The Genesis RMN System features flexible robotic arms holding Genesis magnets for increased system angulation and associated imaging angulation. | Source: Stereotaxis

Stereotaxis Inc. this week announced that its Genesis surgical robot has received regulatory approval in China. The company said the system delivers safe and precise cardiac ablation to treat arrhythmias.

Genesis uses small magnets that rotate along their center of mass, allowing for responsiveness to physician control. Flexible, rugged robotic arms hold the agents to increase the potential range of motion and allow for wider X-ray angulation, according to Stereotaxis.

Founded in 1990, Stereotaxis has developed surgical robots for minimally invasive endovascular intervention. The St. Louis, Mo.-based company said its systems can expand access to minimally invasive therapy and enhance the productivity, connectivity, and intelligence in the operating room.

China market

China’s National Medical Products Administration (NMPA) granted the approval to Stereotaxis and Shanghai MicroPort EP Medtech Co. for the Genesis robotic magnetic navigation (RMN) system. Stereotaxis said it marks a “significant milestone” as it expands access to minimally invasive robotic technology in China.

In 2021, the company inked a collaboration with MicroPort EP for distribution and commercialization in China.

“We are delighted to receive NMPA clearance for the Genesis System in China,” stated David Fischel, Stereotaxis chair and CEO. “This approval represents another key milestone as we establish the foundations for significant growth across key focus geographies. Our investment to advance the substantial innovations underscores our commitment to pioneering the frontiers of medical technology to improve the lives of patients with cardiovascular disease around the world.”

MicroPort EP plans to begin a full launch of Genesis through existing sales teams. The companies said the approval is a key element of their broader collaboration. That includes development, integration, and commercialization of Stereotaxis’ robotic system, robotically navigated catheters, and the MicroPort EP Columbus 3D mapping system.

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Stereotaxis marks recent milestones

Earlier this month, Stereotaxis announced that physicians at the University of Kansas Health System successfully treated its first patients with its Genesis system. The smaller RMN system can improve the patient experience, provide greater patient access, and increase lab space, said the company.

In August, Stereotaxis submitted its next-generation GenesisX system to the U.S. Food and Drug Administration (FDA) following its receipt of the CE mark in Europe. The company said its technology has been used to treat more than 150,000 patients around the world, including in Portugal and Italy.

In addition, a hospital in Kentucky performed the first procedures with the Genesis surgical robot late last year. Stereotaxis also has an ongoing collaboration with Abbott, which had milestone developments last fall.

Editor’s Note: This article was syndicated from The Robot Report sibling site MassDevice. Stereotaxis featured on its 2024 list of 10 surgical robotics companies to follow in 2024.

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The OEC 3D Imaging System. | Source: GE HealthCare

GE HealthCare Technologies Inc. last week announced that it has added new clinical applications to its OEC 3D mobile CBCT C-arm portfolio. The Chicago-based company said the additions will enable precise and efficient imaging during endoscopic bronchoscopy procedures in the practice of interventional pulmonology.

Complex pulmonary and thoracic procedures require precise intraoperative imaging systems, explained GE HealthCare. The position of a nodule can differ from pre-operative CT images, it noted. This happens as a result of differences in respiratory patterns, patient positioning, and other factors, resulting in CT-to-body divergence at the time of the procedure, said the company.

GE HealthCare claimed that its operational electronic chart (OEC) 3D intraoperative mobile cone beam computed tomography (CBCT) offers “imaging excellence” and versatility. It said it can aid in everyday procedures ranging from neuro-spine and orthopedic trauma to interventional procedures such as bronchoscopy.

OEC 3D enables the visualization of both 2D and 3D images of the lung using a single mobile C-arm. The lung suite now includes an augmented fluoroscopy overlay of 3D points of interest and adjustable motorized 3D scans.

OEC interfaces continue to expand

During bronchoscopy procedures, clinicians can use navigation or robotic assistance with the OEC Open interface to automatically transfer 3D volumetric data after reconstruction.

GE HealthCare recently added a verified interface with the Intuitive Ion endoluminal robotic bronchoscopy system. The company said it continues to expand OEC open interfaces for a variety of clinical procedures as an agnostic ecosystem. It’s currently verified with eight third-party systems across robotics, navigation, and augmented reality (AR) vision.

“As we continue to build out our OEC ecosystem, GE HealthCare is excited about the addition of the Intuitive Ion robotic system to our OEC Open interface,” said Christian O’Connor, global general manager for surgery at GE HealthCare. “This interface provides interventional pulmonologists using the OEC 3D C-arm a seamless experience during minimally invasive, robotic-assisted bronchoscopy procedures.”

“With Intuitive’s Ion Robotic Bronchoscopy System now verified to interface with GE HealthCare’s OEC 3D through the OEC Open interface, I believe we can now reach and diagnose almost any nodule in the lung,” stated Dr. Dominique Pepper. She is medical director of bronchoscopy and respiratory care at Providence Swedish South Puget Sound and a consultant for GE HealthCare.

“This is a game-changer for clinicians – this can help us confidently and accurately provide answers when we see a suspicious area of interest,” Pepper said.

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About GE HealthCare

GE HealthCare said it is a global medical technology, pharmaceutical diagnostics, and digital solutions innovator. The company said its integrated systems, services, and data analytics can make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. It said it is a $19.6 billion business with approximately 51,000 employees worldwide. 

First introduced in 2021, the OEC 3D mobile CBCT C-arm provides precise 3D and 2D imaging in a variety of procedures. During bronchoscopies, clinicians can use CBCT visualization features, such as Lung Preset, to help optimize viewing of airway structures and Augmented Fluoroscopy with Lung Suite to help confirm tool-in-lesion.

The OEC 3D enables a transition from 3D to 2D imaging through one versatile mobile CBCT imaging C-arm. GE said it includes an intuitive user interface and workflow to further optimize space in the bronchoscopy suite.

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

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While Johnson & Johnson has mostly kept its Ottava surgical robot under wraps, it said the system offers surgical teams the freedom and flexibility to adapt to clinical workflows and individualize patient needs. | Source: Adobe Stock

Johnson & Johnson MedTech announced today that the U.S. Food and Drug Administration granted its Ottava surgical robot investigational device exemption, or IDE.

The regulatory nod comes just under a month after the company said it submitted Ottava for IDE. It allows Johnson & Johnson MedTech to begin a clinical trial for the robotic platform at U.S. sites. The company is now preparing clinical trial sites to receive Ottava systems, enroll patients, and begin surgical cases.

Johnson & Johnson first shared details on the Ottava surgical robotic platform about four years ago. However, since then, the company has remained quiet on the topic, though. In October 2021, J&J pushed back the platform’s development timeline by about two years due to multiple factors.

The initial unveiling of Ottava highlighted a six-armed approach for the robot. A November 2023 update shed more light on Ottava and some changes in its look over the past three years.

The company said Ottava incorporates four robotic arms into a standard-size surgical table. Its unified architecture allows for an “invisible design,” according to J&J. The robotic arms are available when needed and are stowed beneath the surgical table when not.

Johnson & Johnson MedTech said the design removes barriers to movement and collaboration in robotic operating rooms. It also offers surgical teams the freedom and flexibility to adapt to clinical workflows and individualize patient needs.

“We are bringing the best of J&J MedTech’s surgery expertise to the Ottava system and taking a holistic view of the science of surgery to enable new experiences across all surgical modalities in service of patients around the world,” said Hani Abouhalka, group chair for surgery at Johnson & Johnson MedTech. “Meeting this milestone brings us a step closer to delivering on our promise to make technology more human, care more adaptive, and people more connected so that surgery works better for everyone.”

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Johnson & Johnson designs Ottava for versatility

Johnson & Johnson said it designed Ottava to set a new standard for the modern operating room and transform the surgical experience. The system’s unique architecture combines with J&J’s digital ecosystem to deliver versatility in meeting patient and surgeon needs.

With the four low-profile robotic arms, the company designed Ottava to support robotic, laparoscopic, hybrid, and open surgery with more working space for clinical teams. The system’s architecture supports features like “twin motion” in which the table and robotic arms move together. This aids in intraoperative repositioning and multi-quadrant access without re-docking.

Ottava also exclusively features trusted Ethicon instrumentation designed for performance and precision. J&J said this supports a more consistent experience between traditional laparoscopic and robotic procedures.

The company said its Polyphonic digital ecosystem can connect the portfolio across surgical technologies, robotics, and software while also using its scale.

In the future, J&J said it expects Polyphonic to empower Ottava with data and advanced insights. This would support clinical decision-making, learning and collaboration.

“We are excited about reaching this important milestone and progressing our differentiated general surgery robotic platform for the benefit of patients and surgeons,” said Rocco De Bernardis, president of Ottava at Johnson & Johnson MedTech. “With approval to move to clinical investigation, our teams are focused on training clinical trial investigators and teams as they enroll patients and prepare for cases.”

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

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The Genesis RMN system is part of the cardiac program at the University of Kansas Health System. | Source: Stereotaxis

Stereotaxis Inc. last week announced that physicians at the University of Kansas Health System successfully treated the first patients with its Genesis system.

The first use of the Genesis robotic magnetic navigation (RMN) system comes as part of a robotic heart program at the health system. Genesis delivers the benefits of robotic precision and safety to cardiac ablation to treat arrhythmias, said the St. Louis, Mo.-based company.

“For years, advanced robot technology has been instrumental in our ability to deliver superior care to our patients, allowing us to navigate complex cardiac procedures with improved accuracy and safety,” said Dr. Seth Sheldon, cardiac electrophysiologist at the health system. “The robotic precision and stability offered by the Genesis System allows us to deliver precise, personalized treatments to our patients, ultimately improving outcomes and quality of life.”

Genesis uses smaller magnets that rotate along their center of mass, allowing for responsiveness to physician control. The smaller system can improve the patient experience, provide greater patient access, and increase lab space, said Stereotaxis.

Flexible, rugged robotic arms hold the agents to increase the potential range of motion and allow for wider X-ray angulation.

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More about Stereotaxis

A hospital in Kentucky performed the first procedures with the Genesis surgical robot late last year. Stereotaxis also has an ongoing collaboration with Abbott, which had milestone developments last fall. 

“We are proud to continue our partnership with the health system to deliver exceptional cardiac care to patients in Kansas City,” said David Fischel, chairman and CEO of Stereotaxis. “We look forward to continuing to support their successful and impactful robotic heart-rhythm care program.”

In August, Stereotaxis submitted its next-generation GenesisX system to the U.S. Food and Drug Administration (FDA) following its receipt of the CE mark in Europe. The company said its technology has been used to treat over 150,000 patients around the world.

MassDevice listed Stereotaxis as one of the 10 surgical robotics companies worth following in 2024.

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

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The robotic technology used for the Aquablation procedure. | Source: Procept BioRobotics

Procept BioRobotics Corp. last week announced that the U.S. Food and Drug Administration has approved an Investigational Device Exemption, or IDE, trial of its Aquablation therapy.

The San Jose, Calif.-based company also recently received Breakthrough Device Designation to investigate the use of Aquablation therapy for prostate cancer. The FDA awards such designations in exceptional cases, expediting the review of novel therapies that can improve the lives of people with life-threatening or irreversibly debilitating diseases or conditions.

The technology could “change the way urologists treat localized prostate cancer for millions of men,” stated Dr. Inderbir Gill, founding executive director of USC Urology, part of the Keck School of Medicine at the University of Southern California.

Procept BioRobotics develops personalized treatment

Aquablation uses ultrasound-guided, robot-assisted, heat-free waterjet to resection and precisely eradicate prostate tissue. The system provides the surgeon with a multi-dimensional view of the patient’s prostate.

This approach therapy enables personalized treatment planning tailored to each patient’s unique anatomy, claimed Procept BioRobotics. It allows the surgeon to specify which areas of the prostate to remove while preserving the anatomy that controls erectile function, ejaculatory function, and continence.

Aquablation promises to be an effective cancer treatment while maintaining the patient’s quality of life, said Procept BioRobotics. (The company was featured on MassDevice‘s list of the top urology device stories so far in 2024.)

Procept BioRobotics initially received FDA IDE for its Aquablation procedure in September 2023. The company’s next-generation Hydros surgical robot — cleared by the FDA in August — delivers Aquablation therapy.

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Aquablation trial to follow patients for 10 years

The WATER IV PCa trial will compare Aquablation to radical prostatectomy. It will focus on harm reduction by using Aquablation as a first-line treatment in comparison with radical prostatectomy, said Procept BioRobotics.

The company added that it expects the study to enroll up to 280 men with Grade Group 1 to 3 localized prostate cancer. It will take place across 50 centers, following the patients for 10 years.

The trial has a co-primary endpoint based on morbidity evaluated at the six-month follow-up. Longer-term follow-up will focus on both the reduction in treatment-related harm and oncologic events, Procept said.

“A significant opportunity exists to improve safety and quality of life outcomes for men needing treatment for prostate cancer,” said Reza Zadno, CEO of Procept BioRobotics. “We believe Aquablation therapy has the ability to become a first-line treatment for localized prostate cancer. Initiating a randomized trial against radical prostatectomy is the first big step in pursuing a prostate cancer-specific indication, which no other energy-based treatment has today,”

“It is exciting to see that the FDA approved an IDE after a prompt and thorough review of the trial design, and we look forward to seeing the results of the forthcoming trial and are hopeful about the possibilities of this novel technology,” said Gill. He is also chairman of the Catherine & Joseph Aresty Department of Urology at Keck. 

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

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The Unity Knee MC tibial insert. | Source: Corin

Corin Group PLC last week said it has received 401(k) clearance from the U.S. Food and Drug Administration for for its Unity Knee medial constrained, or MC, tibial insert. The company said this option will enable surgeons to independently stabilize the medial compartment during a standard or robotic-assisted total knee arthroplasty, or TKA.

The Unity Knee MC Tibial Insert was designed to help restore native knee kinematics by stabilizing the medial condyle while allowing lateral translation. It is suitable for use with or without the posterior cruciate ligament (PCL), said Corin.

The Cirencester, U.K.-based company said Unity Knee has been used in more than 75,000 surgical cases since its 2012 launch. Corin claimed that the system has demonstrated some of the best performance across the U.K. and Australian implant registries and that it is committed to growing the brand.

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Unity Knee MC compatible with ApolloKnee robot

The Unity Knee MC Insert is manufactured with ECiMa bearing technology, a vitamin E-enriched, highly cross-linked polyethylene that provides low wear characteristics, oxidative stability, and enhanced mechanical performance. As part of the Unity Knee system, it is compatible with ApolloKnee, Corin’s next-generation robotic-assisted surgical platform.

“Studies have demonstrated that a balanced joint has a greater impact on total knee replacement outcomes than component alignment alone.” stated Christopher Plaskos, Ph.D. and vice president of global clinical innovation at Corin.

“Combining Unity Knee MC with the robotic soft tissue-balancing capabilities of ApolloKnee, a new level of natural joint kinematics and stability can be achieved throughout the range of motion,” he added. “We believe this will provide patients with a more natural-feeling knee.”

“ApolloKnee provides an objective, dual-compartment, sensing and tensing balance assessment prior to bone resections, allowing surgeons to optimize knee function in real-time,” said Corin. “The combination of advanced implant design and unique robotic-assisted balancing aims to improve patient outcomes and satisfaction.”

Corin plans to continue expanding product line

“With the recent 510(k) clearances of the Unity Knee MC and PS-C Tibial Inserts, we’re expanding the range of solutions for surgeons to achieve personalized dynamic knee balance,” said Jim Pierrepont, global franchise lead at Corin. “These advancements reflect our ability to respond quickly to market needs while delivering high-quality innovations.”

“We’re also anticipating further clearances in the coming months, which will strengthen our implant, Apollo, and CorinConnect digital portfolios,” he said. “With our agile R&D pipeline, we remain committed to providing differentiated solutions that enhance patient outcomes.”

The Unity Knee MC Tibial Insert is exclusively available in the U.S. through a limited market release.

The company said its combination of robotics, artificial intelligence, and data to plan, implement and learn, along with clinically proven implants, is intended to deliver improved outcomes and maximize value for patients, surgeons and healthcare providers.

Editor’s note: This article is syndicated from The Robot Report sibling site MassDevice.

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The Intuitive da Vinci 5 (top left), Sony microsurgery assistance robot (top right), Stryker Mako (bottom left) and Globus Medical ExcelsiusGPS (bottom right) are all featured in the top surgical robotics stories of 2024 so far. | Images courtesy of the companies

Editor’s Note: This article was syndicated from The Robot Report’s sibling site MassDevice. 

Surgical robotics has been a hot topic within the medtech space, and it doesn’t seem like it’s stopping any time soon.

Over the course of 2024, we’ve seen all kinds of stories across surgical robotics. From regulatory nods and product launches to recalls and warning letters, plus some M&A in between, the surgical robotics space has been active over the past nine months.

At DeviceTalks West, co-located with RoboBusiness, in Santa Clara, California, Oct. 16-17, a wide range of robotic technologies will be featured. (Learn more about the event and register at West.DeviceTalks.com.)

If you need a refresher, here’s a list of 10 surgical robotics companies you need to know, published back in February. (Note: As you’ll read below, a lot has happened since then.)

Ahead of DeviceTalks West, let’s take a look at the surgical robotics stories that have garnered MassDevice’s readers’ attention in 2024:

Globus Medical faces FDA warning letter over surgical robotics platform

The Excelsius GPS system. | Source: Globus Medical

In August, shares of Globus Medical took a hit after the FDA published a warning letter alleging violations at a Pennsylvania facility.

According to the FDA letter, the inspection centered around the company’s Excelsius GPS surgical robot and associated interbody spine and cranial modules. Excelsius GPS’ uses include locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

The FDA inspection revealed that the devices “are adulterated,” or not in conformity with current good manufacturing practice requirements. Specifically, the FDA found a failure to submit a report to the FDA no later than 30 calendar days after the firm received or otherwise became aware of information that reasonably suggested that the device in question may have caused or contributed to a death or serious injury.

Globus Medical issued a statement saying “We are confident that we have the data and documentation to support swift resolution in this matter.”

Intuitive details da Vinci 5 launch plans following FDA nod

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

Intuitive, the longtime leader in surgical robotics, further cemented its place atop the space with FDA clearance for its next-generation robot this year.

In March, the company won FDA 510(k) clearance for the da Vinci 5, adding it to a portfolio that features the multiport X and Xi systems and the single-port SP. The company also has Ion, its robotic-assisted platform for minimally invasive biopsy in the lung.

New features of the da Vinci 5 include updated surgeon controllers and powerful vibration and tremor controls, next-generation 3D display and image processing capabilities, and Force Feedback technology, among other enhancements.

Shortly after picking up FDA clearance, company officials outlined their launch plans for the new robot.  Intuitive expects its limited rollout to continue into 2025 to optimize manufacturing and supply chain ahead of a full launch. (Medical Design & Outsourcing explored what the da Vinci 5 launch plans could teach other device developers. And here’s more about the da Vinci 5’s design.)

Karl Storz acquires Asensus Surgical

The Luna surgical robotics platform. | Source: Asensus Surgical

Asensus, formerly TransEnterix, made waves in the surgical robotics space when it agreed to be acquired by Karl Storz in June for 35¢ per share in cash.

Following some scrutiny over a lack of disclosures, Research Triangle Park, North Carolina–based Asensus said it would file for bankruptcy protection if shareholders failed to approve the Karl Storz merger. However, in August, the company’s shareholders gave the green light for the deal to go ahead and the acquisition closed in August.

Karl Storz believes the deal enhances its portfolio and market presence within the surgical robotics space. The company particularly highlighted the ongoing development of Asensus Surgical’s next-generation Luna platform.

Asensus also develops the Senhance surgical robot platform. It also develops the Intelligent Surgical Unit (ISU) for Senhance. Asensus designed ISU as a real-time intraoperative surgical image analytics platform. It leverages augmented intelligence to help reduce surgical variability.

Medtronic advances its surgical robotics offerings

The Hugo robotic surgery system. | Source: Medtronic

Medtech giant Medtronic continues to plug ahead with its Hugo surgical robot, a potential rival to da Vinci down the line. In May, the company announced the initiation of additional clinical studies for Hugo to expand its indications to hernia and gynecology.

The studies are underway to support a planned submission to the FDA for the Hugo system. Hugo, first unveiled in September 2019, is a modular, multi-quadrant platform designed for various surgical procedures with wristed instruments, 3D visualization and surgical video capture options in Touch Surgery Enterprise. It already has install bases growing across 25 countries outside the U.S.

In addition to the advancements for Hugo, Medtronic introduced its new Live Stream function for the Touch Surgery ecosystem of digital technologies in July. Touch Surgery Live Stream includes 14 new AI algorithms designed to enhance its digital capabilities within post-operative analysis. The algorithms deliver AI-powered surgical insights for laparoscopic and robotic-assisted surgery.

As the company pushes ahead in surgical robotics, it has a new figure helping to lead the effort. In September, the company announced that Dr. James Porter joined the company as chief medical officer of Robotic Surgical Technologies and Digital Technologies. Medtronic expects Porter to play a key role in driving focus on patients and robotic and digital innovation.

Medrobotics puts its surgical robotics assets up for sale

The Flex 360 robotic surgery system from Medrobotics. | Source: Tiger Group

In May, Tiger Group and Liquidity Services announced the availability of all surgical robotics assets from a Medrobotics plant at auction.

They made available all assets from the company’s fully furnished, 40,000-square-foot plant in Raynham, Massachusetts. That included the purchase or lease of the building. Assets, including surgical robotics platforms used by nearly 30 hospitals around the world, were made available in a turnkey sale.

Medrobotics boasted an FDA-cleared, CE-marked surgical robotic platform for several years. The company designed its minimally invasive Flex system to access hard-to-reach anatomy for otolaryngology, colorectal and gastroenterology procedures.

However, the company hit a number of stumbling blocks over the past several years — including a significant IP case loss — leading to the sale of these assets.

Mendaera enhances its medical robotics offerings with the purchase of Avail’s technology

The Avail Medsystems telepresence console can beam video, audio, and information to laptops and tablets. | Source: Avail Medsystems

Avail Medsystems, a company aiming to establish virtual connections between medical device sales reps and operating rooms, shut down last November due to lack of funding. In March, the now-shuttered company found a home for its technology.

Medical robotics startup Mendaera agreed to purchase the Avail technology and hired some of its employees. The deal included “substantially all” of Avail’s assets.

Avail’s system consisted of a 6-ft-high tower equipped with high-resolution cameras, monitor and sound that connected parties separated by feet, miles or oceans. The company’s cameras provided a crisp and clear view of surgical suites. The built-in speakers enabled seamless conversation between surgeons and outside parties working on a proprietary laptop interface.

In addition to the purchase of Avails’ assets, Mendaera continued its solid exit from stealth mode by closing a $73 million Series B financing round in September. Mendaera’s platform under development includes robotics, AI, real-time imaging, and virtual connectivity. The company designed it for accessibility across specialties and sites, helping to meet the growing demand for needle-based interventions.

Johnson & Johnson to pay significant damages in Auris shareholder suit

A Delaware judge ruled in September that Johnson & Johnson must pay $1 billion in damages to Auris Health shareholders.

The ruling claimed that J&J breached its agreement to acquire Auris, which went through for $3.4 billion in February 2019. The deal also included up to an additional $2.35 billion in payments to shareholders based on various milestones.

J&J failed to have the suit dismissed in 2021, leading to a decision from Vice Chancellor Lori Will of the Delaware Court of Chancery. Will ruled that J&J breached the agreement and failed to support the acquired iPlatform technology. According to the report, this would have led to increased payments to Auris shareholders.

Reuters says Will’s ruling stated that J&J breached the agreement “almost immediately after closing.” The judge deemed that J&J declined to put resources toward advancing iPlatform and instead pitted it against its own Verb device that it developed in partnership with Google sibling company Verily.

According to Reuters, J&J said it disagrees with the ruling and is considering an appeal. The company also said this ruling has no bearing on its current robotics program, which includes the much-anticipated Ottava system. J&J remains on track to submit the Ottava surgical robot for FDA investigational device exemption (IDE) in the second half of this year. Meanwhile, the company’s DePuy Synthes unit launched an updated platform to enable the use of its Velys robot in spine procedures.

Sony wants a stake in the surgical robotics market

Sony developed a microsurgery assistance robot that is capable of automatic surgical instrument exchange and precision control. | Source: Sony

Sony put its hat in the surgical robotics ring, unveiling its microsurgery assistance robot in May.

The Tokyo-based company said its microsurgery assistance robot is capable of automatic surgical instrument exchange and precision control. It developed the robot to assist in microsurgical procedures by using a microscope to work on extremely small tissues, such as veins and nerves. The system tracks the movements of a surgeon’s hands and fingers using a highly sensitive control device. Movements are then replicated on a small surgical instrument that operates similarly to the movement of the human wrist.

According to the company, the system addresses practical challenges in conventional surgical assistant robotics, such as interruptions and delays caused by manually exchanging surgical instruments. Sony’s R&D team developed the system to allow for the automatic exchange of parts through miniaturization.

Sony’s researchers hope to use the robot assistant in a wide variety of surgical procedures.

Stryker continues to expand the Mako platform

The Mako robotic-assisted surgery system. | Source: Stryker

About a year ago, Stryker suggested that the robotic platform would have significant application expansions in 2024. It said it expected a Mako Spine launch in the second half of 2024, with Mako Shoulder out by the end of 2024. Both launches have yet to commence ahead of the final three months of 2024, though.

Stryker also launched Mako Total Knee 2.0 in March 2023 and rolled out a direct-to-patient marketing campaign in August 2023.

This year, the company said it wants to extend a surgeon’s Mako SmartRobotics experience in and beyond the operating room. To execute this, it announced the myMako app for Apple Vision Pro and iPhone in February. When used on Apple Vision Pro, myMako allows surgeons to visualize and review patients’ Mako surgical plans anytime, anywhere.

The company calls the new innovation “a brilliant, immersive visual experience.” It marks the latest potential innovation for Mako, which the company expects to continue expanding as the year goes on.

Another Mako update comes in the form of the company’s direct anterior reconstructive technology (DART). Stryker aims to reduce intra-operative fluoroscopy in direct anterior hip replacement procedures. Mako SmartRobotics, as part of the DART ecosystem, demonstrated accuracy in surgical planning for total hip arthroplasty without the use of fluoroscopy.

Think Surgical inks countless collaborations for its surgical robotics platform

Think Surgical’s TMINI miniature robotic system. | Source: Think Surgical

Fremont, California–based Think Surgical develops the TMINI system, which received FDA clearance in May 2023. TMINI features a wireless, robotic handpiece. It assists surgeons in performing total knee replacement.

In June, the company made perhaps its most noteworthy deal when it entered into a limited distribution agreement with Zimmer Biomet. Dr. Nitin Goyal, Zimmer Biomet’s chief science, technology, and innovation officer, said at the time that the deal made the company the first to offer two complementary robotic systems for surgeons looking to incorporate robotic assistance while performing a knee replacement. (Zimmer Biomet also offers the flagship Rosa platform. Rosa, which recently expanded into shoulder replacement, has four applications, including the knee.)

The collaboration bore fruit in September, when the FDA cleared the miniature surgical robot for use with the orthopedic giant’s Personalized Knee System. Clearance makes Think Surgical the only company offering a robotic system providing both an implant-exclusive option with the Persona Knee system and an open implant platform for use with implants from multiple other manufacturers for total knee arthroplasty.

Think Surgical says it aims to offer surgical robots that support implants from multiple manufacturers. The Zimmer Biomet clearance follows FDA clearance for TMINI with Medacta knee systems in August, plus clearance for new software in July.  The company has since added a number of implant options to its system. That includes collaborations with Maxx Orthopedics, b-ONE Ortho and Signature Orthopaedics.

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The TMINI robotic surgical system features a wireless handpiece that assists surgeons in performing total knee replacements. | Source: THINK Surgical

THINK Surgical Inc. last week announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the use of its TMINI surgical robot with Zimmer Biomet Robotics’ Persona system.

“TMINI addresses surgeon demand for ergonomic, wireless, handheld robotic systems, and we believe this will accelerate the adoption of robotics in knee procedures, particularly in the outpatient setting,” stated Stuart Simpson, CEO of Think Surgical.

Fremont, Calif.-based THINK Surgical develops and markets orthopedic robots. The privately held company claimed that its robots are open platforms that support implant brands from multiple manufacturers. This allows surgeons to drive the choice of implant, it said.

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THINK Surgical continues surgical robot partnerships

THINK Surgical called the availability of Persona on an exclusive version of TMINI “a major milestone.” The company entered into a limited distribution agreement with Zimmer Biomet earlier this year.

TMINI, which received FDA clearance in May 2023, features a wireless, robotic handpiece. It assists surgeons in performing total knee replacement.

Following a CT-based three-dimensional surgical plan, the TMINI automatically compensates for the surgeon’s hand movement to locate bone pins along precisely defined planes. Cutting guides are then connected to the bone pins for accurate bone resection.

This latest clearance follows FDA clearance for TMINI with Medacta knee systems last week, plus clearance for new software in July.

THINK Surgical claimed that the FDA approval makes it “the only company offering a robotic system providing both an implant-exclusive option with the Persona Knee system and an open implant platform for use with implants from multiple other manufacturers for total knee arthroplasty.”

The company has since added a number of implant options to its system. That includes collaborations with Maxx Orthopedics, b-ONE Ortho, and Signature Orthopaedics.

Zimmer Biomet offers Persona, TMINI for knee replacement

Dr. Nitin Goyal, Zimmer Biomet’s chief science, technology, and innovation officer, said his company‘s deal with THINK Surgical made it the first to offer two complementary systems for robot-assisted knee-replacement surgery. The partners said they plan to introduce the customized TMINI system in select U.S. markets in the second half of 2024.

Think Surgical said its go-to-market strategy supports two distinct customer segments. One segment prefers an open platform where customers can choose from a range of implants on the robot. The other prefers an exclusive platform with the Persona knee system, it said.

Zimmer Biomet, which has offices in Montpelier, France, and Warsaw, Ind., also offers the flagship Rosa platform. Rosa, which recently expanded into shoulder replacement, has four applications, including the knee.

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

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Auris Health’s Monarch surgical system can perform robotic-assisted bronchoscopy and urology procedures. | Source: Johnson & Johnson

A Delaware judge ruled that Johnson & Johnson, or J&J, must pay $1 billion in damages to Auris Health shareholders, according to media reports.

Reuters, Bloomberg Law, and others reported that the ruling claims that J&J breached its agreement to acquire Auris, which went through for $3.4 billion in February 2019. The deal also included up to an additional $2.35 billion in payments to shareholders based on various milestones.

Vice Chancellor Lori Will of the Delaware Court of Chancery ruled that J&J breached the agreement and failed to support the acquired iPlatform technology. The report said this would have led to increased payments to Auris shareholders.

Reuters said Will’s ruling stated that J&J breached the agreement “almost immediately after closing.” The judge deemed that the company declined to put resources toward advancing iPlatform. Instead, the company pitted it against its own Verb device.

J&J allegedly misled Verb Surgical

In a 2021 denial of J&J’s effort to dismiss the Auris shareholder suit, Fortis Advisors, acting on behalf of Auris shareholders, claimed a partnership between J&J’s Ethicon and Google company Verily’s Verb Surgical began raising questions. During acquisition talks, Auris founder Dr. Fred Moll and his colleagues were led to believe that Auris could run independently of Verb after the acquisition, according to Fortis.

Fortis alleged that, after the acquisition, the Auris team had to enter into a covert “bakeoff” with Verb Surgical, diverting employees and resources. After the iPlatform won out over the Verb Surgical Robot, Ethicon bought out Verily’s stake in Verb and rolled Verb into Auris, according to Will back in 2021.

The latest report quoted Will saying that iPlatform “effectively became a parts shop for Verb.”

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Monarch and Ottava surgical robots unaffected by ruling

The ruling wasn’t a complete loss for J&J, however. Will rejected contract claims involving Auris’ other device, the Monarch robotic-assisted surgical system.

While she did rule with Auris shareholders on one count of fraud involving Monarch, the judge also dismissed allegations of J&J defrauding Auris by convincing it to accept deferred payments J&J never planned to make. 

According to Reuters, J&J said it disagrees with the ruling and is considering an appeal.

The company also said this ruling has no bearing on its current robotics program, which includes the much-anticipated Ottava system. J&J remains on track to submit the Ottava surgical robot for FDA investigational device exemption (IDE) in the second half of this year.

J&J blamed missed milestones on technical issues with Auris devices, said Reuters. The company also claimed that the merger agreement allowed it to use Auris products in any way that advanced its robotics program. However, Will’s opinion disputed that, the report said.

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

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Obvius Robotics Inc. this week said that the U.S. Food and Drug Administration has granted breakthrough device designation for its Certa Access System for central venous catheterization, or CVC.

CVC procedures require access to one of the great veins — internal jugular, subclavian, or femoral — to place a multi-lumen catheter for rapid replacement of blood volume, administration of emergency medicines and analgesics, and hemodynamic monitoring.

Complication rates can range from 4% to 11%, noted Obvius Robotics. The Sunrise, Fla.-based company said this underscores a significant need for better and more consistent outcomes.

“CVC procedures are required for a wide variety of conditions and patients for life-saving care every single day,” stated William Cohn, M.D., chief medical officer of Obvius Robotics.

“Despite this fact, the procedure still has high complication rates, and many health systems lack the expertise to reliably conduct the procedure on critically ill patients in a timely manner,” he added. “A breakthrough is truly needed to improve care.”

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Obvius Robotics moves Certa toward clinical access

Obvius said it designed Certa to incorporate robotics as well. It aims to improve the accuracy, safety, and consistency of accessing targeted anatomy.

For CVC procedures, the company said that its system could aid clinicians of varying levels of training and experience. Obvius said it will assist in safely and effectively achieving vascular access.

Certa remains investigational as Obvius readies a submission to the FDA for market clearance. The company completed initial clinical cases for the handheld device in June 2023. It says the system allows users to quickly visualize the target vessel and advance a needle to the target location in seconds.

The company wants Certa  to become the new standard of care for CVC access, said Russell Seiber, president and CEO of Obvius.

“We are excited that the FDA has recognized the potential of the Certa access system to be a breakthrough for patients and clinicians,” he said. “We believe this technology could improve care critical care settings by democratizing vascular access procedures.”

Obvius Robotics was founded in 2020. Seiber said he conceived the idea for Obvius Robotics when an emergent liver-failure patient required a central line placed to stabilize very low blood pressure. This is a life-saving procedure that can be challenging for physicians.

Despite significant expertise in placing these lines, the critical care physician could not successfully gain vascular access with the difficult anatomy of the patient. While the line was eventually placed, Seiber wanted to find a system to address this common problem. 

Over 20 million central lines are placed globally each year, making it one of the most common medical procedures in the world, said Obvius. However, between 200,000 and 550,000 patients currently suffer from preventable complications each year, it noted. 

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

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The Senhance Surgical System is intended to keep time and cost per procedure comparable to traditional laparoscopies. | Source: Asensus Surgical

KARL STORZ Group today announced that its KARL STORZ Endoscopy America Inc. subsidiary has acquired all outstanding shares of Asensurs Surgical Inc. for 35¢ per share in cash. Asensus has developed digital laparoscopy systems.

“Asensus’ cutting-edge technology and expertise in robotic surgery complements our comprehensive portfolio of surgical solutions,” stated Karl-Christian Storz, CEO of KARL STORZ. “This enhances our portfolio and market presence, strengthening our position in the growing robotic and digital surgical market, particularly with the development of the next-generation LUNA system.”

“We are thrilled to welcome 200-plus talented Asensus team members into our company,” he added. “Together, we will revolutionize healthcare by delivering better outcomes for patients and surgical teams worldwide.”

Founded in 1945, KARL STORZ SE & Co. KG said it is an international leader in endoscopy. The Tuttlingen, Germany-based company, now in its third generation of family ownership, employs 9,400 people in more than 40 countries worldwide.

KARL STORZ’s portfolio includes 13,000 products for human and veterinary medicine, and it reported fiscal 2023 sales of €2.17 billion ($3 billion U.S.). The company has production sites in Germany, the U.S., Switzerland, and Estonia.

Asensus Surgical worked to make robot surgery accessible

Asensus Surgical has developed “intra-operative augmented intelligence technology” for use in operating rooms around the world. The Research Triangle Park, N.C.-based company, founded as TransEnterix, said its approach to digital laparoscopy is intended to make robot-assisted surgery more accessible.

It has developed the Senhance Surgical System and the Intelligent Surgical Unit (ISU) for Senhance. Asensus designed ISU as a real-time intraoperative surgical image analytics platform. It uses human-robot collaboration to help reduce surgical variability, said the company.

In February 2023, Asensus unveiled the LUNA integrated surgical system. It features a next-generation surgical platform and instruments, plus real-time intraoperative clinical intelligence. Its final component, a secure cloud platform, applies machine learning to deliver clinical insights.

In November, the company inked a manufacturing deal, but the U.S. Food and Drug Administration (FDA) ordered it to recall Senhance because of unintended movement.

Asensus said it was targeting 2025 for FDA clearance for LUNA. In January 2024, the company showed it to surgeons, conducting an in-vivo lab evaluation.

LUNA is currently under development and has not been submitted to the FDA or other global regulators for clearance. The system is not yet available for sale in any market.

Transaction took time

In June, Asensus Surgical agreed to be acquired by KARL STORZ. Asensus’ board unanimously approved the agreement.

However, with scrutiny over a lack of disclosures, the company pushed its planned special meeting of shareholders from Aug. 7 to Aug. 20. Ahead of the meeting, Asensus said it would file for bankruptcy protection if shareholders failed to approve the Karl Storz merger.

On Aug. 20, the number of shares represented in person or by proxy totaled about 161.4 million. That represented approximately 59.2% of the 272.6 million total shares outstanding and entitled to vote.

Asensus recorded more than 137 million votes in favor of the merger, with more than 23 million votes going against the resolution. The meeting tallied just over 1 million votes abstaining.

Stockholders also voted to approve certain compensation for executive officers in connection with the merger. That vote totaled nearly 124 million in favor, with 34 million against and around 3.5 million abstaining.

A third vote was not necessary because Asensus received sufficient votes to go through with the merger. Asensus Surgical filed an SEC Form 8-K to confirm that its shareholders voted to approve its planned merger with Karl Storz.

Jefferies LLC served as financial advisor to Asensus Surgical, and Ballard Spahr LLP served as legal counsel to Asensus Surgical. UBS Investment Bank served as financial advisor to KARL STORZ, and Ropes & Gray LLP served as legal counsel to KARL STORZ.

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KARL STORZ welcomes surgical robots to its portfolio

KARL STORZ said it identified Asensus for acquisition because of its talent and technology.

“As a potential partner, Asensus turned out to be a perfect fit due to its similar philosophy and vision, and its experience in bringing its first-generation Senhance robot to market,” said the company. “Its second-generation LUNA System is also positioned to offer enhanced robotic precision, greater dexterity and a superior range of motion manipulation, which complements KARL STORZ’s advanced visualization capabilities.”

“We are thrilled to complete this merger with KARL STORZ, which marks an exciting new chapter for Asensus,” said Anthony Fernando, president and CEO of Asensus Surgical.

“By joining forces with a leading company in endoscopy that became a system provider for integrated MedTech, we are well-positioned to accelerate the development and delivery of our innovative robotic and digital surgical solutions,” he said. “This union will benefit patients and surgeons worldwide by advancing precise, safer, and more predictable surgical outcomes.”

Editor’s Note: This article was syndicated from The Robot Report sibling site MassDevice. 

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Jupiter Endovascular is working to develop a new class of endovascular procedures using Endoportal Control. | Source: Jupiter Endovascular

The ability to robotically steer catheters can improve endovascular procedures, according to medical device providers. Neptune Medical yesterday announced $97 million in Series D financing and the launch of subsidiary Jupiter Endovascular Inc.

“Neptune Medical is thrilled to announce the successful closure of our Series D financing and the spinout of Jupiter Endovascular,” stated Alex Tilson, founder and CEO of Neptune Medical.

“These significant milestones allow us to sharpen our focus on GI [gastrointestinal] robotics while empowering Jupiter to drive innovation in endovascular treatments,” he added. “We are grateful to our investors for their unwavering support and confidence in our vision.”

Neptune Medical’s foray into the robotics space was bolstered by the recent appointment of surgical robotics pioneer Dr. Fred Moll as chair of its board. The shift also allows Jupiter Endovascular to focus on its own technology platform, said the Burlingame, Calif.-based company.

“The spinout of Jupiter Endovascular is a strategic move that aligns with our long-term goals,” said Moll. “With dedicated resources and leadership, Jupiter is well-positioned to revolutionize endovascular therapies.”

“Meanwhile, Neptune will continue to push the boundaries in GI robotics, delivering transformative solutions to patients and healthcare providers,” he noted. “We intend for both companies to lead the way in innovating within their respective specialties.”

More on Neptune Medical spinout of Jupiter Endovascular

Jupiter Endovascular exited stealth mode with $21 million in new financing. The Menlo Park, Calif.-based company is developing the Endoportal Control platform, which it said will bring the precision and control of direct surgical access to catheter-based surgeries.

“The procedure uses an endoportal device that navigates flexibly through the vasculature via percutaneous access,” explained Jupiter Endovascular. “Once in position, the endoportal device can be fixed into a stable state to deliver an interventional treatment with surgical-like precision and control from an endovascular access point.”

Jupiter earmarked its funding to support an upcoming pivotal trial for pulmonary embolism. It also plans to put money toward developing additional clinical applications of its Endoportal technology.

Following the exit of stealth mode, the company appointed Carl J. St. Bernard as CEO. He joins from Alta Biomaterials and has more than 30 years of experience in the life sciences space.

“The Endoportal Control technology, which leverages Jupiter’s unique and exclusive intellectual property to create a catheter-based device that flexibly navigates through a patient’s vasculature before fixing into a stable position, is designed to give interventionalists the confidence and support they need to deliver a prescribed cardiovascular therapy,” said St. Bernard. “This represents a generational advance in technology with the potential to revolutionize the treatment of millions of patients worldwide.”

Sonder Capital, other investors support novel approach

Sonder Capital and Olympus Corporation of the Americas participated significantly in Neptune Medical and Jupiiter Endovascular’s funding. Other existing and new investors also participated, said Neptune Medical.

“For decades, the field of catheter-based therapies has been limited by the technological constraints of catheters that lose stability and control within the anatomy,” said Kate Garrett, managing partner at Sonder Capital.

“Jupiter Endovascular has developed a revolutionary approach with the potential to overcome these constraints by providing clinicians the precision and control of a surgical approach while maintaining the minimally invasive profile of an endovascular procedure,” she said. “This novel approach may address a significant unmet clinical need in patients with disease residing in complex cardiovascular anatomies, such as the pulmonary arteries.”

Founded in 2019 by Moll and Jay Watkins, Sonder Capital has funded healthcare technology providers including Intuitive Surgical, Procept Biorobotics, and Auris Medical.

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

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Velys Spine, a system for planning and instrumenting spinal fusion procedures. | Credit: J&J/DePuy Synthes

Johnson & Johnson’s DePuy Synthes this week launched a dual-use robotics and standalone navigation platform that uses its Velys robot in spine surgery. This marks the latest development for Velys, J&J’s robotic orthopedic surgery system that won its first FDA clearance for total knee surgery in 2021. In June, Velys won FDA clearance for unicompartmental knee arthroplasty.

The medtech giant’s orthopedics unit developed the spine surgery Velys system in collaboration with eCential Robotics. eCential announced FDA 510(k) clearance for this platform last month. The companies designed the Velys active robotic-assisted system (Velys Spine) for planning and instrumenting spinal fusion procedures. Areas include the cervical, thoracolumbar and sacroiliac spine.

DePuy Synthes said the companies aim for the technology to help surgeons tackle their most complex challenges. The dual-use system offers standalone navigation and an active robotics platform for flexibility in approach and planning. Active robotics enables surgical guidance tailored to surgeon preference.

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The company said the distinctive features and capabilities of active robotics could “establish a new standard in spine surgical care.”

Velys Spine offers a customizable experience with pathology-specific workflows, aided by offerings like the Velys adaptive tracking technology and Velys trajectory assistance. It joins the DePuy Synthes core spine portfolio of products, the company said.

DePuy Synthes — the largest orthopedic device company in the world — anticipates full commercial availability in the first half of 2025.

“We are shaping the next frontier of orthopaedic innovation with a relentless focus on digital advancements and excellence in the field of surgical robotics and navigation,” said DePuy Synthes chair Aldo Denti. “Our dedication extends to enhancing patient care through significant strides in spine surgery. This is a major step in growing our Velyx Portfolio and in our commitment to supporting spine surgeons and their patients with advanced tools.”

Meanwhile, competitor Stryker — which has seen a great deal of success with its Mako robotic surgery systems — expects a Mako Spine launch in the second half of 2024, with Mako Shoulder out by the end of 2024.

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Robots promise speed and precision for dental procedures. | Credit: Perceptive

Perceptive yesterday announced the completion of a fully automated dental procedure on a human using its advanced robotic system.

The Boston-based startup designed its technology with integrated advanced imaging, artificial intelligence, and robotics. It aims to set a new standard of care in dentistry.

So far, Perceptive has raised $30 million. Its investors include PDS Health, Dr. Ed Zuckerberg (father of Facebook co-founder and CEO Mark Zuckerberg), Innospark Ventures, KdT Ventures, Primavera Capital, Plaisance Capital, and Y Combinator.

The company’s dental system uses AI-driven 3D imaging software with a robotic arm. It claimed that its robot enables speed and precision in dental procedures, and it is starting with restorative dentistry.

Perceptive added that its proprietary system could eventually complete tasks such as crown placements in just 15 minutes. Crown placements currently require two office visits of at least one hour each, it noted.

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Perceptive robot uses AI to analyze 3D data

Perceptive explained that its AI robotics system uses 3D volumetric data for diagnostics and treatment planning to enable early and accurate diagnoses. The procedure starts with optical coherence tomography (OCT) scans of the patient’s tooth and mouth using the company’s handheld intraoral scanner.

The scanner captures 3D images beneath the gum line, through fluids, and under the tooth surface. Patients can also visualize their dental conditions through the images to better understand their needs.

The system then uses AI algorithms to analyze the 3D data and plan the procedure with efficiency and precision, said Perceptive. By automating the procedures, the technology enables more high-quality patient treatments in less time, it said.

Perceptive also said its system reduces the need for manual labor and minimizes the chances of human error.

“We’re excited to successfully complete the world’s first fully automated robotic dental procedure,” said Dr. Chris Ciriello, founder and CEO of Perceptive. “This medical breakthrough enhances precision and efficiency of dental procedures and democratizes access to better dental care for improved patient experience and clinical outcomes.”

Editor’s note: This article is syndicated from The Robot Report sibling site MassDevice.

Warning for the squeamish: the following video shows a real dental procedure on an actual patient.

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The Senhance Surgical System keeps time and cost per procedure comparable to traditional laparoscopies. | Source: Asensus Surgical

Challenges facing developers of surgical robots include regulatory approvals, low tolerance for error, and financing. Asensus Surgical Inc. and Karl Storz SE this week issued a filing with the U.S. Securities and Exchange Commission defending the proxy statement about their planned merger.

On June 7, the Asensus Surgical agreed to be acquired by Karl Storz for 35¢ per share in cash. Asensus’ board unanimously approved the agreement, and the company filed a definitive proxy statement on July 5. That statement called for a special meeting of stockholders scheduled for Aug. 7.

Research Triangle Park, N.C.-based Asensus recently obtained Food and Drug Administration approval for its Senhance Surgical System.

Asensus Surgical refutes stockholder allegations

After filing the proxy statement, Asensus Surgical said it received a number of demand letters from purported stockholders. Those letters alleged that there were disclosure deficiencies in the proxy statement. Asensus refuted the allegations.

“The company denies that it has violated any laws or breached any duties to the company’s stockholders, denies all allegations in the demand letters, and believes no supplemental disclosures to the proxy statement were or are required under any applicable law, rule or regulation,” it said in a statement.

However, Asensus decided to voluntarily supplement its proxy statement with new disclosures. The company said it decided to do this to eliminate the burden and expense of potential litigation, to moot claims under the demand letters, to avoid a potential delay or disruption for the merger, and to provide additional information to stockholders.

Asensus said its disclosures comply fully with the applicable law. Nothing in the disclosures reflects an admission of the legal necessity or materiality under applicable law, the company added.

More on the alleged disclosures

The seven disclosures center around confidentiality agreements, the use of consultants, financial advisors, and certain contacts with companies.

Disclosure 1 covers meetings held between Asensus CEO Anthony Fernando representatives of three global medical device manufacturers. Discussions centered around the possibility of strategic collaborations. In connection with those discussions, the company entered into a confidentiality agreement with three companies and a financial sponsor. None contained a standstill provision, asserted Asensus Surgical.

Disclosure 2 amends disclosures made for update calls on which alternatives and a Plan B were discussed. The Asensus board authorized the retention of a consultant to assist management with a preliminary analysis of the company’s cash, sources of cash and secured and unsecured obligations.

Disclosure 3 modified the company’s description of its engagement with Jefferies as a financial advisor. Asensus engaged Jefferies to offer financial advice and assistance in connection with a sale or other transaction. The only offer the company received related to this was its letter of intent from Karl Storz.

Disclosure 4 covered discussions around the activities of management over the two years prior to finding a buyer. That included the discussions with the companies in Disclosure 1. The Asensus board also formed a transaction committee for a number of reasons outlined in the filing.

Disclosure 5 outlined contact between Fernando and the companies engaged in Disclosure 1. Representatives from three companies congratulated Asensus’ CEO on the proposed letter of intent from Karl Storz. The company said none demonstrated any interest in any potential transaction.

Disclosure 6 amended a statement of Jefferies’ calculated terminal values by adding “per the management of Asensus.”

Disclosure 7 clarified that cash flow values were derived from a weighted average cost of capital calculation.

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

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