The Neurotech Revolution Goes to Washington!
Insights from Paradromics CEO Matt Angle on the Bioeconomy and Biomanufacturing White House Summit
Matt Angle, the founder and CEO of Paradromics, attended the White House Summit on Biotechnology and Biomanufacturing on September 14, 2022, along with about 100 other biotech representatives from industry and academia. The summit followed the signing of the White House’s biotechnology and biomanufacturing executive order and the bipartisan CHIPS & Science Act and builds on its vision for the future of technology innovation in the United States, especially advanced semiconductor and electronics manufacturing capabilities.
Paradromics is bringing to market the first high data-rate brain computer interface (BCI) for advanced medical applications (read: “Why We Invested in Paradromics”). The Connexus® Direct Data Interface collects neural signals from miniature arrays of microelectrodes (1600+) in the cortical brain. That data is transferred wirelessly through the skin to a computational system for interpretation. This direct access to neural signals enables the application of advanced digital technologies to create new therapies for neurological and brain-related conditions. The first clinical use is a BCI-enabled assistive communication device for severely speech-motor impaired patients to provide fully autonomous use of a computer to generate text or synthesized speech.
Because BCI, and neurotechnology more broadly, sits at the intersection of biology and digital technology, it also sits at the intersection of these biotech initiatives and the wider CHIPS Act. I recently talked with Matt to get his impressions of the summit and what these initiatives signal for the future of neurotech.
We were thrilled that you got invited to this White House summit. Why do you think that you were selected?
- I was equally thrilled to be invited! I saw my invitation as a recognition of the important role that neurotechnology will play in the growing bioeconomy.
Were there others in attendance from the neurotech or BCI community?
- Not this time, but I’m willing to bet that the next time this group assembles, you’ll see a robust neurotech presence.
The bioeconomy garnered a lot of attention in the press this past week, from the Executive Order (launching the National Biotechnology and Biomanufacturing Initiative) and the industry summit you attended. In addition to more widely covered topics, like biosecurity and synthetic biology, what key topics emerged for you?
- I was very impressed by the comments from Nina Tandon, CEO of EpiBone. (Link to video of Dr. Tandon’s comments)
- She spoke about issues related to platform technologies and how they get regulatory approval.
- Her company faces a discrepancy between how surgeons can use traditional bone grafts and the way the product is regulated. Surgeons have wide discretion to use bone grafts in any of the over 200 bones in the body, but the company is required to pursue separate regulatory approval for each individual bone. This indication-by-indication approach by the FDA creates an onerous burden for applying the technology widely. She described the situation as “platform technologies, patchwork regulation.”
- The field of BCI faces an analogous situation, where the same brain implant placed in different areas of the brain could treat different conditions, but expanding applications under the current regulatory framework would require indication-by-indication approvals. Neurotech more generally could also benefit from a regulatory mindset that is more geared toward platforms.
What is something else you learned that might not have received a lot of press?
- One common thread across industries is that the government is often one of the first customers for a new technology, and it can stimulate innovation not just through grants and tax breaks, but also through the procurement process. There were many points raised about how government customers can change their buying trends to support domestic biotechnology and biomanufacturing.
- There is an important analog here for neurotech. One of the biggest customers for medical devices is actually CMS (through Medicare coverage). Here too the government has an opportunity to adjust its policies to drive medical innovation by creating a clear path to coverage and reimbursement for innovative neural devices.
- I had a chance to speak to Secretary Becerra (Xavier Becerra, Secretary of the Department of Health and Human Services) about the importance of ensuring Medicare coverage for devices with FDA Breakthrough Device designation. Establishing a well-defined and efficient pathway to bring to market and obtain coverage for new treatments really is crucial to advancing the bioeconomy. For neurotechnology and BCI, many of these devices are first-in-class and address needs that are currently either insufficiently met or not addressed at all. These are truly breakthrough devices, and many Medicare patients could benefit from coverage of these treatments.
Thank you for representing the interests of the neurotechnology community; I know that you have the whole field in mind when you attend events like this. I think the neurotech community feels a deep sense of kinship with the larger synthetic biology community. John Cumbers (Founder and CEO of SynBioBeta) has been such an advocate for us, as evidenced by our main stage neurotech panel at SynBioBeta earlier this year.
What else inspired you at the Summit?
- Well, speaking of SynBioBeta, I was invited to their luncheon after the summit where I heard synthetic biology OGs like Jason Kelly (co-founder and CEO of Ginkgo Bioworks) recount the nascent days of the synthetic biology community. They had a collegiality around their shared belief in the transformative potential of synthetic biology and a shared struggle in convincing the world of its value and importance.
- While I listened, I really had that same feeling about our own neurotechnology community and the early industry leaders like Marcus Gerhardt (Blackrock Neurotech), Tom Oxley (Synchron), Carolina Aguilar (INBRAIN Neuroelectronics), Ben Rapoport (Precision Neuroscience), Andreas Forsland (Cognixion), Anna Maiques (Neuroelectrics), and so many others.
- It was really inspiring. Synthetic Biology is only a few years ahead of Neurotech, and look at what that field has become. In a few years, many of the companies now attending the BCI meetings will be unicorns, and lawmakers are going to be reaching out to better understand how to respond to and support the neurotech revolution.
Let’s talk about the CHIPS Act and biomanufacturing: How do you see neurotech fitting in?
- BCI is very interesting from a manufacturing and supply chain perspective. The next generation of BCIs involve traditional medical device manufacturing processes that resemble those used for neurostimulators, but they also involve more advanced microelectronics and microelectronic packaging. Additionally, many of them use new materials and processes to create the actual electrode interfaces.
- We know that the semiconductor and microfabrication supply chain is vulnerable. Securing domestic production was the main driver of CHIPS. The medical device supply chain is also somewhat vulnerable, as we saw during the ventilator crisis [early in the COVID-19 pandemic]. The industry is fragmented and is used to working in low volumes with long lead times. It could also use further investment.
- Moreover, some of the novel technologies and manufacturing processes from companies like Paradromics, Blackrock Neurotech, and Neuralink are 100% in-house and only exist within the company that developed them. Keeping these processes in-house for manufacturing at scale will require capital investment. It’s critical that this investment happens both from the company perspective and the national perspective. This is where most of the value is being created.
You were on my home turf. Did you have a great trip to DC?
- Yes! I stayed at my favorite DC hotel, the Tabard Inn, and the night before the summit, I walked to the Lincoln Memorial for inspiration.
One last and very important question: Did you get any White House swag?
- Yes. As it turns out, they had White House branded Hershey’s Kisses at the coffee station. As an aside, if you ever invite a bunch of people to an over three-hour summit that starts at 8 am, bagels or pastries are probably a stronger play than Hershey’s Kisses. Luckily, I grew up only a few miles outside of Hershey, Pennsylvania, and have acquired the taste, so they provided both an adequate meal substitute and souvenirs for the kids. Thanks, Joe!
I totally understand. I’m a sucker for the stevia packets with the Presidential Seal on them!
Matt, thanks again for representing the neurotechnology community in Washington. There are so many things to be excited about.
For those that want to hear more about Brain Computer Interfaces, and hear Matt and I crack some jokes — watch for the release of our upcoming podcast on SKRAPS, where we are joined by Marcus Gerhardt of Blackrock Neurotech. It’s not to be missed.
Prime Movers Lab invests in breakthrough scientific startups founded by Prime Movers, the inventors who transform billions of lives. We invest in companies reinventing energy, transportation, infrastructure, manufacturing, human augmentation, and agriculture.
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