Neuralink and the Long Path to Approval

Sep 11, 2021 | Blog


Issue #64. Friday, September 11
Hello Everyone,

For the edition of the Zoic newsletter, we will be looking at a variety of topics, spanning from food allergies to gene therapy to a review of data and IP as well as an update on COVID-19 vaccine progress. We’ll be spending the first half on brain implants and therapy, spurred by Elon Musks’ Neuralink recently holding a press conference, which generated even more interest in the company and the field. This area has been featured several times in the newsletter before, and we’ll go into some of our thoughts and other comparable technologies.-Neal

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Healthcare and the Future Value of Real Estate
Special guests, John Milne and Andrew Haslam join the podcast to discuss healthcare and the future value of real estate and where it’s all going during the pandemonium caused by the COVID pandemic. Furthermore, they discuss the cannibalizing of retail by Amazon and Walmart as well as the future outlook for office space.

John Milne is an experienced healthcare executive and the first physician certified as a WELL AP by the International Well Building Institute, with a robust history of leading large scale strategic initiatives focused on new market growth, including the design, development, and implementation of new healthcare facilities with cultural integration of advanced technologies. As Senior Vice President for Real Estate Strategy and Operations at Providence, he’s accountable for the management of a $16 billion real estate portfolio, including 51 acute-care hospitals, across 8 western states.

Andrew Haslam is the Vice President, Real Estate Strategy at Providence. An accomplished healthcare executive with proven success in corporate strategy, real estate, construction, development, design, and planning oversight. Haslam is determined to create innovative care delivery models supported by wellness-focused built environment strategies.

Listen in on:
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Deal Flow News & Insights

Neuralink and the Long Path to Approval
Neuralink’s recent press conference featured the company’s prototype device gathering brain signal data from pigs. Some saw this as proof of the company’s progress, while others saw this as mere theater. It is certainly true that what was shown has been done before; electrical signals can be acquired from probes, either with older, larger technology, or more up to date ones that match the Neuralink ones’ size. The claims of the platform are certainly possible, such as being able to treat a variety of mental conditions such as epilepsy. However, it is an extremely long path to getting these indications approved. Even if the application is first for monitoring, the device would need to show several years worth of animal data, with a human trial and submission to the FDA, possibly through a 510k. Any treatment claims, as mentioned in the conference, would have to go through additional, and probably even longer regulatory approval times.
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However, even as Neuralink has probably the most notoriety, other companies are making strong progress in the same claim areas. A company recently received breakthrough designation for its brain-computer interface implant to address patients with paralysis. This implant shown strong promise in its initial application and may be used for other brain applications as well. The device also does not require open brain surgery, a great improvement over older implants.
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Another company is also further along than Neuralink. Neurapace recently raised an additional amount for its platform, which is also a brain implant system. This system has been shown in feasibility trials to reduce seizures and helping to treat epilepsy. Current probes are very poor in even finding the brain areas responsible for epilepsy, being left in sometimes without a surgical intervention due to the lack of good data. The Neurapace system could substantially advance care for epilepsy patients, especially for those that are resistant or non-responsive to pharmaceutical treatment.
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In other industries, we look at two seemingly quite different fields, food allergies, and gene therapy. However, these both could still be of interest to us. First, food allergies are actually another quickly growing industry, with a large acquisition recently in this space. This was particularly for therapies to treat food allergies, showing that the pharmaceutical industry is looking at this actively. However, food allergies can also be of strong interest in diagnostic technologies. A quick to result, easy to use and inexpensive device can be very useful for determining if a meal contains allergens, and also track the progress of prescribed therapies.
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Gene therapy is most probably a technology that requires a high degree of regulatory activity, thus making it not a match to one of our metrics. However, it is still a field to keep an eye on as it is also rapidly moving. It is a technology that is actually seeming to move beyond the hype cycle and seeing real-world results, in cases such as HIV or in cancer therapy. Thus, it may be possible, like with immunotherapy in general, for technologies to be acquired early on in their development, which may make it fit our time scale.
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IP News
We are also continuing to look at articles in a broader sense, both in general investment and industry trends as well as IP. For example, this article highlights the idea expressed by the Economist a few years ago that Data Is The New Oil. This is particularly true where consumer wellness applications and services are concerned. By contrast with medical health data, wellness devices, like Apple Watch, Fitbit, and others, are not regulated yet. The ability to generate valuable and uniquely relevant data can provide a portfolio company with a significant competitive advantage in using advanced Machine Learning algorithms. Zoic considers data a valuable IP asset. Therefore, our approach to IP includes analysis of various technology, business, and partnership strategies to ensure that wellness data stays private, secure, and commercially valuable.
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COVID-19 Vaccine
Finally. also in broader industry news, we are actively tracking the COVID-19 vaccine progress, along with many others. We have discussed vaccines in the past, even before the pandemic, and how they were an underserved field. Now, the advancements of vaccines can not only help with the pandemic but also with other infectious diseases and also immunotherapy. The development of vaccines is still a complex affair, though. In the past weeks, two leading COVID-19 vaccine developers announced major delays in their Phase III clinical trials. On September 8, AstraZeneca announced that it was pausing trials for its Oxford Vaccine because a participant had developed symptoms consistent with transverse myelitis, a rare but serious inflammation of the spinal cord caused by a viral infection. The Oxford Vaccine, a collaboration between AstraZeneca and the University of Oxford, relies on a weakened version of a chimpanzee virus to deliver COVID-19’s signature “spike protein” to the body’s cells, stimulating an immune response. It had been thought that humans would not become sickened by the chimpanzee virus itself. Now, some are questioning that assumption, although it is not yet known whether the participant’s illness is linked to the vaccine. Also, on September 4, Moderna Therapeutics announced that it was slowing enrollment in trials for what many had considered to be the leading COVID-19 vaccine candidate. According to Moderna, the delay stemmed from an attempt to recruit more candidates from ethnic minority groups. However, the stock sales by Moderna’s top executives might call that explanation into question. As NPR reported, company executives have sold $90M worth of stock since June 1, with certain selling decisions made immediately prior to public announcements on vaccine progress.
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What We’re Reading
The Adjacent User Theory
Private Equity Pipelines are Picking Up
AstraZeneca Covid-19 Vaccine Study Put on Hold
COVID-19’s Impact on Nonprofits

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