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SAN FRANCISCO, June 16 (Reuters) - Billionaire entrepreneur Elon Musk expects his brain-chip startup Neuralink to start its first human trial this year, he said on Friday in France. Speaking at the VivaTech event in Paris, co-founder Musk said Neuralink plans to implant a tetraplegic or paraplegic patient during a webcast monitored by Reuters. The FDA acknowledged in an earlier statement to Reuters that the agency cleared Neuralink to use its brain implant and surgical robot for trials but declined to provide more details. On at least four occasions since 2019, Musk predicted that Neuralink would soon start human trials. Neuralink employees who sat on the company's animal board, which has come under federal scrutiny for potential financial conflicts, stood to benefit from the implant's quick development.

Persons: Elon Musk, Musk, Neuralink, didn't, Rachael Levy, Hyunjoo Jin, David Gregorio Our Organizations: FRANCISCO, Billionaire, Reuters, Twitter, SpaceX, Food, Drug Administration, FDA, Department of Transportation, U.S . Department of Agriculture's, Thomson Locations: France, Paris, U.S, Washington, San Francisco

Neuralink's valuation jump in secondary trades is in sharp contrast to other startups. About 85% of pre-IPO companies are currently valued in secondary trades at an average discount of 47% to their last funding round, according to data provider Caplight. The maximum amount sought for the Neuralink shares marketed for sale at a $7 billion valuation was just $500,000, according to the email seen by Reuters. Sim Desai, chief executive of Hiive, an online platform where the shares are traded, said demand for Neuralink stock has been "tremendous." Neuralink stock that some of the employees hold has jumped around 150% in value in just two years, based on the secondary trades.

Persons: Elon, Kip Ludwig, Musk, Neuralink, Sim Desai, Arun Sridhar, Sridhar, Galvani, Rachael Levy, Marissa Taylor, Krystal Hu, Greg Roumeliotis, David Gregorio Our Organizations: U.S . National Institutes of Health, Reuters, U.S . Food, GSK Plc, Sciences, FDA, U.S . Department of Agriculture, Department of Transportation, Thomson Locations: Neuralink's, U.S, Washington ,, New York

☆ US lawmakers seek probe of how Elon Musk's brain chip venture oversees animal experiments
▼ + stars: | 2023-05-12 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +3 min

REUTERS/Dado Ruvic/Illustration/File PhotoWASHINGTON, May 12 (Reuters) - U.S. lawmakers will ask regulators to investigate whether the make-up of a panel overseeing animal testing at Elon Musk's brain-chip startup Neuralink contributed to botched and rushed experiments. The lawmakers have shared the draft with peers to gather more signatures and plan to send it to the USDA on Monday. A spokesperson for Blumenauer said the USDA did not respond to an earlier request from lawmakers for a probe into Neuralink in the wake of that story. Musk and Neuralink representatives, and spokespeople for the USDA and the agency’s inspector general, did not respond to requests for comment. The Inspector General and the USDA did not respond to a request for comment on the progress of that investigation.

The membership of the panel at Musk’s company, Neuralink, raises questions about potential violations of conflict-of-interest regulations aimed at protecting research integrity, a dozen animal-research and bioethics experts told Reuters. Autumn Sorrells has chaired an oversight board approving animal experiments by Elon Musk’s brain-chip startup, Neuralink, and also run the company’s animal care program. Reuters couldn’t determine the compensation terms of the Neuralink IACUC members who are also company employees. The independence of such boards, Nicolelis said, is critical to protecting the integrity of animal research that could impact humans in future clinical trials. These institutions generally prohibit people with direct financial interests from serving on IACUCs or voting on animal experiments.

March 27 (Reuters) - Elon Musk's brain implant company Neuralink has approached one of the biggest U.S. neurosurgery centers as a potential clinical trials partner as it prepares to test its devices on humans once regulators allow for it, according to six people familiar with the matter. Barrow has helped standardize brain implant surgeries in which the patient can remain asleep, a key step in making it more acceptable to a broad set of the population, Ponce said. This is in line with Musk's vision for Neuralink's brain chip. The billionaire CEO of Tesla Inc (TSLA.O) and majority owner of Twitter has said Neuralink's brain implants will become as ubiquitous as Lasik eye surgery. Neuralink's implant is a brain computer interface (BCI) device, which uses electrodes that penetrate the brain or sit on its surface to provide direct communication to computers.

The Justice Department’s decision to subpoena government witnesses who would normally testify voluntarily to help build the government’s criminal case was highly unusual, according to a half-dozen legal and animal welfare experts. The inspectors wanted APHIS to take a tougher stance against the company for the mistreatment of the beagles. Yet, this did not happen with any of the agency's inspections of Envigo, public records show. TENSIONS RISETensions between Gibbens and Miller escalated shortly after Envigo appealed some of the findings from the October inspection, emails show. Gibbens told Envigo APHIS would strike the citation because the company ultimately provided the requested information.

Oct. 7, 2021 - APHIS director Robert Gibbens declines the request, citing “optics” and the risks of COVID-19 exposure. Oct. 25, 2021 – Three APHIS inspectors find 13 violations at Envigo, seven of which are “direct" or "critical." Nov. 16-19, 2021 - APHIS inspects Envigo and finds 26 violations, 14 of which are "direct" or "critical." Feb. 16, 2022 - Miller informs her staff that Goldentyer has removed her from working on any more Envigo inspections. March 8, 2022 - APHIS employees inspect Envigo and find five violations, two of which are “direct.”May 3, 2022 - APHIS inspects Envigo and only cite the company for failing to fix the dangerous flooring.

☆ Factbox: Elon Musk's missed deadlines for FDA approval of Neuralink brain-chip trials
▼ + stars: | 2023-03-02 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +1 min

March 2 (Reuters) - Several times since 2019, billionaire Elon Musk has predicted his brain-chip company, Neuralink, would soon secure FDA approval for human trials. But the company's application was rejected in early 2022, Neuralink staffers told Reuters, and the company is still working through the agency's concerns over the safety of the experimental implant. Here is a history of Musk's predictions of FDA clinical-trial approval:July 2019: Musk says Neuralink is aiming to receive regulatory approval for human trials of brain implants by the end of 2020. February 2021: Musk tweets: “Neuralink is working super hard to ensure implant safety & is in close communication with the FDA. Reporting by Rachael LevyOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks
▼ + stars: | 2023-03-02 | by ( Rachael Levy | Marisa Taylor | ) www.cnbc.com time to read: +19 min

Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device. "Everybody in the industry was saying: 'Oh my God, they're going to run straight into a brick wall,'" Ludwig said of Musk's bid for FDA approval. For example, NeuroPace, which makes the brain implant to treat epilepsy, received final FDA approval in 2013 – 16 years after the company's launch. Beyond grants, it provides access to government experts who advise on how to gain FDA approval and commercialize a device. Musk's emails to Neuralink staffers often come from his SpaceX address, said two people who reviewed them.

☆ Factbox: Neuralink, other brain-chip makers face long road to FDA approval
▼ + stars: | 2023-03-02 | by ( Marisa Taylor | ) www.reuters.com time to read: +2 min

March 2 (Reuters) - Neuralink, founded in 2016, has yet to receive FDA approval to test its brain chip in humans. It received U.S. approval for human testing in July 2021, five years after applying to the U.S. Food and Drug Administration (FDA). NEUROPACENeuroPace (NPCE.O), founded in 1997, didn’t secure FDA approval for its brain implant to treat epilepsy until 2013. BLACKROCK NEUROTECHBlackrock Neurotech, established in 2008, has tested its brain implant in humans for almost two decades. The company had hoped to secure approval to commercialize the implant from the FDA by last year but is still working on it, according to the company.

☆ U.S. investigating Elon Musk's Neuralink over hazardous pathogens
▼ + stars: | 2023-02-09 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +5 min

Feb 9 (Reuters) - The U.S. Department of Transportation said on Thursday it is investigating Elon Musk's brain-implant company Neuralink over the potentially illegal movement of hazardous pathogens. The Department of Transportation spokesperson said the agency took PCRM's allegations "very seriously." Reuters reviewed the UC Davis records cited by PCRM in its letter. Neuralink messages and records not shared with UC Davis are not subject to such information requests. A UC Davis spokesperson would only say that the university abides by all biohazard and lab safety regulations.

☆ Elon Musk's Neuralink may have illegally transported pathogens, animal advocates say
▼ + stars: | 2023-02-09 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +5 min

Reuters reviewed the UC Davis records cited by PCRM in its letter. PCRM obtained the records from UC Davis through public information requests. Neuralink messages and records not shared with UC Davis are not subject to such information requests. A UC Davis spokesperson would only say that the university abides by all biohazard and lab safety regulations. During its partnership with UC Davis, Neuralink grew frustrated with what it regarded as the slow pace of testing on primates, current and former company employees told Reuters, and has since built out extensive in-house animal testing facilities.

The agency did not respond to requests for comment on its record monitoring animal research experiments nationally. The USDA inspector general has published at least three reports since 2014 critical of the agency’s lax oversight, though its criticism dates back to the 1990s. Neuralink says on its website that it champions animal welfare and tries to reduce animal testing where possible. Two academic studies conducted in 2009 and 2012 found that animal research committees approved between 98% and 99% of experiments proposed by researchers. Envigo was made to sign the consent decree giving up the beagles only after the USDA inspector general and the Justice Department investigated and found evidence of inhumane treatment.

☆ U.S. lawmakers push for more oversight of Elon Musk's Neuralink
▼ + stars: | 2022-12-08 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +3 min

Dec 8 (Reuters) - U.S. House Representatives Earl Francis Blumenauer and Adam Schiff want further U.S. Department of Agriculture (USDA) scrutiny of Elon Musk's Neuralink following a Reuters report that outlined mistakes in the brain chip company's animal testing program, their offices said on Thursday. A USDA spokesperson said the agency could not comment on Neuralink and referred Reuters to the inspector general's office, which also declined to comment. In total, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, Reuters found. Blumenauer's and Schiff's offices declined to comment on what they want the USDA to do beyond the inspector general's investigation. Schiff has also been critical of Musk's $44 billion acquisition of Twitter Inc, accusing him of "sabotaging safeguards against digital misinformation and hate."

☆ Factbox: Neuralink: what you need to know about Elon Musk's brain chip company
▼ + stars: | 2022-12-07 | by ( ) www.reuters.com time to read: +3 min

Dec 7 (Reuters) - Neuralink, the Elon Musk company that Reuters reported on Monday is the target of a federal investigation over its animal trial program, has been trying to develop a brain chip that would enable the paralyzed to walk and the blind to see. In a presentation webcast last week, the company showcased improvements in the speed and capabilities of the chip. Neuralink has yet to secure U.S. regulatory approval to move to human trials - unlike competitor Synchron, which has less ambitious goals for its medical advances. Neuralink has missed Musk's publicly stated deadlines to start human trials and this year submitted its application to the Food and Drug Administration to begin them. Musk said last week he believes Neuralink can start human clinical trials in six months.

☆ Exclusive: Musk’s Neuralink faces federal probe, employee backlash over animal tests
▼ + stars: | 2022-12-05 | by ( Rachael Levy | Thomson Reuters | Award-Winning Journalist Covering Corporate Governance. Her Reporting Has Prompted Federal Investigations | ) www.reuters.com time to read: +16 min

Reuters could not determine the full scope of the federal investigation or whether it involved the same alleged problems with animal testing identified by employees in Reuters interviews. Musk has pushed hard to accelerate Neuralink’s progress, which depends heavily on animal testing, current and former employees said. Delcianna Winders, director of the Animal Law and Policy Institute at the Vermont Law and Graduate School, said it is “very unusual” for the USDA inspector general to investigate animal research facilities. In September, the company responded to employee concerns about its animal testing by holding a town hall to explain its processes. “We’re extremely careful,” he said, to make sure that testing is “confirmatory, not exploratory,” using animal testing as a last resort after trying other methods.

☆ Factbox: What does Elon Musk's brain chip company Neuralink do?
▼ + stars: | 2022-12-05 | by ( ) www.reuters.com time to read: +2 min

Neuralink has produced several examples of testing aspects of its technology successfully on animals, including a video in 2021 that showed a macaque playing a simple videogame after being implanted with a brain chip. In a presentation webcast last week, the company showcased improvements in the speed and capabilities of the chip. Neuralink has yet to secure U.S. regulatory approval to move to human trials - unlike competitor Synchron, which has less ambitious goals for its medical advances. Neuralink has missed Musk's publicly stated deadlines to start human trials and this year submitted its application to the Food and Drug Administration to begin them. Musk said last week he believes Neuralink can start human clinical trials in six months.

☆ Elon Musk says expects Neuralink to begin human trials in six months
▼ + stars: | 2022-12-01 | by ( ) www.reuters.com time to read: +2 min

Nov 30 (Reuters) - Elon Musk said on Wednesday a wireless device developed by his brain chip company Neuralink is expected to begin human clinical trials in six months. The company is developing brain chip interfaces that it says could enable disabled patients to move and communicate again. He then said at a conference in late 2021 that he hoped to start human trials this year. Neuralink has repeatedly missed internal deadlines to gain U.S. Food and Drug Administration (FDA) approval to start human trials, current and former employees have said. It received U.S. regulatory clearance for human trials in 2021 and has completed studies in four people in Australia.

At Fortune 100 companies, only 12 chief executives were women as of July 15, the same number as a year earlier, according to Heidrick. The Heidrick & Struggles also report showed 86 CEOs in the group were white, down slightly from 88 in the prior period. "If you want to accelerate the rate of the change in the C-suite, then it (diversity) has to be embedded in the succession plan," Taylor said. In a separate survey, Heidrick found record levels of board seats filled by first-time directors at 43%. Nearly half of the appointees last year were women, while 41% were racially or ethnically diverse, similar to rates in 2020.

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