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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FDA warns Globus subsidiary HBT over ViaCell production facility issues

Globus Medical

The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) 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.

The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues.

In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away from the agency’s core current good tissue practice requirements.

“For example, since the start of ViaCell processing in October 2016 through August 2017, you have had monthly sterility failure rates of [redacted] during seven of those months, with one month having a sterility failure rate of [redacted]. Your firm failed to conduct an investigation of all these sterility failures to determine the cause. You also failed to investigate additional sterility failures that occurred from October 2017 through February 2018. By neglecting to identify the cause of the sterility failures, you also failed to take appropriate corrective action(s) to prevent recurrence of the failures,” the FDA wrote in its letter.

The agency also noted a failure to “validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests,” according go the FDA notice. The example provided again related to the facility’s ViaCell manufacturing process.

The federal watchdog said that it has received two responses from the company so far this year, but outlined some “comments and concerns” in relation to their corrective actions.

The FDA said that it received a response in May outlining corrective actions, but voiced concerns that the actions mostly focus on sterility testing which it said were not reliable, and did not address validation issues with the ViaCell manufacturing process. The agency also noted that while the company reported a decrease in sterility failure rate, it did not discuss plans to “determine the cause of the sterility failures” or why the rate of failures was so high.

The federal watchdog also posted a response to a letter received in September with concerns over the company’s corrective steps.

In its response, Globus’ HBT subsidiary said that it launched additional validation activities covering ViaCell production in May, but the FDA stated that its concerns about the firm’s validation of the ViaCell production process remain.

The agency noted a number of issues it has with the company’s corrective process, including another noted reliance on sterility testing and concerns over possible contamination during processing.

“A disinfection or sterilization process must be validated based on the capability of that process to reduce or eliminate an expected level and mix of microorganisms on the particular product that will be put through the process. Thus, you should carefully consider the capability of your microbiological testing, disinfection, and sterilization processes when you evaluate pre-processing cultures to determine whether or not the HCT/Ps should be processed,” the FDA wrote in its notice.

The FDA also knocked the company on not excluding or discarding samples from donors positive for Clostridium, Streptococcus pyogenes or “any other microorganism that you have determined to be difficult to eliminate, unless you have a terminal sterilization process validated to a sterility assurance level of 10-6.”

In its last point, the agency referenced a lack of positive results from all environmental and personnel monitoring sample testing, saying that having producing no positives is “highly unusual, especially when your sterility failure rates were so high.”

“We strongly suggest you review your environmental monitoring program to ensure that it is capable of detecting microorganisms in your environment and on your personnel,” the federal watchdog wrote.

The FDA gave the company 15 working days to respond to the issues.

Last month, Globus Medical posted third quarter earnings that handily topped expectations from analysts on Wall Street.

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Globus Medical Q3 beats The Street

Globus Medical

Globus Medical (NYSE:GMED) today posted third quarter earnings that handily topped expectations from analysts on Wall Street.

The Audubon, Pa.-based company posted profits of $35.2 million, or 35¢ per share, on sales of $169.2 million for the three months ended September 30, for bottom-line growth of 37.6% on sales growth of 11.5% compared with the same period last year.

Adjusted to exclude one-time items, earnings per share were 39¢, ahead of the 32¢ consensus on The Street, where analysts were looking for sales of $167.5 million, which the company topped.

“The third quarter marks the fourth consecutive quarter of double-digit organic growth for Globus Medical, as our U.S. spine business continues to take market share, growing by 7.5%; our international revenue increased by 16.8%; and emerging technologies contributed $6.3 million. During the third quarter, we completed the acquisition of Surgimap, the leading surgical planning software for spine.  The addition of Surgimap will further strengthen Globus Medical’s ExcelsiusGPS platform by streamlining workflow and enabling superior data analytics.  The level of adoption we are seeing by surgeons in accounts with our ExcelsiusGPS robotic system continues to show positive momentum and the pipeline for potential robotic sales is robust,” CEO Dave Demski said in a press release.

Globus Medical lifted its guidance for the full year 2018, expecting to see sales of $705 million and non-GAAP diluted EPS of $1.62, up from earlier guidance of $700 million in sales and non-GAAP EPS of $1.55.

Globus Medical shares rose 1.1% today, closing at $57.47.

In September, Globus Medical said that it t acquired Nemaris and its Surgimap planning software for an undisclosed amount.

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Globus Medical whales on Wall Street’s Q2 expectations

Globus Medical (NYSE:GMED) today whaled on the consensus expecation with its second-quarter results and raised its outlook for the rest of the year.

Audubon, Pa.-based Globus posted profits of $45.0 million, or 44¢ per share, on sales of $173.4 million for the three months ended June 30, for a bottom-line gain of 56.9% on sales growth of 13.8% compared with Q2 2017.

Adjusted to exclude one-time items, earnings per share were 44¢, 9¢ ahead of The Street, where analysts were looking for sales of $168.0 million.

“The second quarter marks the third consecutive quarter of double-digit organic growth for Globus Medical, as our U.S. spine business continues to take market share, growing by 4.2%; our international revenue increased by 7.2%; and emerging technologies contributed $13.8 million,” CEO Dave Demski said in prepared remarks. “We are very pleased with the strong sales of our ExcelsiusGPS robotic system, and more importantly, the level of adoption we are seeing by surgeons in accounts that have purchased the technology. The synergy of this transformational technology, combined with the most innovative suite of spinal implants in the industry, is expected to provide a powerful platform for our future growth.”

Globus said it now expects to report adjusted EPS this year of $1.55, up from $1.52 previously, on sales of $700 million, compared with prior guidance for $695 million.

The company also said it promoted CFO Dan Scavilla to chief commercial officer, saying he’ll keep the finance chief role until a replacement is found.

GMED shares closed up 2.7% at $52.85 apiece today.

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Globus Medical launches trauma devices

Globus Medical (NYSE:GMED) said today it launched the Anthem ankle fracture system and Anthem proximal humerus fracture system.

The Audobon, Penn.-based company touted the release as its trauma division’s fourth and fifth product line over the past 10 months.

The recently launched Anthem ankle fracture system includes seven plating options and is designed to minimize soft tissue irritation from implant prominence, Globus Medical said.

The Anthem proximal humerus fracture system is intended to treat shoulder fractures and features polyaxial screw technology the company

“This is an exciting time for Globus Trauma as we continue to execute our product launch strategy and build a comprehensive Trauma product portfolio. With each new product introduction, our goal is to design systems that help streamline the procedure, increase versatility, reduce operative time, and improve patient care,” orthopedic trauma VP Barclay Davis said in a press release.

In May, Globus Medical topped estimates with its first-quarter results and raised its outlook for the rest of the year.

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Analyst’s rating changes push Cardiovascular Systems up, NuVasive and Globus down

Ratings changes by an analyst with Bank of America-Merrill Lynch elevated one medical device company’s stock today in pre-marker trading but pushed two others down.

Appearing this morning on Bloomberg television, BAML’s Bob Hopkins said Wall Street isn’t foucsed enough on the July 31 investor day at Cardiovascular Systems (NSDQ:CSII), according to Seeking Alpha. The St. Paul, Minn.-based company plans to emphasize new product releases in the near term and could be in store for sustained double-digit earnings growth, Hopkins said.

The analyst upgraded his rating on CSII shares from “underperform” to “buy” and boosted his price target from $30 to $40, representing a 33% premium on yesterday’s $30.78 closing price. The upgrade sent the stock up 1.1% to $31.12 today before the market’s opening.

NuVasive Inc. (NSDQ:NUVA) and Globus Medical (NYSE:GMED) didn’t fare as well, as Hopkins downgraded both stocks to “underperform.

That sent NUVA shares down -2.2% to $51.60 apiece pre-market and pared -2.7% from GMED shares, which were at $51.85 before the open.

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OptiScan taps ex-Hansen Medical chief Vance for CEO | Personnel Moves, May 23, 2018

OptiScan taps ex-Hansen Medical chief Vance for CEO

OptiScan Biomedical tapped former Myoscience and Hansen Medical chief Cary Vance to be its new CEO, replacing interim head William Mince.

“I am excited to join OptiScan at this pivotal point in the company’s growth. I believe that the cutting-edge OptiScanner diagnostic system provides a unique platform to transform the way patients are managed in the ICU,” Vance, who led Hansen to an $80 million acquisition by Auris Health back in July 2016, said in prepared remarks. “I look forward to leveraging my experience in building and growing successful commercial organizations, as well as the current team’s deep technical insight and expertise, to maximize utility and value for patients, nurses, physicians and hospitals.”

“On behalf of the board of directors, I am pleased to welcome Cary to OptiScan,” added Paul Mieyal. “Cary’s proven ability to lead an organization as it leverages disruptive medical technologies, transforms existing markets, and establishes new standards will drive OptiScan’s commercialization strategy and activities in the global hospital market. Separately, the board would like to thank William Mince for his important strategic guidance and operational leadership during his tenure at OptiScan.” Read more


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Globus Medical shares rise on Q3 beat

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Globus Medical

Shares in Globus Medical (NYSE:GMED) rose today after the medical device maker beat expectations on Wall Street with its 3rd quarter earnings results.

The Audubon, Penn.-based company posted profits of $25.6 million, or 26¢ per share on sales of $151.7 million for the 3 months ended September 30, seeing the bottom line shrink 2.4% while sales grew 11.9% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were 30¢, just in line with consensus on Wall Street where analysts were expecting to see revenue of $150.4 million.

“We are very pleased with our third quarter performance.  We saw further acceleration in our U.S. spinal implant business, continued growth in the Japan market, and industry leading profitability, even as we invested heavily in Emerging Technologies. As previously announced, we received FDA clearance during the quarter for the ExcelsiusGPS robotic and navigation system.  While still in the early stages of our commercial launch of this game-changing technology, we are thrilled about the unprecedented level of interest we have received so far from surgeons and hospital systems,” CEO Dave Demski said in a press release.

The company reaffirmed its guidance for the full fiscal year 2017, expecting to see sales of $625 million and non-GAAP earnings per share of $1.27.

Shares in Globus have risen 7% so far today, at $34.05 as of 2:34 p.m. EST.

Globus Medical’s solid performance in the 3rd quarter made it stand in a quarter that’s often rough for spinal companies, according to Leerink Partner analyst Richard Newitter.

“We continue to believe GMED is on the cusp of a significant rev growth re-acceleration heading into 4Q17 and 2018 as the company’s emerging tech (robotics & trauma) begin to contribute more meaningfully. Historically, GMED’s stock & multiple have tended to work during rev growth acceleration periods, and we expect GMED is about to generate one of its strongest growth rebounds over the next 12-14 months,” Newitter said in a letter to investors.

In late August, Globus Medical said that it named David Demski as its new chief executive officer, replacing David Paul who stepped down due to health issues but will stay on as executive chairman.