Microrobot system is designed to float inside stroke patient for autonomous thrombectomy

Expanding care to stroke victims is one of medtech’s biggest opportunities, and startup Artedrone is developing a microrobot system that can navigate to blood clots for autonomous mechanical thrombectomies.

Backed by Truffle Capital, Artedrone has submitted findings from its preclinical program for publication in an unnamed research journal as it continues testing to lock in the Sasha system’s design for its first-in-human procedure sometime in 2027.

The Paris-based startup is trying to raise a €20 million ($22.5 million U.S.) Series B funding round to finalize that preclinical work and fund the first-in-human studies, with a Series C round following to finance a pivotal study by 2028.

“An idea behind the company is to democratize these very complex procedures,” Artedrone CEO Liane Teplitsky, former head of global robotics at Zimmer Biomet, told Medical Design & Outsourcing.

Sasha system creates medical digital twin

The Sasha system is designed to use MRI or CT imaging — the same scans that can locate and confirm a blood clot in a stroke victim — to create a digital twin of the brain vasculature to chart a path for the catheter to reach and remove the clot.

At a cath lab or interventional neuroradiology lab, an interventionist would insert the catheter in the patient’s groin and up to their carotid artery.

“That’s the base camp,” Teplitsky said. “After that, you push a button and the robot is let out. It’s propelled by the blood flow — it’s not active in that way — until there’s a bifurcation, like a fork in the road.”

“We’ve already pre-planned, we know exactly where we want to go, and that’s where our external magnet comes in,” she added. “It pushes or pulls the magnet [on the catheter] in the right direction, and then it continues along that pathway as we let out a little bit more line automatically to the next spot. If there’s another bifurcation, we use the magnet again.”

Artedrone uses magnets to address clots

The blood slows as the catheter nears the clot that’s blocking the vessel, at which point the magnet positions the distal end of the catheter to grab the clot.

“It acts as suction like an aspiration catheter, but you see very different properties than a normal aspiration catheter,” said Teplitsky, who described it as a magnetic suction cup. “You turn on the suction and we have a feedback loop that tells us whether we’re really adhered [to the clot before] we start pulling back.”

The line is engineered to be flexible enough to navigate to the clot, but strong enough to grab and remove it, withdrawing back into the guiding catheter and out of the patient by the operator at the table.

“You basically push a button and it pulls it back through the vasculature,” she said. “[Like] an aspiration catheter, there’s always the risk of the clot breaking up as you pull back, but the bottom line is we’ve got the base camp catheter as close as we think we can get to it to be able to pull it back. … We have some pretty good results showing that it’s very effective.”

Teplitsky declined to divulge the system’s materials for competitive reasons. In a statement, Artedrone said the microrobot’s magnetic suction cup “exhibits at the same time the appropriate magnetic properties for the magnetic actuation and the appropriate design to optimize the interaction with the clot.”

“The cup is connected to an innovative section with antagonist properties such as a high flexibility and a low strain,” the company said. “This section is connected to a multilayer structure with the appropriate properties for pushing.”

Challenges ahead for Artedrone

“We want to get to Level II stroke centers, maybe even cardiac care centers where you have hands that are expert in getting into the carotid, and then after that they don’t have to get to that brain vasculature, which takes another two to seven years of training depends on who you talk to and what country you’re in,” Teplitsky said.

“One of the biggest challenges and opportunities is that we know the interventional neuroradiologist will certainly have to be involved, but our long-term play is going to be in these Level II stroke centers, potentially with the interventional cardiologist as one of the leads,” she continued. “So, how do we figure out the best way forward for our first in-human — which centers we want to go to, who do we want to partner with, and what does that look like — and really map that out with the risk-benefit for the patients?”

Locking in the system’s design, finalizing development and building documentation for regulatory review is “a relatively straightforward path at this point,” Teplitsky said, with FDA 510(k) clearance the likeliest route.

Their test equipment has so far included 3D models of pig and human anatomy with accurate vasculature, blood pressures, viscosity, and temperature.

“I keep talking with my team about creating some IP around this test bench, because it’s been just about as much work as actually the product at this point,” she said. “We’ve learned some great lessons from that. Now we have a really robust in vitro model that translates to the in vivo model, so you can go in and feel very confident as you move from one to the next.”

But there are two big remaining challenges that are common for medtech developers working with robotics.

“One is make sure that it’s really meeting a need, and I feel we’ve done this,” she said. “We know what we’re trying to do. There’s a huge need out there. People will be willing to pay for it because there’s this huge burden and huge costs associated with stroke, the third-leading cause of long-term disability in the world. The second [challenge] is ease of use. … Because of the user population that we want to go to, it really needs to be straightforward.”

The technology could end up being useful for other neurovascular procedures or in endovascular or cardiovascular applications.

“There’s definitely opportunity as we look at the whole system, not only the catheter component, but what we’re doing around imaging, AI, catheter delivery,” she said. “All those different components could definitely be applied to different places.”

Editor’s note: This article was syndicated from The Robot Report sibling site Medical Design & Outsourcing.