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

The veil is starting to lift on medical robotics startup Mendaera Inc. as it exits stealth mode and heads toward regulatory submission with a design freeze on its first system and verification and validation imminent.

Two former Auris Health leaders co-founded the San Mateo, Calif.-based company. Mendaera also has financial support from Dr. Fred Moll, the Auris and Intuitive Surgical co-founder who is known as “the father of robotic surgery.”

“Among the innovators in the field, Mendaera’s efforts to make robotics commonplace earlier in the healthcare continuum are unique and can potentially change the future of care delivery,” stated Moll in a release.

But Mendaera isn’t a surgical robotics developer. Instead, it said it is working on technology that combines robotics, artificial intelligence, and real-time imaging in a compact device “no bigger than your fist” for procedures including percutaneous instruments.

Mendaera co-founder and CEO Josh DeFonzo. | Source: Mendaera

Josh DeFonzo, co-founder and CEO of Mendaera, offered new details about his startup’s technology and goals in an exclusive interview, as he announced the acquisition of operating room telepresence technology that Avail Medsystems developed.

Avail, which shut down last year, was founded by former Intuitive Surgical and Shockwave Medical leader Daniel Hawkins, who’s now CEO at MRI automation software startup Vista.ai. 

“We’re a very different form factor of robot that focuses on what I’ll describe as gateway procedures,” DeFonzo said. “It’s a different category of robots that we don’t believe the market has seen before [as] we’re designing and developing it.”

Those procedures include vascular access for delivery of devices or therapeutic agents; access to organs for surgical or diagnostics purposes; and pain management procedures such as regional anesthesia, neuraxial blocks, and chronic pain management. DeFonzo declined to go into much detail about specific procedures because the product is still in the development stage.

“The procedures that we are going after are those procedures that involve essentially a needle or a needle-like device and real-time imaging, and as such, there are specific procedures that we think the technology will perform very well at,” he said. “However, the technology is also designed to be able to address any suite of procedures that use those two common denominators: real-time imaging and a percutaneous instrument.”

“And the reason that’s an important point to make is that oftentimes, when you are a specialist who performs these procedures, you don’t perform just one,” added DeFonzo. “You perform a number of procedures: central venous catheters [CVCs], peripherally inserted central catheter [PICC] lines, regional anesthetic blocks that are in the interscalene area or axial blocks. The technology is really designed to enable specialists — of whom there are many — the ability to perform these procedures more consistently with a dramatically lower learning curve.”

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Mendaera marks progress to date

Preclinical testing has shown the technology has improved accuracy and efficiency in comparison with freehand techniques, regardless of the individual’s skill level, asserted DeFonzo. User research spanned around 1,000 different healthcare providers ranging from emergency medicine and interventional radiology to licensed medical doctors, nurse practitioners, and physician’s assistants.

“It seems to be very stable across user types,” he said. “So whether somebody is a novice, of intermediate skill level, or advanced, the robot is a great leveler in terms of being able to provide consistent outcomes.”

“Whereas when you look at the same techniques performed freehand, the data generally tracks with what you would expect: lesser skilled people are less accurate; more experienced people are more accurate,” DeFonzo noted. “But even in that most skilled category, we do find that the robot makes a fairly remarkable improvement on accuracy and timeliness of intervention.”

Last year, the startup expanded into a production facility to accommodate growth and volume manufacturing for the product’s launch and said its system will be powered by handheld ultrasound developer Butterfly Network’s Ultrasound-on-Chip technology.

Butterfly Network won FDA clearance in 2017 for the Butterfly iQ for iPhone. | Source: Butterfly Network

Mendaera’s aim is to eventually deploy these systems “to the absolute edge of healthcare,” starting with hospitals, ambulatory surgical centers and other procedural settings, said DeFonzo. The company will then push to alternative care sites and primary care clinics as evidence builds to support the technology.

“The entire mission for the company is to ensure essentially that high-quality intervention is afforded to every patient at every care center at every encounter,” he said. “We want to be able to push that as far to the edge of healthcare as possible, and that’s certainly something we aim to do over time, but it’s not our starting point explicitly.”

“As a practical starting point, however, we do see ourselves working in the operating room, in the interventional radiology suite, and likely in cath labs to facilitate these gateway procedures, the access that is afforded adjacent to a larger intervention,” DeFonzo acknowledged.

Mendaera said it expects to submit its system to the U.S. Food and Drug Administration for review through the 510(k) pathway by the end of 2024 with the goal of offering the product clinically in 2025.

“What we really want to do with this technology is make sure that we’re leveraging not just technological trends, but really important forces in the space — robotics, imaging and AI — to dramatically improve access to care,” said DeFonzo. “Whether you’re talking about something as basic as a vascular access procedure or something as complex as transplant surgery or neurosurgery, we need to leverage technology to improve patient experience.”

“We need to leverage technology to help hospitals become more financially sustainable, ultimately improving the healthcare system as we do it,” he said. “So our vision was to utilize technology to provide solutions that aggregate across many millions, if not tens and hundreds of millions, of procedures to make a ubiquitous technology that really helps benefit our healthcare system.”

Mendaera’s research and development group will work with employees from Avail on how to best add the telepresence technology to the mix.

“We see a lot of power in what the Avail team has built,” DeFonzo said. “Bringing that alongside robotic technology, our imaging partnerships and AI, we think that we’ve got a really good opportunity to digitize to a further extent not only expertise in the form of the robot, but [also] clinical judgment, like how do you ensure that the right clinician and his or her input is present ahead of technologies like artificial intelligence that hopefully augment all users in an even more scalable way.”

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Intuitive Surgical’s da Vinci 5 is the device developer’s fifth-generation surgical robotics system. | Source: Intuitive Surgical

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

Intuitive Surgical’s da Vinci 5 has more than 150 design enhancements and innovations since the surgical robotics developer’s fourth-generation systems, including one feature that an Intuitive leader described as “groundbreaking.”

“Da Vinci 5 looks similar to [multiport predecessor da Vinci] Xi,” Intuitive President Dave Rosa said in a discussion of the upgrades and enhancements. “It built on Xi’s highly functional design, which has been used around the world in more than 7 million procedures.”

Rosa discussed da Vinci 5’s design along with Intuitive CEO Gary Guthart and Chief Medical Officer Dr. Myriam Curet.

“Da Vinci 5 takes surgical precision to a new level,” Rosa said. “The system is designed with next-generation surgeon controllers and patient-side manipulators with additional sensors. This combination translates to super-smooth, low-resistance and highly precise motion at both slow and high speeds. Unwanted tremor and vibration filtration is the best we’ve ever brought to market.”

The da Vinci 5’s 3D surgical imaging system is the “highest quality and most natural” ever developed by Intuitive, he said, and has additional capability for future generations of surgical endoscopes and vision software.

From a computing power standpoint, da Vinci 5 has 10,000 times more than the fourth-generation Xi system for integration with the My Intuitive app, Intuitive Hub video platform, SimNow virtual reality simulator and Case Insights, which lets surgeons review their surgeries with objective performance indicators and video of critical steps.

The extra computing power could support future features and integration such as better integration of preoperative images as Intuitive brings those into the surgical field, Rosa said.

“It sets us up for our innovation teams internally to make a lot of progress over the coming years,” he said.

Intuitive’s ‘groundbreaking’ Force Feedback tech

Curet described Intuitive’s new Force Feedback technology on the da Vinci 5 as “groundbreaking for robotic surgery.” The system measures subtle forces exerted on tissue during surgery and relays that feeling back to surgeons, a feature that the device developer says is unique to the da Vinci 5 system.

“In preclinical testing, surgeons who used the Force Feedback feedback instruments on da Vinci 5 exerted significantly less force on tissue, which could translate into less tissue trauma during surgery when compared to da Vinci Xi,” she said. “With our customers, we intend to study how this could translate to real-world clinical and patient-reported outcomes as surgeons of all experience levels use this technology in a broad range of procedures.”

“We believe that the ability to measure force during robotic surgery adds an important new data stream to surgical data science,” Curet continued. “Our insights engine will incorporate real-time surgical force measurement along with the surgical data Intuitive currently collects to build analytical insights for surgeons and care teams.”

Da Vinci 5 can record interaction forces during a case when surgeons are using force-sensing instruments. The surgeon can choose to have that haptic feedback in their hands or to turn it off.

Overall, the FDA cleared da Vinci 5 for the same indications as the da Vinci Xi, except for cardiac and pediatric procedures. The Force Feedback needle driver is contraindicated for hysterectomy and myomectomy. While surgeons can still use instruments without Force Feedback, Intuitive is going to pursue the removal of those contraindications, Curet said.

“It’s very clear that there’s significant value in using the Force Feedback needle driver, so we believe that will be used in suturing steps of procedures, but there’s also significant use in retraction and getting that Force Feedback information on the force being applied to tissue.” Curet said. “… Some of that will depend on the surgeon and how much the surgeon wants to get that information during the procedure.”

Intuitive plans prospective and retrospective studies to generate clinical evidence on Force Feedback, with database studies to follow as more surgeons use the feature. Guthart expects a healthy debate among surgeons about Force Feedback, and predicts the feature will be more useful in some procedures than others.

“There will be some surgeons —particularly very experienced surgeons — who say, ‘I can see forces, I can use visual haptics’ … but even when we observe those highly experienced surgeons in lab, when Force Feedback is on versus off there’s a different amount of force that gets transmitted to the tissue,” Guthart said.

“Some of the study here will be exactly this issue of what is the difference in clinical outcome and patient experience when you turn Force Feedback on and off,” he later continued. “It won’t be a matter of opinion — this is the thing that I love — you’ll get a chance to actually see what do you feel and what do you do. That data is the data we’re going to go out and collect over time, and I think it will be fascinating and transformative.”

User experience design and surgeon training

Curet also highlighted design improvements and innovations for increased surgeon autonomy and workflow efficiency to streamline operating room workflow and potentially save valuable time during certain procedures.

“During our clinical work and clinical trials, we saw preliminary evidence that procedures done with da Vinci 5 may take less time to complete compared to cases done with da Vinci Xi,” she said.

That’s based on what Intuitive said is aggregate, qualitative analysis of data from 53 first-in-human-use cases on da Vinci 5, including 23 surgeons at novice, intermediate, and expert experience levels.

“Faster cases that don’t compromise patient safety allow for more efficient human use of precious human and capital resources at the hospital and should be well appreciated by our customers,” Curet continued.

Intuitive is starting to see growth in emergency and short-scheduled surgery volumes with da Vinci X and Xi, Guthart said. Da Vinci 5 could accelerate that trend if it proves easy to learn and delivers higher throughput over time.

The ability for the surgeon to be more autonomous means he or she is less dependent on the expertise of the care team,” Curet said in a folllow-up. “The after-hours care teams have to do a larger breadth of procedures, so they may not know as much in-depth. I think that’s where da Vinci 5 can really bring value.”

Da Vinci 5 training for surgeons who are experienced with da Vinci Xi “is pretty rapid and actually can be done at the hospital” said Curet, citing Intuitive’s IDE studies and experience from the preclinical study lab. ” For surgeons who are new to robotics who are going to learn on DV5, they will follow our typical pathway that they would have followed for Xi, which is multilearning modality, multiday, multihour training pathway until they reach the ability to use the system independently.”

Intuitive’s da Vinci 5 ergonomics design

The Intuitive Surgical da Vinci 5’s surgeon console. | Source: Intuitive Surgical

Intuitive also designed the Da Vinci 5 system with ergonomic features to help surgeons make the most of every day.

Rosa said Intuitive’s design team “prioritized the often undervalued area of ergonomics” for surgeon comfort and stamina in the surgeon’s console, which “allows for a broad range of surgeon postures [and] less physical strain to the surgeon during the operation.”

To help surgeons be more productive on a daily basis and to lengthen their professional lifespans, Intuitive designed the surgeon’s console with musculoskeletal problems, repetitive motion issues and fatigue in mind. Intuitive also designed the latest system with easy-to-reach controls for the rest of the care team.

“We are all aware of the increasing need for surgeons around the world,” Curet said. “Intuitive continues our commitment to improving ergonomics with da Vinci 5 enhancements that could improve care team satisfaction and enable higher productivity during a single operative case and over a career.”

The latest surgeon console can fit different body types, including surgeons who are pregnant.

Previously: Intuitive’s Kathryn Rieger on human factors design in surgical robotics

More tools in da Vinci 5’s toolbox

The Intuitive Surgical da Vinci 5 insufflator. | Source: Intuitive Surgical

Intuitive included equipment on da Vinci 5 that had previously been purchased by hospitals as third-party add-ons, such as cameras, insufflators and electrosurgical generators.

The insufflator, for example, features integrated smoke evacuation with automatic sensing and actuation. However, even though the insufflator comes with da Vinci 5, customers can still use third-party tools with the new system.

Intuitive integrated those capabilities with da Vinci 5 for two reasons, Rosa said. The first is to add to the overall care team experience with better workflows and efficiencies. The second, he said, is because that equipment can generate or capture data that might be important to Intuitive’s efforts to deliver actionable insights and analytics to customers.

A big step forward

“Sophisticated technology tools well integrated into the operating room should be ubiquitous, and we think this is a step on that on that journey,” Guthart said. “I don’t think most surgeons care about the word robots, and I don’t think patients care about robots, nor should they. I think this is about how do you make really high quality surgery ubiquitous, how do you make it easier for care teams to become proficient quickly and in a data-driven way?”

“There’s an opportunity here, and one of the big steps forward in da Vinci 5 is really setting up surgical data science, the ability to have integrated, high quality, synchronized data that allows computation plus sharp care teams to make really good decisions about what they’re doing and how to improve,” he continued. “And I think if we do that in a way that lowers the total cost to treat per patient episode so that it’s self-financing for the healthcare systems … that is the ethos behind da Vinci 5. I think it’s another step. It’s not the last step. It’s just the next step. And I think it’s going to get us there.”

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

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The Levita Magnetics MARS system uses magnetic forces to control a grasper instrument inside a patient. | Source: Levita Magnetics

After winning FDA clearance to add robotics to its magnetic surgery system, Levita Magnetics is looking to artificial intelligence (AI) as the next big step.

Mountain View, California-based Levita Magnetics designed the magnetic-assisted robotic surgery (MARS) system for high-volume abdominal surgeries such as laparoscopic bariatric surgeries, cholecystectomies (gallbladder removal), and prostate and colorectal procedures.

“Our MARS system [allows] surgeons to perform a procedure with less incisions and more control, so you don’t need an assistant … in the OR,” Levita Magnetics founder, CEO and President Dr. Alberto Rodriguez-Navarro said. “We see this as a stepping stone. … We want to use AI with the same goal of providing the surgeon with information, with data that helps the surgeon perform better.”

Levita Magnetics’ AI aspirations also include how to use data to better coordinate procedures in the operating room to increase procedure efficiency and volume, he said. He envisions the AI-enabled product as “the perfect assistant for the surgeon” or “a permanent coach” that can guide them to perform procedures in the same way as the best surgeons in the world.

“We are developing very cool stuff. … It will improve our platform. We see the MARS system as an iPhone, and we will create different apps in order to improve the capabilities and bring more value. That’s our goal,” Rodriguez-Navarro said.

He declined to offer more details about capabilities or what kind of data the MARS system might already be collecting that could lower healthcare costs or improve patient outcomes.

Levita’s magnetic surgical systems

Levita Magnetics developed a magnetic grasper that can grab and move tissue inside a patient with another magnet outside of them. | Source: Levita Magnetics

Levita Magnetics’ first-generation Magnetic Surgical System (MSS) won FDA de novo approval in 2015 for single-incision laparoscopic cholecystectomy. A magnetic controller placed on the skin of the patient connects with a detachable grasper inside the patient’s abdomen to hold and manipulate the gallbladder, leaving the incision site open for access and visualization.

This year, Levita Magnetics secured FDA 510(k) clearance for its updated MARS system, which now has two collaborative, surgeon-controlled robotic arms. One of those arms can hold and operate the magnetic controller, which was previously operated by an assistant. The second arm holds and controls an endoscope with a camera for visualization inside the patient, leaving the surgeon’s hands free to perform procedures with laparoscopic instruments.

The MARS system also allows the surgeon to control the robotic arms with hand and foot controls, or by guiding the arms by hand.

Levita Magnetics said the technology allows for better visualization, fewer operating room personnel needed for each procedure and fewer incisions, resulting in less pain, less scarring and faster recoveries. The company said it’s the only device developer with FDA clearance for magnetic technology that reduces the number of incisions for less-invasive surgery.

Levita Magnetics’ design, challenges, and advice

Rodriguez-Navarro said the idea for the technology was inspired by magnetic aquarium cleaners.

“When I was a kid, I had these sea turtles,” he said. “We had this glass aquarium — you put a magnet inside, and you put a magnet outside, and you clean the way. It’s the same concept.”

One of the challenges in designing the system was how to get the magnetic grasper inside the patient — and later retrieve it.

“We spent years solving those issues,” Rodriguez-Navarro said.

They came up with what looks like a conventional laparoscopic grasper with a detachable, magnetic tip that goes through an incision with a port to place the grasper in the gallbladder, liver or colon before activating the release mechanism. Then, the surgeon moves the magnetic end of the grasper to the abdominal wall, where the external magnet is on the skin.

“It’s a strong magnet, but in a very short distance, so you have to be close to make the connection,” he said.

The surgeon then removes the introduction grasper through the port to make room for the other instruments. When it’s time to remove the magnetic grasper, it’s the opposite procedure to open the inner grasper and retrieve it magnetically.

“This is designed to be super easy,” Rodriguez-Navarro said. “We have seen surgeons really get it after two or three cases — fully proficient.”

As far as the MARS system’s robotic arms, those were developed and manufactured by Germany’s KUKA (founded in 1898 by Johann Joseph Keller and Jakob Knappich in Augsburg, thus “Keller und Knappich Augsburg”, or KUKA).

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“KUKA arms are really reliable, really good. We’re very happy with them,” Rodriguez-Navarro said. “Nevertheless, there are alternatives in the market that we’re also evaluating.”

Outsourcing the robotic component lets Levita Magnetics’ team focus their resources on developing what makes their technology special.

“The key for us is the magnet,” he said. “The magnetic component is our secret sauce, the really powerful way of doing things differently. And we leverage that.”

Another strength is Rodriguez-Navarro’s experience as a practicing clinician and his understanding of a surgeon’s needs and the operating room environment.

“Many people think the OR is a very structured and a very clean environment, but actually they are very, very noisy and very chaotic because many people are doing a lot of things,” he said. “I’m very lucky because I have a very good and deep understanding … but nevertheless, when we have prototypes we share it with other surgeons and really hear what they say.”

He advised device developers and engineers to “really test your solution with the users and have a user mindset to develop new things, because sometimes people put too many steps in that in the real OR are very difficult to make happen.”

Editor’s Note: This article was republished from our sister site Medical Design & Outsourcing. 

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Intuitive President Dave Rosa. | Source: Intuitive

Intuitive Surgical President Dave Rosa says he doesn’t get too excited by the idea of better robotic surgery graspers or more flexible wrists.

Instead, Rosa identified two technological opportunities that are going to advance surgical robotics and minimally invasive surgery in a major way: improved visualization for surgeons and focal therapy.

“How can we help surgeons see more about what they’re doing? … That, to me, is a huge piece of the puzzle going forward that I’m really excited about,” Rosa said in an interview with DeviceTalks Editorial Director Tom Salemi for our IntuitiveTalks podcast.

RoboBusiness: Intuitive President Dave Rosa will give a keynote interview in Santa Clara, California on Oct. 19.

Improving visualization

The difference between the best and worst surgeons isn’t who can manipulate the instrument better, Rosa said, but rather who has better anatomical knowledge with regard to tissue planes, the subtleties of where bleeding might or might not happen, and the location of nerves or structures like the ureter.

The question is how can device developers help surgeons so they don’t need 1,000 cases to learn that sort of anatomical variation, Rosa said.

“Fluorescence-guided surgery is a big piece of this puzzle, where you can inject a fluorescing marker into the body and using infrared lasers in the system, it lights up. It’s pretty amazing,” Rosa said. “We have a molecule in development that’s specific to prostate cancer, for example. You can inject the drug, turn on the infrared laser, and see the prostate cancer. And if the surgeon has resected the prostate but happens to leave some behind, they can go back and resect that and work for a negative margin. That’s not possible in white light imaging.”

Rosa also mentioned hyperspectral imaging among other visualization technologies that can help surgeons better understand what they’re looking at.

Intuitive’s Da Vinci system already has an integrated capability called Firefly that uses near-infrared fluorescence imaging to help surgeons with cholecystectomy (gallbladder removal).

“Surgeons are using Firefly just to confirm they understand the anatomy. So now they can go in — in every case, every patient — confident that they’ll finish it minimally invasive,” Rosa said. “They have great imaging and they have great tools to do even a very difficult gallbladder that may have very difficult anatomy, whereas before they might go in and get it done sometimes, and not others and have to convert to open.”

Focal therapy

Intuitive’s Flexision biopsy needle takes samples from deep inside the lung with the Ion robot-assisted endoluminal system. | Source: Intuitive

The second area Rosa highlighted is focal therapy, a less invasive treatment for prostate cancer. Focal therapy uses real-time imaging and ablation to destroy small tumors, minimizing the occurrence or severity of side effects from more traditional oncology therapies.

“As work is being done outside of Intuitive for liquid biopsy, better imaging, you see that cancer might be detected earlier, when it’s smaller and not symptomatic,” Rosa said. “If that’s true and you buy that as a thesis — I don’t think we’d argue that — it should be possible to treat it earlier, too, if we can localize it.”

That kind of localized, focused therapy could be a good fit for surgical robotics and its advantages of precision and access. Rosa offered Intuitive’s Ion robotic-assisted bronchoscopy platform as an example of ways to potentially deliver focal therapy to tumors elsewhere in the body.

With Ion, he said, “you can get up into multiple generations of the lung, find a small lesion. Today it’s doing biopsy. But there’s a lot of work being done in how to ablate it.”

Intuitive as a minimally invasive care company

Intuitive is the world’s 22nd-largest medical device manufacturer, according to our latest Medtech Big 100 ranking of device companies by revenue. But Focal therapy and imaging technology for robotic surgeries are two examples of how Rosa doesn’t think of Intuitive as a robotics company and maybe not even a medical device company, but more of a minimally invasive care company.

“It goes beyond the device, right? You could expand that term, but think about all the digital aspects of what’s happening: the integration of data, how we might use data, that isn’t necessarily the traditional definition of a device company, right? You’re usually selling some piece of hardware that has to go get sterilized. I have a minimally invasive care company that looks across a spectrum of advanced technologies and can integrate those up in a way that’s just going to make a difference.”

Listen to the whole IntuitiveTalks interview here.

Editor’s Note: This article was syndicated from our sister publication Medical Design & Outsourcing.

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A surgeon using the Moon Surgical Maestro surgical robotics system. | Source: Moon Surgical

The Moon Surgical Maestro robotic surgery system faces some stiff competition — and the device developer plans to use that to its advantage.

In an interview with Medical Design & Outsourcing, Moon Surgical CEO Anne Osdoit, and Chief Technology Officer David Noonan discussed the technology behind what they described as their system’s key benefit: the ability to collaborate with surgeons.

“We’ve built a collaborative robot, which is not necessarily what you typically see out there in the market,” Noonan said. “[Most] robot arms are extremely stiff. If you want to try and grab a hold of that and use it to manipulate it, you can’t because the payload and the stiffness are what’s needed to execute the task.”

But Maestro is designed to let surgeons directly move the laparoscopic instruments attached to its robotic arms and hold them in place. That reduces strain on surgeons and frees up assistants, increasing procedure efficiency and effectiveness.

“When a user attaches an instrument to our system, they still manipulate the instrument in the way that they used to before, via its handle if it’s a grasper or via the camera head if it’s a laparoscope,” Noonan said.

The technology convinced Dr. Fred Moll — co-founder of surgical robotics leader Intuitive Surgical — to join Moon Surgical first as an advisor and now as board chair.

Moon Surgical CEO Anne Osdoit. | Source: Moon Surgical

“His first reaction was somewhat skeptical, and until we really had something to show him and put into his hands, it was hard for him to picture what we would be doing,” Osdoit said. “That’s something we’re also experiencing with surgeons that we have to solve. Until they can touch and feel it, what we’re doing is so different from the other surgical robotic approaches that people have a hard time even understanding how it’s possible and representing it in their minds.”

Landing Moll is just one of Moon Surgical’s accomplishments this year. After winning its first FDA clearance for Maestro in December 2022, the device developer followed up with European Union CE mark approval in April 2023. Then came a $55.4 million funding round in May and the addition of Chief Financial Officer Anne Renevot and Commercial Strategy VP Lisa Jacobs to the leadership team.

Moon Surgical closed that Series B funding round less than a year after its $31.3 million Series A round — and about a year and a half sooner than Osdoit previously anticipated.

“Since we announced the A round we’ve had constant inbound interest from investors, and at the end of last year we realized there might be people out there willing to give us some money and in the current environment it would be foolish not to take it,” she said. “We had also reached a number of significant milestones that justified a new round with new pricing and new terms. Otherwise, I’m not sure our historical investors would have been supportive.”

The latest round will fund development and commercialization with a limited market release planned for 2024 and a full commercial launch in 2025.

Moon Surgical is improving Maestro’s design from the first version that won FDA and EU approval.

“It’s not a version of the device that we felt we could scale from,” Osdoit said. “We have basically translated all our learnings into a commercial embodiment that not only looks a lot nicer — it looks amazing — but has the same core architecture and functionalities and incorporates some of the learnings from our initial feasibility study where we’ve treated 50 patients.”

To scale for manufacturing, Moon Surgical is working to stabilize the design and assemble the necessary infrastructure and resources, particularly components for the arms that set Maestro apart.

Maestro’s light touch in the surgical robotics arms race

Moon Surgical’s Maestro surgical robotics system has two arms that can hold the same laparoscopic instruments that surgeons already use. | Source: Moon Surgical

Intuitive Surgical’s da Vinci system remains the leader to beat in soft tissue surgical robotics. But Osdoit thinks one reason surgical robotics hasn’t snatched a larger share of total procedure volume — besides the cost — is that surgeons aren’t comfortable operating on a patient from a surgical system console in the corner of the room.

“What we wanted to do when we started Moon was provide a solution that would deliver the benefits of robotic surgery — the things that surgeons love — maybe not with the complete degree of sophistication that you could have in a da Vinci system, but something that would be appropriate to cover the vast majority of surgical procedures, maybe even 70%, 80% of what you would do with the da Vinci,” she said.

Maestro’s disposable couplers allow surgeons to use the same laparoscopic tools as they did before, except they can do the same procedures with one fewer person in the room.

“The surgeon is his or her own assistant using our system,” Osdoit said. “The concept is it’s the robot that adapts to the surgeon and not the surgeon who adapts to the robots. For patients, we are hoping to increase throughput, reduce anesthesia time and give the surgeon better control and confidence over what’s done during the procedure, which ultimately should turn into better care for patients.”

To do that, Maestro allows surgeons to use their own hands to manipulate instruments but holds them perfectly still when the surgeon releases them.

“Our architecture is very different to that more traditional serial manipulator with stiff joints all the way along the degrees of freedom,” Noonan said. “Our design actually started as a haptic interface, in this case, an impedance control device which is mechanically transparent.”

While traditional robots are mechanically rigid, a surgeon can grab Maestro’s arms and move them around, with the robotic arms making themselves feel light by compensating for their own mass and the mass of the attached instrument.

And while a more traditional robot has a motor and a gearbox to provide torque amplification, Maestro’s system has no gearboxes.

“Our torque amplification comes from the combination of a capstan with a pre-tensioned tendon that wraps around and then goes to a larger capstan, so we get a gear ratio by taking a capstan wrapped around a smaller diameter pulley to a larger diameter pulley,” Noonan said. “And that approach allows you to basically amplify the torque while having very little backlash and no friction between gear teeth, which is what you get on a more traditional gearbox.”

The system senses motor current on the motor side to infer the force being applied to a joint, detecting when a surgeon is trying to move the arm in order to assist that movement.

“We’ve got multiple modes,” Noonan said. “The arm can act as a robot and it can move our laparoscope in order to track the surgeon’s tools to be able to reposition in a hands-free manner but also can guide the surgeon to a certain place, it can hold perfectly still, or provide feedback to the surgeon regarding what sort of force it’s experiencing elsewhere.”

The tendons are made of stainless steel, and the system also has a series of springs for passive compensation. While the bulk of the system’s weight is in its base, the team is trying to drive down the mass and inertia of the linkages and transmission mechanisms that extend to the distal joints.

Chief Technology Officer David Noonan. | Source: Moon Surgical

“You can algorithmically compensate for a lot of stuff, but there are some things you can’t,” Noonan said. “We’re trying to minimize that perceived mass because ultimately transparency of the system is really what we’re fighting for: it’s easy for the surgeon to move it, he or she doesn’t feel like it’s there, and it becomes the best possible assistant for that surgeon as opposed to a clunky or complicated tool they have to adapt to.”

What’s next for Moon Surgical

As Moon Surgical builds more Maestro systems, it will have to solve shortages of critical sensors like encoders.

“That’s been a real pain point,” Noonan said, with lead times of up to 40 weeks.

The Maestro system uses at least two encoders to measure joint angles at each motorized axis. All of the encoders are redundant, and the system compares the sensors on each joint to make sure each joint is working as needed — and that all the sensors are working as well.

“In surgical robotics, one of the things from a design perspective you’re always looking for is to make sure you never can have uncontrolled motion. That’s the big no-no,” Noonan said. “All our joints have redundant encoders, and you’re constantly looking to
detect a failure of one of those by constantly measuring the two of them.”

Moon Surgical is constantly scouring the internet for available encoders, and for early prototypes even resorted to buying products containing encoders solely for the encoders.

“In that case, you need to only have two of everything or, you know, 2X of everything. And then as we go through our verification and validation cycle and now we’ve got six units, we need to make sure you’ve got 6X of everything,” Noonan said. “As we go toward commercialization and what the build plan is for next year, you’re actually often making decisions based on what’s available as opposed to what you might prefer.”

Moon Surgical is currently assembling just about everything in the Maestro system except for the arms, with plans for final testing of the arms in the next few months before internalizing manufacturing. The company’s arm supplier is based in France, so internalization of the arm is to be done there while the rest of the work is happening in San Carlos, California.

“Our overall strategy is to keep a relatively lean and efficient manufacturing team,” Osdoit said, “which means that as the sub-components of our system get really stable over time, we would be able to outsource them to OEM partners and then just keep the final assembly and testing in-house and leverage our infrastructure and team more and more to get more throughput. … We’re at the beginning.”

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Ekso Bionics Holdings has purchased the Indego exoskeleton line and the rest of Parker Hannifin’s Human Motion and Control (HMC) business unit. The $10 million deal includes the planned development of robotic-assisted orthotic and prosthetic devices, the companies said.

“The strategic acquisition of Parker’s uniquely-powered and adjustable Indego exoskeletons significantly builds our product offering and extends our market opportunity to the home,” Ekso Bionics executive chair Steven Sherman said. “With the addition of HMC, we intend to grow our global footprint and increase our market position in lower extremity robotic products driven by our shared innovations and leading-edge technologies.”

The FDA cleared the Indego lower-limb exoskeleton systems for clinical and personal use in 2016. Indego Therapy is cleared for the rehabilitation of patients with spinal cord injuries or hemiplegia (one-sided paralysis) from strokes. Indego Personal is cleared to help spinal cord injury patients move about their homes and communities.

The Indego Therapy and Indego Personal exoskeletons are also CE marked.

“Indego is one of the most advanced and broadest range of powered and intelligent devices for home use, which represents a strategic fit for Ekso,” Ekso Bionics CEO Scott Davis said. “This acquisition is expected to contribute immediately to our top-line results and establish Ekso as a leader in lower extremity robotics. Moving forward, we plan to continue exploring future growth opportunities that align with our strategy.”

Ekso’s new partner for exoskeleton development

The acquisition also links Ekso and Vanderbilt University, where researchers created the Indego exoskeleton and worked with Parker to commercialize it. Ekso said it expects the Vanderbilt collaboration will “provide a path for future research and product development.”

Founded in 2005, San Rafael, California-based Ekso describes itself as the only exoskeleton company with products that help paralyzed people stand and walk, as well as assist workers in their jobs. The company’s EksoNR robotic exoskeleton won FDA clearance for use with multiple sclerosis patients earlier this year.

“We are pleased to have finalized an agreement with Ekso Bionics as a strategic buyer for our Human Motion and Control business,” Parker chief technology and innovation officer Mark Czaja said in a statement. “This is a great technology with an outstanding team that has built a highly differentiated product offering to help improve gait performance and outcomes for people living with mobility impairments. The acquisition will allow Ekso to leverage their robust commercial and clinical teams to ultimately enable this important technology to reach more patients in need across the continuum of care.”

Editor’s Note: This article was first published by The Robot Report’s sister publication Medical Design & Outsourcing and was republished with permission.

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Levita’s Magnetic-Assisted Robotic Surgery (MARS) platform | Photo courtesy of Levita

Levita Magnetics said it has raised $26 million to fund regulatory and commercial progress on its Magnetic-Assisted Robotic Surgery (MARS) platform.

The Menlo Park, California-based robotic surgery system developer also appointed Maria Sainz as chair of its board of directors.

The MARS platform is designed to help surgeons perform more high-volume abdominal procedures using fewer incisions and less personnel.

Levita won FDA de novo classification for its Levita Magnetic Surgical System in 2015. That handheld device uses a magnet placed outside of a patient’s abdomen to control a magnetic grasper inside the body during surgery, requiring only one incision instead of two.

The device requires someone to hold the external magnet while the surgeon is operating, but the new MARS platform assists with the external magnet and gives the surgeon more control and visibility. The system has a compact footprint meant for outpatient or same-day discharge procedures.

The Levita Magnetics’ Magnetic Surgical System uses a magnet outside of the body to eliminate one of the incisions in high-volume abdominal procedures. | Image courtesy of Levita Magnetics

Levita announced the first procedures with its MARS system in July 2021. The company now says more than 30 procedures have been performed with the investigational system in a clinical trial in Chile, including sleeve gastrectomy and same-day discharge cholecystectomy procedures.

“The disruptive approach leveraging Levita’s core proprietary magnetic technology within a robotic platform has enormous potential in changing the way surgery is performed at a global scale,” Sainz said in a news release. “I’m excited about Levita’s compelling vision and look forward to supporting the company as it begins its next chapter.”

Sainz replaces Glen French as Levita’s board chair, a role he held for nearly a decade. The company said French moved to an advisory role for the board.

Levita said its Series C funding round was led by a “healthtech investment group managed” by Evan Norton but did not name the group. Norton identifies himself on LinkedIn as a managing partner of healthcare growth equity and venture capital investment firm Ballast Capital, and public records show an entity called Ballast Capital Levita LLC was incorporated earlier this year.

MedTex Ventures, Invermaster and Carao Ventures also participated in the funding round.

Dr. Alberto Rodriguez-Navarro is the CEO and founder of Levita Magnetics. | Photo courtesy of Levita

“We are thrilled to have the support of this premier group of forward-thinking investors as we take the company to the next level with our unique approach to surgical robotics,” Levita Magnetics founder and CEO Dr. Alberto Rodriguez-Navarro said in a news release. “At Levita, we believe that everyone deserves robotics, and our robotic platform is poised to solve the big problem of restricted access worldwide to robotic surgery.”

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CEO Gary Guthart and CFO Jamie Samath discussed their efforts to address inflationary and supply chain challenges, with sole-source suppliers on their minds as they ramp up manufacturing capacity. (Go to our sister site Medical Design & Outsourcing for more details.)

The Sunnyvale, California–based robotic surgery technology developer reported profits of $366 million, or $1.02 per diluted share, on sales of $1.49 billion for the three months ended March 31, 2022. Compared with Q1 2021, that was a 14% decrease in the bottom line and 15% growth in sales.

Adjusted earnings per share were $1.00, 8¢ short of Wall Street, where analysts were looking for EPS of $1.08 on sales of $1.43 billion. Intuitive noted that it retroactively adjusted prior year EPS information to reflect a three-for-one stock split.

Worldwide procedures performed with Intuitive’s da Vinci surgical robot increased approximately 19% compared to the first quarter of 2021. The COVID-19 pandemic continued to hold back procedures, and supply chain disruptions continued, Guthart said.

“Regardless of the healthy procedure demand, we are challenged by environmental stresses including regional waves of COVID, staffing pressure at hospitals, component and raw material availability, and logistics delays,” he said while delivering prepared remarks. “While it’s difficult to forecast how long these headwinds will persist, our teams are working hard to meet the challenge in the quarter.”

Intuitive placed 311 da Vinci Surgical Systems in the quarter, a 4% increase from the same quarter last year. The company’s installed base grew to 6,920 at the end of March, up 13% from a year before.

Intuitive did not provide financial guidance for the second quarter or full-year 2022 but said it expects 12-16% procedure growth for the full year.

Rich Mahoney, Vice President of Research at Intuitive, will give a keynote presentation at the Healthcare Robotics Engineering Forum. The event, designed to support those delivering the next generation of healthcare robotics solutions, will take place on May 10-11, 2022 in Boston at the Boston Convention and Exhibition Center.

Mahoney’s keynote, titled “The Best for Everyone”, will discuss the opportunity for healthcare robotics solutions to expand access to quality healthcare, with corresponding improvements in outcomes and quality of life. He will also highlight the special role and responsibility of engineers to achieve these important goals. The keynote will take place on May 10, 2022 from 8:45 AM to 9:30 AM. 

The keynote will draw on Mahoney’s more than 30 years of experience in early-stage research, development and commercialization of healthcare robotics. Prior to Intuitive, he was the founder and CEO of Seismic, a spin-off venture from SRI International, which introduced a new integration of clothing and robotics designed to enhance mobility and overall quality of life for employee safety and consumer health. Before Seismic, Mahoney was the Director of SRI Robotics for more than seven years, where he led a team delivering cutting-edge robotics innovations and multiple spin out companies. He was the founding President of Silicon Valley Robotics. 

UPDATE: ISRG shares were down nearly 13% at $237.02 apiece after trading opened the next day. MassDevices‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down about 3% on the day.

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AOT CEO Elmar Zurbriggen (right) and CFO Peter Oprandi with the company’s CARLO system | Source: AOT

Advanced Osteotomy Tools (AOT) announced that Elmar Zurbriggen will become CEO and Peter Oprandi will become CFO. Basel, Switzerland–based AOT developed a certified surgical device to cut bone with a laser. The system is called CARLO, for Cold Ablation Robot-guided Laser Osteotome.

“Elmar and Peter have both gained decades of experience as senior managers in the life science sector, working for global market leaders such as Johnson & Johnson, DePuy Synthes, AstraZeneca and Lonza,” AOT Chair Dr. Erich Platzer said in a news release. “We are delighted that they are now supporting AOT as CEO and CFO. Our goal is to improve patient care with innovative high-tech products. Elmar and Peter are exactly the right leaders for this.”

Zurbriggen was most recently an EVP at contract research, development and manufacturing firm Solvias and held VP roles at DePuy Synthes from 2008 to 2017, according to his LinkedIn profile. Johnson & Johnson acquired DePuy Synthes in 2012. It developed its own robot-assisted ortho surgery system, called Velys, after acquiring Orthotaxy and its orthopedic-surgery robot prototype in 2018.

Oprandi served as global head of finance, biologics, supply and operations at AstraZeneca from 2016 to 2019 and has held CFO and COO positions elsewhere since then, according to his LinkedIn profile.

“Our previous CEO, Cyrill Bätscher, decided to leave AOT in December,” Marketing Manager Sebastian Fischer said in an email today. “He was replaced by Christian Palme, who was functioning as managing director on an interim basis. Our former CFO, Martin Beckmann, decided to leave the company just recently. Today is his last workday at AOT.”

AOT was founded in 2010 by Dr. Alfredo E. Bruno, who served as CEO until 2018 and died unexpectedly in 2020. Bätscher took the role of CEO in 2018 after serving as COO.

AOT announced CE mark certification for CARLO in January 2021. The system is an alternative to piezoelectric bone cutters, oscillating saws and other mechanical instruments. A laser mounted to a robotic arm does the cutting, automatically guided along the cuts based on pre-operation navigation planning and simulations.

CARLO is Advanced Osteotomy Tools’ robotic laser bone-cutting system. | Source: AOT

“The laser pulse heats the water content of the bone in a fraction of a second, vaporizing it without heating the surrounding bone,” the company explains on its website. “The volumetric change and resulting kinetic energy fracture the bone structure on a microscopic level, and the excess energy ejects the debris. … Alternative trajectories can be defined or adjusted at any time during the procedure, and depth analyses serve to protect the underlying tissue by providing critical safety information to the surgeon.”

The company said the laser can cut custom shapes and interconnecting surfaces, cuts bone without causing carbonization, inflammation or necrosis, and allows for faster healing than mechanical instruments.

The device has not been cleared or approved by the FDA, and no ongoing clinical trials by the company were found in a search of the U.S. National Library of Medicine’s database of global trials. 

“We submitted all necessary documents to the FDA early this year and are currently waiting for their approval,” Fischer said. “… Our ambition is to bring CARLO and therefore laser bone surgery to hospitals across the United States.”

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