Introducing 4D Surgical

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We are in a golden age of brain science. There are new gene therapies, cell therapies, and brain-computer interfaces that could slow dementia, quiet epilepsy, restore function lost to stroke or injury, and keep us sharp and thinking well for decades longer. But the brain is the hardest organ in the body to reach. Most therapies cannot get where they need to go. You can’t fix what you can’t see or reach, and right now there’s no easy, precise, and scalable way to access the living brain.

4D Surgical’s mission is to make accessing, interfacing with, and repairing the brain safe and easy to perform at scale. We are creating universal physical access to the brain so that drugs, cells, gene therapies, electrodes, and treatment devices can reach their intended target.

Background

The human brain is composed of billions of neurons that define our existence, memories, consciousness, and health. Protective mechanisms both external (skull) and internal (blood-brain barrier) have evolved to keep the brain safe.¹ However, this “walling off” limits our ability in modern times to treat and heal the brain. More than three billion people live with a neurological condition.^2,3 These conditions are the leading cause of illness and disability worldwide.^2,3 To treat these conditions, we need a way to safely bypass the brain’s protective measures.

Gene^4,5 and cell therapies,^6,7 when injected into a specific location in the brain, have enabled miraculous, life changing cures. Fibers of light, if delivered to precise locations in the brain, can treat epilepsy or destroy tumors.^8,9

Brain-computer interfaces (BCIs) implanted in or placed on the surface of the central nervous system have been used to restore lost motor function,¹⁰ speech,¹¹ and central vision.¹² The use of high channel count BCI is just in its infancy. Our emotions, memories, vision relays, and other rich data highways lie deep beneath the brain’s surface. We believe that universal image-guided physical access to these deep regions, and not just the surface of the brain, is critical to unlocking the full potential of this burgeoning field.

In light of these transformative biotech and device advancements, humanity now stands on the threshold of being able to interface with the mind and alleviate brain conditions once deemed impossible to treat. However, our inability to quickly and precisely access the brain remains a critical challenge.

The Bottleneck

Today, it takes some of the most specialized and highly trained neurosurgeons more than 12 hours to deliver a gene therapy to the deep brain for Huntington’s disease (a fatal neurodegenerative disease).³ Access to the deep brain has changed little over the last 50 years and still relies on invasive open surgery or manual stereotactic techniques. These artisanal surgical approaches, and the limited number of surgeons skilled in the art, cannot scale to help treat the millions of patients in need.

Delivering a gene therapy to stave off dementia or administering a cell therapy for stroke rehabilitation should not require a full day in the operating room with a world-renowned neurosurgeon. We believe treatments should be more akin to a one-time outpatient visit to an infusion center: fast, easy, safe, and accessible to all in need.

The Need Is Now

The need for scalable brain access is not a future that is 10 years away. Transformative, disease-modifying therapies are coming online and the existing healthcare infrastructure is not ready to meet the demand.

The FDA recently approved a life-changing therapy for AADC deficiency that requires a brain surgery to deliver a gene therapy directly to the brain.⁵ Cell therapies for Parkinson’s and epilepsy that require surgical implantation into the brain are moving to their pivotal trials after very promising clinical results.^5,13 A treatment for Huntington’s disease, is under accelerated review at the FDA and could be on the market within 6 months.¹⁴

Millions of patients are currently affected by these four indications alone. Surgical delivery of gene and cell therapies currently takes a small pool of elite neurosurgeons 8-12+ hours to perform for each patient. The aging of the neurosurgeon population (median age 55),¹⁵ projected surgeon shortages over the coming decade,¹⁶ and the more than 10 years required to train new neurosurgeons together represent a supply curve moving opposite to demand.

We need a delivery approach that takes a couple of hours, not a day. We need an approach that doesn’t depend on one of the few hundred practicing stereotactic neurosurgeons to deliver safely and effectively. We need to leverage real-time data and autonomous systems to extend what surgeons can do by handling the tasks that are hard or tedious for humans. And we need a procedure that’s standardized and easy to perform, so any neurosurgeon or qualified health care professional can deliver these therapies precisely and with confidence.

4D Surgical’s Approach to Universal Brain Access

The solution starts with complete visualization of the living brain in a way that doesn’t harm it.

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MRI provides that way in. It can image the structure and function of the living brain in 3D. It does not use ionizing radiation and there are no adverse effects caused by repeated and continuous imaging.

In addition to sight, we need precise and repeatable access to the brain tissue itself in a way that is scalable and does not introduce user variability. This is where high-precision robotics is the key.

4D Surgical is combining these two foundational technologies to establish a universal brain access platform that doesn’t require new science to realize. This choice is by design, so that we can help patients as fast as possible by leveraging the best medical imaging technology available today and the novel robotic solutions developed at 4D Surgical.

We are building a robotic treatment platform that works inside the MRI and uses real-time imaging to guide therapies to exactly where they are needed. This unlocks a faster and universal way of delivering advanced neurotherapies to the brain. Combining live 3D data streams with precision robotics will also unlock autonomous delivery steps to enhance the surgeon’s capabilities and enable a new healthcare delivery platform.

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If you are developing novel therapies, brain biotech, or treatment devices that need precise and more automated delivery to the brain, please reach out.

If you are conducting preclinical studies and are interested in utilizing the 4D Surgical platform, or are a healthcare professional interested in learning about future capabilities of the platform, please don’t hesitate to reach out.

If you are interested in working at 4D Surgical, please see our current openings here.