• Precision Neuroscience is developing a brain implant that sits on the surface of the brain's cortex.
• Founded by Neuralink alums in 2021, the company aims to bring a "minimally invasive" BCI to market.
• Its first goal is to "restore independence" to the millions with paralysis.

Even in a city where high-stakes deals are made daily, few would expect that behind an unassuming Manhattan facade lies a team of neuroscientists developing a device that could change the relationship between machines and humans.

But change often hides in plain sight, undetectable until it isn't.

Precision Neuroscience is developing a brain-computer interface, a system that creates a direct link between the brain's electrical activity and a computer. This type of technology has been in development for decades, but thanks to AI, the latest generation promises to reveal a wealth of new information about the brain.

I met Precision's president and chief product officer, Craig Mermel, in March at an AI conference. The company stood out as one of a few hardware companies among a sea of startups building productivity tools and coding platforms.

The AI boom, Mermel told me, had turbocharged modern medicine's capacity to collect data about the brain. At a moment when many of the conference attendees talked about the technology's implications in broad terms, Mermel made them seem real — and imminent.

Precision was founded in 2021 by a group that included some Neuralink alums, including Ben Rapoport, a practicing neurosurgeon and electrical engineer who now serves as its chief science officer.

The company's initial goal is to "restore independence" to severely paralyzed people in a less invasive way than its competitors, like Neuralink. That means helping those with paralysis communicate with others, use computers, or even hold a desk job by channeling their neural activity into commands for external technologies.

"The set of conditions that we're treating all have in common is paralysis. So it's people who basically have the ability to think like we do, but not the ability to move, especially move their hands," Rapoport told me during a visit to the company's office.

How it works

Rapoport handed me a slip of yellow film, which the company calls the "Layer 7 Cortical Interface." The name reflects its ambitious goal: to create a seventh layer that sits atop the six cellular layers of the human cortex, the brain's outermost region.

The Layer 7 Cortical Interface is about one-fifth the thickness of a human eyelash. One end is embedded with an array of 1,024 electrodes that can record and stimulate brain activity. These electrodes have wires that run lengthwise, linking the film to custom electronics that process neural data and convert those signals into computer commands so patients can interact with the real world using thoughts alone.

The device is designed to rest on the brain's motor cortex — a small region located behind the frontal lobe that translates thoughts into actions — and conform to its surface, never directly damaging the tissue.

Once in place, it generates a detailed view of the brain's activity. Or, as Precision puts it on its website, "the world's highest resolution picture of human thought."

The competition

Rapoport was part of the founding team at Neuralink, Elon Musk's high-profile neurotechnology venture. It launched in 2016 and has raised about $1.3 billion, according to PitchBook.

He told the newsletter Neurotech Futures last year that he left Neuralink in 2018 because brain-computer interface technology needed to be extremely safe and scalable for it to become a "clinical reality."

"Some changes were needed in the way the technology was being implemented," he said.

Neuralink's N1 implant is a coin-sized, battery-powered device that sits on the skull and connects to ultra-thin threads — embedded with electrodes — that are woven into the brain's cortex.

In an April 2024 update on its website about the status of its clinical trials, Neuralink detailed how the implant is inserted into the brain.

"At a high level, the surgery involved a neurosurgeon exposing the target region of the cortex (e.g., scalp incision, craniectomy, durectomy), the R1 Robot performing the insertions of threads of the N1 Implant, and the neurosurgeon mounting the body of the N1 Implant in the craniectomy and closing the scalp."

In a follow-up email to Business Insider, Mermel said Neuralink's system is based on "penetrating micro-electrodes, which cause damage when they're inserted into the brain."

Precision, he said, has shown that it is "possible to extract information-rich data from the brain" without damaging it.

Neuralink did not immediately respond to a request for comment from Business Insider.

In July, Neuralink announced it had successfully completed implant surgeries on its eighth and ninth human patients. The company is expecting to implant 20,000 chips a year by 2031 to generate at least $1 billion in revenue, Bloomberg reported.

Invasive forms of brain-computer interfaces typically involve implanting electrodes directly into the brain by way of a craniotomy, which involves removing a section of the skull to temporarily expose the brain, or a craniectomy, in which the removed bone is not replaced.

Blackrock's Neurotech, which launched in 2008, makes a modified version of the Utah Array — a micro-electrode array that penetrates up to 1.5 millimeters into the brain. It's been used for "studying neural circuits, investigating the mechanisms of brain function, and developing neural prosthetic devices," according to Neurotech's website.

Synchron, another company in the BCI race, makes a "Stentrode," a thin, flexible electrode array that doesn't require open-skull surgery. Instead, it's inserted into the brain through the jugular vein. Its aim is to "restore control of a touchscreen in people with limited hand mobility using only their thoughts," according to its website.

What's different about Precision

Rapoport's thesis is that placing the device on the brain's surface itself is less invasive than its competitors and enough to gather valuable intel about how the brain operates.

"When we think about the ways that we want the brain to interface with the digital world, most of what we think about is the conscious thought that takes place in the brain," he said. "Essentially all of that takes place at the surface" in the "outermost few millimeters."

The company's Layer 7 Cortical Interface is designed to be easily replaced or moved. It's also modular, so multiple arrays can be combined to cover more regions of the brain.

The device is just one component, however. The method of insertion is another.

Precision is also developing a minimally invasive "cranial microslit" implant procedure to bypass the need for a full craniotomy, Mermel said by email. This involves making a small incision, less than 1 millimeter into the skull, through which the Layer 7 Cortical Interface is inserted and placed on the brain's surface, he said.

Clinical studies

In 2021, the FDA gave Synchron a green light to start clinical trials. In 2023, Neuralink received approval to start trials. Precision, at an earlier stage in its road to commercialization, announced its first clinical studies in 2023.

Since then, the company has conducted clinical studies on 47 volunteer patients — all of whom were already undergoing brain surgery for other reasons. The devices were placed on their brains during surgery to read, record, and map activity on the brain's surface.

In these clinical studies — limited to 15 to 30 minutes — one or two electrode arrays were typically placed on a patient's brain while they engaged in activities such as speaking, playing rock-paper-scissors, or operating a joystick, so AI algorithms could learn the typical neural patterns associated with that activity.

In April, Precision said it received FDA clearance to use its electrode array in the "recording, monitoring, and stimulation of electrical activity on the surface of the brain." The clearance authorizes the array for commercial use for up to 30 days. Studies are already underway, but the company declined to share the number of patients who are participating in these longer clinical studies.

The value of the data

Brain-computer interfaces serve as translators of sorts, converting the brain's electrical language into the vernacular of machines — and eventually, into real-world action.

Precision says its system captures about 1 to 2 billion data points per minute from each patient. It analyzes the data in real time and leverages AI algorithms to translate the raw data and electrical signals into computer code.

The goal is to collect data from a diverse sample of patients, Rapoport said.

"In the entire field of neuroscience, we have never had such a diverse set of high-quality, high-resolution, long-term recordings from dozens of patients' brains until we started doing this, and this includes Neuralink," he said.

Between all of its studies, it has gathered enough data to begin building what he described as a "neural foundation model."

The main focus of this machine learning model will be to decode speech and motor intention from the brain to ultimately help patients control computers and smartphones, Mermel said. However, he added, the company is exploring future use cases for its technology, including assisting surgeons during neurosurgery, treating conditions such as depression, and aiding in stroke recovery.

"When you have something that is safe and effective for a niche group of people, it begs the question: Are there ways to scale it beyond that original use case?" Rapoport said.

All 17 experts ousted from the federal vaccine advisory committee have spoken out about the drastic changes that anti-vaccine advocate and current US health secretary Robert F. Kennedy Jr. has made since taking office. Those changes include unilaterally restricting access to COVID-19 vaccines and summarily firing the entire Advisory Committee on Immunization Practices (ACIP), which had guided federal vaccine policies for more than 60 years.

"We are deeply concerned that these destabilizing decisions, made without clear rationale, may roll back the achievements of US immunization policy, impact people’s access to lifesaving vaccines, and ultimately put US families at risk of dangerous and preventable illnesses," the fired experts write in an editorial published in JAMA.

Kennedy dismissed the entire committee on June 9, accusing the former members of lacking public trust and being "plagued with persistent conflicts of interest," despite the committee's transparent disclosure and conflict of interest policies.

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Under the Trump administration, the Food and Drug Administration is eagerly embracing artificial intelligence tools that staff members are reportedly calling rushed, buggy, overhyped, and inaccurate.

On Monday, the FDA publicly announced the agency-wide rollout of a large language model (LLM) called Elsa, which is intended to help FDA employees—"from scientific reviewers to investigators." The FDA said the generative AI is already being used to "accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets."

"It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications," the announcement promised.

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News broke yesterday that researchers in Philadelphia appear to have successfully treated a 6-month-old baby boy, called KJ, with a personalized CRISPR gene-editing therapy. The treatment corrects an ultra-rare mutation in KJ that breaks a liver enzyme. That enzyme is required to convert ammonia, a byproduct of metabolism, to urea, a waste product released in urine. Without treatment, ammonia would build up to dangerous levels in KJ—and he would have a 50 percent chance of dying in infancy.

While the gene-editing treatment isn't a complete cure, and long-term success is still uncertain, KJ's condition has improved and stabilized. And the treatment's positive results appear to be a first for personalizing gene editing.

Now, who doesn't love a good story about a seemingly miraculous medical treatment saving a cute, chubby-cheeked baby? But, this story delivers more than an adorable bundle of joy; the big triumph is the striking timeline of the treatment's development—and the fact that it provides a template for how to treat other babies with ultra-rare mutations.

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Oncologist Vinay Prasad, a divisive critic of COVID-19 responses, will be the next top vaccine regulator at the Food and Drug Administration, agency Commissioner Martin Makary announced on social media Tuesday.

Prasad will head the FDA's Center for Biologics Evaluation and Research (CBER), which is in charge of approving and regulating vaccines and other biologics products, such as gene therapies and blood products.

"Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward," Makary wrote on social media.

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Under President Trump, the Food and Drug Administration may no longer approve seasonal COVID-19 vaccines updated for the virus variants circulating that year, according to recent statements by Trump administration officials.

Since the acute phase of the pandemic, vaccine manufacturers have been subtly updating COVID-19 shots annually to precisely target the molecular signatures of the newest virus variants, which continually evolve to evade our immune responses. So far, the FDA has treated these tweaked vaccines the same way it treats seasonal flu shots, which have long been updated annually to match currently circulating strains of flu viruses.

The FDA does not consider seasonal flu shots brand-new vaccines. Rather, they're just slightly altered versions of the approved vaccines. As such, the regulator does not require companies to conduct lengthy, expensive vaccine trials to prove that each slightly changed version is safe and effective. If they did, generating annual vaccines would be virtually impossible. Each year, from late February to early March, the FDA, the Centers for Disease Control and Prevention, and the World Health Organization direct flu shot makers on what tweaks they should make to shots for the upcoming flu season. That gives manufacturers just enough time to develop tweaks and start manufacturing massive supplies of doses in time for the start of the flu season.

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It's been a wild ride for investors in Rivian Automotive (NASDAQ: RIVN) and Nio (NYSE: NIO), filled with ups and downs. Both companies have previously had solid momentum behind them, and faced headwinds, setbacks, or disruptions. Both also still have much to prove to investors.

One analyst recently cast doubt on Rivian's gross profit, and Nio will need to show that it can offset the effects of China's brutal price war. Let's dive into both electric vehicle (EV) makers below and see what may lay ahead for them.

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Gross profit in doubt?

One of the biggest takeaways from Rivian's fourth quarter was that it achieved $170 million in gross profit, which is simply total revenue minus the cost of revenue. It was a sizable win compared to analysts' estimates of $49 million in gross profit and was the company's first quarterly gross profit in its short history.

While the company certainly made progress -- Rivian's cost of revenue dropped 18.6% while revenue spiked 31.9% higher -- there was a small drawback. That came in the form of sharply higher sales of regulatory credits, which added $299 million in revenue during the fourth quarter. Regulatory credits are awarded to automakers that produce and sell electric vehicles, and the excess can be sold to other automakers that need the credits to meet emissions standards.

Rivian expects sales of regulatory credits to be similar for 2025 and guided for a positive gross profit for the full-year. Doing so would be a big step toward proving to investors that it has a path to profitability.

At least one analyst disagrees with Rivian's management. Bernstein's Daniel Roeska warned that the company may fail to reach that goal until 2027.

It's true that Rivian will face challenges. Its delivery growth has stalled, so much of the automaker's gross profit improvement will come from a reduction in revenue costs. The company lacks a revenue catalyst, with the R2 not set to hit the roads until the first half of 2026.

Gross profit will be something that analysts and investors both focus on throughout 2025, and it would go a long way if Rivian could achieve its full-year positive gross profit.

Where art thou, revenue growth?

Meanwhile, Nio is expected to see strong momentum throughout 2025, driven by two new brands, Onvo and Firefly. In fact, during Q4, the company's deliveries broke down to 52,760 from its premium Nio brand and 19,929 from its Onvo brand. As deliveries of both Onvo and Firefly accelerate it is expected to drive strong revenue and delivery growth, but that didn't materialize quite as expected during Q4 with Firefly only having just launched.

Nio's Q4 deliveries were up 45% compared to the prior year, but its total revenue jumped a much lesser 15.2%, suggesting that the exhaustingly brutal price war in China is having a large effect on its pricing power.

Nio's first-quarter deliveries were in line with management's guidance at 42,094. But investors must remember the disappointment from that guidance, as it fell far short of analysts' original expectation of 65,000 in deliveries.

Information source: Nio delivery press releases. Graphic source: Author.

Something to prove

Over the past three years, Rivian and Nio have shed 70% and 82% of their value, respectively, and both certainly have much to prove to investors on their way toward profitability. It won't happen overnight, but if Rivian can achieve full-year 2025 gross profit, perhaps even with less reliance on regulatory credit sales, and Nio can offset the weight of China's price war, both will set themselves up for a much brighter future.

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Last week, Health Secretary and anti-vaccine advocate Robert F. Kennedy Jr. announced the Trump administration would hack off nearly a quarter of employees at the Department of Health and Human Services, which oversees critical agencies including the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Centers for Medicare and Medicaid Services (CMS).

The downsizing includes pushing out about 10,000 full-time employees through early retirements, deferred resignations, and other efforts. Another 10,000 will be laid off in a brutal restructuring, bringing the total HHS workforce from 82,000 to 62,000.

"This will be a painful period," Kennedy said in a video announcement last week. Early yesterday morning, the pain began.

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