Edwards Lifesciences posts posts Street-beating Q4, mixed-bag 2018 earnings

Edwards Lifesciences (NYSE:EW) today posted fourth quarter and full year 2018 earnings that topped earnings per share expectations on Wall Street, but missed on full-year sales consensus.

The Irvine, Calif.-based company posted profits of $7 million, or 3¢ per share, on sales of $977.7 million for the three months ended December 31, seeing a swing to black ink on the bottom line while sales grew 10% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share for the quarter were $1.17, just in line with the consensus on Wall Street where analysts expected to see sales of approximately $976 million, which the company topped.

For the full year, Edwards Lifesciences posted profits of $722.2 million, or $3.38 per share, on sales of $3.7 billion, for bottom-line growth of 23.7% while sales grew 8.4% compared with the previous year.

After adjusting to exclude one-time items, earnings per share for the year were $4.70, in line with the consensus on Wall Street where analysts expected to see sales of $3.8 billion, which the company narrowly missed.

“We are pleased to report strong fourth quarter performance that delivered 10 percent sales growth on an underlying basis, consistent with our expectations, driven by our portfolio of innovative technologies.  For the full year 2018, we reported 10 percent growth on an underlying basis, also in line with our guidance.  Profitability was also strong in 2018, with adjusted EPS growing over 20 percent, even as we continued to invest aggressively in our innovation initiatives and infrastructure. We are as convinced as ever in the tremendous opportunity to improve patients’ lives by addressing deadly conditions and bringing significant value to the healthcare system,” chair & CEO Michael Mussallem said in a prepared statement.

The company reiterated financial guidance for the 2019 fiscal year, expecting to post adjusted earnings per share of between $5.05 and $5.30.

For its upcoming first quarter of 2019, Edwards Lifesciences said that it expects to post sales of between $950 million and $1.01 billion and adjusted EPS of between $1.15 and $1.25.

“Our strong 2018 performance reinforces our confidence in our focused innovation strategy and our longer term outlook, and we anticipate an exciting 2019 as we pursue important therapies that will benefit many more patients. We look forward to launching a number of new technologies as well as achieving important milestones across all of our product lines. We are confident that our differentiated strategy and focus on leadership will continue to create value and benefit the patients we serve,” Mussallem said in a prepared release.

Shares in Edwards Lifesciences rose 1% today, closing at $170.42.

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FDA warns on air embolism risk with infusion pumps, fluid warmers, rapid infusers

The FDA today released a medical device safety communication warning of air-in-line and air embolism risks, as well as the risks of false alarms for such events, associated with infusion pumps, fluid warmers and rapid infusers.

The FDA reinforced the dangers of air-in-line issues, which can lead to potentially life-threatening air embolisms, but also warned of the risks associated with false alarms triggered by air-in-line sensors. Such false alarms could lead to injury due to the possible interruption of infusion therapy, which “could be problematic if crucial medications (for example, Epinephrine) are being infused,” according to the release.

Read the whole story on our sister site, Drug Delivery Business News

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5 Guidelines for Writing a Useful Clinical Monitoring Report

Taking Your Report from Good to Great

By Brandy Chittester, Chief of Clinical Operations

A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection.

Unfortunately, this important task often doesn’t get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list.

Whether you’re a monitor out in the trenches or a sponsor overseeing a study at a high level, here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

1. Do Your Homework Before the Site Visit

To ensure all the information will be available to write the report, you should be thoroughly prepared for the site visit. Before you arrive on site, you should be able to answer the following questions:

• What data should be source-verified?
• How many queries are outstanding?
• Will the regulatory documents should be reviewed and what updates are needed?
• What data and action items still are outstanding?

A monitor’s time on site is often limited. Taking the time to look into these issues ahead of time will help you prioritize tasks and make the most of the time you have.

In addition to site-specific preparation, you must also be sure to understand the visit report template and the purpose of each question, since these templates can vary from one sponsor to the next. Likewise, you should always consult the monitoring plan for the study to be sure to complete activities during the visit as required by the sponsor.

2. Take Good Notes During the Visit

To make sure you don’t miss an important step, you should keep the monitoring report template open throughout the visit, making note of activities as they are completed.

We can’t overstate the importance of taking good notes. So many things that happen during a monitoring visit seem obvious at the time (like a follow-up item to correct a source worksheet or to re-review select data points), but in many cases, those items are forgotten soon after you leave a site.

Some suggested methods for keeping notes might be for you to mark off sections of the report as tasks are completed or use highlighting or another font color to show what requires assistance from the site. Although monitors always want to cross off every item on the list during a site visit, there almost always will be items that require follow-up later. No matter how you choose to do this, you need make note of what items require your attention after the visit to ensure nothing slips through the cracks.

Each monitor will find his or her own way of taking notes, but filling in the report during the visit is a good way to keep important issues top of mind.

3. Write the Report as Soon as Possible

The report should be written as soon as possible after the visit. The best-case scenario is to write the report before preparing for and going on the next visit, but this is not always possible or practical. The next best practice would be to write one report before writing the next. When a report sits incomplete for a few weeks and other visits have taken place in the meantime, the likelihood that the report will be accurate and complete is low, even with the most thorough notes.

4. Check Reports Carefully

A great monitoring report should be clear, concise and grammatically correct. Sloppy oversights, such as grammar mistakes and carrying over information from a previous report, can diminish confidence in your work. Copying and pasting information from a previous report may seem like a shortcut, but it leaves too much room for error. You should start fresh and check your work carefully when you’re finished.

5. Be Sure the Report Only Includes Essential Information

A good clinical monitoring report should be a summary of items you reviewed during the visit—no more, no less.

Too much narrative or detailed descriptions of what was in compliance can make finding what was out of compliance more difficult. You also should avoid documenting details that are already on record elsewhere. For example, if an adverse event has been submitted to the sponsor, there is no reason to include detailed information about the event again in the monitoring report.

Bonus: Take the Report from Good to GREAT

In general, monitors do an acceptable job documenting in their reports the issues noted during site visits. However, a monitor’s job doesn’t end with simply documenting issues; he or she also needs to document the efforts made to bring the site into compliance. Additionally, a monitor should document any discussions or actions taking place to prevent issues from reoccurring. Adding such details to monitoring reports illustrates the ongoing efforts by the sponsor and site to work together to address issues in real time and ensure the study stays compliant.

Writing effective monitoring reports requires an in-depth knowledge of the job, the study protocol, the site, their practices, the sponsor’s procedures, the monitoring plan, the report template and, of course, the regulations.

As a leading medical device CRO, IMARC Research has extensive experience in writing monitoring reports. Before you write your next monitoring report, download this resource for more tips and a checklist you can follow to ensure your clinical monitoring reports are as complete, accurate and useful as possible.

Get the Whitepaper
 

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FDA green-lights Siemens Healthineers Magentom Lumina 3T MRI

Siemens Healthineers has received FDA clearance for its Magnetom Lumina 3 Tesla MRI scanner.

The scanner features BioMatrix patient personalization that helps improve productivity and ensure consistent quality, according to the company. It has a wide, 70 cm bore and GO technologies that are powered by artificial intelligence to speed up MRI workflow.

Magnetom Lumina 3 Tesla can speed up a whole spine exam up to 20% faster than conventional systems. Day Optimizing Throughput and 46 engines can support standardized, highly reproducible scan procedures. It makes workflow more efficient with an optional dockable table and new Turbo Suite acceleration packages that reduce scan time on routine musculoskeletal examinations.

“With the MAGNETOM Lumina, Siemens Healthineers is transforming care delivery by providing high performance with a strong return on investment,” said Jane Kilkenny, VP of magnetic resonance at Siemens Healthineers North America, in a press release. “The patient experience is enhanced with a state-of-the-art infotainment system, lightweight and flexible coils, and new speed applications that enable the provider to get the patient on and off the table faster.”

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Philly jury hits J&J’s Ethicon with $41m judgment in pelvic mesh case

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon has been hit with a $41 million verdict in a pelvic mesh product liability suit in Philadelphia, according to a report from the Mesh News Desk.

A jury in Philadelphia found that Ethicon’s Gynemesh, Prolift and TVT-O meshes were defective, and that the company was negligent in manufacturing the devices, according to the report.

The plaintiff, Suzanne Emmett, was implanted with a Prolift pelvic mesh to treat pelvic organ prolapse, a TVT-O mesh as a treatment for incontinence and a Gynemesh implant, according to the Mesh News Desk report.

The verdict includes $25 million in punitive damages, $15 million in compensation and $1 million to Emmett’s husband, according to the report.

The company has not yet commented officially on the case, and has not stated if it plans to appeal the decision.

Last November, a state judge in Pennsylvania ordered a new trial in a suit alleging a that a woman was injured by Ethicon’s TVT-Secur pelvic mesh implant.

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Trelleborg acquires molded components company Sil-Pro

Trelleborg recently announced that it has acquired Sil-Pro, a Delano, Minn.–based medical device manufacturing outsourcer with a specialty in silicone and thermoplastic molding.

Financial terms of the deal, which closed Jan. 2, were not disclosed. Founded in 1998 and owned by two generations of the Carver family, Sil-Pro has an employee count in the 200 to 500 range, according to its LinkedIn profile.

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

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Pain-management firm SPR Therapeutics seeks to raise $20m

SPR Therapeutics has raised $8 million of a $20 million Series C round of funding that began Jan. 19, according to an SEC filing.

The Cleveland-based company’s Sprint peripheral nerve stimulation (PNS) system is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The product was launched in November 2018 for treating complex regional pain syndrome, a chronic pain condition affecting the limbs that can be caused by trauma, injury or surgery.

The company also recently announced that it has named Peter Staats, M.D., as its chief medical advisor. Staats brings nearly three decades of entrepreneurial experience in pain management and neuromodulation technology to the role, according to a company statement.

Staats has served as the president of the American Society of Interventional Pain Physicians, the North American Neuromodulation Society, the New Jersey Society of Interventional Pain Physicians, and the Southern Pain Society, and has co-edited or authored 10 textbooks on pain medicine and written nearly 300 articles, book chapters and abstracts on the diagnosis and management of complex pain problems.

Staats founded the Division of Pain Medicine at Johns Hopkins University School of Medicine in 1994 and served as its director for 10 years. He later was a founding partner in Premier Pain Centers in New Jersey, which recently merged with National Spine and Pain Centers.

Staats will provide advice and guidance to SPR in the areas of patient selection, clinical trial design, physician training, product enhancements, and reimbursement strategies, among others, the company said.

SPR Therapeutics said in October that it received $10 million from two new grants and a contract from the US Dept. of Defense, all to support its percutaneous peripheral nerve stimulation therapy intended as a non-opioid pain relief therapy for both acute and chronic pain.

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Accuron spins out urology business to Temasek

Accuron Technologies announced that it is spending out its medtech business into an integrated urology business owned by Temasek. The company expects the process to be completed by March this year.

“Accuron MedTech has been managed as an independent division of Accuron Technologies for some time now. The spin out will enable Accuron MedTech to be more agile in managing its operations, putting it on a stronger platform for sustained growth and technology commercialization,” Philip Yeo, chairman of Accuron Technologies, said in a press release. “The move will also allow Accuron Technologies Limited to focus its resources to pursue opportunities in the growing aerospace and industrial businesses.”

Accuron MedTech says that its revenue has grown more than 30% over the past three years after launching new products like the Delta II, the first SmartLitho for stone treatment.

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Vicarious Surgical raises $10m more

Vicarious Surgical has raised another $10 million for the virtual reality-augmented robot-assisted surgery platform it’s developing, according to an SEC filing.

The latest round of funding follows on the heels of a  nearly $17 million round announced in April 2018. Charlestown, Mass.-based Vicarious first reported a $2.4 million raise in January 2016 and another $800,000 in October of that year.

Vicarious has said its device “combines virtual reality with proprietary human-like surgical robotics to enable surgeons to perform minimally invasive surgery through a single micro-incision,” claiming to have achieved “the goal of surgical robotics since the field’s inception – to shrink the surgeon and put them inside the patient.”

Its website lists Khosla Ventures, AME Cloud Ventures, and Innovation Endeavors as investors. The company did not identify the names of investors for the current round.

 

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FDA sets March dates for microbiology, neurology device panel meetings

The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases.

In the microbiology devices panel meeting, slated to be held March 8, a committee of microbiology device experts will discuss and make recommendations regarding novel or alternative approaches to clinical studies and devices intended to detect Human Papillomavirus nucleic acid, according to the release.

“These approaches will take into consideration scientific data generated since the approval of the first High Risk HPV screening device in 2003 as well as the effects of HPV vaccination on clinical studies of devices for HPV detection,” the FDA wrote in its posting.

Topics slated to be discussed include clinical study design and comparator methods, as well as potential changes to the HR HPV device indications for use considering “continually evolving cervical cancer screening guidelines,” according to the release.

During its neurological devices panel, slated to be held March 21, a committee will explore the FDA de novo application for Israel-based Neuronix’s NeuroAD Therapy System, according to the FDA release. The system is intended to provide concurrent neurostimulation and cognitive training to treat mild to moderate Alzheimer’s dementia.

The company is currently engaged in a multi-site clinical study of the system in the U.S. and Israel. The NeuroAD system and its associated procedure combines transcranial magnetic stimulation with custom-tailored cognitive exercises, according to the company’s website.

Both panels are slated to meet between 8:00 a.m. and 5:00 p.m. EST at the Gaithersburg, Md.-based Hilton Washington, according to the postings.

Yesterday, the FDA announced that it tentatively plans to hold a meeting of the General and Plastic Surgery Devices Panel, March 25-26. The meeting will take place at the FDA’s headquarters in Silver Spring, Md

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Mylan wins race for generic Advair approval

FDA has approved the first generic of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug, this one by Mylan (NSDQ:MYL), six months after rejecting Mylan’s application.

Canonsburg, PA-based Mylan’s shares jumped 7% to $30.82 at market close after yesterday’s late-afternoon announcement, and were trading at $30.96 mid-morning today. GSK’s stock dipped 2% to$38.70 on the news late yesterday, but had more than recovered by noon today, reaching $39.23.

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

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Laminate Medical brings in $12m for dialysis vascular support device

Israeli medtech start-up Laminate Medical Technologies said today that it raised $12 million in a new round of financing slated to support its VasQ vascular support device.

The company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure.

The VasQ regulates flow by constraining and shaping optimal geometrical parameters of the fistula, the company said, and reinforces and shields the vulnerable perianastomotic vein against high pressure, wall tension and flow levels.

The round was joined by Asahi Kasei (TYO:3407) and Tal Capital, as well as a number of private investors, Laminate Medical Tech said.

“We are so happy to be a part of the company’s journey. I believe VasQ has a high potential to become the standard of care for vascular access surgery,” Asahi Kasei Medical prez Takeshi Himeno said in a prepared statement.

The company said that it recently launched U.S.-based clinical trials of the VasQ system as it seeks FDA approval of the device. The system already has CE Mark approval in the European Union.

“After the success of treatments in Europe, including application of the device in hundreds of patients in Germany and other European countries, we are now preparing to enter the American market. We have completed the infrastructure for this, and are working in cooperation with leading hospitals across the USA to carry out the necessary clinical trials for FDA approval. The current round is an important expression of faith on the part of the existing investors, and a significant boost from investors with experience in a variety of fields, who understand the need for the solution and the answer that it provides for dialysis patients. Furthermore, the fact that Asahi Kasei Medical has joined us as an investor in the company gives us an important advantage for a future entry into the Japanese market,” Laminate co-founder & CEO Tammy Gilon said in a press release.

In February 2017, Laminate Medical said that it raised $8 million Series B financing round to support the VasQ device.

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Abiomed touts CE Mark for Impella Connect, posts Street-beating FY2019 Q3 earnings

Abiomed (NSDQ:ABMD) said today that it won CE Mark approval in the European Union for its Impella Connect cloud-based Impella heart pump console and released fiscal year 2019 third quarter earnings that topped expectations on Wall Street.

The Danvers, Mass.-based company said its Impella Connect is a cloud-based platform that allows physicians and hospital staff to view the Impella console remotely, as long as they have an internet connection.

“Impella Connect is an extremely valuable resource that allows me, as well as allied health professionals and nursing staff, to have direct visualization of data from the Impella console and to closely monitor patients on hemodynamic support, in real time,” Dr. Rajeev Narayan of the Vassar Brothers Medical Center said in a prepared statement.

The system has already won FDA premarket approval, and is in a limited market release in the US, Abiomed said, with 36 hospital sites already using the technology. The first European center slated to use the technology is Hamburg, Germany’s University Heart Center.

“Impella Connect is a technological advancement which represents the next frontier of heart recovery products. Impella Connect, along with our 24×7 onsite and on-call support, enables physicians, nurses and ICU staff to increase productivity, improve patient outcomes, and help patients return home with their native heart,” prez & CEO Michael Minogue said in prepared remarks.

In its earnings release, Abiomed posted profits of approximately $44.9 million, or 97¢ per share, on sales of approximately $200.6 million for the three months ended December 31, for massive bottom-line growth of 233.6% while sales grew 30.2% compared with the same period during the previous year.

Earnings per share were just ahead of the 94¢ consensus on Wall Street, where analysts expected to see sales of approximately $196 million, which the company also topped.

“We are proud of our 100,000th patient milestone and we will continue to grow the field of heart recovery and improve patient outcomes by partnering with our customers to use real-world data to identify and validate best practices and protocols. We remain focused on disciplined execution and sustainable growth so that even more patients around the world can benefit from heart recovery,” prez & CEO Michael Minogue said in a press release.

The company lifted its full fiscal year 2019 financial guidance, expecting to post sales of $780 million, up from previous guidance of between $765 million and $770 million.

Abiomed added that it also updated its GAAP operating margin expectations from between 28% and 30% to between 29% and 29.5%.

Shares in Abiomed have risen 6.4% so far today, at $361.35 as of 11:26 a.m. EST.

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Senseonics wins MRI-safe FDA nod for Eversense CGM

Senseonics announced that it has received notice from the FDA that its Eversense sensor no longer has to be removed for MRI scanning.

“Based on our testing, we have demonstrated hat it is safe for patients to leave the Eversense Sensor in place, even when they need to have an MRI,” Tim Goodnow, president and CEO of Senseonics, said in a press release. “Now patients using Eversense CGM do not need to worry about an emergency MRI or delay getting a scheduled MRI based on their glucose sensor. All other CGMs currently on the market are required to be removed before an MRI scan, according to their FDA indications. This is a first for the CGM category.”

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

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GT Medical lands $10m Series A for IsoRay’s GammaTile

GT Medical Technologies said today that it landed a $10 million Series A round for the GammaTile brachytherapy it co-developed with IsoRay (NYSE:ISR) to treat brain tumors.

Richland, Wash.-based IsoRay and the Barrow Neurological Institute formed GT Medical to develop the technology to embed Cesium-131 brachytherapy seeds in collagen tiles to treat malignant meningioma, according to regulatory filings, inking a formal co-development deal in March 2017. By January of the following year the deal had expanded to include an exclusive, 10-year manufacturing & supply pact for GammaTile. In July 2018 GammaTile won 510(k) clearance from the FDA.

Today GT Medical said proceeds from the Series A round, led by MedTech Venture Partners with participation from BlueStone Venture Partners, are earmarked for further GammaTile commercialization. The device is already under limited release.

“GammaTile Therapy was developed by a team of brain tumor specialists who were running out of options for their patients. Their urgency to find a viable solution for these patients led to the creation of GammaTile Therapy, which is designed to be immediate, safe, predictable, and effective,” GT Medical president & CEO Matthew Likens said in prepared remarks. “With this funding, in addition to adding seasoned industry executives to our team, we look forward to building and expanding our commercialization efforts so that we can offer this new option to patients at brain tumor treatment centers across the United States.”

“GT MedTech’s mission is in line with our investment goal of supporting innovative technologies that address unmet needs in vital disease areas,” added MedTech Venture managing director and partner Radu Cautis. “We are enthusiastic about the potential of GammaTile Therapy to address the shortcomings of current treatments and elevate the standard of care for patients with brain tumors.”

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Judge awards plaintiffs’ attorneys $366 million in Boston Sci pelvic mesh cases

Attorneys representing thousands of plaintiffs who sued Boston Scientific (NYSE:BSX) over alleged pelvic mesh injuries will receive $366 million, or 5% of the total recoveries in the cases.

U.S. District Court Judge Joseph Goodwin in the Southern District of West Virginia wrote in a pretrial order that plaintiffs’ attorneys were “required to spend tens of millions of dollars without guarantee of success” over nine years, representing 104,000 patients.

“Tens of thousands of cases have been resolved, for a total sum to date of $7.25 billion,” Goodwin wrote, adding that not all cases have been resolved. “These costs continue but are a small part of what the common benefit fund was designed to compensate.”

The court in Charleston, W.Va. has overseen seven multidistrict litigation (MDL) cases rolled into what Goodwin characterized as “super-mega-fund litigation.” A committee of plaintiffs’ attorneys appointed to calculate costs petitioned for the 5% sum to be set aside for their colleagues whose work benefited multiple plaintiffs.

“Given the comparable recoveries and awards in similar-sized MDLs, and that 5% of $11 billion is reasonably comparable under all the circumstances with other MDL common benefit fund awards, the court finds the 5% benchmark for the (committee’s)  Petition is very reasonable,” Goodwin wrote. “This litigation is not only one of the largest – if not the largest – mass tort product liability litigations in this nation’s history, but it is the only mass tort products liability litigation in this country that has involved multiple related MDLs, each involving multiple products, coordinated before the same court simultaneously.”

Boston Scientific has won other cases recently, including one in June 2018, in which a jury found that the Marlborough, Mass.-based company was not negligent in the design of its Pinnacle and Obtryx pelvic mesh products and did not fail to warn patients of the risks associated with the meshes, according to court documents.

Boston Sci’s pelvic mesh products drew worldwide scrutiny in 2018 after being covered in a 60 Minutes episode airing claims that the company knowingly purchased inauthentic Chinese plastic materials to make them. The company countered that the 60 Minutes report contained “completely false claims,” and that the story was “irresponsible and misleading.”

The company did not immediately provide comment on the attorneys’ fees order.

 

 

 

 

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FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine sublingual film

Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease.

The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy for Parkinson’s patients experiencing “off” episodes, in which symptoms that are usually controlled by medications resurface.

Sunovion said that the FDA “determined it was unable to approve the apomorphine sublingual film NDA in its present form,” according to a press release.

Read the whole story on our sister site, Drug Delivery Business News

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GE gains on Q4 revenue beat, swing to black

GE Healthcare (NYSE:GE) shares got a bump today after the company topped the consensus forecast for its fourth-quarter sales and swung to black ink for the period, with its healthcare business posting modest bottom- and top-line gains.

The stock rise came despite a Q4 earnings miss and wider full-year losses for the Boston-based industrial conglomerate. GE reported profits of $574 million, or 7¢ per share, on sales of $33.28 billion for the three months ended Dec. 31, 2018. That compares with losses of -$11.0 billion on a sales gain of 5.3% during Q4 2017. Adjusted to exclude one-time items, earnings per share were 17¢, a full nickel below the consensus on Wall Street, although GE beat the sales mark by $688 million.

Full-year losses rose 155.6% to -$22.80 billion, or -$2.62 per share, on sales growth of 2.3% to $113.54 billion; adjusted EPS were 65¢, 6¢ below The Street, where analysts were looking for revenues of $120.71 billion.

GE Healthcare logged Q4 profits of $1.18 billion, up 2.0%, on sales growth of 1.6% to $5.40 billion. Full-year profits were up 6.0% to $3.70 billion on sales growth of 4.0% to $19.78 billion for the healthcare business.

“Our strategy is clear: de-leverage our balance sheet and strengthen our businesses, starting with power. To do this, we are improving execution, customer focus, and how we set priorities across GE. I’m confident in our team, technology, and the global reach of GE’s brand and relationships. We have more work to do, but I’m encouraged by the changes we’re making to strengthen GE and create value for our shareholders, customers, and employees,” chairman & CEO Lawrence Culp Jr. said in prepared remarks.

GE shares were trading up 15.3% at $10.49 apiece today in mid-morning activity.

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FDA final guidance on safety and performance 510(k) medical device registration

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration’s medical device oversight division has rolled out final guidance on an expanded 510(k) registration route retooled to focus on device safety and performance issues, and is seeking industry comment on proposed changes to its predicate device policy.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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Surmodics posts Street-beating FY2019 Q1 earnings

Surmodics (NSDQ:SRDX) today posted fiscal year 2019 first quarter earnings that beat expectations on Wall Street.

The Eden Prairie, Minn.-based company posted profits of $1.3 million, or 9¢ per share, on sales of approximately $22.2 million for the three months ended December 31, seeing a swing from the red on the bottom line while sales grew 30.7% compared with the same period during the previous fiscal year.

Read the whole story on our sister site, Drug Delivery Business News

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Medtronic touts study data for thoracic aortic stent

Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study.

The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented at The Society of Thoracic Surgeons annual meeting in San Diego this week. It was the first five-year, industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR).

BTAI is an emergency medical condition in which the aorta is damaged due to traumatic force to the chest, usually the result of elevated falls or other high-impact injuries such as motor vehicle accidents. It is the second leading cause of traumatic death after head injuries.

“These data from the Rescue trial demonstrate that TEVAR with Valiant Captivia continues to be a valuable, safe, and less-invasive alternative to open surgery for patients facing life-threatening aortic injury of BTAI, especially in the setting of critical multi-system injuries,” said Himanshu Patel, M.D., of the University of Michigan Department of Cardiac Surgery, in a prepared statement.  “This is the first five-year industry-issued dataset ever disseminated. The outcomes demonstrate Valiant Captivia to be a safe and durable therapy for high-risk BTAI patients.”

Patel presented the data at the conference. The Rescue study is a prospective, multi-center, non-randomized, descriptive study that evaluated 50 patients with BTAI of the descending thoracic aorta.  Highlights at five-year follow-up include:

• Kaplan Meier Freedom from All-Cause Mortality of 85.2%.
• No stroke or spinal cord ischemia observed.
• 100% freedom from Type I or III endoleaks.
• Kaplan-Meier Freedom from Secondary Procedures of 90.6%.
• 100% freedom from retrograde type A dissections, conversions to open repair, or aortic perforations.
• 100% complete exclusion of the traumatic injury maintained.
• No instances of stent graft kinking, fracture, loss of patency, or migration.

Subjects enrolled had a mean injury severity score of 38.4 ± 14.4 and 70% (35 of 50 subjects) whose BTAI extent was grade III or higher, including one grade IV free rupture, indicative of this extremely high-risk patient cohort. The extent of arch repair required full (40%, or 20 of 50) or partial (18%, or 9 of 50) left subclavian artery coverage. Of the 31 patients available at five years, 90.3% (28 of 31) received clinical follow-up, while 67.7%  (21 of 31) received imaging follow-up.

“The Valiant Captivia five-year transection results demonstrate our commitment to life-saving treatments and transparency in reporting long-term data to improve patient safety,” said John Farquhar, vice president and general manager of Medtronic’s aortic business. “These data also support our continuing focus on providing safe and durable endovascular repair to patients who have traditionally been challenging to treat.”

 

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Cardiovascular Systems posts Street-beating FY2019 Q2 earnings

Cardiovascular Systems (NSDQ:CSII) today posted fiscal year 2019 second quarter earnings that beat expectations on Wall Street.

The St. Paul, Minn.-based company posted profits of $492,000, or 1¢ per share, on sales of approximately $60.2 million for the three months ended December 31, seeing a swing from the red on the bottom line while sales grew 14.4% compared with the same period during the previous fiscal year.

Earnings per share for the quarter were ahead of the 1¢ loss consensus on Wall Street, where analysts were looking for sales of $59.7 million, which the company also topped.

“We are driving market leading performance with orbital atherectomy and we are executing on our key growth initiatives to introduce new products and launch our business in new markets around the world,” prez & CEO Scott Ward said in a press release.

Cardiovascular Systems updated its financial guidance, narrowing its full year sales guidance to between $243 million and $247 million from previous guidance of between $240 million and $250 million. The company said it expects to post a net loss equal to 1% to 2% of revenue, with gross profit as a percentage of revenue of approximately 80%.

“Revenues grew 13.8% during the first half of fiscal 2019. Our key revenue drivers came in on plan; domestic atherectomy grew 10% and we added $4.2 million in new revenue from international distributors and the domestic sale of OrbusNeich angioplasty balloons and Zilient guidewires. We anticipate similar contributions from these drivers during the second half of fiscal 2019. As a result, we remain on track to achieve the midpoint of our fiscal 2019 revenue guidance range. In conjunction with our pre-announcement of second quarter revenue results on January 7, we narrowed our fiscal 2019 revenue expectations to a range of $243 million to $247 million from a range of $240 million to $250 million. Our gross margin and profitability expectations for fiscal 2019 remain consistent with the financial guidance we provided at our analyst day meeting on July 31, 2018,” Ward said in a prepared statement.

Shares in Cardiovascular Systems rose approximately 3.4% today, closing at $30.06.

Earlier this month, Cardiovascular Systems said that it won approval from Japan’s Ministry of Health, Labor and Welfare for its Diamondback 360 coronary orbital atherectomy system and its Classic Crown and ViperWire Advance coronary guidewire FlexTip.

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Hologic FY2019 Q1 earnings beat The Street

Hologic (NSDQ:HOLX) today posted fiscal year 2019 first quarter earnings that topped expectations on Wall Street.

The Marlborough, Mass.-based company posted profits of $98.6 million, or 36¢ per share, on sales of approximately $830.7 million for the three months ended December 29, seeing profits shrink by 75.8% while sales grew 5% compared with the same period during the previous fiscal year.

Adjusted to exclude one-time items, earnings per share were 58¢, just ahead of the 57¢ consensus on Wall Street where analysts were looking for sales of $817.9 million, which the company topped.

“We posted strong results in our first fiscal quarter, with both revenues and EPS exceeding our guidance ranges. Growth was driven by acceleration in our largest businesses – U.S. breast health, international, and global molecular diagnostics – all of which posted double-digit constant currency growth to start our year,” prez & CEO Steve MacMillan said in a press release.

The company updated its guidance for the remaining fiscal year, expecting to see sales of between $3.305 billion and $3.335 billion, up from previous guidance of between $3.29 billion and $3.335 billion. It also lifted its full year non-GAAP EPS guidance from between $2.38 and $2.42 to between $2.39 and $2.43.

For its coming second quarter, Hologic said it expects to post sales of between $795 million and $810 million, with non-GAAP EPS of between 55¢ and 57¢.

Shares in Hologic rose 2% today, closing at $45.01.

Last month, Hologic touted a win in a court case against a Chinese competitor and former employee the company accused of misappropriating trade secrets.

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These headphones can clean your ears

Startup SafKan developed its ear-cleaning headphones with help from a ProtoLabs grant. (Image courtesy of SafKan)

Tucson-based startup SafKan has developed a pair of headphones that can professionally clean a patient’s ear in just 35 seconds.

Winner of Protolabs’ Cool Idea! Award, SafKan is working on meeting customization requirements during the pivotal beta program stage for its device, OtoSet. The headphones have disposable silicone nozzles that spray a warm saline solution against the walls of the ear canal while sucking the solution and wax back into the nozzles and disposable outflow containers, avoiding messy spills, the company said.

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

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Magnolia Medical closes $20m Series C

Magnolia Medical Technologies said today that it closed a $20 million Series C financing round slated to help grow the company’s infrastructure and market initiatives to meet demand for its Steripath Gen2 initial specimen diversion device.

The next-generation device, launched last August, features mechanical initial specimen diversion and improved usability based on input from end users, the Seattle-based company said.

Financing in the round was led by RTW Investments and joined by existing investors HealthQuest Capital, SightLine Partners and Canepa Healthcare. As part of the funding round, RTW Investments partner Dr. Naveen Yalamanchi will join the company’s board of directors as an observer, Magnolia said.

“RTW is committed to supporting innovative healthcare companies that both improve patients’ lives and enable cost-effective delivery of care. Magnolia is uniquely positioned to deliver on both of these requirements with Steripath’s demonstrated clinical performance and financially-backed guarantee. Accurate sepsis diagnosis is a critical priority for every acute care hospital, so we’re excited to partner with Magnolia as the company accelerates adoption of this new standard of care,” Yalamanchi said in a press release.

Funds will also be used to advance the company’s blood and bodily fluid collection and contamination prevention devices, Magnolia Medical added.

“Our mission as a company is to eradicate inaccurate laboratory test results that lead to harmful patient mistreatments and significant avoidable costs. We have made very strong progress in establishing a new standard of care for sepsis testing accuracy and look forward to repeating our proven process with other critical, yet frequently inaccurate, laboratory tests. We are delighted to partner with RTW as we accelerate expansion of the Steripath platform and advance efforts with policymakers to change national blood culture guidelines and contamination benchmarks to improve patient safety and quality of care,” CEO Greg Bullington said in a prepared statement.

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FDA sets date for advisory panel meeting on breast implants

The FDA announced today that it tentatively plans to hold a meeting of the General and Plastic Surgery Devices Panel, March 25-26. The meeting will take place at the FDA’s headquarters in Silver Spring, Md.

The meeting will discuss a range of topics concerning benefit-risk profiles of breast implants, according to the FDA.

Breast implants are considered implantable medical devices. They are implanted under the breast tissue or under the chest muscle for augmentation or reconstructive surgery. They can also be used in revision surgeries.

Two types of breast implants are currently approved for sale in the U.S.. These include saline-filled and silicone gel-filled. Both types have a silicone outer shell and vary in size, thickness, shell surface texture and shape.

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Johnson & Johnson plans €36M expansion in Ireland

Johnson & Johnson’s DePuy Synthes is investing €36 million in expanding research and development capabilities at its Ireland Innovation Center.

As part of the expansion, DePuy Synthes will establish a 3D-printing Development and Launch Center and implement the Johnson & Johnson 3D Bioprinting Laboratory.

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

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FDA approves J&J’s Tremfya self-injection pen for psoriasis

FDA has approved Johnson & Johnson’s patient-controlled injector for Tremfya, a treatment for adults with moderate to severe plaque psoriasis.

The self-injection approval may help Tremfya compete with AbbVie’s (NYSE:ABBV) Humira pen, which was previously approved for self-injection by psoriasis patients.

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

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Siemens Healthineers posts mixed-bag FY2019 Q1 earnings

Siemens (NYSE:SI) Healthineers this week posted first quarter fiscal year 2019 earnings that showed both sales and bottom-line growth, but saw its diagnostics and advanced therapies divisions profits shrink compared with the same period during the previous year.

The Erlangen, Germany-based company posted profits of approximately $394.1 million (EU €345 million), or 39¢ per share (EU €0.34 ), on sales of approximately $3.8 billion (EU €3.3 billion) for the three months ended December 31, for bottom-line growth of 11.3% while sales grew 3.2% compared with the same period during the previous year.

The company reported growth of 7% on the bottom-line for its imaging division, while its diagnostics division saw profits slide 24% and its advanced therapies business saw profits shrink 17%, according to the release.

“Business performance in the first quarter is a story of light and shade. Siemens Healthineers‘ growth trend remains intact and customers’ response to our new Atellica Solution laboratory diagnostics platform continues to be positive. What we are not pleased with, however, is the profit development of our Diagnostics business. We have therefore directly initiated measures to sharpen our focus even more on the business success of Atellica Solution. We confirm our outlook for fiscal year 2019,” CEO Bernd Montag said in a press release.

Siemens Healthineers affirmed its guidance for the remaining 2019 fiscal year, expecting to see revenue growth of between 4% and 5%.

The company said it expects to post a profit margin of between 17.5% and 18.5%, with earnings per share coming in at between 20% and 30% above their postings for its fiscal year 2018.

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Boston Scientific pulls Agile biliary stent on migration reports

Boston Scientific (NYSE:BSX) is initiating a voluntary select recall of its Agile biliary RX fully covered stents over issues with device migrations, according to a recently posted field safety notice.

The Marlborough, Mass.-based company said that it became aware of a higher than anticipated rate of stent migrations, which can require additional interventions and re-stenting “due to lack of stricture resolution,” according to the posting.

Boston Scientific said that it doesn’t recommend the removal of existing implanted devices which are still performing adequately, but advised medical professionals to monitor patients already implanted with the stents according to standard of care.

The voluntary recall affects all batch numbers of Agile biliary RX fully covered stents with model numbers M00586000, M00586010, M00586020, M00586060, M00586070 and M00586080 and GTIN numbers 08714729950219, 08714729950226, 08714729950264, 08714729950271 and 08714729950288, according to the release.

The company suggested that medical professionals stents in inventory immediately discontinue use of them and remove and return all affected devices.

Earlier this month, Boston Scientific touted 12-month data for its Vici venous stent in people with significant obstructions in the illiofemoral venous outflow tract.

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Medtronic touts U.S. results of lung cancer detection trial

Partial results of a huge, real-world study of Medtronic’s (NYSE:MDT) superDimension LungGPS technology found that 65% of patients diagnosed with primary lung cancer (Stages I and II) were at early stages of the disease. Early detection of lung cancer is critical to improving patient outcomes long-term.

The results came from a 12-month follow-up of the 1,215-patient U.S. portion of the Navigate trial. Begun in 2015, the trial was designed to evaluate the performance of the LungGPS electromagnetic navigation bronchoscopy (ENB) technology that the superDimension device uses to navigate the lungs. Results from the European cohort will be released at a later date, the company said in a statement.

Published in The Journal of Thoracic Oncology, the study concluded that ENB-aided diagnosis can be obtained in approximately three-quarters of evaluable patients across a cohort. Navigate enrolled subjects at 37 sites in the U.S. and Europe. Twenty-nine of those sites were in the United States.

ENB procedures provide a minimally invasive, GPS-like approach to access difficult-to-reach areas of the lung, which can aid in the diagnosis of lung disease and potentially lead to earlier, personalized treatment, the company said. Medtronic (Fridley, Minn.) acquired the superDimension lung device as part of its 2015 purchase of  Dublin, Ireland-based Covidien.

According to the American Cancer Society, lung cancer is the leading cause of cancer-related deaths in the United States. Most are diagnosed in the late stages (Stage III or IV), during which long-term survival rates drastically decline. When diagnosed at Stage I, the estimated 10-year survival rate climbs to 88%.

“These data demonstrate that, for the first time, both academic and community-based care clinicians can safely obtain a diagnosis in small, peripheral lung lesions, and then stage and prepare for future treatment in a single minimally invasive procedure,” said co-lead study investigator Erik Folch, M.D., chief of the Complex Chest Disease Center and co-director of Interventional Pulmonology at Massachusetts General Hospital in Boston. “Navigate is the first large, multicenter study to evaluate ENB diagnostic yield and complication rates with prospective, long-term follow up of negative cases. Because we looked at all cases, not just those with easily accessible lesions, Navigate replicates real-world conditions and demonstrates that ENB has the potential to significantly accelerate lung cancer detection, and consequently improve the likelihood of a successful intervention.”

Medtronic said it recently launched a new prospective study at two U.S. centers to evaluate the latest generation of the superDimension, which uses advanced software to enhance the visibility of lung lesions in real-time and aid in improved diagnostic accuracy.this technology at two U.S  centers. A third study, Navablate, will evaluate the safety and performance of Medtronic’s Emprint ablation catheter with the SuperDimension. This prospective, multi-center study will be conducted in up to 30 patients globally.

“We are dedicated to improving lung cancer care across the continuum with platform technologies that identify and manage patients, improve diagnostics, optimize treatment and accelerate recovery,” said Emily Elswick, vice president and general manager of Lung Health, which is part of the Minimally Invasive Therapies Group at Medtronic.

The superDimension system has FDA 510(k) clearance in the United States, CE Mark in Europe, and it has also been approved for use in numerous international markets including Japan, Korea, and China. The Emprint ablation catheter kit has CE Mark only, and is not available in the United States.

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Boston Scientific closes Millepede buyout

Boston Scientific (NYSE:BSX) announced that it has completed its acquisition of Iris transcatheter annuloplasty ring developer Millipede (Santa Rosa, Calif.). The company announced the acquisition plan in December last year.

The deal was worth approximately $325 million with the opportunity for an additional $125 million based on commercial milestone. The company said in December that it expects the deal to be dilutive to its earnings per share for the next several years. Marlborough, Mass.-based Boston Scientific also said that “all dilutive impact is expected to be absorbed via internal trade-offs,” and it expects no impact on net adjusted EPS.

Millipede’s Iris system is a complete annuloplasty ring that reduces the size of a dilated mitral annulus. It is designed to be used with a transeptal delivery system and can also be used as a standalone device or with other devices that are intended for use in patients with severe mitral regurgitation.

The purchase will help Boston Scientific expand its structural heart portfolio.

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Chinese national draws 27-month sentence in Medtronic, Edwards trade theft case

A Chinese National engineer who stole confidential trade secrets from Edwards Lifesciences (NYSE:EW) and ev3, formerly owned by Covidien and now a subsidiary of Medtronic (NYSE:MDT), has been sentenced to 27 months in federal prison, according to a posting from the U.S. Attorney’s Office for the Central District of California.

Wenfeng Lu, 46, pleaded guilty last May to six counts of unauthorized possession and attempted possession of trade secrets. Lu admitted that he stole secrets from the Irvine, Calif.-based labs of both Edwards and ev3 while he worked there from January 2009 until his arrest in 2012, according to the report.

Lu was initially employed by ev3 and later moved to Edwards. At both companies, Lu copied multiple documents with technical information and trade secrets and put them on his personal laptop at home.

During his time under both ev3 and Edwards employment, Lu traveled to the People’s Republic of China multiple times, at times directly after he stole secrets from the medtech firms, according to the report.

In addition to the thefts, Lu was preparing to launch a company to manufacture devices using technology stolen from his employers, according to the report.

“In furtherance of his business, defendant [Lu] applied to the PRC government for funding designed to attract technological talent from places such as the United States, and was selected to receive approximately $2 million RMB (about $328,000 USD) and free rent for a period of three years in a laboratory in a technology park located in Nanjing Province in the PRC. The money and laboratory space was part of a program sponsored by the PRC government to encourage scientists of Chinese descent to return to the PRC with intellectual property to develop biomedical technology in the PRC,” prosecutors wrote in a sentencing memorandum filed with the court, according to the AG report.

Lu was arrested in November 2012 as he was preparing to board a plane to the PRC.

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