Neurotechnology: Breaking Barriers to Address Limitations of the Human Body

Brain-computer interface (BCI) has emerged as a potentially transformative, VC-backed frontier in medtech that is advancing into human clinical trials and gaining momentum. Following in the footsteps of interventional cardiology, technology and clinical innovation are coinciding to create this new opportunity, says BCI expert and Synchron founding CEO Thomas Oxley, and Synchron board director and former Dexcom CEO, Andrew Rasdal.

Brought into the spotlight by Neuralink, a company founded by Elon Musk that reported the first successful implant of its Telepathy device in a human brain in January 2024, the investigational-stage field of brain-computer interfaces (BCIs) holds the promise of restoring autonomy, agency, computer and mobile device control, and the ability to communicate to those who have experienced paralysis, among other high-need medical applications.

BCIs—technologies that can retrieve brain signals, process and translate them into commands to another device, as directed by the user either in wearable/non-invasive or implantable form—might sound like science fiction to some. And, the concept has been under academic evaluation for 20 years. But according to Oxley and Rasdal, BCIs are now a very real, rapidly evolving form of neuroprosthetic: a field combining neurosciences and biomedical engineering, to replace or modulate parts of the nervous system or brain function that get disrupted in neurological disorders or after injury.

During a fireside chat at the recent LSI USA ‘24 Emerging Medtech Summit in Dana Point, CA, moderated by Kimberly Ha, Founder and CEO of KKH Advisors, Thomas Oxley, CEO of BCI company, Synchron, and Board Director and former Dexcom CEO, Andrew Rasdal, explored the current state of this futuristic medtech space. They discussed Synchron’s endovascular approach and progress, its investor strategy, how interventional cardiology and Dexcom serve as role models, and what it will take to get these novel technologies onto the market to help improve patient quality of life. Along the way, they are also paving a new pathway for life-impacting interventional neurotechnology devices.

Synchron’s Pathway to
Restoring Patient Autonomy

For clinical-stage Synchron, which is developing a novel endovascular BCI designed to avoid the need for open brain surgery by using the natural vascular highways of the brain, its model is the interventional cardiology space. “If interventional cardiology could lead to such an explosion of technologies, not just in the mechanical domain with thrombectomy and stenting but in the electrical domain, with electrophysiology, mapping, ablation, pacing, defibrillation, and resynchronization, the brain is a much bigger electrical organ than the heart,” Oxley told the LSI audience. “It seemed obvious to me that that technology will eventually migrate over to the brain, in which case we’re going to see a renaissance revolution of interventional neuro approaches.” 

Synchron and the other BCI companies like Neuralink, BrainGate, Neurable and others are first targeting the unmet needs of not just patients with paralysis, but motor impairment. “Essentially, people who can’t use their hands to control digital devices, and interact with the world, restore independence,” explains Oxley.

Synchron is developing a novel endovascular BCI, Stentrode, designed to avoid the need for open brain surgery by using a minimally invasive procedure similar to the placement of stents, to restore functionality in patients with severe paralysis. Currently, these patients face enormous health challenges, social isolation, and complete dependency on others.

Following the FDA granting Breakthrough Device designation for Synchron’s BCI implant in 2020, the company received FDA approval in 2021 to test its device in humans. Its brain implant is designed to help patients with motor impairment or paralysis wirelessly control digital devices and replace the need for hand gestures to enable hands-free and voice-free screen selections. The novel self-expanding nitinol stent device, coated with a ceramic layer and an electronic circuit, is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein, through a minimally invasive endovascular procedure. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, intended to restore the capability for severely paralyzed people to control personal devices with hands-free point-andclick.

“The challenge for BCI is that you have to get close to the motor cortex, and traditionally, that would require a craniotomy,” says Oxley. “Our technology looks a lot like a cardiac pacemaker, with a stent placed in a vein, that is attached to a lead. We’ve leveraged a lot of the technology from pacemakers and stents, and put it all together. We didn’t want to reinvent the wheel. In totality, it’s a completely novel device, but in its modularity, it’s got a lot of predicates, which makes our journey through regulatory and reimbursement more navigable. I think that’s been very important for the FDA, because we can leverage the established safety profile for stents and leads. It’s also important to have multiple shots on goal for reimbursement.” 

The company has made impressive progress in just the last few months. In February, to ramp up the supply chain and production of its BCI to prepare for commercial demand, Synchron acquired an equity stake in Acquandas, a leading technology provider specializing in state-of-the-art high-precision components for healthcare and other industries.

In April, Synchron announced the launch of a BCI registry in preparation to recruit patients for an upcoming large-scale clinical trial required to seek commercial approval for its device. The trial will assess the impact of tasks such as texting, emailing, online shopping, and telehealth services. As of April, it had implanted its BCI implant in 10 patients, as part of an early feasibility study in the U.S. The company has also moved through a first-in-human study in Australia. They’re in conversations with FDA about what a pathway through clinical efficacy to approval looks like, with their goal being a PMA for a BCI for motor impairment. FDA is contemplating BCI as synonymous with neuroprostheses, and distinct from neuromodulation products, according to Oxley.

Then in July, a 64-year-old male with amyotrophic lateral sclerosis (ALS) in the U.S. became the first person in the world to use Apple Vision Pro via an implantable BCI, with Synchron’s technology. He’s able to use his direct thoughts to control the cursor on the Apple Vision Pro when playing Solitaire, watching Apple TV, and sending text messages. The company also announced the integration of generative AI, powered by OpenAI, into its BCI platform, in a new chat feature. Synchron will continue to assess state-of-the-art large language models (LLMs) that best suit the needs of its BCI users.

Synchron’s Secret to Attracting Investors

Synchron is backed by investors outside of traditional medtech, including Bill Gates and Jeff Bezos. Its latest funding oversubscribed $75 million Series C financing round in December 2022 was led by ARCH Venture Partners, with Gates Frontier, Bezos Expeditions, Reliance Digital Health Limited, Greenoaks, Alumni Ventures, Moore Strategic Ventures, and Project X join ARCH as new additional investors. Existing investors, including Khosla Ventures, NeuroTechnology Investors, METIS, Forepont Capital Partners, ID8 Investments, Shanda Group and University of Melbourne participated in the round. The Series C funding brought the total amount raised since inception to $145 million.

Although the industry appears to have “largely shaken off 2023’s malaise,” writes Norris, those companies still relying on “dwindling” insider cash “will need to find a new lead investor or else face consolidation or shutdown.” Moreover, since only about half of the unicorns formed during the pandemic investment bubble in 2020 and 2021 have come back to raise another round, valuations are still in the crosshairs and “the markdown hammer has yet to fully drop,” cautions SVB.

Although funding was up, investments in the first half split the start-up field clearly into two baskets: “the haves and the have nots,” according to SVB, with VCs “increasingly focused on quality over quantity.” Moreover, deals may take longer to put together, with many investors waiting to form solid syndicates before pulling the trigger, and checks may be smaller than anticipated. Although down rounds are not as common as in 2023, down or flat rounds are still sitting at “the highest level in recent decades,” the SVB report states.

So how did they bring in money from the likes of Gates and Bezos, along with medtech, academic, and other types of investors? Oxley explains that they told their story in different ways to different investor bases.

“There’s a data-enabled biotech story with what we’re doing,” he told the LSI audience. “The tech story is how does our technology converge with consumer technology. We’re using iPads to prove that our technology works, that’s what it looks like. It’s a medical device that controls an iPad. Then, we’re a medtech company, with the same reimbursement and regulatory risks that we have to burn down. For different audiences, we have slightly different talk tracks of where this will go in the future, and then different groups give different valuations for where things might go.”

Lessons from Rasdal’s Dexcom and Interventional Cardiology Journeys

Oxley explained that his team wanted to bring Rasdal aboard at Synchron because of his expertise in directing first-of-a-kind PMA products through to market, and as they saw similarities between the BCI tech they wanted to build and continuous glucose monitoring (CGM). “Both involved sensing technology, lifestyle modification, digital enablement, a digital app to engage with the technology, and no obvious reimbursement pathway,” says Oxley. 

As former CEO of diabetes device company Dexcom, Rasdal has decades of operational experience. He has delivered first-to-market products through the complex clinical, regulatory and reimbursement pathways, to commercialization of a CGM product, followed by a successful IPO, and reimbursement following seven years later. (Dexcom reported an impressive $3.62 billion in sales in 2023, up 24% from the previous year.) Rasdal’s CV includes senior roles as the cardiovascular space made its incredible transformation into the interventional era, at Medtronic Vascular, Arterial Vascular Engineering, EP Technologies, and Advanced Cardiovascular Systems.

Rasdal believes in Synchron’s mission to become the first implantable BCI to reach commercialization and help millions of people with paralysis and other health issues reconnect with the world. “For me, BCI unlocks independence for people who otherwise can’t live independently at all. Not just for them, but for the millions of people who care for them as well,” he told the LSI ’24 audience. “When I got to know that Synchron is developing more than just a product, it’s a platform technology that has the potential to create new markets, like what I saw happen in cardiology through balloon angioplasty, stents, and interventional electrophysiology. I saw that BCI can serve as a platform to further unlock the whole neuro arena.”

His experience fits well with the pioneering road that Synchron is on now. He offered the LSI audience his advice on what it takes to bring a novel concept successfully to market and impact patient lives, and how to best prepare.

“You need to build a great team that has a common unified vision, and keep solely focused on that,” Rasdal says. “Deliver on something that works, and I can’t emphasize enough that you do that by having a really strong foundation for your technology. Dexcom’s pathway included many product iterations, but its first iteration as a fully implantable device that a patient wears for one year to monitor glucose wasn’t adequate to grow the CGM market to what it is today. We learned our lessons, and based on our solid technology platform we made the decision to switch to a three-day, patient-delivered subcutaneous product with a first-of-itskind graphic display element. We went into humans successfully. Our platform is what enabled us to move very quickly, and we had a good team to move forward with that. The result of that decision put us in a position from a technological standpoint of being first. We also worked closely with FDA through the regulatory process, building strong trust and credibility, as the CGM product was a category that had never been approved by the agency.”

Having a fundamentally strong platform allowed that technology to evolve into more usable products, until today, it’s a standalone substitute to manage blood glucose, and a large market opportunity,” he told the LSI audience. And, he sees that same nimble, iterative philosophy being important for Synchron.

As Oxley and Rasdal concluded their fireside chat at LSI ’24, they described how BCI technology has captured the imagination of researchers, innovators, and patients around the world. In their view, a BCI implant placed non-surgically in close proximity to different areas of the brain has the potential to unlock so many huge unmet clinical needs. These include the difficult conditions of epilepsy, ALS, spinal cord injury, degenerative disease, and movement disorders like cerebral palsy and Parkinson’s disease. When a patient with motor impairment is able to make a selection on a screen independently, to communicate or perform a task, and restore agency for that patient, that is a very powerful reason why innovation into this high-potential frontier truly matters.

Thomas Oxley, MBBS, BMedSc, FRACP, PhD, is a vascular and interventional neurologist and world expert in brain computer interfaces. He is founding CEO of brain computer interface company Synchron, based in New York City. He is Professor of Medicine, University of Melbourne, Australia, as well as Clinical Instructor, Attending in the Department of Neurosurgery, Mount Sinai Hospital.

Dr. Oxley has performed over 1600 endovascular neurosurgical procedures, including cerebral aneurysm coiling and clot retrievals in acute stroke. He has published over 100 internationally peer reviewed articles in journals including Nature Biotechnology, Nature Biomedical Engineering, New England Journal of Medicine and The Lancet. He has over 120 patents filed, with about 50 granted.

Dr. Oxley has raised over $140M in private capital and grants. Synchron is developing implantable neurotechnology that utilizes the blood vessels as the natural highways into the brain. The first product is currently in human clinical trials: a brain computer interface to enable people with impaired upper limb function to control digital devices directly from the brain. Synchron represents the advent of implantable electronics into the field of neurointervention.

Mr. Rasdal brings more than 30 years of experience of developing and commercializing novel medical devices. As former CEO of Dexcom, Inc., he led the company through FDA approval, a successful IPO, and commercialization of its continuous glucose monitor product for diabetes. He currently serves as executive chairman of Epitel, a company that developed the first wearable, wireless electroencephalogram system to detect seizure conditions. As founding CEO of Obalon Therapeutics, Inc., he led the company through FDA PMA approval, an IPO, and commercialization of a novel product for obesity.

Before Dexcom, Mr. Rasdal was President of Medtronic Vascular. He also served as Vice President of Global Marketing at Arterial Vascular Engineering (AVE), Inc., which was purchased by Medtronic for $4.3 billion. Prior to AVE, he held positions at EP Technologies, which was acquired as a public company by Boston Scientific, and Advanced Cardiovascular Systems, which became the vascular division of Guidant and ultimately acquired by Abbott.

Mr. Rasdal holds a Master of Management from the Kellogg Graduate School of Management and a B.Sc. from San Jose State University.