What drove you towards the concept of micro-robots in medicine?
My journey into the realm of micro-robots began with my academic focus on robotics. Despite the industry's inclination towards larger, multi-armed medical robots, I found such developments counterintuitive. The real necessity, in my view, lies in minimizing the physical intrusion while maximizing functionality, hence my attraction to the concept of micro robots. This approach seemed radically different from the prevailing trends in medical robotics.
My "aha moment" came during my time in the U.S., working on a drug reformulation strategy project for a pharmaceutical client. It dawned on me that while many medical conditions are hyperlocalized, the prevailing drug delivery methods are systemic, affecting the entire body. This realization opened my eyes to the potential of micro robots not only for surgical interventions but for precise therapeutic deliveries as well, forming the core of Bionaut Labs' mission.
Why focus on the central nervous system (CNS at first)? What future applications for your products do you anticipate?
The CNS presents a unique set of challenges and opportunities that align with the capabilities of micro-robots: poor access due to the blood-brain barrier, inadequate standard of care for numerous conditions, and technical advantages related to the head's size facilitating magnetic propulsion. These reasons make the CNS an ideal starting point for our interventions.
Looking ahead, we have already begun exploring applications beyond the CNS, including in the liver and the eye. Our goal is to broadly apply our technology across various parts of the body, leveraging the initial success in the CNS to overcome technical and perceptual hurdles in medical practice.
The concept behind the Bionauts seems intuitive. Can you elaborate on the technology and explain why something similar has not been developed before?
Magnetic propulsion is at the heart of the Bionauts’ movement, a concept intuitive yet challenging to implement effectively. The innovation lies in creating a device small enough for safety yet capable of being controlled by relatively weak magnetic fields. This balance requires intricate design in terms of shape, materials, and magnetic field modulation. Additionally, the challenge extends to drug delivery; the micro robot must carry and release therapeutic agents efficiently. Our approach combines precise formulation and release mechanisms, ensuring effective treatment delivery within the constraints of a tiny device.
You have designed specific robots for specific diseases you target. What progress have you made towards FDA approval?
Bionaut Labs is advancing with two main clinical programs. The first targets Dandy-Walker malformation, aiming for an IDE submission to the FDA this year, in collaboration with the Mayo Clinic. This initiative is part of the early feasibility studies pathway, reflecting the device's novelty and significant medical need.
Our second program focuses on treating pediatric glioma in the brain stem, utilizing a drug-device combination strategy. We have received orphan drug designation for this approach, highlighting its promise for addressing unmet needs in glioma treatment. Additionally, we are exploring collaborations with pharmaceutical companies to extend our technology's application to complex CNS disorders, leveraging our unique ability to deliver treatments directly to the deep brain.
How did Bionaut Labs attract high-profile investors and partners like the Mayo Clinic and Gates Ventures so early in its journey?
Our foundation at Bionaut Labs was significantly strengthened by our previous entrepreneurial success with PrimeSense, which was acquired by Apple. This early achievement provided us with the credibility and access to high-tech investors, such as Upfront Ventures in Los Angeles and later, Khosla Ventures. Our ability to continually deliver on our promises transformed initial skepticism into solid support. Progressing from ex vivo proofs of concept to in vivo testing in both small and large animals, and establishing collaborations with top hospitals, demonstrated our commitment and capability, attracting further investment. Ultimately, the enthusiasm and support from physicians, hospitals, and the broader medical community underscore our potential and validate our approach, emphasizing the importance of our solutions to end users over the investors.
Looking ahead, where do you see Bionaut Labs in five years?
In five years, Bionaut Labs will hopefully be recognized as a pioneer and a major platform company in the field of remote-controlled micro-robots, potentially as a public entity or a substantial private organization. Our vision includes treating a wide array of conditions across various payload types, expanding beyond neuro-oncology to areas like neuro-regeneration, pain management, and epilepsy, while also exploring territories outside the CNS.
This expansion should be achieved not only through our internal programs but by significantly growing our collaboration with pharma partners. Our commitment to innovation and the potential revolutionary impact of our work is aimed at improving patient care on a global scale, making a significant mark in the medical field.