Intuitive remains the dominant surgical robotics company, but corporations ranging from Medtronic to Vicarious Surgical look to compete.Robotic-assisted surgery remains one of the hottest spaces in medtech. Intuitive, which pioneered the field in the 1990s and early 2000s, continues to innovate. At the same time, a host of other companies are looking to compete.
Companies making headlines in the robotic surgery space over the past year include:
|Intuitive Surgical||Da Vinci Xi, Da Vinci X, Da Vinci SP, Ion|
|Johnson & Johnson||Monarch, Velys, Ottava|
|Siemens Healthineers’ Corindus||CorPath GRX|
|Vicarious Surgical||Beta 2|
|Stereotaxis||Genesis RMN, Vdrive, Niobe|
Here is the latest news on some of the most notable companies in robotic surgery:
Intuitive Surgical: Work continues on next-gen robotsIntuitive is best known for its da Vinci surgical robotics system. But there is a buzz around its Ion system, with its fully articulating catheter making its way through the lungs for cancer biopsy. Watch out for even more from Ion down the road. For example, Intuitive has obtained German regulatory approval for a clinical study of Ion ablation technology.
During a keynote interview at October’s DeviceTalks West in Santa Clara, California, Guthart said there could be even further opportunities for the Ion technology down the road: “It opens up opportunities for tubular structures outside the lung as well. I think over time, that opportunity will grow.”
Meanwhile, work continues on the next generations of Intuitive’s robotic systems.
Guthart acknowledged during the company’s Q2 earnings call 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.”
Founded in 1995, Intuitive remains the dominant company in the robot-assisted surgery space with its Da Vinci robots. But it is facing challenges. For example, trade-ins of da Vinci robots are significantly down because there’s a lower volume of older-generation systems out there. There are also supply chain disruptions impacting the timing of system builds. Meanwhile, hospitals are feeling pressure on their spending.
Medtronic: Doing a limited market release with HugoMedtronic (NYSE:MDT) announced in October that it received three significant global market entrance and indication expansion approvals for its Hugo surgical robotics system.
The Fridley, Minnesota-based company won CE mark clearance for general surgery indication, Health Canada license for general laparoscopic surgery indication, and Ministry of Health, Labor and Welfare approval for urologic surgical and gynecological laparoscopic indications in Japan.
The new indications and approvals enable access to robotic-assisted surgery in Europe, North America and Asia to extend the benefits of minimally invasive surgery.
Hugo represents the medtech giant’s bid to take on Intuitive in the space.
The FDA granted Hugo an investigational device exemption approval last year. Bob White, EVP and president of Medtronic’s Medical Surgical Portfolio, said in August that the company planned to commence the resulting pivotal trial soon.
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.
As Medtronic VP of Marketing for Surgical Robotics Mike Stow related at DeviceTalks Boston in May: “We looked at the current state of robotics going back 10-plus years, and we realized there was an opportunity for us to come in. Customers were saying, ‘Hey, could you make something more flexible that fits better into our rooms and into our hospital setting?’”
In the robotic spine surgery space, Medtronic competes with its StealthStation navigation, O-arm, and Mazor systems.
Johnson & Johnson: Questions about OttavaThe last time Johnson & Johnson management mentioned Ottava in an earnings call was in January.
“We recognize that we will have to continue to be committed to developing Ottava and entering into the general surgery market with a highly competitive offering. And we are working through that as soon as possible, and we will provide updates as we progress,” J&J CEO Joaquin Duato said during the company’s Q4 earnings call, transcribed by The Motley Fool.
A company statement shared with MassDevice in August 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.”
Meanwhile, 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 won a new 510(k) in May.)
J&J acquired Auris in 2019 for $3.4 billion. The Fortis lawsuit alleges that the Auris team was subjected post-acquisition to a covert “bakeoff” with Verb Surgical, the joint venture that J&J had with Google sister company Verily. The internal competition diverted employees and resources, according to the lawsuit.
J&J describes the lawsuit as “wholly without merit.”
Despite the questions about Ottava, Monarch continues to advance. The recent 510(k) for urology opens it to the kidney stone treatment space. Company officials in April said Monarch-enabled procedures have exceeded 14,000 since launch.
In the ortho robotic surgery space, Velys system procedures are over 2,000, company officials added. J&J’s DePuy Synthes orthopedic device business boasts that Velys is a first-of-its-kind, table-mounted ortho surgery robot with an efficient design that integrates into any operating room. (DePuy Synthes officials discussed Velys during a DeviceTalks Weekly podcast in January.)
Stryker: Mako sales remain strongDespite increased competition in the robotic orthopedic surgery space from J&J’s DePuy Synthes, Zimmer Biomet and Smith+Nephew, Stryker is still enjoying strong Mako sales.
Mako sales were up 19% year-over-year in Q2 2022. But by the third quarter, company officials reported soft installation levels amid delays stemming from variability in the hospital environment. “However, our order book remains strong, and we expect a good fourth quarter for Mako,” Investor Relations VP Jason Beach said during the Q3 earnings call.
In addition, Stryker CEO Kevin Lobo noted good progress with the development of spine and shoulder applications for Mako.
Stryker in March announced the launch of its Insignia hip stem for total hip and hemiarthroplasty procedures. The Insignia stem is Mako-compatible.
Siemens Healthineers’ Corindus: A new headquartersCorindus is the creator of the CorPath GRX system. The company describes the CorPath GRX as the first and only FDA-cleared and CE-marked medical device for robotic-assisted coronary interventions. The system has also enabled Corindus to be a pioneer in telerobotic surgery.
Siemens Healthineers acquired Corindus for $1.1 billion in 2019.
In April, Corindus announced the opening of its new Newton, Massachusetts headquarters, which at 77,000 ft² is more than twice the size of its former headquarters in Waltham.
The production area alone tripled in size to 25,000 ft². Corindus designed the production space to facilitate the flow of materials through the building. The 6,000 ft² R&D space is also three times larger than at the previous headquarters.
Vicarious Surgical: Moving forward with next-gen robotVicarious Surgical (Waltham, Massachusetts) recently announced that it continues to progress in developing its Beta 2 surgical robotics platform. The company plans to showcase the finalized system in early December.
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. Updates to the previous Beta 1 system focus on ergonomic changes for surgeon comfort and improved 3D visualization, sensing and motion capabilities.
“During the third quarter, our team completed the integration phase of the Beta 2 system build, and I’m incredibly encouraged by the results of our cadaveric testing,” CEO Adam Sachs said in the company’s Q3 earnings release.
Titan Medical: Manufacturing of Enos system to start later this yearToronto-based Titan Medical announced on Aug. 11 that it expects manufactured units of the Enos robotic-assisted surgery system to become available later this year.
Enos has a light, camera and multiple arms that drive instruments by the tableside. Instead of multiple arms coming from multiple directions and through multiple incisions, the arms, instruments and camera enter the patient’s body through a single 25 mm insertion tube.
The company said it has been in an ongoing dialogue with FDA through the agency’s Q-Submission program. Titan plans to apply for an investigational device exemption (IDE) in mid-year 2023. The initial target indication is benign gynecologic surgical procedures. In June, the company announced that “multiple disruptions” pushed its IDE submission timeline to mid-2023 from the previously slated first quarter of 2023.
An FDA response would then follow that submission 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.
Titan aims to launch Enos commercially in early 2025 after securing a De Novo market authorization from the FDA.
It’s been a busy year for Titan outside of Enos, with Cary Vance coming in as president and CEO this summer. The company is still working to regain compliance with the $1 minimum bid price requirement on the Nasdaq exchange.
Asensus Surgical: New installations clouded by RussiaResearch Triangle Park, North Carolina-based Asensus (formerly TransEnterix) has been making waves, both in the U.S. and abroad.
Asensus is looking to expand the use of its Intelligent Surgical Unit (ISU) with plans for a full-scale commercial launch of 5 mm articulating instruments by the end of 2022. It’s also submitted a 510(k) application for pediatric clearance.
So far this year, Asensus has initiated five new Senhance programs: three in Germany, one in Japan, and one in the Commonwealth of Independent States, which includes Russia and many other republics of the former Soviet Union. There were 1,900 procedures performed during the first nine months of 2022, up 27% from last year.
Moon Surgical: A disruptor in robotic surgery?Moon Surgical is the Paris– and San Carlos, California–based surgical robotics company developing the Maestro system. Call the Maestro a robotic surgical assistant — it’s designed to be small, adaptable and integrated into existing clinical workflows.
CEO Ann Osdoit said in a June announcement of Moon Surgical’s $31.3 million Series A fundraising that the company is looking to make the Maestro system capable of being used in any laparoscopy in any operating room, revolutionizing minimally invasive surgery through collaborative and adaptive robotics.
With Maestro, the surgeon is still in the operating room performing the actual surgery, but the system’s arms assist the surgeon in properly moving tools and locking them into place. It could especially be helpful in short-staffed operating rooms.
“It’s a simple device that is going to be integrated well into the clinical workflow,” Osdoit said during a DeviceTalks Weekly interview that aired June 22.
Alan Au, managing partner at GT Healthcare, which led that fundraising round, said at the time that the Maestro system’s data-driven capabilities in underserved laparoscopic procedures could make robotic surgery accessible across all geographies.
The company has further backing from one of the biggest names in surgical robotics, with Intuitive co-founder Dr. Fred Moll serving as a board advisor.
Momentis Surgical: Rebrand follows first U.S. procedures
Momentis Surgical — formerly Memic Innovative Surgery — developed the first and only FDA-authorized surgical robot that features miniature humanoid-shaped arms, with shoulder, elbow, and wrist joints that provide high dexterity and unprecedented articulation.
The company’s Anovo system, previously called “Hominis,” is indicated for use in robotic-assisted transvaginal benign surgical procedures. Uses include benign hysterectomy, salpingectomy, oophorectomy, adnexectomy, and ovarian cyst removal.
It’s possible to introduce multiple instruments into the body through Anovo’s single portal, and the robotic arm articulation offers optimal access and working angles.
Tel Aviv, Israel-based Momentis announced in June that the first U.S. patient procedures were completed with Anovo for robotic-assisted transvaginal hysterectomy.
Virtual Incision: To infinity and beyond…While some surgical robots operate in the U.S., others operate around the globe. Virtual Incision’s robot will go beyond even those geographies.
Through a NASA grant, Virtual Incision’s MIRA platform will be used in a technology demonstration aboard the International Space Station. The Lincoln, Nebraska-based outfit’s miniaturized robotic-associated surgery (RAS) platform will be used on NASA’s 2024 technology demonstration mission.
MIRA includes a small, self-contained surgical device inserted through a single midline umbilical incision in the patient’s abdomen. It allows for complex, multi-quadrant abdominal surgeries utilizing existing minimally invasive tools and techniques familiar to surgeons.
The platform received IDE approval in October 2020, then won approval for an IDE supplement in April. Last year, the company completed a $46 million Series C financing round to support the surgical robot platform.
Stereotaxis: New headquarters highlights progressStereotaxis 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-based company’s technology has treated more than 100,000 patients worldwide. In March, Stereotaxis opened a new 45,000-ft² headquarters facility in the renovated historic Globe Building in St. Louis’s Downtown North Urban Insight District.
Stereotaxis also added industry veterans to its executive team, with former Intuitive director Frank Van Hyfte and former Acutus Medical VP Tim Glynn joining this summer.
Stereotaxis had positive news during its recent Q3 earnings report:
- The CE mark submission of the MAGiC ablation catheter successfully passed a completeness check by the notified body. It’s in the midst of its technical review.
- There is progress in the development of the accessible next-generation robotic system. It remains on track for an initial launch next summer.
- Stereotaxis’ collaboration with MicroPort is advancing. Chinese regulatory submission of Stereotaxis’ Genesis system is coming soon.
Monteris Medical: New data supports robot-guided laser therapyMinnetonka, Minnesota-based Monteris designed its NeuroBlate minimally invasive surgical robot system for a controlled laser thermotherapy known as laser interstitial thermal therapy (LITT).
NeuroBlate uses MRI-guided laser light to ablate (destroy) brain lesions or unwanted tissue. Patients treated with NeuroBlate have had conditions including epilepsy, gliomas, brain metastases and radiation necrosis.
The company announced in October that it secured $73 million in financing: $35 million in new Series D raise and a $38 million debt facility.
Earlier this year, the company published data on 89 patients from the Laantern prospective, multi-center registry. The data demonstrated that LITT offers an effective alternative to traditional surgery for patients with newly diagnosed and recurrent glioblastoma while also delivering the benefits of a minimally invasive surgical procedure, including short recovery time and the reduced potential for side effects.
The paper’s lead author, Division Chief of Neuro-Oncology at the University of California San Francisco Weill Institute for Neurosciences Dr. John de Groot, called LITT “a critical tool for achieving maximal safe cytoreduction of the tumor.”
Zimmer Biomet: Happy with Rosa utilization uptick
Zimmer Biomet’s Rosa surgical robot has produced mixed results in terms of rentals compared to upfront sales, but the company maintains a positive outlook on the system.
EVP and CFO Suky Upadhyay said on the company’s second-quarter earnings call that installments remain strong and the company is “very happy with the continued uptick of Rosa and the utilization increases.”
COO Ivan Tornos added that Rosa represents a unique part of an ecosystem comprised of many parts and pieces. The integrated solution with pre-operation software through a partnership with Apple, for instance, creates a different offering in surgical robotics.
“If you go out there and ask physicians why — or payers, for that matter — why are they choosing Rosa other than the outcomes and the technology at play, they like the efficiency, they like the fact that our preplanning is easier, they’re seeing the outcomes,” Tornos said. “And I think those are the reason why we’re seeing the great momentum with Rosa.”
Last month, NeuroOne announced it received expanded FDA 510(k) clearance to market its Evo sEEG Electrode technology for temporary use with brain recording, monitoring and stimulation equipment. ZB has an exclusive development and distribution agreement with NeuroOne for its thin film technology. The plan has been that if NeuroOne secured the 30-day-use clearance from FDA for the Evo sEEG , ZB would sell it to neurosurgeons for use in its Rosa One Brain robot-assisted neurosurgery system.
Smith+Nephew: Cori still in early stages with ‘great potential’Smith+Nephew globally launched its Cori handheld surgical robot system last year and earlier this year added total hip arthroplasty to Cori’s offerings, having previously designed it for total knee arthroplasty.
On the company’s second-quarter earnings call, CFO Anne-Francoise Nesmes noted that Cori’s first assisted hip and cementless knee procedures were completed during the three-month period.
Last month, S+N announced the first knee replacement cases using the Cori system.
CEO Deepak Nath said the company sees “great potential” in Cori as a platform representing “a different paradigm.” He added that feedback from surgeons had provided a range of opinions, but the company is encouraged by early results.
“In Cori, we’ve got a platform that’s still in the early stages in terms of functionality and indications, but we’re adding to it … overnight,” Nath said. “That’s a change from the past where we now have a portfolio, and we’ve got enabling technologies to drive growth.”
The company first launched the Cori surgical system in 2020 in the U.S. after FDA clearance.
According to the company, Cori is a compact, fully mobile offering with a 3D intraoperative imaging system and an advanced robotic sculpting tool. The surgeon uses a pointer to digitally “paint” over the bone surface that needs removal. The surgeon then uses a handheld cutting tool that has a robotic feature. The robotic feature automatically halts the spinning of the tool’s burr if it’s outside the painted area.
EndoQuest: Scar-free surgery
The company’s Endoluminal Surgical (ELS) system is still in the investigational stage with no FDA clearance at this time. It offers enhanced dexterity to rival that of an actual surgeon, according to the company. ELS is also meant to perform an array of procedures through several natural orifices.
Associate editor Sean Whooley and senior editor Danielle Kirsh contributed to this report. This story originally ran on Aug. 19, 2022. Updated Nov. 14, 2022, with recent news.