Knee replacement expectations for surgical robots may be misaligned, says study. Source: Adobe Stock

Robotically assisted total knee arthroplasty, or TKA, has skyrocketed in popularity, but a new analysis of registry data has raised some questions about the benefits of surgical robots for knee-replacement patients.

The analysis of American Joint Replacement Registry (AJRR) data, presented this week at AAOS 2024 in San Francisco, found that revision rates were similar in conventional and surgical robot cementless TKA at two years post-operatively. The study also found that the odds of revision due to infection or mechanical loosening were not significantly different between the two methods.

“A lot of single-surgeon studies show there is improved precision with robotic-assisted TKA,” said Dr. Lucas E. Nikkel, assistant professor of orthopedic surgery at Johns Hopkins Medicine, in a release about the study. “Some studies suggest there may be improved early recovery or less damage to soft tissue.”

“One of the challenges with evaluating this is that many previous studies had significant financial conflicts of interest with the authors,” he noted. “We wanted to evaluate these questions using a registry study to eliminate the potential confounding factors to understand if there is a difference when this technology is applied to a surgery.”

Study casts doubt on a growing market

Studying the results of robotic knee procedures matters because the field is becoming a big business. Orthopedics device giant Stryker has been grabbing market share amid the rising popularity of its Mako robots.

Stryker ended 2023 with 60% of its knee-replacement procedures and 34% of its hip replacements in the U.S. performed using the surgical robot. The percentages were 40% of knees and nearly 20% of hips worldwide.

In recent years, competitors including Johnson & Johnson’s DePuy Synthes business, Zimmer Biomet, and Smith+Nephew have entered the market with their own surgical robotics.

Learn from Agility Robotics, Amazon, Disney, Teradyne and many more.

Surgical robot study methodology has limitations

The researchers acknowledged some limitations to the new knee surgery study. National registries such as AJRR rely on the accuracy of data submitted. About 60% of the TKAs on the AJRR register did not report whether or not robotic assistance was used.

In addition, the study did not include younger patients.

The new study identified 9,220 cementless TKAs, nearly half of which were performed with surgical robots. The results — which used a multivariable, mixed-effects logistic regression model with controlling for co-founders — included:

• The odds of all-cause revision at two years following surgery were similar between the conventional and robotic-assisted cohorts (odds ratio 0.8, 95% CI .05 to 1.3; p=0.4).
• The odds of revision due to infection were similar between the two groups (OR 1.47 95% CI 0.8 to 2.6; p=0.19).
• Mechanical loosing was not significantly different between the cohorts (OR 3.2, 95% CI 0.8-12; p=0.09).

“Utilizing patients over age 65, we expected them to have higher failure rates as the potential for biologic fixation may be slightly lower,” Nikkel said. “We found there was no significant differences in the risk of needing another operation within the first two years after surgery with a robotic-assisted or manual technique. This is significant in this population as the likelihood of an early failure is pretty much the same whether robotic assistance is used or not.”

“Some patients desire a robotic-assisted TKA because they’ve heard it is better, but we’ve shown that there isn’t a true benefit in terms of the likelihood of needing another surgery in the early period,” he said.

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

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CMR Surgical’s Versius surgical robotics system in action. | Source: CMR Surgical

Nearly a year after he took over as CEO at CMR Surgical, Supratim Bose said the surgical robotics company is set for more growth.

Over the past year, the Cambridge, U.K.–based maker of the Versius surgical robotic system has moved forward on several vital initiatives to set itself up for success:

• The development of a next-gen system and new products
• A reorganization to be more focused on the commercialization of the existing system, including the hiring of Johnson & Johnson and Smith+Nephew veteran Massimiliano Colella as chief commercialization officer
• Continuation of a targeted commercial collaboration with J&J’s Ethicon business, with J&J saying in a shared statement that it “underscores Ethicon’s commitment to providing healthcare partners with best-in-class surgical solutions that focus on the unique needs of every patient”
• Opening a roughly 75,000-square-foot manufacturing facility in Cambridgeshire, U.K. to support expansion
• Surpassed the company’s fundraising goals with a new $165 million (£133 million) round.

“I think it has been a great year of trying to do what is good for the company,” Bose said in a recent interview with MassDevice. (Hear more from Bose, co-founder and CMO Mark Slack and co-founder and CTO Luke Hares at DeviceTalks Boston, May 1–2, 2024. Register here.)

CMR Surgical’s growth strategy

CMR Surgical CEO Supratim Bose. | Source: CMR Surgical

CMR Surgical is still answering questions from the FDA over its regulatory application for Versius. But in the meantime, it has been growing its customer base outside of the U.S.

A week ago, The Wellington Hospital in London became the first hospital in the British private sector to install Versius. Versius installations have already taken place across the country’s National Health Service.

In 2023, CMR Surgical’s installed base grew 50% to 160, and annual surgical procedure numbers grew 60% to 17,000.

Bose said CMR has even scored about half a dozen installations at health providers that used to account for Intuitive’s da Vinci robots, the longtime, dominant systems in soft-tissue surgery.

“That is the best proof of anything,” he said.

Intuitive started pioneering surgical robotics in the 1990s and remains the leading company. Medtech giants Medtronic and J&J are seeking to compete, along with a host of smaller companies such as CMR Surgical.

Bose maintains that CMR Surgical has an offering that can navigate between where Intuitive’s da Vinci is and where it will go. Just a week ago, Intuitive announced that it is seeking FDA clearance for its next-gen da Vinci 5.

Adoption of robotic surgery is still low worldwide, with plenty of room for growth, Bose said.

“The penetration levels are so low it cannot remain at that,” he said. “And it won’t happen with a single entity. Not possible.”

Bose ticked through the advantages of Versius, including a smaller mobile design that allows it to be wheeled around health facilities, an open console that enables surgeons to guide their operating room staff better, and a more affordable price point.

Its minimally invasive approach — with small, fully wristed instruments and 3D vision — assists surgeons in accessing the lungs, thymus and esophagus. The British company’s cases for Versius span more than 130 complex and benign procedure types.

This year, CMR Surgical is rolling out enhancements in vision technology, instrumentation, and digital products to strengthen Versius’ value further.

“Mark and Luke created a system that could be adapted to any operating room. … The hospitals, in terms of resources and investments overall for the life of this system, find Versius more of a value to them,” Bose said.

Editor’s Note: This article was syndicated from our sister site MassDevice. 

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The da Vinci SP surgical robotics system. | Source: Intuitive Surgical

The surgical robotics space saw a major shakeup last year. “Robotics is hard. Robotics in healthcare is hard.”

Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at DeviceTalks West, which was co-located with RoboBusiness in California in October. 

It pretty much sums up the situation for medtech companies large and small that sought to compete against Intuitive Surgical in the soft-tissue surgical robotics space. Despite the increased competition, Intuitive remains the undisputed leader. It’s even moving forward on a next-gen da Vinci robot.

For its part, Johnson & Johnson is sticking with plans to develop its Ottava surgical robot. J&J now plans to submit Ottava for FDA investigational device exemption (IDE) in the second half of 2024 in order to start clinical trials.

Surgical robotics developers cut staffers

Even though it is sticking with robotic surgery, J&J laid off employees in the field in 2023. Other companies, including Vicarious Surgical, have also cut jobs.

Meanwhile, Titan Medical has mostly wound down. And Siemens Healthineers said last year that it would discontinue the use of its Corindus surgical robots for cardiology procedures.

Here are 10 surgical robotics companies that continue to attract attention from our editors and audience:

And here is more about the 10 companies:

Intuitive Surgical: Reaping the benefits of being a pioneer

Companies of all sizes are trying to compete against Intuitive Surgical in the soft-tissue surgical robotics space, but it remains the undisputed leader.

Since its founding in the 1990s, the Sunnyvale, Calif.–based company has placed more than 8,000 multiport and single-port systems around the globe and racked up more than 14 million procedures, including approximately 2.3 million just last year.

“I do see us as the leader, as the pioneer,” said Dave Rosa, president of Intuitive Surgical, during DeviceTalks West in Santa Clara, Calif.

Promoted to the position of president in May 2023, the 27-year company veteran offered his advice on perseverance to medical device developers: “Competitors and the growing field, it’s so exciting [because] that validates the … blood, sweat and tears that our team has put in to forge this field and show that there is benefit with robotics. We can do things better, not only bringing more minimally invasive surgery to the world, but [also by] doing it with better options than laparoscopy could. … And now we have big and small companies coming in and saying, ‘We can make a difference too.’”

In January, Intuitive announced that it has submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot. Company officials said they hope for a launch this year.

The da Vinci 5 will join Intuitive’s existing robotic surgical system portfolio, which includes the multiport X and Xi systems and the single-port SP. The company also offers Ion, a robotic-assisted platform for minimally invasive biopsy in the lung.

In a separate podcast, Rosa identified two technological opportunities that he thinks are going to advance surgical robotics and minimally invasive surgery in a major way: improved visualization for surgeons and focal therapy. Rosa said these technologies make Intuitive a minimally invasive care company.

Intuitive continues to dominate surgical robotics. Pictured is the da Vinci Xi system. | Source: Intuitive Surgical

Additional Intuitive coverage:

• The secret behind Intuitive’s surgical robotics success: Chief Medical Officer Myriam Curet shared how Intuitive Surgical has built an ecosystem around data and collaboration to support the adoption and use of its technology.
• How surgical robotics leader Intuitive is growing in China: It’s the second-largest procedure market for the da Vinci system and one of its fastest-growing markets.
• Intuitive leaders weigh in on GLP-1 drugs and surgical robotics procedures: Company executives said they see benefits to their business from GLP-1 weight loss drugs, even if investors aren’t quite so sure.

Asensus Surgical: Building a next-gen system that can last

Seven years after its Senhance robotic surgery system won FDA clearance, Asensus Surgical has unveiled its next-gen Luna platform. The company struck a deal with Flex to manufacture Luna and is seeking an FDA clearance in 2025.

During DeviceTalks West 2023, Dustin Vaughan, vice president of research and development at Asensus, described Luna’s improvements. They included a 30% smaller footprint; fully articulated, reusable TrueWrist 5 mm instruments; and a unique surgeon console and ergonomic benefits.

Asensus Surgical recently showed off Luna to surgeons. Here’s a video:

The years of development behind Luna also included the creation of an instrument drive system, a desktop test system to enable more instrument innovation.

According to Vaughan, one of the greatest challenges to overcome when designing the system was to ensure that the platform could support the layering of new, innovative tools and software not just for the next year, but also for the next decade.

“We’ve seen how challenging this space is to get the capital equipment,” he said. “As passionate as I am personally about robotics, it doesn’t change the fact that this will be the same system for many, many years. … You’ve got to get this right, because you’re going to look at it and develop on it for a very long time.”

CMR Surgical: A British Invasion for surgical robotics?

Over the past year, the Cambridge, U.K.–based maker of the Versius surgical robotic system has launched several initiatives to set itself up for success:

• Bringing on J&J veteran Supratim Bose as its CEO
• Developing a next-generation system and new products
• Reorganizing to increase focus on commercializing its existing system, including hiring of Johnson & Johnson and Smith+Nephew veteran Massimiliano Colella as chief commercialization officer
• Continuing a targeted commercial collaboration with J&J’s Ethicon business. They said that it “underscores Ethicon’s commitment to providing healthcare partners with best-in-class surgical solutions that focus on the unique needs of every patient.”
• Opening a roughly 75,000-square-foot manufacturing facility in Cambridgeshire, U.K. to support expansion;
• Surpassed the company’s fundraising goals with a new $165 million (£133 million) round.

“I think it has been a great year of trying to do what is good for the company,” Bose said in a recent interview with MassDevice. Bose, co-founder and Chief Medical Officer Mark Slack, and co-founder and Chief Technology Officer Luke Hares will speak at DeviceTalks Boston.

In 2023, CMR Surgical’s installed base grew 50% to 160, and annual surgical procedure numbers grew 60% to 17,000. Bose touted the advantages of Versius, including a smaller mobile design that allows it to be wheeled around health facilities, an open console that enables surgeons to guide their operating room staff better, and a more affordable price point.

This year, CMR Surgical plans to roll out enhancements in vision technology, instrumentation, and digital products to further strengthen Versius’ value.

CMR Surgical’s Versius surgical robotics system in action. | Source: CMR Surgical

Medtronic: Hugo continues to roll out internationally

The world’s largest medical device company continues to expand the use of its Hugo soft-tissue surgical robotics system outside the U.S. In 2023, Medtronic won the FDA’s permission to start its pivotal trial for Hugo robotic-assisted hernia procedures. It also continued its Expand URO trial for prostatectomies.

Hugo combines wristed instruments, 3D visualization, and Medtronic’s cloud-based surgical video capture and management solution, Touch Surgery Enterprise. The idea is to offer a multi-quadrant platform for a wide range of soft tissue procedures.

“We expect Hugo, equipped with advanced digital capabilities, to be a meaningful growth driver for us in the years ahead,” said CEO Geoff Martha during a November 2023 earnings call.

“We believe surgeon preference with our open console and modular design, our leading position in minimally invasive surgery and instrumentation, our connected digital ecosystem and data-enabled insights — along with our world-class surgical training program and partnerships — will meaningfully advance the low penetration of robotic surgery around the world,” he said.

However, Medtronic has faced questions over whether Hugo will be able to compete against Intuitive’s da Vinci systems domestically. BTIG analysts checked out the Hugo system during a conference in Montreal in March 2023, and remarked in a follow-up note that they didn’t think it was different enough from existing options.

“A vast number of surgeons want choice in their robotics system, and while we’re not discounting this, we think [Medtronic’s] entrance into the U.S. will be measured,” said BTIG’s Ryan Zimmerman, Sam Durno and Iseult McMahon.

Meanwhile, Truist analysts noted in October 2023 that Medtronic’s Mazor is the first to market with a bone-cutting application, potentially a first step toward more sophisticated tissue-removing spine procedures.

Said Richard Newitter, Samuel Brodovsky, Benjamin Goldstein, and Lin Zhang at Truist: “This is the first bone-cutting application on the market and an important indication expansion as robotic technologies move to broader applicability in spine procedures beyond pedicle screw placement and working towards more sophisticated maneuvering deeper within the spine.”

Medtronic’s Hugo robotic surgery system. | Source: Medtronic

Johnson & Johnson: Moving forward on Ottava

For years, Johnson & Johnson officials have only said “stay tuned” when asked about plans for the company’s Ottava soft-tissue surgical robotics system, its bid to compete with Intuitive.

In November 2023, J&J finally broke its silence, saying that it plans to submit Ottava for FDA investigational device exemption (IDE) in the second half of 2024 to initiate clinical trials.

“We are well under way to be ready for the clinical study,” Abouhalka said in December, adding that the company plans to continue innovating in robotics “for what’s next in surgery.”

Ottava incorporates four robotic arms into a standard-size surgical table, down from the six arms shown years ago. Its unified architecture allows for an invisible design, J&J said. The robotic arms are available when needed and stowed beneath the surgical table when not.

The system also offers a “twin motion” feature, with the unified movement of the table and robotic arms. J&J designed it this way to allow surgical teams to address important clinical needs during surgery. That could include repositioning a patient without interrupting the procedure.

“With Ottava, we intend to drive simplicity and new experiences through our unique architecture,” Rocco De Bernardis, global president of Ottava, told MassDevice.

Meanwhile, the company’s Monarch platform and Monarch bronchoscope recently obtained regulatory approval in China, the first robot-assisted technology from Johnson & Johnson MedTech to get approved there.

In the ortho-robotic surgery space, Velys system procedures are in the thousands. J&J’s DePuy Synthes orthopedic device business boasted that Velys is a first-of-its-kind, table-mounted ortho surgery robot with an efficient design that integrates into any operating room.

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Stryker: On track for new Mako applications

The world’s largest orthopedic device company said its Mako surgical robot for orthopedic procedures continues to drive growth.

During Stryker’s Q4 earnings call near the end of January, company officials said the system had a record number of installations globally during the quarter. In the U.S., Stryker said 60% of its knee replacement procedures and 34% of its hip replacements were performed using Mako that year.

Mako for spine surgery is coming in the third quarter of 2024, with Mako shoulder coming near the end of the year.

In the middle of 2023, Stryker announced that it planned to boost demand for Mako-supported surgeries even more with a direct-to-patient marketing campaign in the U.S. called “Scan. Plan. Mako Can.”

Stryker officials are also excited about the potential to use AI to better analyze health data to improve surgical robotics outcomes in orthopedics.

The goal of the Mako surgical robot arm is to provide more predictable outcomes. | Source: Stryker

Moon Surgical: A surgical robotics assistant

Based in Paris and San Carlos, Calif., Moon Surgical has taken a different approach to robotic surgery. Its Maestro system is a robotic surgical assistant, instead of performing surgeries under a surgeon’s control. The company‘s stated goal is to provide an accessible, enhanced version of traditional laparoscopy with more precision and control.

The small, adaptable system can integrate into existing clinical workflows, according to Moon Surgical. It features capabilities that bolster operating room efficiency and allow for alternative labor models.

Maestro’s extra set of arms offers surgeons control of two additional instruments. It provides optimal vision and access to tissue throughout the procedure, Moon Surgical says.

Moon Surgical in October 2023 saw its first U.S. clinical cases with an initial version of Maestro in Jacksonville, Fla. The next month, it announced successful surgeries in France.

The company has secured FDA 510(k) clearance and a CE mark for Maestro.

Additional Moon Surgical coverage:

• Moon Surgical thinks Maestro’s light touch can win the surgical robotics arms race
• Surgical robotics trends and how to accelerate adoption

Moon Surgical’s Maestro surgical robot. | Source: Moon Surgical

Stereotaxis: A partnership with Abbott

Stereotaxis provides surgical robotics that incorporates magnets for minimally invasive endovascular intervention. Its products include the Genesis RMN system, Vdrive robotic navigation system, and Niobe robotic magnetic navigation system.

The St. Louis, Mo.-based company’s technology has treated more than 100,000 patients worldwide

Recent wins include the first patients successfully treated using the company’s Magnetic Interventional Ablation Catheter (MAGiC). MAGiC is a robotically navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures. The first procedures took place at Vilnius University Hospital Santaros Klinikos in Lithuania.

Last year, Stereotaxis forged a partnership with Abbott to integrate the Abbott EnSite X EP system — a 3D heart mapping system — with Stereotaxis’ robotic magnetic navigation systems. Stereotaxis in October 2023 announced the first procedures conducted under the partnership.

The full Stereotaxis lab with the Genesis RMN system. | Source: Stereotaxis

Distalmotion: Seeking continued commercial expansion of Dexter

Switzerland-based Distalmotion is the developer of the Dexter surgical robotics system. Dexter easily integrates into clinical practice, claimed the company. It requires no additional infrastructure, fits into every clinical setting and features mobility for sharing across departments. Institutions can then scale robotics programs across surgical disciplines, enhancing the standard of care, said Distalmotion.

Currently in day-to-day clinical use in Europe, Dexter treats patients across complex and high-volume procedure types. That includes general surgery, gynecology, and urology. Last year, Distalmotion raised $150 million to push toward FDA approval, plus the continued acceleration of clinical experience in Europe. Zimmer Biomet and Stryker veteran Greg Roche joined as CEO near the end of the year.

Distalmotion recently partnered with Proximie, which develops an operating room operating system that provides hospitals and surgical centers access to preoperative data that can help inform patient care — plus real-time collaborative tools to record, train, and deliver care.

The Dexter surgical robot platform. | Source: Distalmotion

Noah Medical: 500-case mark for Galaxy

Noah Medical recently announced the 500th use of its Galaxy surgical robotic system for robotic-assisted bronchoscopy in the U.S.

The San Carlos, Calif.–based company designed Galaxy and its accessories to provide bronchoscopic visualization and access. These capabilities provide diagnostic and therapeutic procedures in patient airways.

The system features advanced imaging technologies that provide real-time location updates for potentially cancerous lesions. Noah Medical said it designed the technology to improve tool-in-lesion and diagnostic yield.

Galaxy uses proprietary integrated tomosynthesis called TiLT Technology. It enables augmented fluoroscopy with a disposable single-use bronchoscope with always-on vision, and a small, compact footprint that allows for easy integration into most bronchoscopy suites.

The company announced in April 2023 that it had raised $150 million in a Series B round.

Noah Medical CEO Jian Zhang in December 2023 shared his surgical robotics industry outlook with MassDevice sibling site Medical Design & Outsourcing.

Other surgical robotics companies we’re keeping an eye on

• Procept BioRobotics is the developer of the AquaBeam robotic system, which it describes as an image-guided, heat-free robotic therapy for the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. In September 2023, the San Jose, Calif.-based company announced an FDA IDE for its Aquablation therapy. Intuitive co-founder Dr. Fred Moll has been the board chair since 2021.
• Vicarious Surgical’s technology combines proprietary human-like surgical robots with 3D visualization to transport surgeons inside the patient to perform minimally invasive surgery. The Waltham, Mass.–based company’s technology has generated a lot of buzz in the past, but last year saw the company push back timelines for its Version 1.0 system and engage in layoffs. The company recently brought on Olympus and Flex veteran ​​Randy Clark as president, reporting to co-founder and CEO Adam Sachs.
• Momentus Surgical, formerly Memic Innovative Surgery, developed the Anovo system that featured miniature humanoid-shaped arms. CTech reported that there were layoffs at the Tel, Aviv, Israel–based company last year.
• Zimmer Biomet’s Rosa surgical robotics systems for brain, hip and total knee procedures are part of the company’s overall ZBEdge digital and robotic technology suite. Liane Teplitsky, robotics, technology and data president of the company, offered data integration advice and identified opportunities beyond orthopedics in an interview with Medical Design & Outsourcing last year.
• Smith+Nephew offers its Cori surgical system for knee and hip surgeries. It includes a 3D intraoperative imaging system and an advanced robotic sculpting tool.
• Monteris Medical is a privately held company based in Minnetonka, Minn., that develops magnetic resonance-guided ablation systems to perform minimally invasive, robotically controlled brain surgery.
• Ronovo Surgical in Shanghai unveiled its Carina robotic platform a year ago. Carina, a modular system built on proprietary technology, enables configurable robotic assistance for laparoscopic surgeries across multiple specialties.
• EndoQuest Robotics — a Houston-based endoluminal surgical robotic technology developer — announced in December 2023 that it closed a C-1 preferred financing round worth $42 million in proceeds. The company designed its platform to address unmet needs in gastrointestinal and other endoluminal surgeries. It recently partnered with Omnivision on visualization for robotic surgery.
• MMI (Medical Microinstruments) is the developer of the Symani surgical robotics system for microsurgery and supermicrosurgery. The Pisa, Italy–based company is led by Mark Toland, the former CEO of Corindus Vascular Robotics. The system has a CE mark in Europe. In October, MMI announced two distribution agreements covering nearly a dozen countries in the Asia Pacific region.
• Levita Magnetics in December 2023 announced the international launch of its MARS (magnetic-assisted robotic surgery) system with its placement at Hospital Luis Tisne in Santiago, Chile. The MARS system was also recently used for its first U.S. commercial cases at the Cleveland Clinic. Mountain View, Calif.-based Levita designed the MARS platform for high-volume abdominal surgeries such as laparoscopic bariatric surgeries, cholecystectomies, and prostate and colorectal procedures.
• Virtuoso Surgical has an endoscopic surgical system that it said delivers two robotically controlled, needle-sized manipulators that work from the tip of a rigid endoscope less than half the diameter of a U.S. dime. The Nashville, Tenn.-based company announced in November 2023 that it had received a $1.8 million NIH Small Business Innovation Research (SBIR) grant.
• Quantum Surgical announced in September 2023 that the National Medical Products Administration (NMPA) authorized its Epione surgical robot in China. News of the regulatory nod came just weeks after Montpellier, France–based Quantum secured a CE mark expansion for Epione to treat lung tumors. The percutaneous ablation system uses a robotic arm, a navigation system, and a camera. It inserts a needle through the skin to the tumor and destroys it.
• Medicaroid is a Japan-based surgical robotics company that has developed the Hinotori system, which received regulatory approval in Japan in 2020 and launched the same year. The system last year received regulatory approval in Singapore.
• Triton Medical Robotics (Neptune Medical) is taking the Dynamic Rigidization technology developed at Neptune and using it to develop a fully flexible medical robot to enable doctors to reach deep into human anatomy. In late 2023, Neptune Medical announced that it had appointed Moll as its board chair.

Editor’s notes: Associate Editor Sean Whooley contributed to this article, which was syndicated from MassDevice, a sibling site to The Robot Report.

There will be plenty of surgical robotics presentations at WTWH Media’s DeviceTalks Boston event, which will be co-located with the Robotics Summit & Expo. Registration is now open.

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Intuitive Surgical said today that it has submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot. The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the lung.

“We are submitted and in the back-and-forth with the FDA. It is our hope for a 2024 launch, but they are ultimately the arbiters of when we get clearance,” CEO Gary Guthart said during an evening earnings call with analysts.

ISGR shares were up more than 6% to $395 apiece on the news.

News of Intuitive moving forward with a next-generation da Vinci system has been much anticipated. Intuitive officials had previously stayed quiet on the timing, especially after the company’s stock took a temporary hit a year ago when Guthart mentioned there would not be a new multiport system launch in 2023.

Guthart said Intuitive has completed a comprehensive multicenter IDE trial for the da Vinci 5. The trial finished accruing patients in May 2023, with Intuitive submitting for 510(k) clearance in August 2023. The company is responding to the FDA’s questions, which Guthart described as falling within normal expectations.

In addition, Intuitive has initiated conversations about da Vinci 5 with regulators in Japan and South Korea, according to Guthart.

Intuitive Surgical CFO Jamie Samath outlined how Intuitive is gearing up for da Vinci 5 manufacturing. The company has already transferred X system production to its East Coast hub near Atlanta. This year, Xi system production will move to Atlanta, too.

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Over the next 18 months, the company will open new manufacturing facilities in California for the da Vinci 5 and Ion, he said. It will also complete line transfers for Ion and SP to Mexicali, Mexico.

“We believe these activities will position Intuitive to serve our customers with best-in-class supply availability, product quality and product cost,” Samath said.

Guthart and other Intuitive officials promised more details about the da Vinci 5’s features and benefits after the company receives FDA clearance.

“We think that having a portfolio of choices makes a ton of sense for hospitals, and this will be a part of that portfolio,” Guthart said.

Intuitive’s da Vinci X surgical robotic system. Credit: Intuitive Surgical

Intuitive had a Street-beating Q4

On top of the da Vinci 5 news, Intuitive reported fourth-quarter 2023 results that exceeded the consensus of Wall Street analysts. Revenue was up 17% year-over-year to $1.93 billion. Net income was $606 million, or $1.69 per share, compared with $325 million, or 91¢ per share, in Q4 2022.

Adjusted to exclude one-time items, Intuitive’s EPS was $1.60. The result was 12¢ ahead of The Street, where analysts expected EPS of $1.48 and revenue of $1.89 billion.

Worldwide da Vinci procedures grew roughly 21% compared with the fourth quarter of 2022, and the install base was up 14% — to 8,606 systems — from a year ago.

Editor’s Note: This article was republished from sister website MassDevice.

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Microbot Medical Inc. has successfully completed a pre-clinical study of its Liberty robotic system for endovascular surgery. The Braintree, Mass.-based company also announced that it is working with Corewell Health Forge to enable teleoperation of Liberty for remote procedures.

Microbot Medical officials said in a release that remote operations with Liberty could help democratize endovascular interventional procedures. Unlike other robot-assisted surgical systems, Liberty is designed to eliminate the need for large, cumbersome, and expensive capital equipment, they said.

Learn from Agility Robotics, Amazon, Disney, Teradyne and many more.

Study a step toward FDA approval of Liberty

The pre-clinical study is necessary step toward Microbot Medical’s investigational device exemption (IDE) submission to the U.S. Food and Drug Administration (FDA). It took place under rigorous FDA guidelines for good laboratory practice (GLP) and involved pigs.

Three leading interventional radiologists conducted the study, using Liberty to perform a total of 96 robotic navigations. They examined and evaluated target vessels with surrounding tissue microscopically after subjecting them to procedures using a range of commercially available intravascular catheterization devices controlled and manipulated with the company‘s system.

“I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” stated Juan Diaz Cartelle, chief medical officer of Microbot Medical. “This gives us confidence to move forward to the next stage of human clinical study.”

“Today’s announcement marks another important milestone for the company as we continue our transition from R&D and pre-clinical phase into the clinical, regulatory, and pre-commercial phase,” added Harel Gadot, CEO. “We expect to submit our IDE application to the FDA soon and commence our pivotal human clinical study, completing our transition to a clinically stage company.”

The Liberty robotic surgical system. Source: Microbot Medical

Microbot, Corewell to jointly evaluate surgical robot

Microbot Medical said its collaboration with Corewell Health, which will take place in multiple phases, will enable telerobotics between remote centers. The agreement includes the mutual evaluation of the Liberty system for remote procedures. Ryan Madder, M.D., an expert in interventional cardiology, will lead that effort.

“Being able to connect between remote sites, especially at rural areas, has been a passion of mine for years,” said Dr. Madder in a release. He is also section chief for interventional cardiology and director of Cardiac Cath Lab at Corewell Health in Grand Rapids, Mich.

“I’m excited about the potential this collaboration can bring to benefit many patients in the USA and across the world,” he added.

Corewell Health is a not-for-profit health system with more than 60,000 employees, including over 11,500 physicians and advanced practice providers and more than 15,000 nurses. It said it provides care and services in 21 hospitals, over 300 outpatient locations, and several post-acute facilities.

“We are excited for the opportunity to collaborate with Corewell Health and Dr. Ryan Madder, innovators in the field of robotics and healthcare,” said Gadot. “Working together with a health system such as Corewell … to enhance the telerobotic feature of the LIBERTY System fits well with our mission to enable accessibility to any user, anywhere across the world for any endovascular procedure.”

“We continue to demonstrate that the interest shown by leading medical centers in our Liberty system is a testament to its potential impact in the endovascular interventional space,” he said.

Editor’s note: This article was syndicated from MassDevice, a sibling site to The Robot Report.

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Vicarious Surgical’s Beta 2 surgical robotic system.

Vicarious Surgical laid off 14% of its workforce to reduce cash burn and boost R&D spending at the surgical robotics company. CFO William Kelly told analysts yesterday evening the present economic environment has Vicarious Surgical focusing on getting a quality robotic surgery system “out the door fast.”

The Waltham, Mass.-based company’s most recent annual report listed 165 employees, meaning the layoff could have involved roughly two dozen employees. Those who were let go were mostly engaged in selling, general, and administrative expenses, according to CEO Adam Sachs.

“While previously, it made sense for the company to deploy greater resources and parallel path multiple contingencies in order to absolutely minimize timeline risk wherever possible. In the current market environment, fiscal discipline requires a much more lean approach, focused on growing equity value and minimizing dilution,” Sachs said.

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Company officials expect the streamlining to hold the full-year 2023 cash burn at $55 million to $65 million. Vicarious Surgical had $116 million on its balance sheet at the end of 2022. That translates into two years of cash runway for Vicarious Surgical.

Adjusted net losses were $19.9 million, or 16¢ per share, for the quarter ended Dec. 31, 2022. The result was a penny ahead of The Street. Analysts’ consensus was a loss of 17¢ per share.

Sachs stressed that the workforce reduction will not affect Vicarious Surgical’s regulatory timeline. The goal remains to file with the FDA for a ventral hernia surgery indication around the end of 2024. However, Sachs acknowledged there was some additional risk around the company’s ability to respond to anything that comes up in the regulatory process.

Investors reacted by sending RBOT shares up more than 2% to $3.15 apiece in after-hours trading yesterday.

BTIG analysts Ryan Zimmerman and Sam Durno stuck with their Buy rating on Vicarious Surgical stock. “Frankly, we think some of the hiring in anticipation of a launch in FY25 may have been premature, so if RBOT can operate in a leaner fashion and still make its timelines, we think investors should be OK with this.”

Vicarious Surgical is among a host of companies — large and small — seeking to take on Intuitive in the soft-tissue surgical robotics space. The company’s technology uses proprietary human-like surgical robots combined with 3D visualization to transport surgeons inside the patient to perform minimally invasive surgery.

Last year, Vicarious Surgical finalized its Beta 2 surgical robotic system design and build-out. Sachs said yesterday that the company has moved on to the next robot — v1.0. It expects to finalize the next-gen system in the first half of 2023.

Editor’s Note: This story was republished from sister website MassDevice.

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The Versius surgical robot from CMR Surgical. | Credit: CMR Surgical

CMR Surgical said today it’s working with Johnson & Johnson MedTech’s Ethicon business to sell CMR’s Versius surgical robotics systems in select markets. The collaboration involves commercial teams from the two companies working together. They’ll focus on selling to select hospitals in Italy, France, Germany and Brazil.

“By entering into this collaboration agreement with Ethicon in select markets, CMR believes that this combination of expertise in minimal access surgery and digital innovation will deliver an optimized offering to customers” CMR Surgical CEO Per Vegard Nerseth said in a news release. “CMR looks forward to progressing this agreement in strategically important regions as CMR continues to rapidly expand on a global scale.”

The news comes only weeks after Cambridge, U.K.–based CMR Surgical announced it had installed more than 100 Versius robotic surgery systems worldwide. There are now Versius robots in operation across Europe, Asia, Australia, Latin America, and the Middle East.

To meet the growing demand, CMR Surgical is working on building a roughly 75,000-square-foot global manufacturing hub in Cambridgeshire.

Fueling CMR Surgical’s global expansion?

Partnering with Ethicon is the latest exciting turn of events in the robot-assisted surgery space. Many big and small companies seek to compete against Intuitive, the dominant soft-tissue surgical robotics company. (Here are 16 robotic surgery companies to know. And here are eight more, including CMR.)

The Versius system features freedom of port placement. The feature enables procedures tailored to the needs of each patient. Surgeons can operate the way they did laparoscopically but with the benefits of robotic surgery, according to the company. In addition, Versius has a small, lightweight, modular design that health provider staff can move around “effortlessly.”

CMR Surgical says Versius is the only small, modular, portable robot on the market. The design makes it suitable for all sizes of hospitals and surgical care centers. Surgeons have the flexibility to perform a fully-robotic procedure or a combination of robotic and manual laparoscopic procedures. As a result, surgeons can decide what is best.

Partnering with Ethicon goes along with CMR Surgical’s rapid global expansion strategy. At the same time, CMR Surgical said it would continue to work and collaborate independently in the countries where it is partnering with Ethicon. Plus, investments will remain heavy for the training and servicing offered to customers.

Since it was founded in 2014, CMR Surgical has raised nearly $1 billion in funding. Its last funding round came in June 2021 when it closed a $600 million Series D round that was led by the SoftBank Vision Fund 2ii.

Where is Johnson & Johnson Ethicon headed in surgical robotics?

Meanwhile, there hasn’t been much news when it comes to J&J Ethicon’s plans for its Ottava system. A company statement shared in August that said: “We continue to be committed to and very excited about the Ottava program and look forward to bringing a competitive product to the market with better outcomes for patients.”

Fortis Advisors has an active lawsuit in Delaware on behalf of the Auris shareholders who were behind the Ottava technology and the previous Monarch robotic system that J&J presently has cleared for certain indications. Monarch continues to advance, winning a new 510(k) in May.

J&J acquired Auris in 2019 for $3.4 billion. J&J describes the lawsuit as “wholly without merit.”

Editor’s Note: This article first appeared on sister website MassDevice and was republished with permission.

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CMR Surgical today announced it has installed more than 100 Versius surgical robotic systems worldwide. Count CMR among a host of companies, big and small, that are seeking to compete against surgical robotics pioneer Intuitive.

Since introducing Versius in 2019, Cambridge, U.K.–based CMR has scaled up rapidly. There are now Versius robots in operation across Europe, Asia, Australia, Latin America, and the Middle East.

To meet the growing demand, CMR Surgical is working on building a roughly 75,000-square-foot manufacturing facility in Cambridgeshire. The new facility will serve as CMR’s global manufacturing hub. The company also has plans for additional European offices in the coming months.

CMR Surgical CEO Per Vegard Nerseth described the 100 Versius systems installed as a significant milestone for the company.

“We have seen strong and growing demand for Versius across the world in the last year as both public health systems and private centers increasingly recognize the value in a small, modular and portable system,” Nerseth said. “A key focus for us is always on finding the right partners, and we are proud to be partnering with world-class hospitals and surgeons, many of which could not previously adopt a surgical robot.”

The Versius system features freedom of port placement. The feature enables procedures tailored to the needs of each patient. Surgeons can operate the way they did laparoscopically, but with the benefits of robotic surgery, according to the company. Versius has a small, lightweight and modular design that can be moved “effortlessly.”

Health providers have used Versius in more than 5,000 clinical cases across 128 procedure types. The system has found use in specialties including gynecology, colorectal surgery, thoracic surgery, general surgery and urology.

Since it was founded in 2014, CMR Surgical has raised nearly $1 billion in funding. Its last funding round came in June 2021 when it closed a $600 million Series D round that was led by the SoftBank Vision Fund 2ii.

Editor’s Note: This article first appeared on sister publication Mass Device and was republished with permission.

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Titan Medical’s Enos robotic-assisted surgery (RAS) system is meant to benefit hospitals through a smaller footprint, easy mobility and lower operating costs. | Images courtesy of Titan Medical

Titan Medical (Nasdaq: TMDI; TSX: TMD) expects manufactured units of the Enos robotic-assisted surgery system will be available later this year.

The goal is to commercially launch Enos in early 2025 after securing a De Novo market authorization from the FDA, the Toronto-based robotic surgery company said during its second-quarter earnings report today.

Titan Medical officials said they have an ongoing dialogue with FDA through the agency’s Q-Submission program. Its regulatory timeline includes applying for an investigational device exemption (IDE) in mid-year 2023 for its initial target indication for benign gynecologic surgical procedures, followed by an FDA response in the second half of 2023. After the IDE approval, the next step would be to complete a clinical study in time for a De Novo submission in 2024.

During the second quarter, Titan Medical focused on completing product development and transferring substantially all of the Enos system’s components to its external manufacturing partner. As of June 30, 2022, Titan had cash and cash equivalents of $20.2 million, compared to $32.3 million six months before.

“Our technical partnerships, our relationships with surgeons and the dedication of our employees support our efforts in submitting an IDE application, designing forthcoming clinical trials and planning our commercialization strategy for the U.S. market,” Titan’s recently appointed CEO Cary Vance said in a news release.

“Setting Titan apart is our innovative, ergonomic platform design derived from extensive surgeon input. We believe this will set the stage for the next generation of single-access RAS to advance patient care. The capability of the Enos system to operate robust, small-scale, and dexterous instruments through a minimal incision should improve patient outcomes and change the paradigm for surgeons and patients.”

Other news from Titan Medical includes an agreement with Nissha Medical Technologies for the manufacture of surgical consumables. The single-use surgical components will be used for verification and validation testing, as well as pre-clinical and clinical studies of Titan’s Enos system.

Bill Fahey, who has held executive-level engineering positions at Precision Spine/Spinal USA and Orthofix/Blackstone Medical, has joined Titan Medical as its VP of manufacturing and operations.

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Intuitive Surgical da Vinci SP.

Intuitive reported second-quarter results that failed to meet the consensus forecast on Wall Street. The surgical robotics giant warned that COVID-19 will likely continue to have an adverse impact on da Vinci procedure volumes.

Sunnyvale, California–based Intuitive said last week that it earned $308 million, or 85¢ per share, off $1.52 billion in revenue for the quarter ended June 30, 2022, representing a 40% bottom-line slide and a top-line gain of 4% compared with the same quarter a year ago.

Adjusted to exclude one-time items, earnings per share were $1.14, a nickel behind The Street, where analysts were looking for EPS of $1.19 on sales of $1.56 billion.

Worldwide da Vinci procedures were up 14% year-over-year in Q2 — but system placements were down 15%.

During a conference call with analysts, Intuitive officials said that trade-ins of da Vinci robots are significantly down because there’s a lower volume of older-generation systems out there. Supply chain disruptions, especially in the semiconductor space, negatively affected the timing of system builds to meet orders. Hospitals, meanwhile, are feeling pressures on their spending, looking to achieve more efficiency gains off existing capital equipment before acquiring more.

Intuitive CEO Gary Guthart said customer demand for procedures was healthy in the second quarter despite a challenging global environment that included COVID-19 lockdowns in the company’s second-largest market — China. “The leading indicator of the health of our business, procedure demand, remains healthy,” he said.

Work continues on next generations of Intuitive’s robotic systems, though Guthart noted that deeper technological opportunities and clinical impact also mean deeper validation work.

“And we’re not afraid of that work. I’d rather do things that are really clinically meaningful for the customer. … So it’s taking a little longer to get to market than it used to, maybe more than a little, it’s costing us more to get there. But that change in environment also means that really well-designed systems probably have longer useful life in the field. And I think we’re starting to see that early evidence of that as well.”

Investors reacted by sending ISRG shares down more than 12% to $197.49 apiece in after-hours trading. By the middle of the next day, they were just down more than 5% to $212.48 apiece.

BTIG analyst Ryan Zimmerman walked away from Intuitive’s evening’s earnings call weighing two divergent assertions that seemed obvious in hindsight: Robotic surgery procedures remain solid as customers increase utilization, but the hospital capital expenditure environment is worse than expected.

“We are maintaining our Buy as we think the sell-off will be bought up by [long-term] investors coupled with ISRG’s own share buybacks and on the potential for a next-gen system launch. We think these are the catalysts needed to get shares working again.”

Editor’s Note: This article first appeared on sister website MassDevice.

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The Mazor X Stealth robot-assisted surgical system. Source: Medtronic

A former Mazor Robotics VP is among three businessmen facing federal insider trading charges and an SEC lawsuit over stock trades leading up to Medtronic’s $1.6 billion acquisition announcement in 2018.

Ron Tavlin was Mazor’s VP of business development from 2017 to 2019. Before that, he’d been a paid consultant for Medtronic. The U.S. Attorney’s Office in Minnesota and the SEC claim Tavlin tipped off his friend Afshin Farahan about the impending deal in 2018, and that Farahan then bought Mazor stock and tipped off friend David Gantman to buy more Mazor stock as well as call options.

Farahan and Gantman made a profit of about $500,000 off the allegedly illegal trades, according to authorities. More than a year late, Farahan gave Tavlin a $25,000 check.

Federal prosecutors also claim that when the Financial Industry Regulatory Authority (FINRA) reached out to Tavlin after the trades with a list of people and entities that had bought Mazor stock, Tavlin said he didn’t recognize any names — even though Farahan and Gantman were on the list.

Tavlin’s attorneys, Matt Forsgren and David Wallace-Jackson, told the Star Tribune of Minneapolis that Tavlin looks forward to telling his side of the story and that the government has drawn “every conceivable inference” against him.

Editor’s Note: This article was republished from sister website MassDevice.

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Moon Surgical (Paris and San Francisco) announced today that it has raised $31.3 million in Series A funding to expand its team and accelerate the development of its Maestro robotic surgery system.

GT Healthcare Capital & Partners led the round. There was also participation from  Johnson & Johnson Innovation – JJDC, Cathay Health — and existing investors including Sofinnova Partners and medtech leaders including Yann Fleureau, Siddarth Satish, Sacha Loiseau and Richard Leparmentier.

“At Moon Surgical, our ambition is to revolutionize minimally invasive surgery through the power of collaborative and adaptive robotics. Our Maestro System can be used in any laparoscopy, in any operating room,” said Anne Osdoit, CEO of Moon Surgical and a partner in Sofinnova Partners’ medtech accelerator, MD Start.

“We are excited to work with our new partners at GT Healthcare, Johnson & Johnson, and Cathay Health as we enter the next stage of our company’s evolution,” Osdoit said in a news release.

The two-year-old company said it has early fully functional systems and driven by more than 30 surgeons across two continents and multiple clinical indications. The company’s goal behind Maestro is to have a system that is small, adaptable and integrated into existing clinical workflows.

“We share the vision of Maestro’s data-driven capabilities in underserved laparoscopic procedures, and hope to support its path in making robotic surgery accessible across all geographies,” said Alan Au, managing partner of GT Healthcare. He is joining Moon Surgical’s board.

Dr. Steve Oesterle, a former Medtronic SVP and venture partner at Cathay Health, said Maestro is about democratizing control during surgery. “We’re all very eager to support this global business in its development so that it can rapidly be used in many surgeries.”

Oesterle and Intuitive co-founder Dr. Fred Moll, chief development officer of J&J’s Auris Health, will serve as Moon Surgical board advisors.

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Creo Medical Group has signed a multi-year collaboration agreement with Intuitive to make certain Creo surgical technologies compatible with the surgical robotic giant’s systems.

The London exchange reacted by sending CREO shares up more than 4% to 100 pence apiece by the close of trading today. As of midday in New York, ISGR shares are up slightly to $221 apiece on the Nasdaq.

Based in the U.K., Creo is developing and commercializing a suite of electrosurgical medical devices. Its patented Kamaptive technology combines adaptive bipolar radiofrequency (RF) and super high-frequency microwave energy in the CROMA advanced energy platform. Kamaptive can dynamically adapt to patient tissue during procedures such as resection, dissection, coagulation and ablation of tissue, according to Creo.

The agreement with Intuitive outlines how the companies will conduct joint clinical studies and includes a number of milestone payments to be made to Creo, amounts undisclosed. The agreement also includes royalty structures for any products that arise in the future from the collaboration.

Creo Medical also announced it brought in £25.2 million ($34.7 million) in revenue in 2021, nearly triple the £9.4 million ($13.0 million) in sales it saw in 2020. Operating loss widened 27% to £29.9 million ($41.2 million) .

“The combination of Intuitive’s robotic platforms and our Kamaptive Technology strives to provide patients with additional treatment options using state-of-the-art technology. The collaboration highlights the versatility of Creo’s technology whilst validating the hard work that has been undertaken by Creo’s engineering team to bring advanced energy to the field of surgical endoscopy,” Creo CEO Craig Gulliford said in a news release.

Gulliford later added: “As well as exploring technical compatibility, our teams have agreed on commercialization terms, including clinical and regulatory fundamentals in an open and collaborative environment, to establish what we hope to be a long-lasting collaboration centered around shared goals of using thoughtfully developed technology to help improve patient outcomes.”

Editor’s Note: This article first appeared on sister website Medical Design & Outsourcing.

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A Delaware judge denied Johnson & Johnson’s motions to dismiss a fraud lawsuit filed by former shareholders of Auris Health. The lawsuit alleges that J&J executives misrepresented their intentions for the robotic surgery company when it acquired Auris Health for $3.4 billion in 2019.

Acting as the representative of the former Auris shareholders, Fortis Advisors sued in 2020 after the medtech giant released reserves related to the additional $2.35 billion in milestone payments that were part of the agreement.

J&J, its Ethicon subsidiary and top corporate officers violated the merger agreement and made false promises during negotiations, according to the lawsuit.

Vice chancellor Lori W. Will in Delaware, in a December 13 order, allowed more than half of Fortis Advisors counts against J&J to proceed, though she dismissed claims against individual J&J executives on jurisdictional grounds.

Surgical robotics is a hot space in medtech. As a result, many companies, large and small, seek to take on the dominant surgical robotics company, Intuitive.

Founded and run by Intuitive co-founder Dr. Fred Moll, Auris was a rising star in surgical robotics with its FDA-cleared Monarch platform and its in-development iPlatform. Moll saw iPlatform as a next-generation successor to Intuitive’s da Vinci robots that dominate the space, according to Will’s description of the case.

Meanwhile, J&J’s Ethicon surgical instruments business found itself increasingly challenged by the rise of robotic surgery. It sought to compete against Intuitive through a partnership with Google’s sister company Verily called Verb Surgical. However, questions about the Verb Surgical robot grew inside J&J, according to Will’s relating of Fortis’ claims.

A separate J&J subsidiary from Ethicon had already invested in Auris, and top J&J executives began arms-length negotiations with Moll and his team in December 2018 to acquire the company. Over the two months of talks, Moll and his colleagues were led to believe that Auris would be able to run independently of Verb after the acquisition, according to Fortis Advisors.

Fortis now alleges the Auris team was subjected post-acquisition to a covert “bakeoff” with Verb Surgical that diverted employees and resources. After the iPlatform won out over the Verb Surgical robot, Ethicon bought out Verily stake in Verb and rolled Verb into Auris, according to Will’s recounting.

“Fortis alleges that the purported bakeoff and the defendants’ restrictions on Auris’s hiring and expansion needs began immediately upon closing,” said Will. “A reasonable inference can be drawn that the defendants planned those actions during negotiations. Fortis has also alleged that the defendants’ post-closing intentions during negotiations, which were inconsistent with the defendants’ statements, were known to the defendants and within the defendants’ — rather than Auris’s — control.”

J&J has denied wrongdoing in the matter, claiming that other factors such as the pandemic delayed Auris from reaching its milestones.

Meanwhile, Moll remains at J&J as its chief development officer for surgical robotics. J&J recently announced a two-year delay in developing the team’s robot, now called Ottava, which may not see human clinical trials until the middle of the decade. The delays come even as another medtech giant Medtronic moves forward with its Hugo robot to compete against Intuitive.

Editor’s Note: This article first appeared on sister publication MassDevice.

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Vicarious Surgical will go public through a $1.1 billion special purpose acquisition company (SPAC) deal, the robotic surgery pioneer announced. Vicarious, which has sought to bring robotics and virtual reality to minimally invasive surgery, will trade on the New York Stock Exchange under the symbol RBOT after the merger with D8 Holdings.

Hong Kong–based D8 Holdings’ acquisition of Vicarious Surgical will add more than $425 million in cash to Vicarious’s balance sheet upon the deal’s close, including a $115 million private investment in public equity (PIPE) priced at $10 per share. Pipe investors include strategic investor BD, new institutional investors and existing investors including Bill Gates, Vinod Khosla’s Khosla Ventures, Eric Schmidt’s Innovation Endeavors, and Philip Liang’s E15 VC.

The move comes nearly a year and a half after the FDA provided breakthrough device designation for Vicarious’ robot, which includes features such as arms that replicate human motion. The system boasts 9 degrees of freedom per arm with 360-degree visualization, all through a 1.5 cm incision.

The Charlestown, Mass.–based company is among a dozen companies that are significant players in the robot-assisted surgery space.

“Our robot can see, reach, and work anywhere inside the abdomen, which effectively shrinks the surgeon and puts her/him inside the human body,” Vicarious Surgical co-founder and CEO Adam Sachs said in a news release touting the SPAC deal.

“Our system fits through a standard door, making it portable from operating room to operating room, and does not require a large footprint or facility construction build-out,” Sachs said. “With cost of goods that are significantly lower than competing products, we believe our robotic solution will offer a cost-effective path to improving patient outcomes and increasing the efficiency of surgical procedures for hospitals and ambulatory surgical centers.”

Sachs described Vicarious Surgical in more detail in a recent appearance on the DeviceTalks Weekly podcast, which is produced by The Robot Report‘s sister publication MassDevice. You can listen to that podcast below:

SPACs have become a hot investment mechanism in robotics, medtech and other industries as the U.S. emerges from the COVID-19 pandemic and resulting recession.

Former Medtronic CEO Omar Ishrak, former Verb Surgical and Volcano Corp. CEO Scott Huenneken, and former iRhythm COO Karim Karti — among others — are each chairing their own SPACs as they look for attractive acquisition targets to take public.

Donald Tang, the co-founder and president of D8 Holdings, is a major private equity figure in Hong Kong. D8’s CEO is David Chu, who founded and built Nautica into a significant lifestyle brand between 1983 and 2003.

Tang said that the D8 Holdings team was excited about Vicarious Surgical’s technology and capabilities and the positive feedback from surgeons and hospitals.

“We consider Vicarious Surgical to be a thought leader in the surgical space, and we believe the market is ready for surgical robots that drive efficiency and improved quality of patient care,” Tang said. “We are excited to work with the Vicarious Surgical team on the next phase of commercialization for their products, bringing what we believe is much-needed innovation and choice to patients and practitioners, both in the U.S. and abroad.”

Editor’s Note: This article first appeared on our sister publication MassDevice.

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