The roboticist Michael Shpigelmacher was one of the founders of PrimeSense, a robotic 3-D vision technology company Apple acquired in 2013.

PrimeSense created technology empowering the Microsoft Xbox Kinect and the iPhone’s Face ID feature, allowing users to use facial recognition to unlock their phones. 

Now Shpigelmacher has set his sights on drug-delivery with Bionaut Labs, a startup aiming to use tiny robots for precision drug dosing. Bionaut recently won $20 million in venture capital funding. 

Microrobots for the central nervous system

Bionaut Labs traces its history back to an observation Shpigelmacher while working for a large consulting firm after the sale of PrimeSense. It seemed strange that many drugs focused on a small region of the body, but the drug delivery mechanism relied on systemic dosing. “There was the ‘aha’ moment,” he recalled. He mulled whether he could “build something for precise anatomical targeting.”

Shpigelmacher reached out to a business partner, Aviad Maizels, with the idea to explore the intersection between miniature robotics and medicine. 

They ended up discovering and licensing research from the Max Planck Institute that uses microrobots for drug delivery. The concept harkens back to the 1966 film Fantastic Voyage, in which a miniaturized submarine travels in the body of an injured scientist to repair brain damage. “So I think for us, the analogy is almost perfect,” Shpigelmacher said. 

But instead of a miniaturized submarine, Bionaut Labs’ devices, which they term ‘bionauts,’ look something like tiny screws. The smaller microrobots are hundreds of nanometers in size while the largest measure in the millimeter range. “It’s a tiny object that is rigid and has a magnetic component, so an externally applied magnetic field generates forces and torques on the device, thereby moving it,” Shpigelmacher said. 

The bionauts travel through the central nervous system with the help of fluoroscopy. “We steer it to the target in the body and have a remote-controlled magnetic trigger to release the payload,” Shpigelmacher said. The screw-like shape is helpful when traveling through dense tissue. 

Dosing questions

“We know that a single Bionaut can carry a dosage that is relevant for the treatment of a clinically representative glioma tumor,” Shpigelmacher added. By steering the bionaut to a specific site in the body, you don’t get systemic waste,” he said. “You can get therapeutic effects with volumes in the single microliter range.”

Once the tiny craft has delivered a drug to a targeted site in the body, it can be retracted using a magnet — similar to picking up a screw with a magnetic screwdriver.

As for the types of drugs that a bionaut can deploy, there are several possibilities, but the dosing for experimental therapies including biologics, oncolytic viruses and cell therapy agents is not well-validated. “The science is open as to what the right dosage will be. We believe that we can play a big role in that exploration,” Shpigelmacher said.

The company is now in discussions with several pharma companies to discuss the potential of Bionauts compared with systemic or intrathecal injection.

Regulatory strategy relies on a platform approach

In terms of the regulatory strategy, the company plans to get FDA approval for the robotic platform, which can then extend to different therapeutic areas. “It is going to be a drug-device combination with the robotic component as an enabler for the drug,” Shpigelmacher said.

With its technology already tested in animals. Bionaut Labs is targeted to have human clinical trials by 2023. 

The company is first aiming to win approval for generic chemotherapy for the treatment of brainstem glioma. Getting approval for a single drug-device combination project should simplify regulatory matters in the long run. “It’s not going to be a 510(k) initially because there are no predicate devices for remote-controlled microrobots. But later on, there will be 510(k)’s from our own device,” Shpigelmacher said. 

Bionaut Labs also acknowledges that it will need to win over the medical community. “I’m acutely aware of the fact that many people view our technology as very unusual. Some people use the phrase ‘science fiction’ to describe our technology,” Shpigelmacher said. 

But the unmet needs in neurology could increase palatability for next-generation technology. “The standard of care for many CNS diseases is poor with some exceptions,” Shpigelmacher said. “We wanted to build one tool that solves many problems rather than necessarily building separate solutions for individual problems.” 

When asked why the company sought VC funding to accelerate research from the Max Planck Institute, Shpigelmacher said that the VC cash could enable the technology to be commercialized 10 years sooner than if it followed a purely academic path. “And it’s not just a return on investment question — it’s actually the lives of patients,” he concluded.