Novocure shares dip on Q4, 2018 earnings miss

Shares in Novocure (NSDQ:NVCR) fell slightly today after the medical device maker missed expectations on Wall Street with its fourth quarter and full year 2018 earnings release.

The St. Helier, Jersey-based company posted losses of $15.6 million, or 17¢ per share, on sales of $69.7 million for the three months ended December 31, seeing losses grow 42.8% while sales grew 29.8% compared with the same period during the previous year.

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

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T2 Biosystems wins FDA breakthrough nod for drug resistance blood test

T2 Biosystems (NSDQ:TTOO) said yesterday that it won FDA breakthrough device designation for its T2Resistance Panel diagnostic designed to detect 13 drug resistance genes from a blood sample.

The T2Resistance Panel is designed to identify 13 genes that the Lexington, Mass.-based company said include “the most clinically important.” This includes genes that indicate a resistance to antimicrobial drugs that can significantly affect the treatment of bacterial infections and several genes listed on the CDC’s Urgent Threat list for antibiotic resistance, T2 said.

The system is intended for use on both gram-positive and gram-negative pathogens from a single patient blood sample and eliminates the need to wait for blood culture, the company added.

“Under the current standard of care, diagnosing bloodstream infections caused by antimicrobial resistant pathogens requires a positive blood culture and subsequent analyses to determine exactly what medication will most effectively treat the infected patient. These conventional methods, including blood cultures and antimicrobial susceptibility testing, take 3 or more days to provide an actionable result. This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need,” medical affairs VP Sandy Estrada said in a prepared statement.

T2 Biosystems said that it expects the T2Resistance Panel to be available for research use only in the U.S. later this year, and that it is hopeful for CE Mark approval in the European Union and commercial availability in the region during the same time frame.

“We’re grateful to the FDA for bringing us one step closer to getting the T2Resistance Panel in the hands of clinicians across the country. With the introduction of this panel, the T2 product portfolio will continue to expand to enable clinicians to make fast, accurate treatment decisions for the more than 2 million people who get an antibiotic-resistant infection each year in the United States alone,” prez & CEO John McDonough said in a press release.

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BioVentrix wins renewed German reimbursement for Revivent TC heart device

BioVentrix said today that it won renewed German reimbursement for its Revivent TC transcatheter ventricular enhancement system.

The San Ramon, Calif.-based company said that the German Institute for Hospital Remuneration reconfirmed NUB 1 status for the Revivent TC device.

NUB 1 status allows participating hospitals to receive full reimbursement for the product and supplemental payments for using technologies not listed in the German healthcare system, BioVentrix said.

The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small titanium anchors along the heart’s outer surface and along one of the inside walls, the company said.

“Attaining NUB Reimbursement Status 1 for a third time is a testament to the impact Revivent TC is having in the German heart failure community. The number of hospitals applying for coverage of Less Invasive Ventricular Enhancement procedures with the Revivent TC system more than doubled. This large increase in product adoption demonstrates the existing therapy gap and growing need for clinically impactful, less invasive, and cost effective HF treatment options. We will continue to partner with German heart failure centers who wish to provide this novel therapy to patients who have limited options available to treat their left ventricular dysfunction,” prez & CEO Kenneth Miller said in a press release.

In October 2017, BioVentrix said that it enrolled the 1st US patient in a pivotal clinical trial of its Revivent TC transcatheter ventricular enhancement system.

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FDA warns against robot-assisted breast cancer surgeries

FDA has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer.

The safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers, according to the agency, which said it “encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.”

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

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FDA head Gottlieb promises timely device reviews post-shutdown

Despite a 35-day government shutdown that directly affected its ability to perform, the FDA said that it still plans to hold itself to established timelines for device and drug reviews for the year.

In a statement released yesterday to the House Appropriations Subcommittee, FDA Commissioner Dr. Scott Gottlieb acknowledged that during the shutdown the agency could not accept new medical product applications that required a user fee, but said that despite the slowdown, “we will work to review this bolus of drug and medical device applications in timeframes that are consistent with our user fee goals.”

“Despite the impacts of the lapse, we will endeavor to mitigate any observable impacts on our review performance goals in the coming year. We’re committed to making sure that patients continue to have access to the treatments they need, and never wavering from our gold standard for safety and effectiveness,” Gottlieb said in the prepared statement.

While the federal watchdog expects to stay on track with device and drug reviews, Gottlieb said that it is lowering its inspectional and import and field sampling goals for the year.

“We won’t be able to conduct as many inspections of food and medical product facilities, and reviews of imports, as we had originally planned. This is because we focused on the highest risk establishments during the lapse, and many other types of inspections didn’t take place. The effected programs include human and animal food, biologics, and devices,” Gottlieb said in a press release.

New goals for the year will use a risk-based approach and focus on “high-risk products, facilities that were never inspected, and firms with troubling compliance records,” according to the release.

Gottlieb said that certain policy work, especially in food and animal health programs, would also be delayed, and concluded by saying that during the immediate future he will be focusing on solidifying staff hiring and retention efforts at the federal watchdog.

Earlier this month, the FDA released draft guidance for brain-computer interface devices, an emerging novel technology that allows users direct control of devices.

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Study of Boston Scientific’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years

Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.

The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.

Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.

Patients, treated between September 22, 2014 and December 24, 2015, were randomized two to one to receive the Lotus valve or CoreValve system at 55 centers spanning North America, Australia and Europe, according to study results.

Main outcomes being explored by researchers were all-cause mortality and all-cause mortality or disabling stroke at two years. Other factors examined included overall stroke, disabling stroke, repeat procedures, rehospitalization, valve thrombosis and pacemaker implantation.

At two years, results indicated similar rates of all-cause mortality, mortality and disabling stroke between the competing valve devices, according to the study results.

All-cause death was reported at 21.3% with the Lotus valve, versus 22.5% with the CoreValve, while rates of all-cause mortality or disabling stroke were 22.8% with the Lotus and 27% with the CoreValve. Rates of overall stroke were 8.4% with Boston Scientific’s Lotus offering, and 11.4% with Medtronic’s CoreValve.

Disabling stroke rates were higher for patients treated with the CoreValve at 8.6% versus a lower 4.7% with the Lotus device, while more Lotus patients were likely to receive pacemakers than those treated with the CoreValve at 41.7% versus 26.1%, according to the results.

“Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm,” research investigators concluded.

Patients in the trial will be followed out to five-years post procedure, investigators said.

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Glaukos rises on Street-beating Q4, 2018 earnings

Shares in Glaukos (NYSE:GKOS) are rising today after the ophthalmological-focused medical device maker posted fourth quarter and full year 2018 earnings that topped expectations on Wall Street.

The San Clemente, Calif.-based company posted profits of approximately $1.8 million, or 4¢ per share, on sales of approximately $54.1 million for the three months ended December 31, for bottom-line growth of 76.8% while sales grew 29.8% compared with the same period during the previous year.

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

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Shockwave Medical sets terms for $75m IPO

Shockwave Medical this week set terms for its initial public offering, looking to bring in approximately $75 million, according to an SEC filing.

The Santa Clara, Calif.-based company said that it plans to float approximately 5 million shares of its common stock at a price between $14 and $16, according to the filing.

The IPO will also include an underwriter’s option to purchase an additional 750,000 shares of stock at the same price, which could bring in an additional $11.3 million for the company. The company could bring in as much as $92 million with a fully-exercised underwriter’s option if shares are offered at the top-end of the range, according to the filing.

Shockwave Medical said that certain existing investors will receive options to purchase up to an aggregate of approximately $10.5 million in common stock in a concurrent private placement at the same price as the IPO, according to an SEC filing.

The company is looking to list its common stock on the Nasdaq Global Market under the symbol “SWAV,” according to the filing.

Net proceeds from the offering are slated to support ongoing commercialization of the company’s Intravascular Lithotripsy, or IVL, devices. Funds will also be used to expand the company’s sales force, medical affairs teams and educational efforts, as well as for possible strategic transactions and for general corporate purposes.

Shockwave Medical has not yet set a date for the offering.

Last month, Shockwave Medical said that it launched a U.S. pivotal trial for its coronary lithotripsy device, which is designed to prepare heavily calcified coronary lesions for stenting.

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Staar Surgical inks deal with Iberian eye clinic group

Staar Surgical (NSDQ:STAA) said today it inked a strategic cooperation agreement with ophthalmology clinic group Vista Oftalmólogos to offer its Evo Visian implantable collamer lenses for patients suffering from nearsightedness.

Vista Oftalmólogos is a 49-clinic group across Spain, France, Portugal and Morocco and employs more than 200 eye doctors and has 1,000 employees, Monrovia, Calif.-based Staar Surgical said.

“Providing the highest level of science-backed vision services to ensure satisfied patients is the common endeavor of every Vista clinic and the Evo Visian ICL fulfills that goal fitting seamlessly into our clinics. Some of our surgeons have used the ICL for years while others are just beginning the journey in providing this life-changing vision correction solution to our patients. With the ICL we have the added plus of a manufacturing company that meets our surgeons’ expectations, which is no small feat in this business. This new strategic cooperation agreement with Staar elevates the importance of the ICL in providing our patients a safe quick vision correction procedure with unmatched levels of patient satisfaction,” Vista Oftalmólogos manager Juan Borreguero said in a press release.

Staar Surgical’s Evo ICL is intended to work with a patient’s natural eye to correct vision and eliminate the need for external corrective lenses. The company said that the Evo lens allows for natural aqueous flow and only requires a single surgical procedure.

“In 10 short years Vista Oftalmólogos has established itself as a leading ophthalmology group in Western Europe and we are delighted they have chosen to make our Evo Visian ICL family of lenses a premium and primary procedure in their clinics. Precision manufactured with our exclusive Collamer material the Evo lens has a well-recognized safety and effectiveness record for the more than 500,000 EVO lenses that have been implanted. The Staar team looks forward to working closely with Vista Oftalmólogos on certifying surgeons, patient education and marketing to facilitate broader awareness and use of the ICL,” Staar Surgical prez & CEO Caren Mason said in a prepared statement.

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Medtronic launches Grafton DBM in Japan

Medtronic (NYSE:MDT) said today that it launched its Grafton demineralized bone matrix bone grafting product in Japan.

The Fridley, Minn.-based company touted the Grafton DBM as the first and only demineralized bone matrix product available in Japan, having won clearance from the country’s PMDA last August.

The newly launched Grafton DBM is a bone graft extender, bone graft substitute and bone void filler intended for use in bony voids or gaps in the skeletal system. The company added that the Grafton DBM has consistently high osteoconductivity scores and that it is the “most utilized and scientifically-studied DBM on the market.”

“Our unmatched combination of biologic therapies, services and expertise help surgeons meet the needs of each unique patient. Grafton is an important option within our comprehensive, market-leading biologics portfolio, and we’re excited that surgeons in Japan now have access to this clinically-proven osteoinductive bone graft product,” spine division prez Jacob Paul said in a prepared statement.

Medtronic said that the Grafton DBM is comprised of multiple forms, and that it is launching the Grafton Putty, Grafton Matrix and Grafton Strip in Japan.

Yesterday, Medtronic said that it won 510(k) clearance from the FDA for its Accurian radiofrequency nerve ablation device for treating chronic pain.

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Vertos Medical’s spinal stenosis treatment wins CE mark

Vertos Medical said it has received CE mark approval for its lumbar spinal stenosis (LSS) treatment device kit.

Aliso Viejo, Calif.-based Vertos said its Mild device kit enables a minimally invasive procedure to remove the cause of stenosis through a portal the size of a baby aspirin. The procedure requires no stitches, general anesthesia, implants or overnight hospital stays, the company added.

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

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Penumbra revenue up but earnings down in Q4

Penumbra (NYSE:PEN) saw its revenue jump more than 25% year-over-year in the fourth quarter, but earnings were down for the Alameda, Calif.–based maker of devices to treat neuro and peripheral vascular conditions.

Alameda, Calif.-based Penumbra’s stock is down about $15.57 per share, or 10.6%, to $131.25 as of midday trading.

The company reported yesterday evening that it earned $6.7 million, or 18 cents per share, for the quarter ended Dec. 31, down from $9.1 million, or 25 cents per share, for the same quarter a year before. Revenue was $120.8 million, up 25.8% year-over-year.

Analysts polled by Yahoo! Finance had expected fourth-quarter profits of 12 cents per share off nearly $115 million in revenue.

“In the fourth quarter, we saw our strongest sequential revenue growth of the year, which resulted in strong year over year growth against difficult fourth quarter comparisons, particularly in our neuro and international markets,” Penumbra CEO Adam Elsesser said in a news release.

“We made great progress across the business, including the launch of our peripheral embolization products into new international markets, which resulted in a shift of revenue from neuro to vascular in the fourth quarter.”

 

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Owens & Minor taps former Thermo Fisher CCO Pesicak as prez, CEO | Personnel Moves – February 27, 2019

Owens & Minor (NYSE:OMI) said this month that it named former Thermo Fisher Scientific chief commercial officer Edward Pesicka as its new prez & CEO, effective March 4.

Pesicka will replace interim prez & CEO Robert Sledd, who will continue to serve as board chair, the Richmond, Va.-based company said.

Prior to his position as chief commercial officer, Pesicka served as CFO for divisions within Thermo Fisher Scientific, the company said. Before joining Thermo Fisher, Pesicka held corporate finance positions, including divisional CFO, at TRW.

“The board is extremely pleased to welcome Ed as the new CEO of Owens & Minor. Ed is a seasoned senior executive with a deep understanding of distribution, manufacturing and service within our industry. He also has a proven ability to lead performance improvement. During his time at Thermo Fisher Scientific, Ed was responsible for leading a portfolio of businesses focused on distribution, manufacturing and services. He demonstrated his sales and financial acumen and developed a reputation for providing outstanding customer service and driving strong financial results. We are pleased that our process resulted in identifying the ideal CEO,” Sledd said in a press release.

“After a thorough search and careful evaluation of candidates, the Board believes we have found the right leader with practical management and people development skills that align with our strategy. Furthermore, as a man of great integrity, Ed fits well with the Owens & Minor culture, making him an excellent fit for the role. We thank Bob for his willingness to step into the Interim CEO role and look forward to continuing to benefit from his wealth of experience as the chairman of our board,” search committee member & lead director Anne Marie Whittemore said in a prepared statement.

“I’m honored to be appointed to lead Owens & Minor, a company with a rich 137-year history of serving the healthcare industry and providing customers with the solutions they need to deliver exceptional patient care. I am committed to uncovering practical and innovative ways of improving the customer experience and driving value for shareholders. I look forward to working alongside our talented teammates and, together, furthering our mission of serving the healthcare industry across the continuum of care with integrity, dedication, innovation and passion,” Pesicka said in a prepared release.

 McGinley Orthopedics appoints ex-Xtant Medical head O’Connell as CEO

McGinley Orthopedics said earlier this month that it appointed former Xtant Medical (NYSE:XTNT) CEO Carl O’Connell as its new chief exec, effective February 4.

Prior to joining Xtant Medical, O’Connell served as extremities global marketing VP for Wright Medical (NSDQ:WMGI). O’Connell has also held positions with Stryker (NYSE:SYK), Carl Zeiss Meditec and Hudson Healthcare Partners, Casper, Wyo.-based McGinley said.

“We are proud to announce Carl O’Connell as our new CEO. With his extensive leadership in the medical device industry and commercialization expertise, we are confident he is the right choice to lead McGinley Orthopedics to new levels of growth and success. Carl has served as an advisor to the company for the last 5 years, and we share his enthusiasm for the outlook of the company,” co-founder Dr. Joseph McGinley said in a prepared statement.

“I am excited to lead what has the potential to be a world-class organization and a considerable competitor and innovator in the market. The company has exciting patented technology that will significantly improve safety and surgical outcomes. I look forward to expanding upon our recent successes and continuing to establish the strategic course to take McGinley Orthopedics to the next level,” O’Connel said in a press release.

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 Cirtronics lifts COO Patterson to prez & CEO

Contract manufacturing firm Cirtronics said last week that it is lifting current COO Dave Patterson to the position of prez & CEO, with founder and former CEO Gerardine Ferlins staying with the company as chief governance officer and board chair.

Patterson joined Cirtronics in 2010 as global sourcing director and become COO in 2012, the Milford, N.H.-based company said.

“Dave has been an integral part of the Cirtronics leadership team for the last eight years. With his steadfast commitment to the culture of Cirtronics and his years of operational experience, he is well equipped to take on his new role,” Ferlins said in a press release.

“I am humbled and very proud to be part of such a great organization. We are an organization led by a purpose – to be an example of how a company can serve society in an ethical and productive way. I look forward to taking the next steps in this journey together with the whole Cirtronics team,” Patterson said in prepared remarks.

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 Surmodics promotes corp dev & strategy VP Arens to CFO

Surmodics (NSDQ:SRDX) said earlier this month that it is promoting corporate development & strategy VP Timothy Arens to the position of CFO, effective immediately.

Arens has been serving as interim CFO since May 2018 following the departure of Andrew LaFrence, the Eden Prairie, Minn.-based company said.

“Tim has been an impressive partner to me and an invaluable contributor to our management team and Surmodics’ success during the past eight years. I am personally delighted that he has been formally appointed to the role. Tim’s excellent financial, operational and strategic skills and strong leadership are ideally suited to his new role as we continue to drive our strategic initiatives and financial goals of consistent and profitable long-term growth,” prez & CEO Gary Maharaj said in a press release.

“I am excited to work with a group of dedicated and talented colleagues to accelerate our strategic transformation while continuing to deliver on our operating commitments. Surmodics is well-positioned to execute on our strategic initiatives including the development of highly innovative products that benefit patients. I am looking forward to being part of that journey,” Arens said in prepared remarks.

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 Magnolia Medical taps Lehr as IP special counsel

Magnolia Medical Technologies said earlier this month that it named Matthew Lehr as its new intellectual property special counsel.

Prior to joining Seattle-based Magnolia, Lehr served as head of the IP litigation department at law firm Davis Polk & Wardwell.

“Intellectual property is a critical asset for any innovative medical device company that invests heavily to develop new technologies that drive important paradigm shifts in medicine. In our case, we have invested well over a decade along with significant resources to create the category known as initial specimen diversion to significantly improve sepsis testing accuracy. We will benefit from Matt’s expertise and active participation as we continue to drive hospital adoption of our Steripath platform to prevent blood culture contamination,” CEO Greg Bullington said in a prepared statement.

“I am pleased to work with Magnolia as they commercialize and protect their groundbreaking technologies, which directly improve the quality of care for patients. The company has built an extensive and broad intellectual property foundation that will allow them to maintain appropriate protection in numerous medical device categories in the years to come,” Lehr said in a prepared release.

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• Isoray moves Cavanagh III from chief scientific officer, COO positions to chief R&D officer
• Deerfield-Oxeon group looks to place more women in boardrooms
• Alivecor names Dr. Shreibati as chief medical officer
• Anaconda Biomed adds Dr. Huysse as CMO, Vidal as manufacturing director
• Zimmer Biomet taps Puryear as CHRO, senior VP
• CathWorks adds Mousavi as global marketing & strategy VP
• Xtant Medical adds five new sales leads

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Masimo beats The Street on Q4 earnings

Masimo (NSDQ:MASI)  stock is up about 5% in value today after the Irvine, Calif.– based maker of noninvasive patient monitoring technologies and technologies reported fourth-quarter results that beat analyst expectations.

Masimo reported yesterday evening that it earned $46.9 million, or 83 cents per share, off $223.1 million in revenue for the quarter ended Dec. 29. Masimo lost $7.7 million, or 15 cents per share, off $207.9 million in revenue for the same quarter a year ago.

Analysts polled by Yahoo! Finance predicted fourth-quarter earnings of 73 cents per share off $219.96 million in revenue.

Masimo CEO Joe Kiani described 2018 as a dynamic year for the company, with strong business momentum.

“Our global organization executed on our strategy to deliver above-market growth and drive operational efficiencies throughout the business,” Kiani said in a news release.

Said Kiani: “Due to the strong finish in 2018, we are now increasing our 2019 product revenue guidance to $912 million and our 2019 non-GAAP earnings per diluted share guidance to $3.08.”

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Bio-Rad whistleblower case heads back to court on appeal

A federal appeals court panel dealt the former general counsel for Bio-Rad Laboratories (NYSE:BIO) a blow, slicing his $11 million jury award by $6 million and sending his whistleblower retaliation lawsuit back to U.S. District Court for a possible new trial.

The three-judge panel sitting in San Francisco ruled that the U.S. District Court judge in the January 2017 trial had improperly instructed the jury that parts of the Federal Corrupt Practices Act  (FCPA) are rules or regulations of the Securities & Exchange Commission (SEC).

That jury had also found that a February 2013 internal report, in which general counsel Sanford Wadler wrote of his suspicion that the company had violated the FCPA in China, was protected whistleblower activity and a significant reason for his firing later that year. The appeals court decided that the internal report did not violate a federal financial regulatory statute because it does not apply to “purely internal reports.”

The appeals court ruled in favor of Bio-Rad on that claim and vacated the $2.96 million in back pay and stocks that the jury had awarded to Wadler, plus the $2.96 million that was doubled under the law. The district court had also awarded Wadler $5 million in punitive damages against the company in 2017, bringing his total award to $10.92 million plus interest from the first trial.

Wadler, who was general counsel and executive vice president when Bio-Rad sacked him in June 2013, alleged that he was fired right before the company was slated to present findings from its investigation into bribery in Russia, Thailand, and Vietnam. Bio-Rad later agreed to a $55 million settlement with the U.S. Department of Justice and the SEC, which found that it paid $7.5 million in bribes to drum up some $35 million in profits.

 

 

 

 

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Robocath wins CE Mark for R-One coronary platform

Robocath said today that it won CE Mark approval in the European Union for its R-One cardiovascular-focused robotics system.

The Rouen, France-based company touted the R-One as the first interventional cardiology-focused robotic system to win CE Mark approval. The system is designed to assist in stenting procedures, Robocath said.

The company said that it is planning a new funding round to support commercialization of the device over the next few years.

“The whole Robocath team is proud to have taken this major step forward in our development, which comes just a few days after our first sale of a training robot to the Medical Training & Testing Center in Rouen. Our entry into the market for interventional vascular robotics represents a substantial opportunity for growth. There is the potential for the R-One solution to be installed in more than 3,000 procedure rooms, performing around 1.6 million interventions each year in Europe alone. Building on our CE mark, we expect to finalize a number of strategic distribution partnerships very shortly in high potential geographic areas, with a Europe and Middle-East wide launch expected in 2020,” founder & chairperson Philippe Bencteux said in a press release.

In late 2017, Robocath said that it added about $2 million (€1.7 million) to the more than $5 million it raised earlier that year.

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Endologix misses the mark with Q4, 2018 numbers

Endologix (NSDQ:ELGX) this week posted fourth-quarter and full-year results that missed the consensus forecasts for sales and earnings for both periods.

The Irvine, Calif.-based stent graft maker’s losses grew 78.7% to -$26.0 million, or -26¢ per share, on sales growth of -18.6% to $24.0 million for the three months ended Dec. 31, 2018, compared with the same period in 2017. Analysts on Wall Street were looking for losses per share of -20¢ on sales of $32.0 million.

Full-year losses were up 24.6% to -$80.5 million, or -91¢ per share, on a -11.5% top-line slide to $109.1 million, compared with the prior year. Analysts were looking for losses per share of -68¢ on sales of $154.0 million.

“Our performance in the fourth quarter and second half of the year reinforces confidence in our strategic planning process and our ability to implement improvements. The objectives we accomplished during the second half of 2018 align with those we laid out during our second-quarter earnings call as part of our strategic reset. As we enter 2019, our single biggest lever will be a consistent and unwavering application of individual and company-wide accountability. We will lean heavily on this lever throughout the year as the critical enabler of consistent delivery on our commitments to patients, customers, investors and other stakeholders. We are determined to sustain the momentum generated over the last two quarters as we continue to take steps to improve the company’s operational and financial footing. While there are still challenges ahead, the entire Endologix team remains singularly dedicated to data-driven superior outcomes in the treatment of [abdominal aortic aneurysms],” CEO John Onopchenko said in prepared remarks.

Endologix said it still expects to log first-quarter sales of roughly $35 million and 2019 sales of “at least” $140 million.

ELGX shares were up 0.5% to 53.12¢ apiece today in mid-morning trading.

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PE giant brands ophthalmology play as Falcon Vision

Private equity giant KKR said yesterday that it’s forming a new company to back plays in the ophthalmology space, tapping a well-known expert in the field to lead its new Falcon Vision business.

Based in Menlo Park, Calif., Falcon Vision is slated to collaborate with Flying L Partners and Bill Link, the co-founder of Advanced Medical Optics, Chiron Vision and Versant Ventures, KKR said.

“Ophthalmology is an important and attractive area for innovation given the unmet need across multiple disease categories, an aging population and the quality-of-life consequences of vision loss,” Link said in prepared remarks. “We are eager to collaborate with Falcon Vision to further our mission of supporting innovative companies to create value in the space.”

“There is a significant opportunity to accelerate much-needed therapies in the ophthalmic sector with flexible capital and operational guidance,” added KKR healthcare strategic growth head Ali Satvat. “We are excited to work with the proven team at Flying L Partners to provide companies with the resources that they need in order to advance new products to treat ophthalmic diseases and preserve vision for millions of patients.”

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LivaNova shares dip despite Q4, 2018 earnings beat

Shares in LivaNova (NSDQ:LIVN) fell today despite the medical device maker posting fourth quarter and full year 2018 earnings that topped expectations on Wall Street.

The London-based company posted losses of $210.6 million, or $4.34 per share, on sales of $297 million for the three months ended December 31, seeing losses grow 88.5% while sales grew 6.7% compared with the same period during the previous year.

Adjusted to exclude one-time items, earnings per share were $1.12, just ahead of the $1.10 consensus on Wall Street where analysts expected to see sales of $295 million, which the company topped.

For the full year, LivaNova posted losses of $189.4 million, or $3.91 per share, on sales of approximately $1.11 billion, seeing losses grow 654.6% while sales grew 9.4% compared with the previous year.

After adjusting to exclude one-time items, earnings per share were $3.55, just in line with the consensus on Wall Street where analysts expected to see sales of $1.11 billion, which the company met.

“We had a strong fourth quarter, which allowed us to achieve all of our targets for 2018. Neuromodulation benefited from commercial expansion in our rest of world region and continued strong performance of our SenTiva vagus nerve stimulation therapy system, in the U.S. and Europe. Cardiovascular maintained solid growth, driven by double-digit sales growth for our S5 heart-lung machine and our oxygenator businesses. We are pleased with the progress of our recently acquired advanced circulatory support business, which grew in the mid-20% range in the fourth quarter. All of this allowed LivaNova to increase our full-year adjusted diluted earnings per share from continuing operations by 7.3% compared to full-year 2017. We intend to continue this momentum throughout 2019, taking actions that strengthen LivaNova’s commitment to improving the lives of patients around the world,” CEO Damien McDonald said in a prepared statement.

LivaNova released guidance for its 2019 year, expecting to see sales growth of between 5% and 7% with adjusted diluted EPS of between $3.55 and $3.75.

“We are entering 2019 with significant momentum to accelerate growth. We continue to focus on our initiatives to fuel sales growth, invest in our TRD program, launch new products and improve our margins. We are investing in advancing our pipeline and implementing programs to reach new patient populations around the globe. We believe these efforts will enable LivaNova to most effectively serve the needs of our customers and patients and create quality, long-term value for our shareholders,” CEO McDonald said in a press release.

Shares in LivaNova have fallen approximately 5.7% today, at $91.67 as of 9:52 a.m. EST.

Last week, LivaNova said that it won national reimbursement through Japan’s Ministry of Health, Labour and Welfare for its Perceval sutureless aortic heart valve intended to treat aortic valve disease.

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Oyster Point raises $93m for intranasal dry eye disease therapies

Oyster Point Pharma said yesterday that it raised $93 million in a Series B round to support the clinical development of its intranasal dry eye disease therapies.

The Princeton, N.J.-based company’s lead product candidates for dry eye disease are designed to stimulate the trigeminal parasympathetic pathway to trigger natural tear film production. The drugs, OC-01 and OC-02, are delivered using an ocular surface-sparing nasal spray.

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

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Mylan shares down on mixed Q4 results

Shares in Mylan (NSDQ:MYL) fell yesterday after the company missed earnings expectations but beat sales estimates on Wall Street with its fourth-quarter financial results.

The Pittsburgh, PA-based company posted profits of $51.2 million, or 10¢ per share, on sales of $3.04 billion for the three months ended Dec. 31, for bottom-line loss of -79% on sales loss of -5% compared with the same period last year.

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

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Merit Medical’s Q4, 2018 top The Street

Merit Medical (NSDQ:MMSI) yesterday posted fourth-quarter and full-year sales and earnings that beat the consensus forecast on Wall Street.

The South Jordan, Utah-based medical device company reported profits of $9.2 million, or 16¢ per share, on sales of $233.2 million for the three months ended Dec. 31, 2018, representing bottom-line growth of 35.0% on sales growth of 22.2% compared with Q4 2017.

Adjusted to exclude one-time items, earnings per share were 48¢, three pennies ahead of The Street, where analysts were looking for sales of $230.4 million.

Full-year profits grew 52.7% to $42.0 million, or 78¢ per share, on sales growth of 21.3% to $882.8 million compared with the prior year. Adjusted EPS came in at $1.69, again 3¢ ahead of the consensus, which called for sales of $879.7 million.

“2018 was an important and very positive year for the company and included the closing of the Becton Dickinson deal, the acquisitions of Cianna Medical and Vascular Insights, and the execution of our global growth and profitability plan,” founder, chairman & CEO Fred Lampropoulos said in prepared remarks. “As we look forward, we are also comfortable adding a forecast for 2020, which we currently believe will be in the range of 8% to 10% core revenue growth, an addition of 100 to 150 basis points to gross margin and net income improvement of approximately 14% to 19%.”

Merit said it expects to post EPS of $1.97 to $2.08 this year on sales of $1.01 billion to $1.03 billion.

MMSI shares closed down -3.2% at $57.48 apiece yesterday.

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FDA clears Medtronic Accurian RF nerve ablation device

Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its Accurian radiofrequency nerve ablation device for treating chronic pain.

“Medtronic has a long-established track record of bringing to market improved options to support clinicians with state-of-the-art technology, like the Accurian RF ablation system, which was designed for consistency and efficiency,” pain therapies president Dr. Marshall Stanton said in prepared remarks. “Medtronic is committed to advancing the treatment of pain as we introduce new options to help patients throughout the care continuum.”

“The Accurian RF ablation platform is a significant addition in my practice because I know I’ll get the same lesion every time in every channel due to how responsive the generator is in managing power and temperature,” added Dr. Leo Kapural of Winston-Salem’s Carolinas Pain Institute & Center for Clinical Research. “RF ablation requires both precision and flexibility. Accurian is intuitive and easy to use and enables me to easily upgrade the system and perform enhanced lesions with cooled RF probes.”

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Tandem shuffles C-suite, beats The Street with Q4 results

Tandem Diabetes Care (NSDQ:TNDM) beat estimates on Wall Street today with its fourth-quarter and full-year financial results.

The company also announced today that its CEO, Kim Blickenstaff, plans to assume the role of executive chairman and that COO John Sheridan will become president and CEO on March 1.

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

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Wright Medical posts street-beating Q4, 2018 earnings

Wright Medical (NSDQ:WMGI) today posted fourth quarter and full year 2018 earnings that beat expectations on Wall Street.

The Amsterdam-based company posted losses of approximately $33.8 million, or 27¢ per share, on sales of $238.1 million for the three months ended December 31, seeing a swing into red ink while sales grew 9.4% compared with the same period during the previous year.

After adjusting to exclude one-time items, earnings per share were 11¢, ahead of the 5¢ consensus on Wall Street, where analysts expected to see sales of approximately $237 million, which the company topped.

For the full year, Wright Medical posted losses of $169.5 million, or $1.51 per share, on sales of approximately $836.2 million, seeing losses shrink 16.3% while sales grew 12.2% compared with the previous year.

Adjusted to exclude one-time items, earnings per share were at 0¢, ahead of the 7¢ loss-per-share consensus on Wall Street, where analysts expected to see sales of $835 million, which the company topped.

“As previously reported, our fourth quarter results represent an outstanding performance across all our businesses.  This performance was driven by continued strong shoulder growth in the quarter, which included the ongoing launch of our Perform Reversed glenoid and continued contributions from our Simpliciti shoulder system.  We anticipate that these products, as well as accelerating adoption of our Blueprint enabling technology and the upcoming launch of our Revive revision shoulder system, will continue to drive strong shoulder sales growth in 2019 and beyond.  We also had strong adjusted EBITDA with 210 basis points of EBITDA margin expansion for the full-year and our adjusted gross margins of nearly 80% are some of the best in high-growth medtech. In our U.S. lower extremities business, we got off to a very strong start with Cartiva revenue of $9.5 million, which exceeded our expectations in the fourth quarter.  On January 1, Cartiva was fully launched with our U.S. lower extremities sales force, including the integration of the former Cartiva distributors that we have chosen to retain.  We also saw continued strong growth in our core products as well as in total ankle.  Our U.S. biologics business continued to be driven by the ongoing roll-out of Augment Injectable.  We intend to continue to focus on strong execution and new product launches throughout 2019,” prez & CEO Robert Palmisano said in a press release.

Wright Medical released guidance for the 2019 year, expecting to sales of between approximately $954 million and $966 million for the full year with non-GAAP adjusted EPS of between 17¢ and 25¢.

Shares in Wright Medical have stayed steady in after-hours trading after dropping approximately 4.2% today to close at $30.02.

Earlier this month, Wright Medical said that it inked a refinancing deal looking to exchange $112.1 million in existing 2% convertible senior notes due 2020 for $120.2 million in newly issued 1.625% senior notes due 2023.

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Corindus closes $15m private placement

Corindus Vascular Robotics (OTC:CVRS) said today that it closed a $15 million private placement round.

The Waltham, Mass.-based medical robotics company said it sold a total of approximately 10.9 million shares of its common stock at a purchase price of approximately $1.38 per share, for aggregate proceeds of approximately $15 million.

Net proceeds from the private placement are expected to be approximately $14.8 million, which the company said it plans to use for general corporate purposes, according to a press release.

Earlier this month, Corindus said that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions.

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How fast is Protolabs growing? Turns out it’s really fast

Quick-turn manufacturer Protolabs has an enviable problem: It needs hundreds of qualified advanced manufacturing workers, and it needs them fast.

When Protolabs CEO Vicki Holt started with the Maple Plain, Minn.-based company five years ago, it had 750 employees. Now it has 2,700, with plans to add hundreds more this year. Most of Protolab’s growth has been organic, too.

“We like to grow leaders from the people that come into the company. … The technology is changing so quickly, and we have to be at the forefront of those technologies,” Holt said yesterday, after helping to show a few dozen Dunwoody College of Technology students around Protolabs’ CNC machining plant in Brooklyn Park, Minn.

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

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Orthofix slumps on top-line misses

Orthofix (NSDQ:OFIX) missed the consensus for its fourth-quarter and 2018 sales, sending its share price down by double digits today in mid-afternoon trading despite a huge bottom-line gain.

Lewisville, Texas-based Orthofix reported profits were up 465.8% to $8.9 million, or 46¢ per share, on sales growth of 3.6% to $121.1 million compared with Q4 2017. Adjusted to exclude one-time items, earnings per share were 55¢, 7¢ ahead of the consensus on Wall Street; however, analysts there were looking for sales of $121.5 million.

“With the recent FDA approval of the M6-C artificial cervical disc, the primary focus in our spine business is on the launch in the U.S., which we expect will happen late in the second quarter,” said president & CEO Brad Mason, who also announced plans to retire. “This approval is an important milestone in our transition to a top-line growth story beginning in the second half of this year and accelerating in 2020.

“What I’ve always done best and enjoyed the most in my career is starting and fixing companies. I love the challenges associated with these phases in a business’s lifecycle,” Mason added. “Now with the stage set for the company’s next chapter, I’ve finished what I came to do. Because of the tireless efforts of the talented and dedicated Orthofix team, we’ve accomplished everything and more than I ever expected. Therefore, I believe it is the right time for both the company and for me to pass the reins to a new leader who will take Orthofix through the next chapter and capitalize on this enormous potential.”

Orthofix said Mason plans to stay on until a replacement is found and consult thereafter. The company forecast adjusted 2019 EPS of $1.75 to $1.82 on sales of $472.0 million to $477.0 million.

OFIX shares were off +12.5% to $59.25 apiece today in mid-afternoon activity.

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Stryker closes Arrinex buy

Stryker (NYSE:SYK) said yesterday that it closed its acquisition of Arrinex and its Clarifix cryoablation technology intended for treating chronic rhinitis.

Kalamazoo, Mich.-based Stryker said that Menlo Park, Calif.-based Arrinex was founded in 2013 and began commercializing the Clarifix technology in late 2017.

Stryker said that the acquisition will expand its ENT portfolio and that the Clarifix technology will address a large segment of the ENT market in which the company does not currently compete.

“The acquisition of Arrinex is highly complementary to Stryker’s ENT portfolio, which is part of our Neurotechnology business. This acquisition aligns with our focus on providing ENT physicians with new technologies that deliver more treatment options and better patient outcomes,” neurotechnology, instruments & spine group prez Spencer Stiles said in a press release.

Earlier this month, Stryker said that it launched a select voluntary recall of Lifepak 15 monitor/defibrillators over issues in which the device locks up and may not deliver life-saving therapy, adding that it has received six reports of deaths related to the issue.

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Boston Scientific closes $4B debt offering for BTG buyout

Boston Scientific (NYSE:BSX) said yesterday that it closed a $4.3 billion debt round it plans use to defray the cost of buying BTG (LON:BTG)

The Marlborough, Mass.-based medical device company said the flotation comprised $850 million worth of 3.45% notes due 2024, $850 million in 3.75% notes due 2026, $850 million of 4.0% notes due 2029, $750 million of 4.55% notes due 2039 and $1.0 billion of 4.70% notes due 2049.

Apart from covering some of the $4.24 billion BTG buyout, which is slated to close mid-year, Boston Scientific said it also plans to use the proceeds to redeem a collective $1.18 billion in notes due 2020 and pay down some of a $1 billion term loan and other short-debt.

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Intersect ENT shares dip despite street-beating Q4, 2018 earnings

Shares in Intersect ENT (NSDQ:XENT) have fallen slightly today despite the medical device maker released fourth quarter and full year 2018 earnings that met consensus expectations from analysts on Wall Street.

The Menlo Park, Calif.-based company posted losses of $5 million, or 16¢ per share, on sales of approximately $32.8 million for the three months ended December 31, seeing losses grow 59.6% while sales grew 11% compared with the same period during the previous year.

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

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Insightec wins expanded Medicare coverage for essential tremor treatment

Incisionless neurosurgery company Insightec said it has won Medicare coverage for its Neuravive MR-guided focused ultrasound device in 13 more states, effective April 1, 2019.

Health insurance administrator Noridian extended coverage to Medicare recipients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington, and Wyoming. Insightec’s Neuravive technology is designed to treat essential tremor that has not responded to medication. The approval extends coverage for the procedure to a total of 38 U.S states.

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

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The history of clinical research

John Lehmann, director of business development, IMARC

The history of clinical research is both fascinating and troubling. It’s a series of trial and error, followed by regulations that put patient safety ahead of profits.

In fact, it’s the reason IMARC Research exists—and why we’re proud to be a partner in compliance for so many medical device companies.

This short video shows several events from the past century that shaped many of the ethical guidelines and regulations we still use today to protect patients.

Take a minute to watch the video and explore our History of Clinical Research timeline for more detail.

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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Can AI take medical device manufacturing to the next level?

Artificial intelligence could improve medical device manufacturing efficiency and reduce risk, but it’s still a work in progress.

[Image from Unsplash]

Artificial intelligence is driving the world and our habits. Some of the world’s most well-known companies are using AI: Apple in Siri, Tesla in self-driving cars, Amazon in Alexa and even Netflix.

Now companies like machine-learning and AI consulting company Wovenware are bringing AI to medical device manufacturing and other advanced industries to make the process more efficient while reducing risk.

Artificial intelligence is the capability of a machine to perform tasks that would normally be done by a human. Through machine learning, computers are taking in troves of data and learning mistakes while enhancing the jobs of engineers in the manufacturing process.

“Engineers have more time to do the important work,” said Carlos Meléndez, COO and co-founder of Wovenware (San Juan, Puerto Rico). “They don’t have to worry about things that they will not be able to fix.”

For example, a predictive algorithm can gather data about a medical device that was taken out of a production line because of a problem with the device. Using data and performance records, AI can determine the probability of that particular device being scrapped. If the algorithm shows a 99% chance that the device is going to be scrapped, it won’t be sent to the engineering department. Engineers then have more time to dedicate to more important processes, said Meléndez.

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

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