dimecres, 28 de febrer del 2018

GI Dynamics shareholders approve $2m offering

GI Dynamics

GI Dynamics (ASX:GID) said today its shareholders approved an offering worth a total of $1.6 million (AUD $2 million) through the sale of Australian CHESS depository interests in two tranches, with funds slated to support continued development of its EndoBarrier and for general working capital.

The Boston-based company said the placement comes through the sale of approximately 58.8 million CDIs, representing 1.2 million shares of common stock at 28¢ (AUD 35¢) per share in two tranches.

The first tranche, which closed in January, consisted of 28.5 million CDIs, representing 569,341 shares of common stock and raising $779,442 (AUD $996,347), GI Dynamics said.

The second tranche consists of 30.3 million CDIs, representing 606,271 shares of common stock expected to raise $830,000 (AUD $1.1 million).

Shareholders ratified previously issued CDIs and approved the issuance of CDIs under the second tranche upon receipt of all second tranche funds, according to the press release.

Last November, GI Dynamics said its notified body in Europe withdrew its certification for CE Mark approval for its EndoBarrier device, meaning the company can no longer sell the obesity and diabetes treatment in the European Union.

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LivaNova shares up on topped Q4, 2017 earnings

LivaNova logo

Shares in LivaNova (NSDQ:LIVN) rose today after the medical device maker met most of the expectations on Wall Street with its fourth quarter and full fiscal year 2017 earnings results.

The London-based company posted losses of $111.7 million, or $2.32 per share, on sales of $278.4 million for the 3 months ended December 31, seeing losses grow 61.5% while sales grew 11.5% compared with the same period during the previous year.

After adjusting to exclude one-time items, earnings per share were 89¢, just ahead of the 77¢ consensus on Wall Street where analysts were expecting to see sales of $262.7 million.

For the full year, LivaNova posted losses of $25.1 million, or 52¢ per share, on sales of $1 billion, seeing losses grow 60% while sales grew 4.9% compared to the previous fiscal years.

Adjusted to exclude one-time items, earnings per share were $3.54, ahead of the $3.32 consensus on Wall Street where analysts were expecting to see sales of $1.1 billion, which the company narrowly missed.

“We had a tremendous fourth quarter, meeting all of our financial targets for the year. Neuromodulation benefited from the strong performance of our newest VNS Therapy System, SenTiva, which received U.S. Food and Drug Administration approval in early October 2017. The business also benefited from rescheduled procedures as a result of hurricane impacts in the third quarter. Cardiac Surgery experienced robust growth, driven by sales of our S5 heart-lung machine and our Perceval sutureless aortic heart valve. We are moving forward with the divestment of our cardiac rhythm management business to MicroPort Scientific Corporation, which is expected to close in the second quarter of 2018. All of this allowed us to grow our full-year adjusted diluted earnings per share from continuing operations by 9.2% from full-year 2016. We recently announced the acquisition of ImThera Medical, which complements our neuromodulation business with a device focused on neurostimulation for the treatment of obstructive sleep apnea, and more recently announced our intent to acquire TandemLife, which complements our cardiac surgery business with advanced cardiopulmonary temporary support solutions. We intend to continue this momentum throughout 2018, taking actions that strengthen LivaNova’s commitment to improving the lives of patients around the world,” CEO Damien McDonald said in a press release.

LivaNova released updated guidance for the 2018 year, expecting to see sales grow 4% to 6%, with earnings per share between $3.40 and $3.60.

Shares in LivaNova rose approximately 2.6% to close at $89.74.

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Sorrento Therapeutics wins FDA nod for post-shingles pain patch

Shares in Sorrento Therapeutics (NSDQ:SRNE) soared today after the company announced that the FDA approved its ZTlido lidocaine pain patch designed to treat patients with post-shingles neuralgia.

The company resubmitted its application for ZTlido to the FDA last year after it was rejected by the U.S. regulatory agency in 2016.

Get the full story at our sister site, Drug Delivery Business News.

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Study: Hill-Rom’s Metaneb System lowers risk of post-operative pulmonary complications

Hill-Rom MetaNebResearchers at the 47th Society of Critical Care Medicine reported this week that Hill-Rom‘s (NYSE:HRC) Metaneb System may help reduce the incidence of post-operative pulmonary complications in high-risk patients.

A 419-patient study found that patients using the Metaneb System combined with standard respiratory therapy spent 1.6 fewer days in the hospital on average compared to the group receiving standard respiratory therapy alone.

Get the full story at our sister site, Drug Delivery Business News.

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ClearFlow raises $7m, looking for $3m more

ClearFlow

ClearFlow raised $7.2 million in a new round of equity financing, according to an SEC filing posted this week.

Money in the offering came from five anonymous investors, with the first sale recorded on February 15.

The Anaheim, Calif.-based company is looking for an additional $3 million before closing the offering, according to an SEC filing, which would bring the total possible in the round up to approximately $10.2 million.

Last June, ClearFlow said it won FDA 510(k) clearance for its FlowGlide active clearance technology system designed to prevent or reduce clot occlusions during chest drains.

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Stryker closes $664m Entellus Medical buy

Stryker acquires Entellus Medical

Entellus Medical (NSDQ:ENTL) said today it closed its $664 million sale to Stryker (NYSE:SYK), becoming a wholly owned subsidiary of the Kalamazoo, Mich.-based medtech firm.

Plymouth, Minn.-based Entellus, founded in 2006, makes a family of minimally invasive balloon device products, including its flagship Xpress device, that are designed to treat blocked sinuses. Earlier this year it closed the $81 million buyout of Spirox and its Latera absorbable nasal implant.

In the deal, Stryker paid $24 per share for each share of Entellus, paying an approximate $664 million for the company.

As part of the completed merger, Entellus terminated a loan agreement with Oxford Finance, paying a fee of approximately $1.2 million with the early termination of the agreement, the company said in an SEC filing.

Earlier this month, Stryker said it won expanded FDA indications for its Trevo thrombectomy device, now cleared as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset

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How GE is measuring blood pressure with selfies

selfie-smartphone-app

[Image from unsplash.com]

Regular blood pressure measuring could soon be completely cuffless, thanks to a group of scientists and researchers who are working on creating algorithms to detect blood pressure using a smartphone camera.

Scientists at GE Global Research, Michigan State University and the University of Rochester Medical Center are working on making algorithms that can analyze video from a smartphone’s camera to detect the blood pulsing below the skin to read blood pressure.

“This new cuffless approach involves capturing a short video of your face and hands lasting 5 to ten seconds, during which we observe and analyze what’s happening beneath the skin to estimate your heart rate and blood pressure,” Lalit K. Mestha, an engineer at GE Global Research, said in a press release.

Get the full story on our sister site, Medical Design & Outsourcing.

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Report: Medtech faces 2018 challenges, FDA a bright spot

diceFinancial trends for the medical device industry last year point to a continuing series of challenges for large and small companies alike in 2018, ranging from a tightening M&A landscape to an even tighter funding scene – with the FDA making a surprise appearance as a potential bright spot.

According to the Pharma, Biotech and Medtech 2017 in Review report from EP Vantage, the editorial arm of life science market researcher Evaluate, the trends of 2017 augur worst for smaller medtech enterprises.

“In medtech the funding crunch still exists for small companies,” Elizabeth Cairns, author of the report’s medtech section, said in prepared remarks. “Last year so few venture deals were done, and so few IPOs got away, that there is a real possibility that the pool of start-ups could dry up completely if this trend is not reversed.”

Here are a few key points on the medtech market from the report:

  • The big keep getting bigger – and doing better. No company with a market capitalization of more than $10 billion saw its share price decline.
  • Medtech indices surge. The Thomson Reuters Europe index went from a -12% drop in 2016 to growth of 16% last year. In the U.S., the Dow Jones U.S. Medical Equipment Index and the S&P Composite 1500 HealthCare Equipment & Supplies index went from 2016 growth of 5% to 7% to 30% and 31%, respectively.
  • M&A values stay up, volume still in decline. Although the total value of all mergers last year was $98.5 billion – the second-highest after 2015 and more than twice as high as 2016, buoyed by the third- and fourth-largest medtech deals on record (Abbott-St. Jude and BD-Bard) – the number of deals was the fewest since then financial crisis of 2009 at 183.
  • It’s the same story with VC funding. At $5.1 billion, 2017’s total was the highest on record for venture capital spending (the top 10 rounds made up half of the total spend), but the number of deals was the lowest since 2006 at 225.
  • IPO market stays quiet. Initial public offerings were slow last year, with only 10 companies issuing flotations. Only half were in the U.S., with nearly a third coming from Sweden alone. Unusually, foreign IPOs raised more, at $141 million OUS to $100 million domestically. And the OUS stocks fared better too, gaining 47% compared with 8% for their U.S. peers.
  • FDA gets faster. The federal safety watchdog approved 50 devices in record time last year, with its 14-month average halving the average approval time in 2013 and running five months better than 2016. There were twice as many high-risk device approvals (PMA and HDE) as in 2013, to boot.

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Medtronic inks 5-year partnership with Lehigh Valley Health Network

Medtronic logo

Medtronic (NYSE:MDT) today announced a five-year strategic partnership with Lehigh Valley Health Network looking to develop value-based solutions for patients within the network.

The LVHN serves a total of eight hospitals across seven counties in Northeastern Pennsylvania, Fridley, Minn.-based Medtronic said.

The healthcare network’s partnership with Medtronic will aim to create programs for more than 70 major medical conditions with goals of reducing cost by $100 million and improving outcomes for as many as 500,000 patients.

“This agreement is exciting not only for Medtronic and LVHN, but also for the healthcare industry, by serving as a template for how we can work together to achieve our mutual goals of better clinical and economic outcomes. By working in partnership, trusting each other, and combining our expertise, we will create new models of care that are more connected and coordinated. Ultimately, these value-based programs will contribute to a more sustainable health system and a healthier community,” Medtronic chair & CEO Omar Ishrak said in a prepared statement.

Initial programs created through the partnership will focus on cardiovascular disease, stroke and lung cancer with additional areas to be identified later. Both groups aim to create programs across 10 to 15 conditions initially with initiatives in therapy optimization, episodic care bundles and chronic care management.

“As LVHN continues navigating the daunting challenges in today’s healthcare environment, we are actively searching for new approaches and partners for providing better care and better health at better cost to our community. The opportunity to create innovative programs through this first-of-its-kind partnership with Medtronic will enable both organizations to improve patient experiences and outcomes at a reduced cost,” LVHN prez & CEO Brian Nester said in a press release.

Last week, Medtronic saw its shares take a hit after it announced its robot-assisted surgery platform has fallen behind schedule, despite fiscal third-quarter results that topped the consensus forecast on Wall Street.

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The most disruptive medical device innovations of all time

When it comes to disruptive medical device innovations, it’s easy to lose the perspective of history. Here are devices through history that definitely made a difference.

Chris Newmarker, Managing Editor and Danielle Kirsh, Assistant Editor

disruptive medical device innovationsWhether you’re talking about surgical robotics or efforts to bring more value to healthcare, the word “disruptive” seems to get tossed around a lot these days.

So what is truly disruptive? And what is merely revolutionary or just innovative or simply hype?

Take stents as an example. The coronary stent market is already worth billions of dollars; Grand View Research projects it will nearly double to $15.2 billion by 2024. They’ve definitely changed the game because cardiologists in developed countries implant them into patients a lot. They’re a major product for medtech giants including Abbott, Boston Scientific and Medtronic.

But when researchers in the United Kingdom got around to doing a study with a sham control, the results late last year were unbelievable: Stents could be useless for most stable patients; the chest pain reduction they think they’re getting could be a placebo effect.

“Stents still have a place in care, but much less of one than we used to think,” Dr. Aaron E. Carroll, professor of pediatrics at Indiana University School of Medicine, recently wrote in a New York Times post.

If the jury is out on stents, is there anything these days that can be called truly disruptive? The editors at MassDevice and Medical Design & Outsourcing got together and came up with a list of devices through history that were truly game-changes. Cleveland Clinic also comes out with an annual list of top medical device innovations, so just to be provocative, we’re also including a few that appear to be panning out.

Here are some medical devices that seem to be good candidates for a list of most disruptive medical device innovations of all time.

Next>>

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Penumbra shares rise on Q4, FY2017 earnings beat

Penumbra

Shares in Penumbra (NYSE:PEN) rose today after the medical device maker met expectations on Wall Street with its fourth quarter and fiscal year 2017 earnings results.

The Alameda, Calif.-based company posted profits of $9.1 million, or 25¢ per share, on sales of $96 million for the 3 months ended December 31, seeing a massive swing from the red on the bottom line while sales grew 31.4% when compared with the same period last year.

Earnings per share were well above the 1¢ loss-per-share consensus on Wall Street, where analysts were expecting to see sales of $96 million, which the company met.

For the full year, Penumbra posted sales of $4.7 million, or 13¢ per share, on sales of $333.8 million, seeing the bottom line shrink 68.6% while sales grew 26.8% compared with the same period during the previous year, according to a press release.

Earnings per share beat the 14¢ loss per share consensus on The Street, while the company matched the $333.8 million sales expectations.

The company updated its guidance for the coming fiscal year, expecting to post sales of between $400 and $405 million.

Shares in Penumbra have risen 6.3% so far today, at $110.85 as of 11:42 a.m. EST.

In late January, Penumbra released results from the Compass trial of its aspiration thrombectomy system designed to treat acute ischemic stroke, touting that the system was shown to be non-inferior to stent retrievers.

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Profound Medical prices $20m bought deal financing round

Profound Medical

Profound Medical (TSX:PRN) yesterday announced an upcoming $20 million “bought deal” financing round.

In the deal, the Mississauga, Ontario-based company said it will offer 20 million units at a price of $1 million per unit, for gross proceeds of $20 million.

Each unit in the round will consist of a single common share and one-half of a common share purchase warrant, with each warrant exercisable to acquire one common share of the company for five years past the closing date at a price of $1.40 per share.

Profound Medical said that if its common share price on the TSX Venture Exchange rises to greater than $2.80 for a period of 90 days, the company can accelerate the expiry date of the warrants to expire on the 20th day after the notice is given, 60 months from the closing date.

The offering also includes an underwriter’s over-allotment option to purchase an additional 3 million units at the offering price exercisable at any time on or prior to the date 30 days before the closing of the offering. The underwriter’s option could bring in an additioanl $3 million, according to a prepared statement.

Funds raised in the round are slated for supporting working capital and for general corporate purposes.

Last August, Profound Medical said it inked an $8 million “bought deal” financing with a pair of underwriters that it plans to use for its Tulsa-Pro and Sonalleve ablation devices.

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Edwards Lifesciences recalls Cardioband anchors

Edwards LifesciencesEdwards Lifesciences (NYSE:EW) last month recalled the anchors used with its Cardioband mitral valve repair device after receiving a pair of reports that the device came loose from the surrounding tissue.

The Cardioband device, acquired in the $690 million buyout of Valtech Cardio last year, is designed to reshape the mitral valve using specially designed anchors. In a letter to physicians posted by German regulators Jan. 26, Edwards said a manufacturing tweak, although within its specs, was responsible for the issue.

“Through the review of recent case reports, we have noted an increased number and rate of Cardioband anchor disengagement events, both during and in the days after mitral implantation,” according to the letter from quality affairs VP Mark Gayle. “Such anchor disengagements have led, in up to two cases, to Cardioband implant dehiscence requiring intervention.

“Many patients treated with the Cardioband to date are in clinical trials; we recommend following up those patients per their trial protocols. For patients treated outside a clinical study protocol and treated between July and December 2017, we recommend you consider echocardiographic follow‐up between 3 – 6 months after implant, or sooner if symptoms warrant,” Gayle wrote.

An Edwards spokeswoman told MassDevice.com via email today that the company decided to “tighten” the manufacturing process for Cardioband as part of its integration into Irvine, Calif.-based Edwards.

“We expect to replenish inventories and resume treatment of patients in March,” she wrote.

The recalled anchors, which were not implicated in any deaths, pose no risk of embolization because they remain attached to the implant, Gayle wrote. The recall affects only the anchors, not the band or delivery system, the spokeswoman told us.

Edwards closed the Valtech buy in January 2017, paying $340 million in up-front cash and pedging another $350 million in milestones over 10 years. The deal did not include Valtech’s trans-septal mitral valve replacement program; that business was slated to be spun out on its own before the buyout’s closing with Edwards keeping an option to buy.

Or Yehuda, Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August 2016.) Valtech won CE Mark approval in the European Union for Cardioband in September 2015; it is not approved for the U.S. market.

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Intersect ENT posts Street-beating Q4, full-year sales, earnings

Intersect ENTShares in Intersect ENT (NSDQ:XENT) rose today after the medical device maker topped expectations on Wall Street with its fourth quarter and full-year financial results.

The Menlo Park, Calif.-based company posted a net loss of -$3.2 million, or-11¢ per share, on sales of $29.5 million for the three months ended Dec. 31, for sales growth of 22% compared with the same period last year.

Get the full story at our sister site, Drug Delivery Business News.

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Nortech Systems is expanding its Mexico operations

Mexico Nortech Systems

[Image courtesy of Google Maps]

Nortech Systems (Nasdaq: NSYS) says it has signed a lease on for a new facility to be built in Monterrey, Mexico — about 5 miles from Northech’s present location in the northeastern Mexican city.

Nortech (Maple Grove, Minn.) plans to occupy the facility — which is double the size of the present location — by the third quarter of 2018, transferring operations there by the end of the year.

Get the full story on our sister site Medical Design & Outsourcing. 

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Medartis plans Swiss IPO

Medartis

Swiss medtech company Medartis Holding yesterday revealed plans for an initial public offering on the SIX Swiss Exchange slated for the first half of this year.

The company produces fixation products designed for treating small-bone fractures and osteotomies in the lower and upper extremities and the craniomaxiofacial region. All device production is managed in-house at its facilities in Basel, Sweden.

Medartis was founded in 1997, sells products in 44 different countries including the US, Japan, the UK, France, Germany, Switzerland, Australia and Brazil.

“The planned IPO will mark an important milestone in the development of Medartis and will allow us to take the company to the next level. There are numerous opportunities for us to grow, and the timing is right for us to offer shares and seek a listing, in order to be in a strong position to capture these favorable prospects. I am extremely proud of what Medartis and our employees have achieved since our founding just over 20 years ago. Our focus on providing customers around the world with innovative, high-quality, Swiss-made fixation system solutions, combined with continuous support and education, has been the cornerstone of our success,” founder & board chair Thomas Straumann said in a press release.

Medartis reported sales of $112 million (SFr 105 million) and an operational EBITDA of $20.1 million (SFr 19 million) during last year.

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Dexcom beats The Street with Q4 sales, earnings

Dexcom (NSDQ:DXCM) beat expectations on Wall Street with its fourth quarter and full year financial results, growing its quarterly revenue 29% compared to the same period last year.

The San Diego, Calif.-based company posted a net loss of -$9.4 million, or -11¢ per share, on sales of $221 million for the 3 months ended Dec. 31. Adjusted to exclude one-time items, earnings per share were 10¢, handily topping consensus on The Street, where analysts were looking for sales of $215.9 million.

Get the full story at our sister site, Drug Delivery Business News.

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dimarts, 27 de febrer del 2018

Wright Medical turns a $29 million profit in Q4, sales up 12.7%

Wright MedicalWright Medical (NSDQ:WMGI) today made good on its previously predicted 12.7% increase in fourth-quarter sales, boosted by a 29% jump in U.S. sales of its upper extremity surgical solutions for the shoulder, elbow, wrist and hand.

The earnings results, reported after market close, included sales of $217.6 million for the quarter ended Dec. 31. Profits were $29.1 million, or 27 cents per share, a turnaround from a loss of $44.9 million, or 43 cents per share, for the same quarter a year before.

Adjusted non-GAAP earnings were 10 cents per share, beating the 4 cents per share average estimate of analysts polled on Yahoo! Finance.

When it comes to lower extremities products — foot and ankle — U.S. sales were only up about 4% year-over-year during the fourth quarter.

“As anticipated, we did not see any benefit in the fourth quarter in our U.S. lower extremities business from the sales force expansion. Additionally, we had some supply constraints primarily related to a third-party coating vendor in the fourth quarter, which we believe have been addressed. However, this affected our total ankle business during the fourth quarter,” CEO Robert Palmisano said in a news release.

“As previously discussed, we will continue to focus on improving our execution and building our physician relationships to restore growth in our core U.S. lower extremities business and expect to see improvement in 2018 as our larger sales footprint, new products, new reps and expanding relationships begin to take effect.”

For all of 2017, Wright Medical lost $202.6 million, or $1.94 per share, off $745.0 million in revenue, versus a loss of $432.4 million, or $4.20 per share, off $690.4 million in revenue in 2016.

 

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Masimo revenue up 23% in Q4, beating the Street

MasimoMasimo (Nasdaq: MASI) during its fourth quarter enjoyed a Street-beating 23% year-over-year increase in its revenue, fueled by rising adoption of the Irvine, Calif.–based company’s noninvasive patient monitoring technologies.

Revenue rose to $225.2 million for the quarter ended Dec. 30, the company reported after market close today. The sales beat the average of $201.4 million that analysts polled on Yahoo! Finance had predicted.

Fourth quarter earnings were $367,000, or 1 cent per share, down from $215.3 million, or $3.97 per share for the same quarter a year before. The quarter, however, saw a one-time charge of 78 cents per share related to the tax reform Congress passed at the end of last year, and the fourth quarter of 2016 saw a one-time $3.43 per share boost involving a $300 million lawsuit settlement from Philips.

Excluding one-time items, Masimo’s earnings were 79 cents per share during the fourth quarter, up from 54 cents per share a year before and beating the Street’s expectations of 61 cents per share.

“Our fourth quarter and full year 2017 results clearly illustrate the strength of our technology and hence, our business as we once again exceeded expectations for product revenues and earnings,” CEO Joe Kiani said in a news release after market close.

“We realized another record high for shipments of our SET pulse oximeters, which reached 54,100 for the quarter and exceeded 200,000 for the year, a significant milestone for the company,” Kiani said. “We anticipate rising adoption of our technologies as more care providers appreciate the value they provide for patients.”

For all of 2017, Masimo earned $131.6 million, or $2.36 per share, off $798.1 million in revenue, versus profits of $300.7 million, or $5.65 per share, off $394.6 million in sales in 2016.

Masimo in 2018 is predicting earnings of $1.61.5 million, or $2.90 per share, which is ahead of analysts’ estimates.

 

 

 

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Hacking pacemakers is good TV, but is it for real?

hacker hacking cybersecurity hacking pacemakers

[Image from Unsplash]

Worry less about bad people hacking pacemakers and other cardiac devices. Worry more about them disrupting hospitals’ communications networks.

That’s the major message out of the American College of Cardiology’s Electrophysiology Council, which published an article about cardiac devices earlier this month in the Journal of the American College of Cardiology. 

The idea that hackers might target people’s implantable cardiac devices was popularized in a 2012 episode of the Showtime drama Homeland, in which terrorists hacked a fictional vice president’s pacemaker and killed him. Word eventually got out that former Vice President Dick Cheney had the wireless communications shut off on a defibrillator that implanted in him in 2007 during his final years in office.

Get the full story on our sister site Medical Design & Outsourcing.

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Integra Lifesciences reports Street-beating earnings, stock still down

Integra LifesciencesIntegra Lifesciences today reported fourth-quarter and full-year results that beat analysts expectations, but its stock is still down slightly — perhaps because its gross margins were down as it digests more than $1.2 billion worth of acquisitions.

CEO Peter J. Arduini ticked off the Plainsboro, N.J.–based surgical and medical instruments company’s  “significant milestones” from 2017: the $1.045 billion purchase of Johnson & Johnson’s Codman Neurosurgery business, the $205 million buy of Derma Sciences, the global launch of the CUSA Clarity tissue ablation platform, and the launch seven new regenerative products. Integra during the fourth quarter also restored operations ahead of schedule at its Puerto Rico facility, which was affected by Hurricane Maria.

Integra enjoyed adjusted earnings per share of 64 cents per share during the quarter ended Dec. 31, up 23% year-over-year, on revenue of $368.6 million. The results beat the Street, where analysts on average had expected earnings of 56 cents per share off $356.4 million in revenue, according to Yahoo! Finance. Company officials reported better-than-expected results at both of the two newly acquired business, as well as better than expected organic sales.

Adjusted profits for all of 2017 amounted to $1.94 per share, a 10.2% increase over the prior year, with revenue at $1.19 billion. Analysts had predicted $1.86 per share earnings off of $1.18 billion in revenue, according to Yahoo! Finance.

Despite surpassing earnings expectations, Integra’s stock is down about 2.5%, trading at more than $53 per share, near the close of trading today — while the Dow Jone Industrial Average is only down 0.75%.

Integra’s overall earnings were up year-over-year in the fourth quarter: $44.4 million, or 56 cents per share, versus $28.2 million, or 35 cents per share, for the same quarter a year before. But total 2017 profits were down: $64.7 million, or 82 cents per share, versus $74.6 million, or 94 cents per share in 2016.

Integra Lifesciences also has work to do when it comes to improving its margins. Fourth quarter adjusted gross margin was 67.1%, down 310 basis points from the same period a year before. For all of 2017, adjusted gross margin was 68.5%, down 100 basis from 2016.

“The declines were largely attributable to dilution from both acquisitions, unfavorable manufacturing variances associated with restoring operations in Puerto Rico and unfavorable product mix,” Integra CFO Glenn Coleman told analysts during today’s earnings call, transcribed by Seeking Alpha.

Integra Lifesciences expects adjusted gross margin in the 68–69% range in 2018, with revenue in the range of $1.46 billion to $1.48 billion and adjusted earnings per diluted share at the high end of the company’s previously provided range of $2.25 to $2.35 per share.

 

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Facing legal woes, PixarBio takes aim at InVivo

PixarBio (OTC:PXRB) faces its own legal problems: a possible lawsuit by the SEC, legal action by a disgruntled employee who is demanding unpaid wages and former landlords looking for $1.8 million in unpaid rent.

But the 7-person biotech is also looking to launch some litigation of its own, according to a recent document it filed with the SEC – PixarBio plans to sue InVivo Therapeutics (NSDQ:NVIV) for libel and for the patent rights to the company’s scaffold device.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic recalls 48 CRM devices on arcing risk

Medtronic logoMedtronic (NYSE:MDT) informed physicians last month of a problem with 48 of its cardiac rhythm management devices that’s prompting a Class I recall of the devices.

The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality,” according to a January doctors letter from quality & regulatory VP Tim Samsel.

The issue led to a single instance in which an implanted device failed, in which external defibrillation was required to rescue the patient. The affected CRT-Ds are from Fridley, Minn.-based Medtronic’s Amplia, Claria, Compia and Viva lines. The ICDs involved in the recall are from the Evera and Visia lines.

“Due to the nature of this issue, it is not possible to identify which of these 48 devices may fail or when they may fail. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure,” Samsel wrote.

Tests on a small number of devices made using the same technique showed that the failure occurred in 23% of devices; 7.7% of the tested devices failed within the first two high-voltage charges, the company said in the letter. The FDA yesterday gave the recall Class I status, denoting the risk of serious injury or death.

Patients implanted with the affected devices might need to have them replaced, according to the letter.

“Prophylactic device replacement should be strongly considered for patients who have been implanted with one of the devices listed in Appendix A. Medtronic will offer a supplemental device warranty for this affected population,” the company said. “We sincerely regret any difficulties this may cause you and your patients.”

A list of the serial numbers of the affected devices can be found here.

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Boston Scientific closes $1B debt offering

Boston ScientificBoston Scientific (NYSE:BSX) has closed on its previously announced a $1 billion debt offering.

The offering of 4.0% senior notes, which closed yesterday, is mostly earmarked for buying back some of the Marlborough, Mass.–based company’s other debt.

The notes are due March 2028 and are slated for the redemption of the remaining $600 million worth of the Marlborough, Mass.-based medical device company’s 2.65% notes due in October. The balance goes toward repayishort-term debt and toward paying related fees, expenses and premiums, the company said.

Boston Sci said earlier this month that an $861 million tax charge pushed it into the red during the fourth quarter and slashed full-year profits by 70%. The company nevertheless still managed to meet or beat the Street’s expectations.

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EMA committee backs Amgen’s on-body injector for Neulasta

AmgenAmgen (NSDQ:AMGN) said today that a committee for the European Medicines Agency has recommended that the regulatory body approve a label variation for its Neulasta product to include the Onpro on-body injector delivery device.

Neulasta’s Onpro kit includes a pre-filled syringe paired with a single-use on-body injector. The lightweight device is given to the patient on the same day as their chemotherapy regimen.

Get the full story at our sister site, Drug Delivery Business News.

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AtriCure beats the Street during Q4, analysts predict ‘growth acceleration’

Atricure AtriclipAtriCure (Nasdaq: ATRC) — an innovator in treatments for atrial fibrillation and left atrial appendage management — is enjoying a rise in its stock value today after releasing results that beat the Street.

Mason, Ohio–based AtriCure’s stock is up about 2.4% in value, trading at nearly $19 per share, in morning trading after the company reported yesterday evening that it revenue for the quarter ended Dec. 31 was up nearly 12% year-over-year, to $46.1 million. Analyst polled by Yahoo! Finance had predicted $45.4 million in revenue.

Analysts Danielle Antalffy and Rebecca Wang at Leerink suspect Atricure’s U.S. open business is “poised for growth acceleration in 2018 and beyond in this highly underpenetrated market,” and are giving the company’s stock an outperform rating.

AtriCure in September launched its AtriClip Pro-V left atrial appendage exclusion system. The AtriClip Pro-V has an open-ended design combined with a tip-first closure mechanism. The idea is to enable easier navigation and placement during minimally-invasive surgery.

The company earlier this month announced FDA 510(k) clearance for its AtriClip Flex V left atrial appendage closure device. AtriCure touts the Flex V as the first AtriClip device with a trigger release for deployment.

There’s potential for even more innovation. Among the world’s 100 largest medical device company’s, AtriCure was in the top 10 when it came to R&D spending as a percentage of revenue.

Atriure during the fourth quarter narrowed its losses year-over-year, losing $2.6 million, or 8 cents per share, versus a loss of $8.6 million, or 27 cents per share, for the same quarter a year before.

Revenue in 2017 was up about 12.6%, to $174.7 million, beating analysts’ prediction of $174.0 million.

The company had a net loss of $26.9 million, or 83 cents per share, for 2017, compared to a loss of $33.3 million, or $1.05 per share, for 2016. Analysts had predicted a loss of 96 cents per share in 2017.

 

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Halyard Health posts Street-beating Q4, full-year results

Halyard HealthShares in Halyard Health (NYSE:HYH) fell slightly today after the medical device maker met expectations on Wall Street with its fourth quarter and full-year finances.

The company is in the middle of a $710 million divestiture of its surgical and infectious disease prevention business to Owens & Minor (NYSE:OMI), so it reported financial results for both on-going and discontinued operations.

The Alpharetta, Ga.-based company posted profits of $32.8 million, or 70¢ per share, on total sales of $428 million for the three months ended Dec 31.

Adjusted to exclude one-time items, earnings per share were 73¢, ahead of consensus on The Street, where analysts were looking for sales of $416.2 million.

In Q4, the business it’s selling to Owens & Minor brought in $28.4 million in profits, or 61¢ per share, on $261.8 million in sales. Meanwhile, its medical device business posted $4.4 million in net income, or 9¢ per share, on $166.3 million in revenue. Adjusted EPS for Halyard’s discontinued operations were 73¢ apiece, compared to 1¢ apiece for its on-going operations.

For the full year, Halyard posted $1.68 billion in total sales, topping analyst estimates of $1.61 billion. The company reported $79.3 million in net income for 2017, with adjusted EPS of $2.35 apiece.

Its surgical & infectious disease prevention biz brought in $111.4 million, or $2.38 per share, of net income on $1.01 billion in sales. Adjusted EPS for Halyard’s discontinued operations were $2.61 apiece. The company’s medical device business unit posted a net loss of -$32.1 million, or -69¢ apiece, on sales of $611.6 million. Adjusted EPS were -25¢.

“2017 was a strong year and I’m proud of our team’s execution and accomplishments. Momentum in our medical device business continued as we accelerated our growth, increased the number of product launches and delivered earnings ahead of plan,” CEO Joe Woody said in prepared remarks.

“With the divestiture of S&IP on track to close in early second quarter and our playbook for growth, we are well positioned to succeed in 2018. I’m confident about our outlook, and through strategic investments in product innovation, commercial excellence, and M&A we expect to be well positioned to capitalize on the opportunities ahead.”

HYH shares were trading at $48.00 apiece today in morning activity, down -0.7%.

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Medpace stock down after CEO talks of ‘permanent or increasing margin headwind’

MedpaceThe stock of clinical contract research organization Medpace (Nasdaq: MEDP) is taking a hit today after the company’s CEO Dr. August Troendle told analysts that the company is facing a “relatively permanent or increasing margin headwind in the next few years.”

Medpace’s stock is down about 16%, trading around $33 per share, in morning trading. Troendle in a conference call with analysts this morning said he expected the company’s EBITDA margin — its earnings before interest, taxes, depreciation and amortization as a percentage of total revenue — to be 25% in 2018, down from 28% in 2017.

Get the full story on our sister site Medical Design & Outsourcing. 

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Tricuspid repair firm 4Tech taps ex-Boston Scientific execs for CEO, CMO | Personnel Moves for Feb. 27, 2018

4Tech4Tech said last week that it named a pair of BSX veterans as its new CEO and CMO, with onetime chief Mike Ennen stepping away for “family reasons.”

Galway, Ireland-based 4Tech said former Boston transcatheter aortic valve GM Tom Fleming is slated to take the reins from Thoratec vet Ennen as president & CEO in March. The company, which is developing the TriClinch Coil transcatheter tricuspid valve repair device, also said that Dr. Keith Dawkins, Boston’s ex-global medical chief, was named CMO effective Feb. 22.

 Check-Cap promotes COO Ovadia to CEO
Check-Cap (NSDQ:CHEK) promoted Alex Ovadia from COO and R&D VP to CEO, succeeding Bill Densel, “who will provide support to complete a seamless transition,” the company said.
Read more

 Invacare makes it official with interim CFO Leneghan
Invacare (NYSE:IVC) made it official with interim CFO Kathleen Leneghan, naming her SVP and finance chief effective Feb. 22. Leneghan took over last November, when former CFO Robert Gudbranson announced his retirement.
Read more

 Imagion Biosystems names Bischoff as clinical VP
Imagion Biosystems (ASX:IBX) said it named Farideh Bischoff as VP of clinical research.
Read more

 Limflow looks to Claret Medical, Medtronic vets for R&D, sales VPs
LimFlow said it appointed former Claret Medical QA & regulatory affairs VP Zachary Woodson as its own regulatory affairs VP and tapped medtech veteran Theo Mastrokostopoulos as sales & market development VP. The company also named ex-Mölnlycke Health CareCEO Pierre Guyot as chairman of the board.
Read more

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Orthofix swings to Q4 black

OrthoFixOrthofix (NSDQ:OFIX) yesterday put black ink in the ledger for the fourth quarter and beat the consensus forecast as it contemplates moving its corporate registration from Curacao to the U.S.

The Lewisville, Texas-based orthopedics company posted profits of $1.6 million, or 8¢ per share, on sales of $116.9 million for the three months ended Dec. 31, 2017, compared with losses of -$3.2 million on sales growth of 7.7% over Q4 2016.

Adjusted to exclude one-time items, earnings per share were 52¢, two pennies ahead of Wall Street, where analysts were looking for sales of $114.5 million.

Full-year profits rose 103.6% to $6.2 million, or $34¢ per share, on sales growth of 5.9% to $433.8 million compared with the prior year. Adjusted EPS came in at $1.62, a penny ahead of The Street and its sale forecast of $431.3 million.

“2017 was a very strong year for Orthofix. We exceeded our top-line expectations and finished the year with a solid margin improvement trajectory. We also made significant progress in the transformation of our spine fixation business and completed our worldwide restructuring initiatives,” president & CEO Brad Mason said in prepared remarks. “With 2017 in the rear-view mirror, we are now focused fully on executing our 2018 global and business unit strategies. Globally, we expect to drive shareholder value through three pillars, top-line organic growth better-than-market-growth rates, margin expansion through operational improvements and strategic deployment of our capital in ways that we believe will accelerate top-line growth in our core businesses. We are well positioned and expect to execute in each of these areas in 2018.”

Orthofix said it expects to report adjusted EPS of $1.76 to 1.84 this year on sales $450.0 million to $455.0 million.

OFIX shares were up 3.6% to $56.79 apiece today in morning trading.

Orthofix also said its review of redomiciling to the U.S. concluded that the move could confer “a number of benefits” including a lower tax rate and increased cash flow.

“Subject to the outcome of final diligence, the company currently anticipates requesting shareholder approval for this move in conjunction with its annual shareholder meeting later this year,” Orthofix said.

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Abbott, Surmodics ink $25m deal for drug-coated balloon tech

Surmodics, AbbottAbbott (NYSE:ABT) is slated to pay $25 million upfront for the global commercialization rights to Surmodics‘ (NSDQ:SRDX) SurVeil drug-coated balloon, the companies announced today.

The company’s drug-device combo, which is in pivotal trials in the U.S., is designed to treat peripheral artery disease in the superficial femoral artery. According to the deal, Abbott could also negotiate agreements for Surmodics’ below-the-knee and arteriovenous fistula drug-coated balloons, which are still in pre-clinical development.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic thinks these clinics could be the future of diabetes care – here’s why

Medtronic Diabeter clinicManaging a chronic illness can feel like a full-time job. Between juggling multiple appointments with an array of specialists and following a meticulous care plan, patients dealing with conditions like diabetes have a lot on their plate.

Medtech titan Medtronic (NYSE:MDT) wants to help change that. The company’s CEO, Omar Ishrak, placed his faith in value-based care as the future of healthcare. And Medtronic points to its work with Diabeter, a chain of diabetes clinics in the Netherlands that it acquired in 2015, as evidence of its progress towards delivering more value for patients.

Get the full story at our sister site, Drug Delivery Business News.

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Entellus Medical shareholders approve $662m Stryker buyout

Stryker acquires Entellus MedicalEntellus Medical (NSDQ:ENTL) shareholders yesterday approved the $662 million cash merger offer from Stryker (NYSE:SYK).

Plymouth, Minn.-based Entellus, founded in 2006, makes a family of minimally invasive balloon device products, including its flagship Xpress device, that are designed to treat blocked sinuses. Earlier this year it closed the $81 million buyout of Spirox and its Latera absorbable nasal implant.

In a regulatory filing, Entellus said 99.9% of the roughly 21.9 million shares represented at the vote (which is about 85.1% of total shares) voted to approve the $24-per-share offer, with nearly 8,700 voting against and some 10,600 abstaining.

Last September the FDA released an April warning letter sent to Entellus over a study of the Xpress device in pediatric patients, involving use of a dilator in patients under age 12 in frontal and sphenoid sinuses; the trial’s approved protocol only allowed treatment in the maxillary sinus for patients that young, according to the federal safety watchdog.

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NuVasive teases robotics offering with Street-meeting Q4

NuVasiveNuVasive Inc. (NSDQ:NUVA) executives yesterday teased the robot-assisted surgery solution it’s developing for spinal procedures in discussing its fourth-quarter and full-year results, which largely met the forecast on Wall Street.

Chairman & CEO Greg Lucier told analysts during a conference call that San Diego-based NuVasive’s “surgical intelligence platform,” slated to be unveiled at the North American Spine Society meeting in Los Angeles Sept. 26-29, is designed to incorporate “monitoring, planning, imaging, 2D and 3D navigation and automation, and further insights” to optimize spine surgeries.

“We are really excited about this comprehensive solution composed of monitoring and surgical planning. It is a significant step in our evolution from a product-focused company to a systems-based company focused on delivering end-to-end solution that does not only enable predictable clinical and economic outcomes, but also pull-through our implants and creates stickiness in the market,” Lucier said, according to a Seeking Alpha transcript, noting that the the LessRay radiation reduction software it launched last September will be a key component of the system.

That said, however, the NuVasive platform will emphasize navigation over a purely robotic instrumentation arm, he said.

“Most surgeries don’t require a robot. Seventy percent of them are more straightforward and it is those surgeries that we’re focusing on and navigation is a far more impactful tool than adding in a robot. And so I think it’s super important that you segment the market properly and then segment it in terms of the right solutions for it,” Lucier said. “So navigation has big impact across very complex surgeries as well as what we would say is a little bit more simpler ones, but robotics is really relegated to, at least our view, in terms of economics that will support it, that much more complex deformity cases.”

Fourth-quarter earnings meet The Street, sales just miss

NuVasive reported a fourth-quarter profit gain of 275.8% to $24.0 million, or 46¢ per share, on sales growth of 0.2% to $271.7 million for the three months ended Dec. 31, 2017, compared with Q4 2016. Much of that gain was due to an $18.3 million gain on last year’s tax reforms; adjusted to exclude that and other one-time items, earnings per share were 56¢, exactly in line with the consensus on Wall Street, where analysts were looking for sales of $272.6 million.

Full-year profits also surged on the tax wave, rising 123.5% to $83.0 million, or $1.50 per share, on a sales gain of 7.0% to $1.03 billion compared with the prior year. The tax benefit for 2017 was 56.5 million; adjusted EPS were $1.91 for the year.

“2017 was a milestone year for NuVasive as we surpassed the $1 billion revenue mark, driven by impressive international sales growth of more than 20% and achieved record profitability of 18.2% non-GAAP operating margins in the fourth quarter,” Lucier said in prepared remarks. “As we set the stage for 2018, we remain focused on accelerating our growth momentum by furthering our investment in R&D to bring innovative offerings to the market, developing our differentiated intraoperative neurophysiological monitoring services business with the completed acquisition of SafePassage and growing the number of surgeons worldwide who use NuVasive technologies to improve patients’ quality of life.”

NuVasive said it expects to post adjusted 2018 EPS of $2.44 to $2.47 on sales of $1.095 billion to $1.105 billion.

NUVA shares, which closed yesterday up 0.8% at $48.23 apiece, gained another 0.2% today in pre-market trading to reach $48.31.

Shareholder lawsuits in the rearview

In a separate regulatory filing, NuVasive revealed the resolution of a pair of lawsuits brought by investors.

In August 2013, a purported class-action lawsuit filed in the U.S. District Court for Southern California alleged that NuVasive submitted false claims to Medicare and Medicaid in violation of state laws and regulations, made illegal kickbacks to doctors and engaged in off-label promotion of its products and services after the U.S. Justice Dept. opened a probe.

The company in July 2015 settled with the Justice Dept. for $13.5 million and no admission of wrongdoing; the suit won class-action certification in March 2017 and last May NuVasive lost a bid to stay the case. After the denial of an appeal that August and a summary judgment bid this month, NuVasive agreed to pay $7.9 million to settle the case without admitting wrongdoing. The settlement, which the court must still approve, should be fully covered by insurance, the company said in the filing.

Another investor’s lawsuit, a derivatives case brought in California state court in September 2016 with similar allegations, the court granted NuVasive’s bid to dismiss the case with prejudice last September and in December denied the plaintiff’s motion for reconsideration and to vacate the judgment, according to the filing.

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dilluns, 26 de febrer del 2018

Designing for robotics: 2 things you need to consider

Have an idea for an innovative healthcare robot? Here are a few design principles to help you avoid common pitfalls.

Ken Haven, Acorn Product Development

robotics

[Image from istockphoto.com]

When people think of robotics, they often think about warehouses or manufacturing lines, where robots automate multiple processes. But robotics has the potential to reshape the way healthcare is delivered in a variety of applications and locales. While we’re a long way from a robot replacing a physician, there are many opportunities to provide automation in the healthcare arena that can reduce costs and free up healthcare workers’ time to focus more on patient care. Possibilities abound in areas including surgical robots, exoskeletons, telepresence robots and robotics for medication management.

No matter the application, there are a few principles to keep in mind when designing for robotics.

Get the full story on Medical Design & Outsourcing.

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