Globus Medical launches ExcelsiusGPS in EU

Globus Medical

Globus Medical (NYSE:GMED) said yesterday that it launched its ExcelsiusGPS robotic guidance and navigation system in the global market, having completed installations of the system in several European countries.

The ExcelsiusGPS system won CE Mark clearance in the EU in early 2017 with indications for use in both minimally invasive and open procedures for orthopedics and neurosurgery, including procedures for the spine, long bones and cranium. The system is designed to integrate with Globus Medical implants and instruments, with compatibility with pre- and intra-operative CT and fluoroscopic imaging, the company said.

“Surgeons and hospital administrators in the United States have shown tremendous levels of interest in ExcelsiusGPS since it first launched domestically at the end of 2017. Users have realized the system’s ability to help advance patient care and provide tangible benefits for surgeons and their staff. As we begin to scale our efforts abroad, we have seen similar levels of enthusiasm within the international surgeon community and look forward to the continued adoption of ExcelsiusGPS into these markets,” CEO Dave Demski said in a prepared statement.

The Audobon, Penn.-based company touted that the first European procedure using the ExcelsiusGPS was performed at Athens, Greece’s Metropolitan Hospital by Dr. Panagiotis Zoumpoulis in October, and that numerous other surgeries have bene performed at Italy’s Fornaca Clinic and Germany’s Bonivatius Hospital.

“With the addition of ExcelsiusGPS we now offer patients seeking spine surgery a level of accuracy that was not possible without this technology. Our team is committed to providing the highest level of care to our patients by offering the latest advancements in robotic-assisted spine surgery at our facilities,” Dr. Franco Cenech of the Fornaca Clinic, who participated Italy’s first surgeries with the system, said in a press release.

“ExcelsiusGPS is truly a revolutionary technology designed to improve surgeon wellness and patient care. We are excited about the potential impact that robotic guidance and navigation may have in improving screw placement accuracy, MIS efficiency, and reducing radiation exposure,” Peter Klassen of Bonifatius Hospital said in prepared remarks.

Earlier this week, the FDA released a warning letter it sent to Globus Medical subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April.

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Corindus touts first-in-human coronary telerobotics study with CorPath system

Corindus Vascular Robotics

Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India.

The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab.

In the trial, five patients at India’s Apex Heart Institute underwent an elective PCI procedure from a distance of approximately 20 miles away, Corindus said.

The procedures were performed by Apex Heart Institute chair and chief interventional cardiologist Dr. Tejas Patel from inside the Swaminarayan Akshardham temple in Gandhinagar, while his partner, Dr. Sanjay Shah, attended to the patient in person at the Apex Heart Institute.

“The first in human cases of remote robotic PCI represent a landmark event for interventional medicine. The application of telerobotics in India has the potential to impact a significant number of lives by providing access to care that may not otherwise have been possible. For the first time in cardiology’s history, India will shine for this ground-breaking innovation, and I am honored to be a part of this historic occasion,” Dr. Patel said in a prepared statement.

Corindus said that following the study, it plans to begin commercial product development to allow the CorPath system to be used in remote interventions.

“Cardiovascular disease, including stroke, is the world’s most significant and undertreated clinical problem due to limited access to specialized, timely medical care. As a result of existing barriers to care, including increased global poverty and a declining number of trained specialists, only a fraction of patients worldwide receives life-saving treatment, resulting in substantial death or disability. We anticipate that our technology will revolutionize cardiovascular disease treatment by providing specialized and timely medical care to anyone, anywhere,” prez & CEO Mark Toland said in a press release.

Last month, Corindus saw shares rise over 10% after the robotic surgical platform maker beat loss-per-share expectations on Wall Street with its third quarter earnings.

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Neural Analytics adds $10m for robot-assisted brain ultrasound

Neural AnalyticsNeural Analytics yesterday reported raising nearly $10 million in for the robot-assisted brain ultrasound device it’s developing.

Los Angeles-based Neural Analytics’ NeuralBot is designed to work with its Lucid M1 transcranial doppler utrasound to provide non-invasive blood flow monitoring. In June the company won CE Mark approval in the European Union for NeuralBot.

In a funding round begun in May, Neural Analytics said it raised $9.5 million from 18 unnamed investors in an offering of debt, options, warrants and other securities, according to a Nov. 28 regulatory filing.

In January the company raised $15 million in a Series B round led by Alpha Edison.

“We are committed to advancing brain healthcare through transformative technology that empowers neurologists with the critical information needed to make clinical decisions and improve patient outcomes,” co-founder & CEO Leo Petrossian said in June. “Our products provide clinicians with a cost effective and non-invasive assessment of a patient’s brain health, and can help clinicians diagnose brain disorders, potentially without the need for more invasive testing.”

“This technology allows us to look inside the brain, evaluate blood flow characteristics and track emboli in patients. It provides us with critical information on brain health in real-time to help us diagnose neurological disorders, prior to the need for additional, more invasive testing,” added Dr. Claudio Baracchini of Italy’s University of Padua.

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Auris Health closes $220m equity funding round

Auris Health said today it closed a $220 million equity financing round to help support its next-generation robotic surgery platform.

The Redwood City, Calif.-based company said that the round was led by Partner Fund Management and joined by newly invested Wellington Management, D1 Capital Partners and Senator Investment Group and existing investors Mithril Capital, Lux Capital and Viking Global Investors.

The funding round brings the total raised for its Monarch surgical platform up to $700 million, Auris Health said.

“The support of this group of world-class investors will be instrumental as Auris transitions into a commercial-stage company. We are pleased with our progress in launching the Monarch platform, which was initiated earlier this year. This funding will enable us to expand our commercialization efforts for endobronchial applications, and will also support our mission to pioneer the next era of medical intervention across a broader spectrum of procedures,” founder & CEO Dr. Frederic Moll said in a press release.

Auris Health’s robotic Monarch platform has FDA clearance for diagnostic and therapeutic bronchoscopic procedures. The system features a controller interface for navigating the integrated flexible robotic endoscope into the periphery of the lung and combines traditional endoscopic views with computer-assisted navigation based on 3D patient models, the company said.

In October, Auris Health, previously known as Auris Surgical Robotics, touted results from a study of its Monarch platform that indicated that the system was able to reach lung nodules and biopsy tissue with “high accuracy.”

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Mazor Robotics shareholders OK $1.6B Medtronic merger

Mazor Robotics, MedtronicMazor Robotics (NSDQ:MZOR) said that its shareholders yesterday approved the $1.6 billion merger with Medtronic (NYSE:MDT).

The Caesarea, Israel-based company said roughly 53% of its shares were represented in the vote, with about 95% of those cast in favor of the $58.50-per-ADR-share deal.

The world’s largest medical device maker has held a position in Mazor, which makes the Mazor X guidance system and the Renaissance robot-assisted spine surgery platform, since May 2016. In September they closed the third, $40 million tranche of that investment, giving Medtronic a 10.6% stake for $72 million.

Medtronic has said it plans to develop a fully-integrated surgical planning, execution and confirmation system by uniting its existing spine technologies with the Mazor robotic system once the deal closes, expected during Medtronic’s fiscal third quarter ending Jan. 25.

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How a teenage Gary Guthart, Intuitive Surgical’s CEO, got his start at NASA

Intuitive Surgical CEO Gary GuthartToday Gary Guthart is best know as the CEO of Intuitive Surgical (NSDQ:ISRG), the world’s leading medical robotics company. But robot-assisted surgery wasn’t Guthart’s first love, he told MassDevice.com ahead of his keynote appearance at this year’s DeviceTalks West event.

That honor goes to NASA (or, more properly, science). During his teenage years growing up in Sunnyvale, Calif., Guthart told us, he landed a job at the space agency that helped shape the course of his life.

Don’t miss Gary Guthart’s keynote appearance Dec. 11 at DeviceTalks West!

“I was a shy kid and a good math student. It turns out I had a knack for math,” Guthart recalled. “Then, my senior year of high school, a calculus teacher said, ‘Hey, I am going to sign you up for an internship.’ He actually signed me up without telling me.

“I wound up in a human factors research lab run by a woman named Sandra Hart. I wrote software for evaluating the performance of combat pilots when under stress,” he said.

Guthart never looked back, he added.

“I decided, ‘I can’t believe I get paid to do this.’ I got to ride my bike onto, it was at that time a Naval base and a NASA base, so I had a little security clearance and rode through the little armed gates and got to watch experimental aircraft fly in and out of the base and meet shuttle pilots – and all as a teenager,” he said. “I though, ‘I am in. That is it. I don’t care what else I am doing, but if I get paid to do this, this is the best job in the world.’ So that was my entry into science.”

After a nine-year stint in academia, during which Guthart earned a Ph.D. in fluid mechanics, he landed at an applied research lab at Stanford Research Institute when a chance encounter at a basketball game put medical robotics on his radar.

“While I was out at SRI, I would play basketball over lunch every lunchtime on the SRI basketball court. It was a good game, it was full, and I am standing on the sidelines (because I wasn’t a great basketball player) and I am starting with the person next to me, who is also not a great basketball player, and he said, ‘Do you know anything about this kind of non-linear math, I am struggling with this surgical robot I am trying to make?’ That is how I ran into surgical robots,” he told us.

Hear the rest of Gary Guthart’s story Dec. 11 at DeviceTalks West. Register now!

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Mazor posts Q3 miss, wins FDA nod for Mazor X Stealth edition

Mazor Robotics Mazor X

Mazor Robotics (NSDQ:MZOR) today released third quarter earnings that narrowly missed loss-per-share expectations on Wall Street, and announced that it won FDA clearance for its Mazor X Stealth edition.

The Caesarea, Israel-based company posted losses of $16.9 million, or 32¢ per share, on sales of approximately $10.1 million for the three months ended September 30, seeing losses grow 329.2% while sales shrunk 45.8% compared to the same period during the previous year.

Losses per share were just behind the 4¢ consensus on Wall Street.

Mazor also said that the FDA cleared its Mazor X Stealth Edition system, which integrates Medtronic‘s (NYSE:MDT) Stealth navigation with the Mazor X robotic guidance platform.

The integrated device comes as a headwind to the company’s upcoming acquisition by Fridley, Minn.-based Medtronic, originally announced in September.

The world’s largest medical device maker has held a position in Mazor, which makes the Mazor X guidance system and the Renaissance robot-assisted spine surgery platform, since May 2016. In September they closed the third, $40 million tranche of the investment, giving Medtronic a 10.6% stake it paid $72 million for.

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Intuitive doesn’t expect any Chinese expanded quota da Vinci Sales this year

Intuitive Surgical

Intuitive Surgical (NSDQ:ISRG) said yesterday that despite the Chinese National Health Commission publishing a new quota expansion looking to add more surgical robots over the next two years, it does not expect to sell any systems under the new quota this year.

Sunnyvale, Calif.-based Intuitive Surgical saw shares rise over 5% yesterday on the news that the Chinese Government was calling for a total of 197 endoscopic surgical instrument control systems, or surgical robots, by the end of 2020.

That number includes 154 new systems, according to the government release.

Shortly after the announcement, the robotic surgical giant said in an SEC filing that the process to fill the quota could take time, and that it doesn’t see any transactions in it’s immediate future.

“Da Vinci Surgical systems sales under the quota are uncertain, as they are dependent on hospitals completing a tender process and receiving associated approvals. The tender process could be lengthy, and the company does not expect to sell any systems under this quota in 2018,” the company wrote in the filing.

Shares in Intuitive Surgical have dropped 2.8% so far today, at $506.47 as of 9:50 a.m. EDT.

Last month, shares of Intuitive got a pre-market bump after the robot-assisted surgery pioneer posted third-quarter results that beat the consensus forecast, despite lower profits, and upped its outlook on procedure growth for the year.

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Intuitive Surgical shares rise on expanded surgical robot quota in China

Intuitive Surgical

Intuitive Surgical (NSDQ:ISRG) shares have risen over 5% in pre-market trading after the Chinese government released a new Large-Scale Medical Equipment Configuration Plan calling for an additional 154 surgical robot systems to be deployed in the country by the end of 2020.

The official release from the Chinese Government calls for a total of 197 endoscopic surgical instrument control systems, or surgical robots, by the end of 2020. That number includes an additional 154 new systems.

The last time the government issued a similar quota expansion was in 2013, according to a Leerink Partner letter to investors by analyst Richard Newitter.

After the last quota was issued in 2013, the majority of the systems weren’t sold until 2015, Newitter wrote, leading him to believe that a similar purchasing spread will occur with the current quota expansion. He expects that 10% of the 154 units will be acquired in 2018, 30% in 2019 and 60% in 2020.

Currently, Intuitive has more than 80 robotic platforms installed in civilian and military hospitals in the region, according to the letter. Newitter expects that the majority of the new quota, approximately 90%, will go to Intuitive.

“We expect ISRG will fulfill most, if not all, of the new quota but acknowledge that competitive offerings, over time and if available before 2020, might have a shot at winning some of the placement quota,” Newitter wrote in a letter to investors. “While we do not know the exact intentions of the Chinese government, we suspect that ISRG will place the lion’s share (~90%+) of additional systems under the new quota given Da Vinci’s capabilities vs. other systems.”

He went on to say that there is “some risk around quota fulfillment timing” depending on when other major offerings, like those from Johnson & Johnson (NYSE:JNJ), Medtronic (NYSE:MDT), TransEnterix (NYSE:TRXC) and Auris Health, hit the market.

Shares in Intuitive rose over 5% in pre-market trading, and have risen 4.5% in early morning trading, at $512.89 as of 9:36 a.m. EDT.

Earlier this month, shares of Intuitive Surgical (NSDQ:ISRG) got a pre-market bump after the robot-assisted surgery pioneer posted third-quarter results that beat the consensus forecast, despite lower profits, and upped its outlook on procedure growth for the year.

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Bionik Labs pulls trigger on 1-for-150 reverse split

Bionik Laboratories' Arke

Robotic rehabilitation device developer Bionik Laboratories said yesterday that it implemented a 1-for-150 reverse split of its stock.

The ratio was agreed upon by the Toronto-based company’s board of directors, and is intended to satisfy the minimum stock price requirement of the Nasdaq Capital Market.

“The completion of the reverse stock split is an integral step in the process of pursuing a successful listing on Nasdaq. We believe that listing on Nasdaq will expand awareness of the company among the investment community, and potentially provide avenues for additional sources of funding as we work to execute our growth strategy,” Bionik CEO Dr. Eric Dusseux said in a prepared statement.

Bionik Laboratories said that before the split, there were approximately 350.6 million shares issued and outstanding, and that it expects there to be approximately 2.3 million shares post-split. The company also had approximately 41 million exchangeable shares issued and outstanding, and expects there to be approximately 273,575 such shares following the split.

In August, Bionik Labs said that it integrated Amazon‘s (NSDQ:AMZN) Echo and Alexa voice technology into its Arke lower body exoskeleton.

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