Stereotaxis submits Magic ablation catheter for U.S., European approval

The Magic ablation catheter. [Image courtesy of Stereotaxis]Stereotaxis (NYSE:STXS) announced that it submitted its Magic ablation catheter for both European and U.S. regulatory approval.

The company said its FDA and CE mark submissions follow successful clinical results in an ongoing trial. Last month, Stereotaxis announced the first Magic treatments in the European trial supporting its submissions. According to a news release, the company observed “stellar” initial results in the first 20 procedures.

Stereotaxis reports 100% accurate efficacy and no adverse events with the ablation catheter in the study so far.

Magic, a robotically navigated magnetic ablation catheter performs minimally invasive cardiac ablation procedures. It incorporates design features meant to enhance patient safety, procedural effectiveness and efficacy and the physician experience.

Stereotaxis projects commercial availability for the community of robotic electroph…

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10 surgical robotics companies you need to know

The surgical robotics space saw a major shakeup last year. The da Vinci SP surgical robotics system [Image courtesy of Intuitive Surgical]“Robotics is hard. Robotics in healthcare is hard.”

Hani Abouhalka, Johnson & Johnson’s company group chair for Robotics & Digital, said those words at our DeviceTalks West event in California in October.

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

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

Even though it is sticking with robotic surgery, J&J laid off employees in th…

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First cases performed in Kentucky with Stereotaxis robotic magnetic navigation system

The full Stereotaxis lab with the Genesis RMN system. [Image from Stereotaxis]Stereotaxis (NYSE:STXS) announced today that a health provider in Kentucky performed the first patients with its Genesis surgical robotic system.

Physicians at Baptist Health Lexington successfully treated patients using the newest Stereotaxis advancement, the Genesis robotic magnetic navigation (RMN) system.

Electrophysiologists at the same institution became the first to use RMN to treat patients all the way back in 2003. This robotic technology could address heart rhythm disorders through a minimally invasive procedure with robotic precision. Stereotaxis now says that, with the unveiling of its Genesis system, BHL became the first in Kentucky — and one of the first in the world — to offer the latest robotic advancement to treat cardiac arrhythmias.

“Many technologies come and go, but this is an example of a system that has continued to advance due to the clinical value in enabl…

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Stereotaxis performs first surgical robot procedure with Abbott cardiac mapping tech

Stereotaxis (NYSE:STXS) today announced the first treated patients in the U.S. as part of its surgical robotics collaboration with Abbott (NYSE: ABT) + .

In May, the two companies entered a deal aimed at taking robotic electrophysiology to the next level. It sought to integrate the Abbott EnSite X EP 3D heart mapping system — with Stereotaxis’ robotic magnetic navigation systems. The collaboration combines real-time diagnostic information with the precision and stability of surgical robotics.

Physicians across four U.S. medical centers completed the first integrated procedures in the U.S. They took place at Weill Cornell Medical Center, Mount Sinai Morningside, Banner University Medical Center Phoenix, and Overland Park Regional Medical Center.

Dr. Dhanunjaya Lakkireddy of Overland took part in the initial cases. Lakkireddy said in a news release that the combination of technologies enhanced precision and streaml…

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Abbott, Stereotaxis ink robotic surgery partnership

Stereotaxis (NYSE:STXS) announced today that it entered into a collaboration with Abbott (NYSE:ABT) to combine technologies in surgical robotics.

The collaboration aims to integrate the Abbott EnSite X EP system with Stereotaxis’ robotic magnetic navigation systems. Bringing the Abbott cardiac mapping system together with Stereotaxis’ robotic technology could enhance robotic surgery. Together, they provide detailed, real-time diagnostic information with the precision and stability of robotics during therapy delivery.

According to the companies, technology integration enhances the physician experience and streamlines procedural workflow. It also supports the improved treatment of patients with abnormal heart rhythms, according to a news release.

The Abbott EnSite X system received FDA clearance in 2021. It creates highly detailed, three-dimensional maps of the heart, helping physicians identify then treat areas where abnormal rhythms originate…

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Stereotaxis says system placement delays impacted revenues

Stereotaxis (NYSE:STXS) shares took a hit today on fourth-quarter results that missed the consensus sales forecast.

Shares of STXS fell 6.9% to $2.42 apiece in midday trading today.MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — ticked up 1.3%.

The St. Louis-based endovascular surgical robot maker posted losses of $4.5 million. That comes to 6¢ per share on sales of $7.3 million for the three months ended Dec. 31, 2022.

Stereotaxis recorded a 21.6% bottom-line slide deeper into the red on a sales decline of 11.4%. The company’s earnings per share topped estimations on Wall Street by 1¢. However, sales fell short of expectations as analysts forecast $8.5 million in revenue.

Chair and CEO David Fischel said in a news release that Stereotaxis is implementing a new product ecosystem. However, disruptions to that transition came from delays in system placements in 2022, despite …

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Stereotaxis stock up on new orders, progress on next-gen robot

Stereotaxis’ headquarters in St. Louis include an operating room with a Genesis RMN system for demonstration and training purposes. [Image courtesy of Stereotaxis]Stereotaxis (NYSE:STXS) today reported third-quarter results that missed on revenue. However, investors reacted positively to a list of positive news from the surgical robotics company.

St. Louis–based Stereotaxis lost $5.3 million, or 7¢ per share, off $7.7 million in revenue for the quarter ended Sept. 30, 2022. It lost $5.0 million, or 7¢ per share, off $9.1 million in revenue in Q3 2021.

Wall Street analysts had expected $8.2 million in revenue.

However, much of the news was positive for Stereotaxis, which provides surgical robotics that incorporate magnets for minimally invasive endovascular intervention. (It’s included in MassDevice’s list of robotic surgery companies you need to know.)

“Stereotaxis continues to demonstrate robust commercial and technological progres…

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16 surgical robotics companies you need to know

Intuitive remains the dominant surgical robotics company, but corporations ranging from Medtronic to Vicarious Surgical look to compete. The Da Vinci Xi robotic surgery system. Intuitive continues to dominate the space. [Image courtesy of Intuitive]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:

Company Robotic system(s) Intuitive Surgical Da Vinci Xi, Da Vinci X, Da Vinci SP, Ion Medtronic Hugo Johnson & Johnson Monarch, Velys, Ottava Stryker Mako Siemens Healthineers’ Corindus CorPath GRX Vicarious Surgical Beta 2 Titan Medical Enos Asensus Surgical Senhance Moon Surgical Maestro Momentus Surgical Anovo Virtual Incision MIRA Stereotaxis Genesis RMN, Vdrive, Niobe Monteris …
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Stereotaxis stock down amid cloudy outlook

Stereotaxis (NYSE: STXS) today reported second-quarter revenue that missed Wall Street projections, with the surgical robotics company unable to say how quickly revenue will pick up.

Investors reacted by sending STXS shares down more than 18% to $2.10 apiece by late afternoon trading today.

The St. Louis–based company lost $5.1 million, or 7¢ per share, off $6.2 million in revenue for the quarter ended June 30, 2022 — versus a loss of $1.2 million, or 2¢ per share, off $9.1 million in revenue for the same quarter a year ago.

Losses during the second quarter a year ago were less because Stereotaxis received $2.2 million in Paycheck Protection Loan forgiveness. Adjusted net loss for Q2 2022 and 2022 was the same: $2.5 million.

The $6.2 million in revenue during Stereotaxis’ most recent quarter missed The Street, where analysts predicted $7.08 million in revenue. As of June 30, the company had $35.1 million in cash and cash equivalents — and no…

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Intuitive, Acutus Medical veterans join Stereotaxis

Stereotaxis (NYSE:STXS) announced today that it appointed two new vice presidents who both have extensive industry experience.

Frank Van Hyfte will join the St. Louis-based surgical robotics company as VP of Europe, the Middle East and Africa and Tim Glynn will join as VP of market development.

Van Hyfte previously spent more than 15 years at Intuitive Surgical, rising from clinical specialist to director of direct and indirect markets in Europe, the Middle East, India and Africa. He also served in senior commercial leadership roles at Exact Imaging, EDAP TMS and eCential Robotics.

Glynn was most recently VP of business and market development at Acutus Medical. There, he established commercial beachheads in Europe and the U.S. to manage product marketing, physician relationships and business partnerships, Stereotaxis said in a news release. Glynn also served in senior marketing roles at Volcano Corporation.

“We see in Stereotaxis the opportunity t…

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Stereotaxis opens new headquarters in St. Louis

Stereotaxis’ new headquarters are located in the historic Globe Building in downtown St. Louis. [Image courtesy of Globe Building]Surgical robotics company Stereotaxis (NYSE: STXS) is holding a grand opening today for its 45,000 ft² headquarters facility in downtown St. Louis.

The new headquarters is located in the renovated historic Globe Building in St. Louis’s growing Downtown North Urban Insight District. It’s an all-in-one facility housing research and development, advanced manufacturing, and distribution space for the company’s pipeline of robotic surgery technologies.

Stereotaxis more than 130 professionals in 10 countries worldwide. It designed its headquarters to accommodate significant long-term growth.

“Stereotaxis is delighted to inaugurate a modern new headquarters that serves as a foundation for years of progress and growth,” CEO David Fischel said in a news release.

“We appreciate the many community leaders who have support…

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Study: Stereotaxis robotic technology reduces silent cerebral embolism during AFib ablation

Stereotaxis announced the positive results from a study of its robotic magnetic navigation system in atrial fibrillation ablation.

The multi-center, prospective study evaluated 166 patients with paroxysmal or persistent AFib who underwent pulmonary vein isolation using Stereotaxis’ robotic magnetic navigation (RMN) technology or manual contact force ablation catheters. All patients on the study received cerebral magnetic resonance imaging (MRI) within 48 hours before and after the ablation procedure to assess the possibility of cerebral embolism.

Get the full story on our sister site, Medical Tubing + Extrusion.

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