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Doctors take a microscopic vehicle loaded with cancer-causing chemicals, inject it into the human body, and drive it to a malignant tumor to deliver its payload before quickly disembarking.
For most of the 55 years since Fantastic Voyage scaled Raquel Welch and his company to the size of a cell to remove a blood clot from a scientist’s brain, that scenario has been pure science fiction.
However, Bionaut Labs, a remote-controlled medical microrobot start-up, intends to be the first to turn this into clinical reality.
The Culver City, Calif., Company is developing a breadcrumb-sized device that doctors can insert into the spine or skull and magnetically steer toward a goal to deliver an accurate dose of medication. Clinical studies are to be carried out by 2023.
Michael Shpigelmacher, CEO of Bionaut, said he and his co-founder Aviad Maizels founded the company in 2016 to address a fundamental problem in modern medicine: getting a drug in the right dose to the right place.
Most drug deliveries these days are based on diffusion through the bloodstream, which requires large doses to ensure enough active ingredients reach their destination – and often means hit the rest of the body at the same time. “It’s very statistical and not precise,” said Shpigelmacher. “We just wanted to find a way to get there,” the problem area, “instead of flooding a body with therapeutics.”
Shpigelmacher and Maizels worked together in the mid-2000s at PrimeSense, a 3-D sensor start-up that built the Xbox Kinect before it was acquired by Apple in 2013, and stayed in touch as their mutual interest in the emerging field of the world began medical microrobots increased. They focused on research from the Max Planck Institute for Intelligent Systems in Stuttgart and turned to the lab director, a scientist named Peer Fischer, to work together on something they could bring to market.
Fischer became Bionaut’s chief scientific advisor, and the company began funding his research before raising multiple rounds of venture capital from Upfront Ventures, Khosla Ventures and Revolution, among others, to hire a small team and test the technology on live animals at the Culver city office . After four years, says Shpigelmacher, the company will be ready to refine its technology and prepare for experiments on humans.
Bionaut is targeting brainstem glioma, a type of cancer that primarily affects children and young adults, as the first step in proving its technology. Brain tumors are particularly difficult to treat with current technology: radiation and surgery can damage sensitive tissue too much, and the blood-brain barrier prevents most chemotherapy drugs from reaching the tumor. The ability to deliver drugs directly into the tumor itself would be a major advancement.
This is how it works: A doctor inserts a handful of Bionaut devices through a catheter into the spine. Each device is large enough to be clearly visible on a live x-ray. Manufacturing technology exists to make the devices even smaller, but Bionaut chose to keep them close to the millimeter scale to make them less difficult to track and maneuver through the body.
A set of magnets positioned around the head and neck create an external magnetic field that the doctor can control to push the devices up the spine and into the affected area of the brain stem. Once in the correct position, another magnetic signal activates a tiny piston in the hold of each device and expels the drug. Then the doctor can drive the devices back to where they entered the spine and remove them.
Research into the science underlying Bionaut’s technology began decades ago, but has accelerated in recent years.
“There are articles from the ’80s where a person takes a large screw – I’m literally talking about a large screw that you put in your wall – and magnetically controls it to move through a piece of steak,” Shpigelmacher said . “That wasn’t certain, but the concept was there.”
Now the field of precision manufacturing is so advanced that tiny medical devices can be mass produced through a network of suppliers in a similar way to other consumer electronics products. “It’s important that we don’t reinvent the wheel here,” noted Shpigelmacher.
Jinxing Li, an assistant professor of biomedical engineering at Michigan State University who studies medical microrobotics, described Fischer’s team at Max Planck as “one of the pioneers of technology”. Li said he anticipates Bionaut will have a number of new competitors in the coming years as microrobots are used in more and more medical procedures.
Marc Miskin, an assistant professor of electrical engineering at the University of Pennsylvania who works on nanorobots, said the nervous system is particularly well suited to microrobotic interventions. “I would give them a lot of credit for finding a space where they can make a difference and justify how competitive they will be with traditional pharmaceutical approaches,” he said.
Some minimally invasive brain surgery techniques already rely on snaking slender endoscopes and surgical instruments through the spine to reach the skull. “Getting rid of the cable is a great idea,” Miskin said when you can pull it off. “You should definitely do it.”
Bionaut also works with outside researchers trying to develop a pharmacological treatment for Huntington’s disease that affects a number of neurons buried deep in the brain called the basal ganglia. The Bionaut system would not only allow surgeons to avoid cutting open the skull to reach the target area, it could also allow them to use less harmful approach angles through the gray matter that would be impossible without a wireless instrument. “We’re physically relieving them of the straightforward requirements they have to meet today,” said Shpigelmacher.
The next hurdle for Bionaut is the clinical study process. While medical devices usually go through an optimized approval process, the combination of the new technology with drug delivery from Bionaut means that the full regime of food and drug administration must be passed through. The majority of the new drugs to be approved by the FDA fail this way. According to a recent study by MIT, success rates vary widely, depending on the application, from 33% for new vaccines against infectious diseases to only 3.4% for experimental cancer drugs.
In part, Bionaut targets brainstem gliomas first to increase those chances. “It’s a rare disease, there is currently no cure, and it provides proven and approved chemo payloads that kill tumor cells,” said Kevin Zhang, partner at Upfront Ventures, who led the fund’s investment in Bionaut. Treatments that target rare diseases can apply to the FDA for “orphan” status, which offers tax benefits and streamlines the regulatory process. “The best way to improve your chances other than having a good solution,” said Zhang, “is to choose the right problem to solve with high unmet needs.”
As glioma treatment moves into clinical trials, there are plans to expand the technology to other central nervous system disorders and other areas that are difficult to reach with drugs, such as: B. in the eye. Moving into the rest of the body is further out on the horizon.
The first step, however, is to put serious money into the approach to get it out of the lab and into the operating room. When Shpigelmacher first approached investors about the idea of becoming a Bionaut, most pushed back, urging him to wait for academic researchers to refine the science. For Shpigelmacher, commercialization was the way “to get to patients earlier than otherwise would have been the case,” he said. “Not at the pace of science.”
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