Cantel Medical taps ex-Cardinal Health COO Fotiades for CEO | Personnel Moves, March 5, 2019

Cantel Medical CEO Fotiades Cantel Medical taps ex-Cardinal Health vet for CEO
Cantel Medical (NYSE:CMD) said today that it named former Cardinal Health (NYSE:CAH) COO George Fotiades to be its new president & CEO, replacing Jorgen Hansen effective immediately. Fotiades will retain his seat on Cantel’s board, the Little Falls, N.J.-based company said.

“On behalf of the board, I am very pleased to appoint George as Cantel’s new president & CEO. His experience leading companies through significant growth, creating organizational capabilities on a global scale and integrating acquired businesses make him the ideal candidate to lead Cantel at this juncture. George has been a key contributor to the board for over a decade and will make a seamless transition to this role. The board and I look forward to working with George in his new capacity to support the next phase of Cantel’s development,” chairman Charles Diker said in prepared remarks. “We thank Jorgen for his many contributions to Cantel. During Jorgen’s tenure, Cantel made significant progress expanding internationally and completed a number of key strategic acquisitions that have bolstered our market position and driven growth. Jorgen is a talented executive of the highest integrity and we wish him all the best in the next phase of his career.”

“It has been a privilege to lead the team at Cantel. During my tenure, we executed on our ambitious strategy, strengthening Cantel’s business and global reach. By doing so, we have taken the company’s mission of saving lives through infection prevention to the next level. I am proud of what we have accomplished together,” Hansen aded.

“Cantel has an excellent market position and many opportunities ahead for both organic growth and continued acquisition activity,” Fotiades said. “I look forward to working with the board and the executive leadership team in my new role to improve our operating model and performance, drive organic growth, attract and cultivate top leadership talent and identify attractive acquisition candidates and expansion opportunities.”

Cantel took a hit last week when it missed the consensus forecast with its fiscal second-quarter results. Read More

 Activ Surgical’s first CEO is ex-Olympus medical systems prez Usen
Activ Surgical said it named Todd Usen, the former president of Olympus Medical Systems, to be its first CEO. Activ is developing the Smart Tissue Autonomous Robot for imaging and diagnostics during robot-assisted surgeries.

“I’m incredibly thrilled to have Todd join and lead the Activ Surgical team. Todd’s outstanding experience and leadership in the endoscopic space provides a natural synergy to Activ’s disruptive vision of delivering enhanced surgical vision and intelligence,” co-fopunder and chief scientific officer Dr. Peter Kim said in prepared remarks.

“It’s a tremendous privilege to be selected to lead Activ Surgical as its first CEO,” Usen added. “I look forward to working with our board, advisors and Activ Surgical team to realize the full potential of our unique and proprietary technology.”

Usen is also an eight-year veteran of Smith & Nephew (NYSE:SNN), where he held roles including U.S. orthopedics president, and Boston Scientific (NYSE:BSX). Read More

 Globus Medical president Williams bows out
Globus Medical (NYSE:GMED) said president Anthony Williams gave notice Feb 28 of his plans to “pursue opportunities outside of the company,” with his last day slated to be May 31 “to ensure a seamless transition.” CEO Dave Demski is due to take over the Audubon, Pa.-based company’s presidential duties after that. Read More

 BioDirection puts Joshi in the corner office
Concussion and traumatic brain injury device maker BioDirection said it named Sharad Joshi as president & CEO.
Read More

 CathWorks names Feher as CFO
CathWorks named Edwards Lifesciences (NYSE:EW) vet Mike Feher as CFO and finance VP. Last month Cathworks closed a $30 million Series C round for its FFRangio fractional flow reserve device. Read More

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Globus Medical lands Anthem coverage win for Secure-C spinal implant

Globus MedicalGlobus Medical (NYSE:GMED) last week said it won a coverage decision for its Secure-C cervical spine implant from health insurance giant Anthem (NYSE:ANTM).

Audubon, Pa.-based Globus said the decision means the device is covered by the major third-party payers in all 50 states. Anthem has more than 73 million lives under its coverage umbrella, according to Globus. The Secure-C device won pre-market approval from the FDA in 2012 and is is designed to restore normal movement to the neck in patients with disc problems that produce neck and arm pain. It consists of 2 cobalt-chrome endplates and a central polyethylene core that mimics the function of a healthy spinal disc.

Globus said that its seven-year follow-up data show that patients implanted with the device showed statistically superior overall success results (86.3% vs. 70.0% of patients treated via anterior cervical discectomy & fusion); statistically superior composite FDA-defined overall success (79.2% vs. 63.6% for the ACDF comparator); a higher rate of patients showing at least 25% improvement in Neck Disability Index, a measure of pain and function (90.4% vs. 86.0%); a lower rate of subsequent surgery at the original treatment site (4.2% vs. 15.3%); and a lower rate of adjacent-level surgery (4.2% vs. 16.0%).

“The long-term clinical results validate that Secure-C creates a significant improvement in patients’ lives over the long term, an important factor in expanding payer coverage,” president Anthony Williams said in prepared remarks. “With the addition of Anthem, Secure-C is now covered by all major third-party payers in every state and strengthens our position for growth in the cervical artificial disc market.”

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Globus Medical gains on Street-beating prelims | Wall Street Beat

Globus Medical (NYSE:GMED) shares closed up yesterday after the orthopedics company reported preliminary fourth-quarter and 2018 sales numbers that beat the consensus forecast on Wall Street.

Audubon, Pa.-based Globus said it expects to post Q4 revenues of $195.5 million and full-year sales of $712.5 million; analysts on The Street were looking for quarterly sales of $188.2 million and annual sales of $705.2 million.

“Our fourth-quarter and full-year results are indicative of strong momentum in several key strategic areas,” CEO Dave Demski said in prepared remarks. “The fourth quarter marked the fifth consecutive quarter of double-digit organic revenue growth, which is particularly outstanding considering the strong comparable quarter last year. Emerging technologies delivered $14.8 million, or 35% growth, a significant accomplishment given the pent-up demand implicit in the fourth quarter of 2017 when we launched our robotic system. The U.S. spinal implant business grew by over 9% year-over-year, continuing the acceleration we saw in the third quarter, driven by robotic implant pull-through and strong recruiting.”

“We are pleased with our fourth quarter and full year performance,” added CFO Dan Scavilla. “We delivered 12% revenue growth and maintained our industry-leading profitability while investing significantly in growing our emerging technologies business. While we are not announcing fourth-quarter or full-year EPS or EBITDA at this time, our performance in the quarter was consistent with our long history of growing efficiently and profitably.”

Globus set its 2019 guidance at $17.72 per adjusted share on sales of $770 million, saying it plans to release its full results Feb. 21.

GMED shares closed up 2.8% at $39.84 apiece yesterday.

ConforMIS tops consensus

ConforMIS (NSDQ:CFMS) also topped the consensus with its Q4 and 2018 top line, saying it expects to post quarterly sales of $22.0 million and annual sales of $89.8 million, including the $10.5 million royalty settlement of its patent victory over Smith & Nephew last year.

Analysts were looking for Q4 sales of $20.8 million and 2018 sales of $86.37 million. Bedford, Mass.-based ConforMIS, which makes customized orthopedic implants, said it plans to report its full results Feb. 6.

CFMS shares closed up 4.4% at 50.5¢ apiece yesterday.

Tactile Systems surges after killing the consensus

Tactile Systems Technology (NSDQ:TCMD) gained big yesterday after crushing the consensus outlook and predicting double-digit top-line growth for this year.

The Minneapolis-based home healthcare device maker guided to Q4 sales of $45.5 million to $46.0 million and full 2018 sales of $142.8 million to $143.3 million, compared with The Street at $38.9 million and $137.7 million, respectively.

“We are excited to close the year with another quarter of strong execution, with revenue growth in excess of 30%, driven by sales of our Flexitouch systems,” CEO Gerald Mattys said in prepared remarks. “Our Flexitouch sales this quarter were driven by several of our primary growth drivers, including the expansion of and continuing execution from our field sales team, and higher than expected volume from a direct contract with a large commercial payer initiated in the third quarter. 2018 was an exceptional year for Tactile Medical, with record sales growth driven by the successful launch of our Flexitouch Plus system in the second quarter, our targeted selling strategy focused on our most productive accounts and strong sales growth in the Veterans Administration channel.

“Looking ahead to 2019, we remain confident in our ability to deliver 20% plus revenue growth and improving profitability as we continue to expand our share of the $4+ billion U.S. market in lymphedema and chronic venous insufficiency,” Mattys said.

TCMD shares closed up 26.2% at $59.73 apiece yesterday. The stock was trading at $59.16 per share today in early trading, down -0.1%.

Iridex slides despite beating forecast

Iridex (NSDQ:IRIX) shares slid after the company released its Q4 and 2018 prelims, despite topping the consensus forecast yesterday.

The Mountain View, Calif.-based laser device maker said it expects to log fourth-quarter sales of $11.0 million to $11.3 million and 2018 sales of$42.1 million to $42.4 million, topping The Street’s outlook for $10.9 million and $42.0 million, respectively.

“Our fourth-quarter results completed an exciting year for Iridex. Our commercial teams continued to drive growth in Cyclo G6 placements and we shipped a record number of G6 probes in the quarter. Overall, I am encouraged by the progress we made throughout the year, as we executed on multiple fronts across the organization,” chairman & CEO William Moore said in prepared remarks. “Heading into 2019, we remain focused on driving awareness and sales among a broad base of glaucoma specialists and comprehensive ophthalmologists, while continuing to innovate and advance our platform to treat the spectrum of the disease.”

Neuronetics also slips after beating The Street

Neuronetics (NSDQ:STIM) shares also took a hit despite beating The Street for both Q4 and 2018.

The Malvern, Pa.-based company, which makes transcranial magnetic stimulation to treat psychiatric disorders, reported Q4 sales of $15.6 million and full-year sales of $52.8 million, which topped both Wall Street and its own 2018 guidance for revenues of $51.0 million to $52.5 million.

Analysts were looking for Q4 sales of $14.9 million and annual sales of $51.8 million.

“We finished 2018 on a high note, as we continue to successfully execute on our strategy to drive higher NeuroStar Advanced Therapy penetration in the U.S.,” president & CEO Chris Thatcher said in prepared remarks. “As we move into 2019, given the success we have seen to date, we will continue to drive adoption through our key growth drivers – expanding our salesforce and related marketing efforts, continuing to focus on high-value accounts and pursuing additional indications for use for the NeuroStar Advanced Therapy system.”

Neuronetics also said it expects a reimbursement decision from the Japanese Ministry of Health, Labour & Welfare during the second half of this year for NeuroStar.

STIM shares closed down -3.6% at $17.00 per share yesterday. The stock was off -.04% at $16.93 per share today in early trading.

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Analyst downgrades pressure medtech stocks

thumbs downSeveral medical device companies took hits yesterday after analysts on Wall Street downgraded their stocks, on a day when the major market indices each closed up a hair, and even medtech firms that enjoyed upgrades came under pressure.

Globus Medical (NYSE:GMED) suffered the most after Morgan Stanley analyst David Lewis cut his rating on the stock from “overweight” to “equal-weight,” sliding -8.5% to a $39.61-per-share close yesterday, compared with the prior day’s closing price.

In fact, Lewis’s downgrades led the pack in terms of impact, taking Insulet (NSDQ:PODD) and Hologic (NSDQ:HOLX) shares down some -7.4% and -6.5%, respectively. Here’s a look at some of yesterday’s downgrade action:

DOWNGRADES
Company Analyst Old rating New rating Close 1/2/19 %
Globus (GMED) Morgan Stanley Overweight Equal-Weight $39.61 -8.5%
Insulet (PODD) Morgan Stanley Hold Hold* $73.43 -7.4%
Hologic (HOLX) Morgan Stanley Equal-Weight Under-Weight $38.42 -6.5%
Abbott (ABT) Citigroup Neutral Sell $69.50 -3.9%
Medtronic (MDT) Citigroup Buy Neutral $87.92 -3.3%
Henry Schein (HSIC) Robert W. Baird Outperform Neutral $76.39 -2.7%
Smith & Nephew (SNN) JP Morgan Overweight Neutral $36.40 -2.6%
Bayer (BAYN) JP Morgan Overweight Neutral $17.40 -1.0%
*cut price target

The upgrade picture was murkier, with a trio of medical device companies taking hits despite upgrades, but three others gaining (including a bullish move from Lewis on shares of Baxter (NYSE:BAX)):

UPGRADES
Company Analyst Old rating New rating Close 1/2/2019 %
Tactile Systems (TCMD) Northland Capital Under Perform Market Perform $44.59 -2.1%
Stryker (SYK) Evercore ISI In-line Outperform $154.50 -1.4%
Zimmer Biomet (ZBH) Citigroup Neutral Buy $102.28 -1.4%
Bausch Health (BHC) Piper Jaffray Neutral Overweight $20.23 0.1%
Baxter (BAX) Morgan Stanley Under-Weight Overweight $65.30 0.8%
Citigroup Neutral Buy
Apollo Endosurgery (APEN) Northland Capital Under Perform Market Perform $3.65 5.8%

By way of comparison, the three major U.S. market indices all closed up a hair yesterday, with the Dow Jones Industrial Average closing up 0.1% at 23,346.24. The S&P 500 also closed up 0.1%, at 2,510.03, and the NASDAQ index ended at 6,665.94, up 0.5%.

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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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