rapoport mentioned that the company has submitted its initial findings to a scientific journal, and making the data publicly available would represent a significant progression in their journey.
Precision is actively engaged in conducting similar studies with prominent health systems like Mount Sinai in New York City and Massachusetts General Hospital in Boston. Rapoport expressed the company’s aspiration to obtain complete FDA clearance for its first-generation device by the following year.
Rapoport conveyed his immense satisfaction with the early results, describing the experience as a rare opportunity to witness something before it becomes known to the world. He expressed gratitude for being fortunate enough to have such an extraordinary experience.