It was my privilege to attend JP Morgan’s annual healthcare conference this week. I joined the three-day carousel of panel sessions, private meetings, press releases and networking events armed with five guiding questions about neurotechnology.
What will commercial success look like in 2024?
- Federal trust continues to grow: Neurotech companies doffed their caps to the FDA’s leadership across various centers, and commented on a welcome evolution from prior eras. In a track on business models, Christian Howell of Cognito Therapeutics spoke to numerous agencies’ willingness to work with companies early through a variety of programs (TCET, Breakthrough, NTAP, EPFP), as well as the overarching focus on relationship building, real world evidence, and continuous improvement.
- Business model innovation: On the same track, David Maltz of Intervalent and Jenny Rooke of Genoa Ventures discussed emerging business models for neurotech diagnostics, from data productization to direct reimbursement plays, to remote therapeutic monitoring. Butterfly Network announced FDA clearance of its handheld ultrasound. Is 2024 the year of tech-enabled care model innovation in outpatient neurology?
- Storytelling and fundraising : Dr. Tom Oxley of Synchron remarked on a fundraising panel how learning to toggle between storytelling to med tech versus biotech investors played a key role in closing their $75m Series C in 2022. In a later track, former TedMed COO Shirley Bergin stressed the importance of simplicity in storytelling. As investors become more familiar with this space, the tension between complexity and clarity in corporate messaging on clinical impact, regulatory navigation and reimbursement strategy will grow more important.
- AI hype and data thirst: Ultimately, reimbursement decisions require steady evidence building and data generation at all levels – business, product, clinical, economics. Andrei Georgescu of Vivodyne argued that for biotech companies to leverage AI, the bottleneck is quality, complex datasets. Data reuse came up in numerous panels; the majority of diagnostic workup happens without secondary use of data, from ultrasound to eye exams and beyond. Ekaterine Kortkhonjia of JnJ Innovation called for sensors and wearables that can accelerate efficiency in human research while providing clinical benefit and generating novel real-world evidence.
- Reputation-building phase: Parexel’s CEO Jim Anthony commented on how large clinical research organizations and pharma companies have been around for decades, compared to a few years or months for newer companies. He was speaking to diversity in trials and the pace of change, but I found it instructive for today’s neurotechnology leaders, for whom demonstrating responsible leadership to regulators, corporate partners, and the general public will be essential to advancing new medicines and devices to the stage of human trials and beyond.
- Neuromodulation heating up. This is what an established market segment looks like: Boston Scientific’s $3.7B purchase of Axonics, a sacral nerve neuromodulator for incontinence; Medtronic’s FDA approval for deep brain stimulation in Parkinson’s and epilepsy; Nalu Medical’s $65m round.
What is neurotech’s “killer app”?
- For JPM’s biotech attendees, a neurotechnology home run would be a reliable diagnostic test (like a set of biomarkers) for earlier detection of mild cognitive impairment and/or Alzheimer’s disease.
- On the consumer front, most neurotech companies jostled for the spotlight at CES amidst Apple’s VisionPro buzz. A VR in mental health panel moderated by Stanford’s Dr. Walter Greenleaf discussed the upside for wearables that translate brain electricity into something people can experience differently.
- Tarcan Kiper of Neo Auvra spoke of embedded and streamlined “neuropsychological and psychomotor assessments” that produce objective data in VR. Sarah Hill of Healium summed up the consumer appeal neatly: “You can actually see your feelings.”
- Mr. Maltz and Ms. Rooke spoke to the crossover potential and synergies between life science and wellness applications in areas like sleep, personal cognitive optimization, and mood.
What is neurotech’s impact in life sciences, via digital biomarkers and endpoints?
- Mr. Howell, citing a JPM survey of attendee interests, said the top two were GLP-1’s, “ a therapy looking for a disease,” and CNS (Central Nervous System) “a disease looking for therapies.”
- Pharma’s resurgent interest in Alzheimer’s dominated the conversation in brain health. With recent approvals, FDA has signaled their interest in a treatment for Alzheimer’s disease. With investor eyes on Eli Lilly’s new drug, it’s open season for interesting neurotech-enabled research plays for digital biomarkers of cognitive health. To wit, Startup Health announced a new Alzheimer’s Moonshot, launched with the Gates Foundation and the Alzheimer’s Drug Discovery Foundation.
- Brent Vaughan of Cognito Therapeutics and Michael Notaras of Decheng Capital compared neurology drug development today to where oncology was 50 years ago. Neurotech, by accelerating our understanding of neurodegenerative disease, and refining mechanisms of action to interact with human biological systems will usher in the era of precision neurology.
- David Suendermann-Oeft of Modality.AI spoke to the strategy working in large, prevalent diseases, versus more niche, or orphan diseases. Beth Hoffman of Origami Therapeutics contrasted oncology’s focus on destroying cells to neurology’s focus on preserving brain function. On a separate panel, Alex Morgan of Khosla Ventures said neurotech “is where cardiovascular disease was a couple decades ago.”
- Biologically, crossing or otherwise sidestepping the limits of the blood brain barrier came up repeatedly. Some discussion centered on bioelectronics ability to target specific areas of the brain, others about whole-brain simulation platforms to enable digital discovery. “It’s not mining, it’s prospecting,” noted a panelist. Another option is ultrasound, whose recent media coverage doubled as JPM news for Insighttec.
- At the system level, Marc Jones of Altoida pointed to healthcare deserts and innovation in outpatient neurology as key gaps to close. BIOS announced a precision medicine center in Bakersfield, CA. Ms. Kortkhonjia pointed out how sensors and wearables held potential to improve recruitment, monitoring, and efficiency of collecting real-world evidence outside of a lab or clinic. Rune Labs announced a $12m raise for their Apple Watch Parkinson’s app.
- In response to an investor question following a VR and mental health panel, Marc Edwards of ViewMind spoke about how eye-tracking features in headsets could potentially help detect placebo effects.
What is the future of neuroethics?
In today’s fast-paced, AI-driven world of change, determining and respecting boundaries when it comes to brain implants, cognitive alterations, human testing, access, privacy, safety, off-label use, and other related topics spans a critical but under-discussed subject in business circles. I tried to bring it up where I could.
When I asked Dr. Oxley, he asserted the FDA’s competence in protecting society, with leadership who have devoted their careers to neurotech-specific areas, stating their frameworks are “actually super rational and data-driven.”
At a UPenn forum on Neuroscience Innovation, Dr. Anna Wexler responded with examples of her work as a full-time neuroethicist. Citing her desire to move beyond pure academic frameworks, she shared examples of direct engagement with startups and corporate partners, collaboration with patient groups and product teams, and ultimately, her goal of finding new ways to scale efforts beyond one company at a time.
What do more people need to know about?
In short, neurotech and brain health go far beyond what’s locked inside our skull.
- Mr. Edwards was direct: Eyes are part of the brain, offering potential to develop ultra-fine-grain measurement of cognition. For many of us, up to 90% of information that goes into our brain goes in through the eye.
- Beth Rogozinski of Oncoustics spoke to the link between brain health and the microbiome, sharing that 90% of serotonin is produced in our gut.
- Abraham Heifets from Atomwise spoke about AI-enabled inflammation research, and how seemingly unrelated diseases, from psoriasis to IBD, to neuroinflammation and multiple sclerosis could hold biological similarities.
- Other discussions — spanning human longevity and aging, psychedelics, cannabis, genetics and epigenetics, pain and musculoskeletal disease, cardiac care, women’s health from fertility through menopause —invariably mentioned some connection to neurology, cognitive biomarkers, and the need for better brain health measurement and data collection.
- A new federal agency called ARPA-H took the stage to evangelize public-private partnership opportunities in biotech and health innovation. Modeled after DARPA, they offer accelerated funding and other commercial support through dedicated hubs for customer experience and private capital.
While there was a lot I saw, this recap is far from exhaustive, only capturing a swath of the pertinent developments and discussions about brain health at the conference this year. Despite that, one takeaway was clear: 2024 will be a busy year for neurotech.
