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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OrthoSensor’s Verasense intraoperative sensor (pictured) provides feedback to surgeons on soft tissue. The sensor could enhance Stryker’s Mako surgical robotics systems. | Credit: OrthoSensor

Stryker today acquired OrthoSensor and its Verasense intraoperative sensor technology that could enhance Stryker’s Mako robots. Financial terms of the deal were not disclosed.

Stryker officials in a news release noted that Verasense since 2011 has proved itself to be a unique knee balancing solution in Stryker’s Triathlon knee system, providing feedback to surgeons on soft tissue. Stryker said the sensor tech will further boost Mako surgical robotics systems, enhancing workflow through one complete data-driven feedback mechanism.

Additionally, OrthoSensor’s MotionSense remote patient monitoring wearables and mobile application, combined with the OrthloLogIQ cloud-based data platform, could enhance Stryker’s data analytics capabilities.

“Smart devices and implants will play a big role in orthopaedics and we are excited for OrthoSensor to join Stryker as we continue to innovate and advance smart sensor technologies, including intraoperative sensors, wearables and smart implants across our joint replacement business,” said Spencer Stiles, Stryker’s group president of Orthopaedics and Spine.

Related: Stryker strives for market share in orthopedic surgery robots

“Patient recovery will become more active as real-time measurement on key performance insights drive improved outcomes and patient satisfaction,” Stiles said.

It is unclear how the deal will impact strategic partnerships OrthoSensor has had with Stryker competitors Smith+Nephew and Zimmer Biomet.

Kaila Krum, David Rescott and Samuel Brodovsky, analysts at Truist found, it interesting that the deal comes not long after Zimmer Biomet announced a partnership with Canary Medical, with plans to launch smart implants later this year. “Overall, the trend certainly seems to be pointing in the direction of greater data integration into surgery, which should add momentum to novel technologies in the industry.”

Stryker acquired MAKO Surgical for $1.65 billion back in September 2013. In 2019, Stryker acquired both Mobius Imaging and its subsidiary Cardan Robotics for $500 million. Mobius developed point-of-care imaging technology. Its Airo TruCT scanner offers mobile, real-time imaging. And Cardan Robotics was developing robotics and navigation technology systems for surgical and interventional radiology procedures.

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

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Think Surgical’s TSolution One robotic-assisted surgical system for total knee application.

The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the second generation of Think Surgical‘s TSolution One total knee application. The TSolution One is an active robot for total knee replacement. It includes fully automated bone preparation and provides surgeons a choice of implant options.

The newly-cleared version of the system features includes an enhanced pre-surgical planning user interface, quick-change tooling, improved surgeon accessories, and advanced bone model generation, according to Think Surgical.

FDA cleared the first generation of the robot more than a year ago. Based in Fremont, Calif., Think Surgical raised a funding round worth $134 million in March 2019.

“The ongoing evolution of the TSolution One total knee application is a testament to Think Surgical’s dedication and investment in advancing the use of robot technology in the orthopedic setting,” said Think Surgical’s acting CEO Jay Yang said in a news release. “The versatile, open platform provides surgeons with the flexibility of using a variety of implants, while offering hospitals and ambulatory surgery centers a sustainable, high throughput system for their ever-increasing total knee replacement procedures.”

In other healthcare robotics news, Johnson & Johnson (J&J) yesterday shared details about its new Ottava surgical robotic platform. The Ottava system has six arms to provide more control and flexibility in surgery, while its arms will be integrated into the operating table. J&J claimed Ottava has a zero-footprint design to enable patient access, increase space in the operating room, and improve workflow. J&J acquired Auris Health in 2019 for $3.4 billion and brought on Dr. Fred Moll as its chief development officer.

Robot-assisted surgery is currently a hot area in medical technology, with J&J, Medtronic and others seeking to take on Intuitive Surgical, whose da Vinci robot is the market leader. J&J claimed that Ottava will offer more flexibility than any currently available system.

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Faster, smaller and more accessible — those are the three descriptors that Sara Schneider uses to describe the CORI robotic knee surgery system, which Smith+Nephew launched over the summer.

As the director of robotics program management at the company, Schneider faced the challenge of making the design and engineering choices behind Smith+Nephew’s next-generation surgical robot.

The CORI robot is a big deal for Smith+Nephew because ortho surgical robotics is a hot area for medical technology, even as the COVID-19 pandemic forces healthcare systems to scale back elective procedures.

Stryker has enjoyed a great deal of success with its Mako robots, and Zimmer Biomet is seeking to compete with its Rosa systems. Smith+Nephew is making a bet with a system that isn’t the size of a mini-fridge with an arm, that doesn’t rely on pre-operative imaging, and that includes a handheld cutting tool that can fit a particular surgeon’s techniques.

“There’s more flexibility in the approach when you have that handheld piece that’s not anchored into this mammoth piece of equipment,” Schneider said. “I think that the next few months, if not the next few years, will really show us how beneficial that technology is in the hands of surgeons.”

Schneider brings experience to Smith+Nephew

Schneider is an engineer who grew up in Boston. She got involved in ortho surgical robotics after she and her husband moved to Pittsburgh and she took a job as a program manager at Blue Belt Technologies, creator of the Navio robotics system. After Smth+Nephew acquired Blue Belt and its Navio system for $275 million in 2016, Schneider gained a reputation as an organized manager who could keep the many moving pieces of a project on track. She rose through the ranks to become director of robotics program management.

The Navio system had all of the basic ingredients that would eventually go into the CORI. Instead of using pre-planning and imaging to guide the robot, the surgeon places small, reflective discs at strategic places around the surgery site. The discs bounce back infrared light to optical cameras that serve as a tracker.

Once the system has registered the key parameters of the surgery site, the surgeon uses a pointer tool to digitally “paint” over the bone surface that needs to be removed. The surgeon then uses a handheld cutting tool that has a robotic feature that automatically halts the spinning of the tool’s burr if it’s outside the painted area.

“The way that we described this very simplistically is that you could almost perform this surgery with your eyes closed. As long as the surgeon is bringing it close enough, the system will decide, ‘Am I going on or off?’” Schneider said.

The Navio system was a good start for Smith+Nephew. But after a few years on the market, company officials decided it was nearing its intended life from a design standpoint.

Smith+Nephew made a faster surgical tool (center) and a console (bottom) that was the size of a large book when creating the CORI surgical robot. Optical cameras (top) track the procedure so the tool’s burr automatically stops spinning when it is outside of the operating area. Source: Smith+Nephew

Creating CORI

To create the next-gen CORI system, Schneider’s team focused on making the surgical tool faster and reducing the overall size of the system so that it could easily go into the outpatient centers that are increasingly becoming popular for orthopedic surgeries.

The new handpiece, according to Schneider, is significantly faster in terms of bone removal and cutting efficiency — reducing surgical time so that the patient has less time under anesthesia and the surgeon can manage their practice more efficiently.

“We had to make a lot of design decisions about, ‘How are we going to design this handpiece? What optical camera are we going to use? What are the specifications of the CPU (central processing unit) that we’re going to use to achieve those specifications that we’ve set for ourselves?’” Schneider said.

The CORI system is about a quarter of the size of the Navio. While the Navio system stood 3 ft. off the ground, CORI’s console is the size of an Oxford English Dictionary volume and sits on a table.

“I’m working with the technical team and the marketing team to say, ‘How do we meet this user need? How do we compress all of the electronics that we had in Navio into this small console that that’s really more desirable from an OR [operating room] standpoint?’” Schneider said.

“We had a lot of discussions about, ‘How can we still maintain an ergonomic and aesthetically pleasing console shell without taking up a significant amount of space?’ There are trade-offs between product specifications — performance versus size versus cost of goods. There was a lot of putting our heads together and figuring out, ‘How can we balance all of those inputs to give the user the most valuable product?’”

Fortunately, electronic components technology had progressed enough in just a few years that Schneider and her colleagues had more advanced, compact components to swap into the CORI’s design.

“I’ll credit the engineers for just the layout of all the components. There’s a lot that goes into designing how they all stack amongst one another,” Schneider said.

Now that the CORI system is launched for knee applications, Schneider and her colleagues are looking to expand the platform to surgeries on hips and other joints. They’re also looking at additional attachments and accessories to improve user experience, and there’s the prospect from an R&D standpoint of packing in more artificial intelligence capabilities down the road.

“There’s no shortage of work, and we’re excited about what’s to come,” Schneider said.

Sara Schneider, director of robotics program management at Smith+Nephew

Women in medtech

Schneider recalled that when she joined Blue Belt Technologies in 2014, she was one of only a handful of women in the Pittsburgh facility. These days, about a third of the employees in the robotics group are women — a development Schneider credits to Smith+Nephew’s dedication to hiring women and running robust mentorship programs. Half of Schneider’s eight direct reports, in fact, are women.

“If you hire a lot of people that have the same viewpoints and opinions, you’re not going to have folks challenge one another. And when that starts to happen, you don’t end up with the most superior product,” Schneider said. “When I’m looking at hiring people again, I’m thinking about, ‘How can I bring in a new person with a new viewpoint that can challenge the voices that we already have on our team?’”

Editor’s note: For more information about medical technology, visit Medical Design and Outsourcing, a sibling publication to The Robot Report.

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Titan Medical Inc., which has been developing the Sport surgical robot, this week announced that it has received two U.S. patents. One is for methods for positioning a camera during a surgical procedure, and the other covers a gesture-control system. The Toronto-based company said its global intellectual property portfolio now includes 58 issued patents and 84 patent applications. It said it expects to be issued 17 other patents in the coming months.

Sport is a single-port robotic system for minimally invasive surgery. It consists of a surgeon-controlled patient cart with a dual-view camera system and 3D and 2D high-definition vision systems and multi-articulating instruments. Sport also includes a surgeon workstation that provides an ergonomic interface to the patient cart and a 3D high-definition endoscopic view of the procedure. The company said it plans to initially pursue gynecologic surgeries.

After pausing development last November because of fundraising challenges, Titan Medical partnered with Medtronic PLC and resumed work this past summer.

Sport maker patents vision, hand controls

U.S. Patent No. 10,772,703, titled “Methods and apparatuses for positioning a camera of a surgical robotic system to capture images inside a body cavity of a patient during a medical procedure,” is directed at the autonomous positioning of a camera in response to the location of a surgical instrument.

The second patent, No. 10,758,311, titled “Hand controller apparatus for gesture control and shared input control in a robotic surgery system,” is for a novel robotic hand controller with an integrated gesture-control pad used to control one or more robotic functions, including a camera.

Titan Medical said the notices of allowance cover various aspects of robotic surgery instrumentation, autonomous error correction, imaging sensors, visual illumination, graphical user interfaces, and sterile barriers. It also said they include a range of countries and regions including the U.S., Europe, China, Japan, Australia, and Canada.

“I commend Jasminder Brar, our vice president of legal, IP, and strategic initiatives, for his leadership and foresight in formulating an intellectual property strategy that continues to create significant value for Titan’s stakeholders,” stated David McNally, president and CEO of Titan Medical. “As evidenced by our recent strategic announcements, intellectual property is fundamental to Titan’s success, providing a foundation to product commercialization, mitigating against certain risks, protecting the company’s innovations and facilitating value creation.”

“While we are always excited to obtain new patents and allowances, the issuance of these recent patents is especially exciting, as they relate to human-machine interaction, an area where we have paid special attention in advancing the ergonomic friendliness of medical robotics based on feedback from surgeons,” McNally said.

Editor’s note: For more information on medical devices, visit MassDevice.com, a sibling site to The Robot Report.

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CEO Geoff Martha has plans including the Hugo system, which includes a tower, a surgeon console, end effectors, and robotic arm carts. Source: Medtronic

In the four months since Geoff Martha became CEO of Medtronic PLC, he has laid out ambitious goals for what claims to be the world’s largest medical device company.

During Dublin, Ireland-based Medtronic‘s first-quarter earnings call this week, the new CEO said the company’s management will outline plans in the coming weeks for a “new Medtronic” that is more nimble and competitive. Martha touted the pipeline of products the company has built, saying that it was time to play offense and expand market share now that the pipeline is kicking in.

“We’re determined to make this pipeline count, not just for patients, our customers, but [also] for shareholders,” said Martha. He later added: “Over time, longer-term, we want to put the ‘tech’ in medtech. And we want to shift, we want to pool in some of these digital technologies to change our offerings.”

In a research note, Raj Denhoy and other Jefferies Financial Group Inc. analysts described Medtronic’s (NYSE:MDT) strategy as “turning the battleship.”

“It is certain to remain a debate: Can MDT, which has been struggling to consistently achieve even 5% growth the past several years, hope to sustainably grow faster?” they wrote. “How will that be married against profitability? The pipeline is full, and recent acquisitions set MDT on the right footing, making execution the linchpin.”

Martha outlined several technologies that could be key to Medtronic’s growth.

Medtronic pursues lead in robotic surgery

The Jefferies analysts said they expect Medtronic’s minimally invasive therapies group to lead and perform better than the company’s average. A key to the group’s strategy is Medtronic’s new Hugo system, which is intended to rival Intuitive Surgical Inc.‘s da Vinci SP.

Martha said this week that his company has been able to manage through previously disclosed disruptions related to COVID-19 — as well as resolving software issue. The plan is to file for a CE Mark in Europe and an Investigational Device Exemption from the U.S. Food and Drug Administration in early 2021.

“We’re going to be a meaningful player in this market. Go big or go home,” Martha said.

Titan Medical Inc. has also entered into an agreement with Medtronic to advance the development of robot-assisted surgical technologies.

In the orthopedics space, Medtronic is looking to add enhancements to its Mazor X spinal robotic system.

Martha sets sights on surgical AI

Medtronic is looking to further enhance its robotic surgery play after its acquisition earlier this year of surgical artificial intelligence company Digital Surgery.

“We’re integrating their technology into our soft-tissue, robotic-assisted surgery system and also intending to use their surgical video management and clinician decision-support solutions beyond robotics,” said Martha. “In fact, we plan on a limited launch this fall for the Touch Surgery Enterprise, which is an extremely easy-to-use, surgical video-capture solution, paired with a computer and connected to the cloud.”

Medtronic also has a pending purchase of Medicrea International, whose technology incorporates AI into surgical planning for spine cases. It then uses those plans to create personalized spinal implants.

“With Medicrea, Medtronic will be the first company to offer an integrated spine surgery solution that includes AI-driven surgical planning, personalized implants, and robotic-assisted surgical delivery,” Martha said. “This further extends our competitive advantage in Spine.”

For the other five innovations that Medtronic plans to use to drive its industry leadership, visit MassDevice, a sibling site to The Robot Report.

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