Innfocus touts 3-year MicroShunt data

InnFocus said Wednesday that results from a 3-year trial of its MicroShunt drainage system designed to treat glaucoma patients reported a significant reduction in intraocular pressure and the use of glaucoma medication.

Results from the study were published in the Journal of Glaucoma, the company said.

“These results show not only the potential effectiveness but the possibility for sustainability of low IOP with the InnFocus procedure,” lead author Dr. Juan Batlle said in a press release.

Patients in the study had an average pre-surgical medicated intraocular pressure of 23.8 mm Hg, and after 3-years of treatment with the MicroShunt system reported a 55% reduction in IOP at 10.7 mm Hg. More than 80% of the 22 patients studied had IOPs under 14 mm Hg, and 64% did not require any glaucoma meds after the 3rd year, the Miami, Fla.-based company said.

InnFocus said there were no reports of leaks, infections, migrations, erosions, persistent corneal edema, chronic hypotony or serious long-term adverse events during the trial.

The company is pursuing FDA approval for the device as a minimally invasive stand-alone procedure for mild, moderate and sever open angel glaucoma, and says the final phase of its FDA randomized clinical trial comparing the system to trabeculectomy is “underway.”

In late December, InnFocus said it closed a $33.9 million Series C round for the upcoming clinical trial of its MicroShunt device.

In November, InnFocus won the FDA’s approval to add an additional 412 patients to its clinical trial ahead of a bid for pre-market approval. When the federal safety watchdog agreed to allow the trial expansion, CEO Russ Trenary said InnFocus is “poised to become the clear leader in treating all stages of primary open angle glaucoma.”

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Medtronic to present Micra data at FDA leadless pacer committee meeting

Medtronic (NYSE:MDT) said today it will present data on its Micra transcatheter pacing system at an FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee.

The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. The Micra device has an estimated 12-year battery life and is approved as safe for full-body MRI scans, the company said.

The panel is meeting on Feb. 18 in Gaithersburg, Md. to discuss leadless cardiac pacemaker device technology and make recommendations on clinical trial research, post-approval study design and training requirements for the devices, according to the company.

In November, Medtronic touted the results of a clinical trial of the device, saying it met its primary and secondary endpoints. Results from the trial were presented at the American Heart Association’s scientific sessions meeting this week and published in the New England Journal of Medicine, Medtronic said.

Fridley, Minn.-based Medtronic said that 99.2% of patients in the trial were successfully implanted with the device. A total 96% of 725 patients experienced no major complications, which Medtronic said is 51% less than is seen in patients with conventional pacing systems.

Cardiac injuries occurred in 1.6% of patients, complications at the groin site in 0.7% and pacing issues in 0.3%. Medtronic said there were no dislodgments, no systemic infections and a 0.4% rate of system revisions.

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Study: No benefit for biological mesh in hernia repair

Using biologic mesh for abdominal wall hernia repair provides no benefit over using cheaper synthetic mesh, according to a new study from the UT Southwestern Medical Center that compared the 2 materials.

Findings from the study were reported earlier this week in JAMA Surgery.

“In the absence of evidence demonstrating superiority of biological mesh materials, the expense associated with their use cannot be justified,” study author Dr. Sergio Huerta of UT Southwestern said in a press release.

Meshes are used during abdominal hernia repairs, and biological meshes were introduced in the 1990s in hopes of reducing the rate of infections erosions associated with earlier synthetic meshes. Biologic meshes are derived from biological sources, such as pig or cow tissue, and cost on average 350% more than synthetic mesh, according to a UT Southwestern press release.

The study examined 274 published articles covering the use of biologic mesh in abdominal wall hernia repair, as well as the FDA 510(k) approvals of the devices. FDA clearance for the meshes was based on “substantial equivalence” to synthetic meshes, rather than clinical trials.

Outcomes for 1,033 patients were analyzed during the study, which found that follow-up time, operative technique, meshes used and patient selection criteria varied widely, and outcomes such as infection were inconsistently reported across all studies.

The re-examination analysis found only 3 studies which compared biologic meshes to synthetics, none of which were randomized clinical trials. In addition, 16 of 20 studies did not report conflicts of interest and recurrence rates ranged from 0% to 80%.

“The cost of health care is increasing at a pace much greater than the economy can support. Much of the increase in health care expenses has been attributed to the use of new technologies. It is believed that greater application of evidence-based medicine will help control these increasing costs. The use of biological mesh materials for hernia repair is one of many examples in which significant costs could be avoided by tailoring clinical practice based on careful review of the evidence. These devices were approved on the basis of being equivalent to other devices, which cost as much as one-fourth less than the biological equivalent. Until evidence exists demonstrating superiority of biological mesh materials, the expense associated with their use cannot be justified,” study authors wrote.

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MassDevice.com +3 | The top 3 medtech stories for January 29, 2016

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. Bard’s Q4 earnings top estimates

C.R. Bard beat the consensus estimate for its 4th-quarter earnings.

Murray Hill, N.J.-based Bard posted profits of $136.3 million, or $1.79 per share, on sales of $870.8 million for the 3 months ended Dec. 31, 2015, for a bottom-line gain of 1.6% on sales growth of 0.4% compared with Q4 2014. Read more

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2. Spectral Medical looks to raise $10m

Spectral Medical said it inked a deal for a $10 million stock sale it plans to use to fund a clinical trial.

Toronto-based Spectral makes a system designed to diagnose and remove endotoxin from the bloodstream. The offering involves the purchase of 14.3 million shares at 70¢ apiece by a consortium of underwriters, who plan to then sell the stock to the public. Read more

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1. Wright Medical contests $11m hip verdict

Wright Medical asked a federal judge in Georgia to toss the $11 million verdict from the 1st bellwether trial in the multidistrict litigation filed over its Conserve metal-on-metal hip implant.

An Atlanta jury last year awarded plaintiff Robyn Christiansen $1 million in compensatory damages and another $10 million in punitive damages. The jury found Nov. 24 that the Conserve device was defective and that Wright failed to adequately warn patients about its risks. Read more

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FDA: Recall of Arkray Spotchem II test strips is Class I

Arkray is recalling its Spotchem II test strips over inaccurate blood sugar readings in what the FDA has labeled a Class I recall.

The FDA labels recalls as Class I when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The recall includes both the Spotchem II Basic Panel-1 reagent test strips and Spotchem II glucose reagent test strips, which are used to test blood sugar levels in the company’s Spotchem EZ analyzer system.

Arkray is recalling the strips because they “may report falsely low blood glucose levels,” according to an FDA press release, when true levels are above 265/mg/dL.

Because of the false reading, healthcare providers may not diagnose hyperglycemia including Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome quickly enough and may fail to treat the elevated blood glucose levels.

The company said that so far, there have been no reports of serious injuries or illness as a result of the error.

Units from lot numbers PN5C26 and EA4M78 are affected, manufactured between November 2014 and September 2015 and distributed between February 18, 2015 and October 13, 2015.

The strips come in batches of 25 per box, with 99 boxes being recalled. A total of 2,475 strips are affected by the recall, distributed between Florida, Illinois, Kentucky, Michigan, North Carolina, New York, Ohio and Tennessee.

The company said it sent a letter December 18, 2015 to customers with the recalled products, instructing them to return the unused product and that replacements would be shipped accordingly.

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Intersect ENT logs German reimbursement win

Intersect ENT (NSDQ:XENT) said today it clocked a German hospital reimbursement win from InEk, Germany’s Institute for Hospital Remuneration System, for its Propel sinus implant.

The propel device is a small steroid releasing implant designed to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery.

“We believe that the robust clinical evidence supporting Propel was key to this favorable decision, which we received on the 1st application round. While our focus as a company is very much on U.S. commercialization as well as development of our pipeline products, this represents an important step in our efforts to build a foundation for international expansion over the coming years,” CEO Lisa Earnhardt said in a press release.

The company said the German Institute assigned Neue Untersuchungs und Behandlungsmethoden status 1 for its Propel mometasone furoate implants. The NUB Status 1allows for the introduction of new medical products by allowing a limited number of hospitals to receive reimbursement for them.

In October, Intersect ENT said it submitted a supplemental premarket approval application to the FDA to expand the indication on its Propel mini steroid releasing implant to cover frontal sinus surgeries.

The new indication would allow the drug-device combo to be used in the frontal sinuses, located behind the eyebrows, the Menlo Park, Calif.-based company said.

Currently, the Propel is only indicated for placement in the ethmoid sinuses located just behind the bridge of the nose.

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BiO2 Medical drums up $8m from Oxford Finance

Oxford Finance said yesterday it closed an $8 million secured term loan with Angel catheter maker BiO2 Medical, with funds slated to support FDA clearance and an anticipated commercial launch of the catheter in mid-2016.

The Angel catheter is designed to provide access to the central venous system and to trap blood clots before they can reach the lungs, according to the San Antonio, Texas-based company.

“With this equity and venture debt capital secured, we are on the path to commercializing the Angel Catheter in the U.S. We anticipate providing pulmonary embolism prophylaxis to over one million patients who are at high risk of pulmonary embolism and are ineligible for existing venous thromboembolism prevention,” CEO Christopher Banas said in a prepared statement.

This makes the 2nd influx of money to BiO2 Medical this month. Earlier in January, the company said it raised a $9 million Series D round for its Angel catheter, after concluding its pivotal clinical trial a year ahead of schedule.

BiO2 said it also arranged $5 million in venture debt financing from Oxford Finance, with another $3 million due upon winning 510(k) clearance from the FDA for the Angel device. That could happen as soon as the 2nd quarter, BiO2 has said.

The new funds are earmarked for a U.S. launch, boosting the sales force in the U.S. and overseas, “incremental R&D projects” and general infrastructure, the company said.

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Medbio, Inc. expands production capabilities to support continued growth

Medbio, Inc. has expanded its production capabilities with the addition of a new Arburg 470C-165 ton hydraulic molding press with a 5oz shot size. This new machine will add both redundancy and additional capacity to Medbio’s molding capabilities, and will be used for higher volume work.

“Like most of our Arburg machines, this press has cavity-pressure sensing capabilities, using Kistler-brand sensors,” said John Woodhouse, director of sales and marketing at Medbio. “This machine is also equipped with a hydraulic core pull and pneumatic valve gate control, and will have an automated packaging cell.”

The new machine will be operational by January 27th, with the automation equipment scheduled to arrive at the end of February.

Medbio, Inc.
www.medbioinc.com

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ConMed slumps on Q4 earnings release, despite EPS beat

ConMed (NSDQ:CNMD) released its 4th quarter and full year earnings late Wednesday, reporting profits dipping 30% from last year and seeing shares tumble the next day, down nearly 12%.

The Utica, N.Y.-based company reported profits of $7.9 million, or 28¢ per share, on sales of $191 million for the 3 months ended December 31. ConMed saw bottom-line sales slide 30.8% while overall sales dropped 2% compared with Q4 2014, according to the earnings report.

Adjusted to exclude 1-time items, however, earnings per share were 52¢, beating the Street’s expectations by a slim 1¢. Revenue expectations were only marginally off the Street as well.

For the full year, ConMed reported profits of $30.5 million, or $1.10 per share, on sales of $719 million. That amounts to a 5.3% slide on the bottom line while sales shrunk 2.8% compared with its fiscal year 2014.

Even excluding 1-time items, earnings per share shrunk the previous year, with ConMed posting $1.68 for the year, compared to $1.92 in 2014.

Shares drooped in day trading on Thursday, opening at $41.75 and closing nearly 12% down at $36.78.

“We are pleased with our accomplishments during fiscal 2015, particularly the early signs that our turnaround efforts are starting to gain traction. Despite continued headwinds in our export markets, we reversed the trend of top-line deterioration experienced in 2014 and exited 2015 with 2 consecutive quarters of constant currency revenue growth. In addition, gross margin improvement in the 2nd half of the year and lower operating expenses as a result of cost saving initiatives are positive trends we intend to build on entering 2016. Based on progress made in 2015, and with new commercial leadership in place, we are confident in our ability to deliver continued improvement in operational performance in 2016. Our team is committed to capitalizing on the SurgiQuest acquisition, to investing in innovation, and to further enhancing ConMed’s growth opportunities domestically and internationally,” CEO Curt Hartman said in a press release.

ConMed set its 2016 guidance after releasing the earnings, expecting revenue between $760 and $770 million for the year, with expected earnings per share between $1.85 and $1.95.

In the beginning of January, Conmed closed the acquisition of SurgiQuest, which makes the AirSeal device for use in minimally invasive abdominal surgeries.

The $265 million deal, announced just a week after Milford, Conn.-based SurgiQuest filed for a $75 million initial public offering last November, was funded with a $175 million term loan and a $525 million credit revolver.

ConMed said it expects the buyout to add $55 million to $60 million to the top line during fiscal 2016, with net savings of roughly $15 million annually.

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Wright Medical contests $11m hip verdict

Wright Medical (NSDQ:WMGI) yesterday asked a federal judge in Georgia to toss the $11 million verdict from the 1st bellwether trial in the multidistrict litigation filed over its Conserve metal-on-metal hip implant.

An Atlanta jury last year awarded plaintiff Robyn Christiansen $1 million in compensatory damages and another $10 million in punitive damages. The jury found Nov. 24 that the Conserve device was defective and that Wright failed to adequately warn patients about its risks.

The 2-week trial was the 1st of roughly 550 product liability lawsuits filed over the Conserve implant that have been consolidated before Judge William Duffey Jr. of the U.S. District Court for Northern Georgia. The jury, which deliberated for 3 days, initially found that the device was not defectively designed and was not defective when it was sold for implantation in Christiansen.

Yesterday Wright re-submitted a motion for judgment as a matter of law, arguing that Duffey was wrong to re-submit the case to the jury after the 1st verdict came down.

“The court should have dismissed any additional findings by the jury as surplusage and contrary to the instructions on the verdict form and the court’s jury instructions at the end of trial,” Wright argued, according to court documents. “The jury was biased, confused, or both, as reflected by, among other facts, (i) the internal inconsistencies in the original verdict returned on Nov. 20, 2015, (ii) the irreconcilable inconsistencies between the original verdict and 2nd verdict returned on Nov. 24, 2015, and (iii) the jury’s apparent inability to deliberate effectively or follow the court’s instructions.”

As an alternative, should Duffey decline to toss the verdict, he should grant a new trial because the jury ultimately found that Wright proved that the Conserve device could not be made 100% safe and that its benefits outweighed the risks, the company said.

“Plaintiff’s strict liability design defect claim was therefore barred as a matter of law and Wright Medical was entitled to judgment in its favor on plaintiff’s strict liability design defect claim,” Wright argued.

Memphis-based Wright also argued that Duffey erred in his jury instructions when he said the company had to prove that the Conserve device was properly made and had adequate directions and warnings. The negligence finding should also be overturned because the jury didn’t find that Wright failed to use reasonable care.

“There is no legal basis for an award of punitive damages in the verdict returned on November 24, 2015. Punitive damages are not an independent claim under Utah law and can only be awarded in connection with certain claims. As a matter of law, the jury’s finding that Wright Medical made negligent misrepresentations as to the hip replacement components implanted in plaintiff does not support an award of punitive damages under Utah law,” the company averred.

Alternatively, Duffey should strike the punitive damages award because no reasonable jury would have found Wright conduct willful and malicious, intentionally fraudulent or knowingly reckless, the company said. If he declines to toss the punitive award, he should reduce is, Wright said, contending that the 10-to-1 ratio is excessive and contrary to Utah’s 3-to-1 rule.

Christiansen also ought to accept a reduction in the $1 million compensatory damages award because it was “contrary to the overwhelming weight of the evidence, including the parties’ stipulation as to medical expenses, and disproportionate to any injuries suffered by plaintiff,” Wright said.

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Spectral Medical looks to raise $10m

Spectral Medical said it inked a deal for a $10 million stock sale it plans to use to fund a clinical trial.

Toronto-based Spectral makes a system designed to diagnose and remove endotoxin from the bloodstream. The offering involves the purchase of 14.3 million shares at 70¢ apiece by a consortium of underwriters, who plan to then sell the stock to the public.

The company said it plans to use the proceeds  to fund the Euphrates study of its Toraymyxin device and endotoxin active assay, and to commercialize its PMX device.

The Euphrates trial is expected to enroll roughly 446 patients, with a primary endpoint of 28-day mortality. It’s designed to compare the standard of care with treatment using the Toraymyxin device.

The offering includes a 30-day, 2.145-million over-allotment, Spectral said. It’s expected to close Feb 18, according to the company.

Late last year Spectral inked a deal with Fresenius Medical Care to distribute its Endotoxin activity assay devices. to distribute the EAA test and Toraymyxin device in Germany, Denmark, Sweden, Finland, Norway, Poland, Hungary and the Czech Republic.

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Philips, looking to boost health biz, lures Airbus exec Botti

Royal Philips (NYSE:PHG) said today that it named former Airbus (EPA:AIR) executive Jean Botti as chief innovation & strategy officer, effective April 1, in a bid to grow its healthtech division.

Botti, who’s slated to start at the Dutch conglomerate April 1, succeeds Jim Andrew, who stepped down for personal reasons last year, Philips said. Botti has been chief technical officer at Airbus since 2006, following stints at Renault (EPA:RNO) and General Motors (NYSE:GM).

“I am very pleased that Jean Botti has decided to join Philips on our journey to extending our leadership in health technology, capitalizing on opportunities arising from the consumerization and industrialization of healthcare to transform the delivery of care,” CEO Frans van Houten said in prepared remarks. “Jean has had a remarkable and distinguished career and his achievements at Airbus are impressive, ranging from his ability to continually improve the company’s innovation capabilities and building intelligent systems, to embedding quality across the company’s value chain. His track record in driving innovation and change in high-tech industries will prove extremely valuable for Philips.”

“I am excited to join a company that has made it its mission to improve the lives of billions of people every year globally and that has such a strong track record in innovation, advanced technologies and design capabilities,” Botti added. “I am convinced that my experience in the automotive and aviation industries in terms of digital transformation and process optimization will support Philips’ ambitions to drive the personalization and industrialization of care.”

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Bard’s Q4 earnings top estimates

C.R. Bard (NYSE:BCR) yesterday beat the consensus estimate for its 4th-quarter earnings.

Murray Hill, N.J.-based Bard posted profits of $136.3 million, or $1.79 per share, on sales of $870.8 million for the 3 months ended Dec. 31, 2015, for a bottom-line gain of 1.6% on sales growth of 0.4% compared with Q4 2014.

Adjusted to exclude 1-time items, earnings per share were $2.43, 2¢ ahead of expectations on Wall Street.

Full-year profits were $135.4 million, or $1.77 per share, on sales of $3.42 billion, marking a -54.0% profit decline on sales growth of 2.8%. Adjusted EPS came in at $9.08.

“We said a year ago that 2015 was an important year of execution for our strategic investment plan, and we are happy to report that we exceeded expectations for both revenue and adjusted cash earnings per share for every quarter in 2015. We are pleased with the acceleration in our organic revenue growth and profitability; and we remain focused on investing in areas of faster growth with the objective of providing our shareholders with sustainable attractive returns,” chairman & CEO Timothy Ring said in prepared remarks.

Bard said it expects adjusted EPS of $9.90 to $10.05 this year on constant-currency sales growth of 6% to 8%. Analysts on The Street are looking for adjusted EPS of $9.89.

BCR shares closed down -2.7% yesterday at $178.36 each.

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Stealthy GTX Surgery raises $2.1 million for mobile surgical sim

Stealthy mobile developer GTX Surgery raised $2.1 million in a new round of equity financing, according to an SEC filing posted this week.

According to Chicago-based healthcare incubator Matter Chicago, GTX is developing medical simulations using modern video game technologies that will be usable on mobile devices, such as smartphones.

“GTX Surgery rallies communities of medical specialists around cutting-edge surgical simulators that run on the device in your pocket. Utilizing the latest video game technologies, GTX Surgery makes realistic medical simulation available to all medical professionals, regardless of affiliation, location and budget,” Matter Chicago wrote in a post last May announcing that GTX Surgery had joined its incubator community.

GTX Surgery is seeking out Unity gameplay engineers, a popular cross-platform game engine, as well as engine architects, graphics/physics engineers, 3D technical artists and UX designers according to its website, but no other information is listed.

The money came from 4 unnamed investors, according to the SEC filing, and has not yet declared how it plans to spend the newly raised funds.

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MassDevice.com +3 | The top 3 medtech stories for January 28, 2016

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. HeartWare spikes Valtech Cardio deal, settles proxy war

HeartWare International today backed out of its acquisition of Israeli replacement heart valve maker Valtech Cardio and settled a proxy war with activist investor Engaged Capital.

“HeartWare’s decision last fall to acquire Valtech represented a unique opportunity to bring together 2 complementary portfolios for substantial, high-growth markets and create a broad technology pipeline for the treatment of patients with heart failure,” president & CEO Doug Godshall said in prepared remarks. “While we continue to believe Valtech’s portfolio of mitral and tricuspid interventional tools holds tremendous promise, HeartWare finds itself in a different set of circumstances than when we first entered into the agreement.” Read more

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2. Vascular Flow Technologies raises $14.3m

Vascular Flow Technologies said today it raised $14.3 million (£10 million) through multiple rounds of financing to support research & development, strategic joint development and out-licensing agreements with industry partners.

The funding round consisted of 2 tranches; a $10 million (£7 million) loan note restructuring into Series A ordinary preference shares and a $4.3 million (£3 million) Series B financing round led by an undisclosed family office and joined by international and individual angel investors, the company said. Read more

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1. Abbott’s Q4 sales, earnings slide

Abbott today reported 4th-quarter sales and earnings declines but still managed to beat Wall Street’s consensus earnings forecast by a penny.

The Abbott Park, Ill.-based healthcare giant posted profits of $767 million, or 51¢ per share, on sales of $5.19 billion for the 3 months ended Dec. 31, 2015, for a bottom-line slide of -15.2% on a -3.1% sales decline compared with Q4 2014. Read more

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Varian Medical droops on Q1 misses

Varian Medical (NYSE:VAR) saw shares slump after posting Q1 earnings that missed the Street and saw profits and earnings per share shrinking.

The Palo Alto, Calif.-based company reported profits of $89 million, or 92¢ per share, on sales of $757.1 million for the 3 months ended January 1.

That adds up to a 4.6% bottom-line slide while sales grew 2.6% compared with the same period last year.

After adjusting to exclude 1-time items, earnings per share were 99¢, down 2¢ from last year and 13¢ off Wall Street analysts expectations. The Street was looking for $798.2 million in rev, which Varian missed by $41.1 million.

Shares have dropped after the release, sinking approximately 3.6% to trade at 74.92 as of 1:25 p.m. EST.

“Company revenues and earnings came in ahead of expectations for the 1st quarter. Revenue growth was driven by our oncology systems and particle therapy businesses while the imaging components business continued to experience expected pressures on revenues. Our earnings performance was helped by our revenue growth as well as strong SG&A cost controls and an R&D tax credit,” CEO Dow Wilson said in prepared remarks.

Varian released updated outlook for 2016, expecting non-GAAP earnings between $4.55 and $4.65 for the year and $1.06 and $1.10 for the 2nd quarter.

“Including the effects of the R&D tax credit re-enactment and the suspension of the medical device excise tax in the U.S., we now believe that for fiscal year 2016 total company non-GAAP earnings will be in the range of $4.55 to $4.65 per diluted share. We continue to expect that revenues for fiscal year 2016 will increase by about 4 to 5% over fiscal year 2015. For the 2nd quarter of fiscal year 2016, we expect revenues to be up 1 to 2% from the year-ago quarter in dollars. We expect non-GAAP earnings for the 2nd quarter of fiscal year 2016 to be in the range of $1.06 to $1.10 per diluted share,” Wilson said in a press release.

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LabStyle Innovations launching Dario CGM in Q1

LabStyle Innovations Corp. (OTCQB:DRIO) said Tuesday it is launching its Dario blood glucose monitoring system in the 1st quarter of 2016, through both direct-to-consumer sales and online retailers.

Continued commercialization through non-exclusive 3rd party distributers and medical equipment suppliers is expected through Q1 and Q2 of 2016, the company said. The company is working with insurers in hopes of establishing reimbursements.

“The reception we’ve received so far from potential non-exclusive distribution partners including retailers has been overwhelmingly positive. We are building out our U.S. infrastructure and working hard to prepare for launch,” exec veep and North America GM Todd Durniak said in prepared remarks.

The company said it is establishing an east coast North American headquarters and west coast based logistics and warehouse center to handle the launch, expecting to open both in the 1st quarter.

“We look forward to the imminent launch of the Dario in the U.S. and expect to begin shipping product in the current quarter. Entering the world’s largest market for blood glucose monitoring is an important milestone for LabStyle,” CEO Erez Raphael said in a press release.

In late December,  Labstyle Innovations said it won FDA 510(k) clearance for its Dario blood glucose monitoring system, including its blood test strips and the Dario app for Apple (NSDQ:AAPL) iOS devices.

The system is designed to operate around a smartphone and a small glucose meter that communicates with the phone through the audio jack, the company said. The smartphone as a central device is important to the systems functionality and ease of adopting, Durniak told MassDevice.com in an interview in September.

The small plug-in monitor contains everything necessary to take blood glucose readings, which the Dario platform uploads to cloud-based storage where they can be observed, recorded and shared by caretakers, physicians and others, Durniak said.

Israel-based LabStyle Innovations said the Dario blood glucose monitoring system won indications for the “quantitative measurement of glucose in fresh capillary whole blood samples drawn from the finger tips.”

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LabStyle Innovations launching Dario CGM in Q1

LabStyle Innovations Corp. (OTCQB:DRIO) said Tuesday it is launching its Dario blood glucose monitoring system in the 1st quarter of 2016, through both direct-to-consumer sales and online retailers.

Continued commercialization through non-exclusive 3rd party distributers and medical equipment suppliers is expected through Q1 and Q2 of 2016, the company said. The company is working with insurers in hopes of establishing reimbursements.

“The reception we’ve received so far from potential non-exclusive distribution partners including retailers has been overwhelmingly positive. We are building out our U.S. infrastructure and working hard to prepare for launch,” exec veep and North America GM Todd Durniak said in prepared remarks.

The company said it is establishing an east coast North American headquarters and west coast based logistics and warehouse center to handle the launch, expecting to open both in the 1st quarter.

“We look forward to the imminent launch of the Dario in the U.S. and expect to begin shipping product in the current quarter. Entering the world’s largest market for blood glucose monitoring is an important milestone for LabStyle,” CEO Erez Raphael said in a press release.

In late December,  Labstyle Innovations said it won FDA 510(k) clearance for its Dario blood glucose monitoring system, including its blood test strips and the Dario app for Apple (NSDQ:AAPL) iOS devices.

The system is designed to operate around a smartphone and a small glucose meter that communicates with the phone through the audio jack, the company said. The smartphone as a central device is important to the systems functionality and ease of adopting, Durniak told MassDevice.com in an interview in September.

The small plug-in monitor contains everything necessary to take blood glucose readings, which the Dario platform uploads to cloud-based storage where they can be observed, recorded and shared by caretakers, physicians and others, Durniak said.

Israel-based LabStyle Innovations said the Dario blood glucose monitoring system won indications for the “quantitative measurement of glucose in fresh capillary whole blood samples drawn from the finger tips.”

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PE shop Aurora closes Cardiac Science buy

Aurora Capital Group affiliate Aurora Resurgence said today it completed its acquisition of automated external defibrillators Cardiac Sciences assets, concluding its restructuring and purchase.

Waukesha, Wisc.-based Cardiac Science develops, manufactures and markets automated external defibrillators and related accessories, and provides training and services around the devices.

“We are excited to complete this transaction in an expedited time frame, with no disruption to our distribution partners or customers. Our valued partners and customers can expect continued world-class support for their AEDs while we grow the Powerheart AED community of passionate people and organizations committed to saving lives. This is an exciting day for our employees, our customers, and our partners,” Cardiac Science prez Al Ford said in prepared remarks.

“We look forward to a long and successful partnership with the Cardiac Science team. Legislation, demographic trends, and increased awareness continue to drive AED market penetration globally. We believe Cardiac Science is well positioned to capitalize on these trends and further increase its position as an innovative leader in AED deployment,” Aurora Resurgence partner Sean Ozbolt said in a prepared statement.

Earlier this month, the buy was approved by U.S. Bankruptcy Judge Robert Martin, and included a $65 million credit bid and an agreement from Aurora to take on other liabilities including real estate debt, taxes and owed payments.

Though no total value was placed on the transaction, the Milwaukee Business Journal estimated the value at $90 million.

Aurora affiliate CFS 915 bought Cardiac Science’s bank debt through a facilities agreement in September, and removed and replaced existing officers and directors.

The proposed sale of Cardiac to Aurora was met with objections from creditors, including previous officers and employees, accusing the firm of a ‘loan to own’ scheme.

Zoll Medical also opposed the sale, as it wanted its fair chance to pick up the company.

Cardiac Science filed for Chapter 11 in October last year, hoping to restructure debt to speed up its sale, and in the same month filed a motion to seek authorization to pursue the sale.

Previously Opto Circuits (India) Ltd. (BSE:532391) owned Cardiac Science won a $23 million victory over Zoll Medical in a breach of contract lawsuit last May.

A jury in the Los Angeles Superior Court awarded Cardiac Sciences $23.0 million in lost royalties, stemming from a 2002 licensing agreement with LifeCor for patents covering its wearable defibrillator technology. But when Zoll acquired LifeCor in 2006, Cardiac Sciences alleged, Zoll stopped paying the royalties.

Opto Circuits closed its buy of Cardiac Science Corp. (NSDQ:CSCX) in December 2010.

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Fourth-quarter, full-year earnings slide for Getinge

Fourth-quarter and full-year earnings slipped more than -3% for Getinge (PINK:GETI B), the Swedish medtech giant said today.

Göteborg-based Getinge posted profits of $117.4 million (SEK 999 million), or 47¢ per share (SEK 4.02), on sales of $1.11 billion (SEK 9.42 billion) for the 3 months ended Dec. 31, 2015. That’s a -3.1% earnings slide on sales growth of 11.3% compared with Q4 2014.

Full-year profits were $171.2 million (SEK 1.46 billion), or 69¢ per share (SEK 5.83), on sales of $3.55 billion (SEK 30.24 billion), for a -3.0% profit decline on sales growth of 13.4%.

Getinge also said it named Pernille Fabricius as CFO.

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Japan approves Livanova’s Kora 250 MRI-safe pacemaker

LivaNova (NSDQ:LIVN) said today that it won Japanese approval for its Kora 250 MRI-safe pacemaker line.

The Japanese Pharmaceuticals and Medical Devices Agencyapproval for the Kora 250 SR and Kora 250 DR devices covers full-body MRI scans, London-based LivaNova said. The company was formed by the $2.7 billion merger of Sorin Group and Cyberonics last year.

“In collaboration with our established business partner, Japan Lifeline, we are proud to launch our latest generation of full-body MRI conditional pacemakers in Japan where there is a strong demand for MRI compatible medical devices. KORA 250, with its combination of small size, extended longevity and therapeutic solutions, is an ideal solution for Japanese patients and physicians. With this latest launch, LivaNova is aiming to set a new standard in pacing technology in the Japanese market,” cardiac rhythm management president Stefano Di Lullo said in prepared remarks.

Earlier this month, the FDA approved LivaNova’s Perceval sutureless replacement heart valve.

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Hologic dips after posting Q1 earnings beat, revises guidance

Hologic (NSDQ:HOLX) saw shares dip slightly yesterday after posting its fiscal year 2016 Q1 earnings, beating the street across all points and adjusting earnings per share guidance up.

The Marlborough, Mass.-based company reported profits of $84.9 million, or 29¢ per share, on sales of $695.2 million for the 3 months ended December 26.

That amounts to a substantial 190.8% bottom-line gain on sales growth of 6.5% compared with Q1 2014.

Adjusted to exclude 1-time items, earnings per share were 46¢, beating Wall Street analyst expectations of 42¢. The company handily topped revenue expectations of $688.8 million for the quarter.

“We are pleased with our 1st quarter financial results overall. Our U.S. businesses again performed exceptionally well, with double-digit revenue growth. This contributed to improvement in our already strong operating margin, and earnings per share growth at nearly 3 times the rate of revenue,” CEO Steve MacMillan said in a press release.

Hologic saw shares dip despite the beats, dropping approximately 1.8% to close at $35.77 yesterday.

Along with earnings, the company adjusted its guidance for the coming quarter and full FY2016.

Hologic raised its EPS guidance for the year, lifting it from $1.80 – $1.84 to $1.86 – $1.90. Revenue expectations for 2016 got a slight drop, moving to $2.80 – $2.83 billion from its previously listed $2.81 – $2.84 billion.

For the coming quarter, Hologic expects to see revenues between $680 and $690 million, with EPS between 45¢ to 46¢.

“Building on our solid performance in the 1st quarter, we are updating our fiscal 2016 revenue guidance based on a stronger U.S. dollar, but increasing our EPS guidance to reflect greater-than-expected earnings power,” CFO Bob McMahon said in prepared remarks.

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Zimmer Biomet’s Q4 profits plunge

Fourth-quarter profits plunged nearly -81% for Zimmer Biomet (NYSE:ZBH), but the orthopedics giant still managed to beat Wall Street’s earnings expectations by a nickel.

Warsaw, Ind.-based Zimmer Biomet posted profits of $29.7 million, or 14¢ per share, on sales of $1.93 billion for the 3 months ended Dec. 31, 2015. That amounts to a -80.7% bottom-line slide on sales growth of 58.1%, compared with Q4 2014.

Adjusted to exclude 1-time items, earnings per share were $2.09, 5¢ ahead of expectations on The Street.

Full-year profits were $49.7 million, or 26¢ per share, on sales of $6.0 billion, marking a -93.1% profit slide on sales growth of 28.3% compared with 2014. Adjusted EPS were $6.90, missing The Street by 6¢.

“At the close of a transformational year for Zimmer Biomet, we achieved top-line growth supported by sequential improvement from our joint reconstructive and S.E.T. businesses in the U.S. In addition, we finished the year with strong earnings results, as we continued to execute on our global integration plans,” president & CEO David Dvorak said in prepared remarks. “Importantly, the substantial completion of our commercial integration in 2015, combined with the breadth of our musculoskeletal portfolio, positions our sales teams to accelerate our growth as we progress through 2016.”

Zimmer Biomet said it expects to post adjusted EPS of $7.80 to $7.95 on constant-currency sales growth of 1.5% to 2.5%.

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Boston Scientific pairs with Accenture to launch Advantics HF patient care app

Boston Scientific (NYSE:BSX) said today it partnered with Accenture to develop Advantics care pathway transformation, a cloud-based digital health platform for hospitals designed to improve outcomes and reduce cost for treating patients with chronic cardiovascular diseases.

The companies said Advantics is designed to aid healthcare providers in making more informed decisions based on patient population health patterns and data analytics.

“Boston Scientific and Accenture designed this digital health platform to help providers standardize care, reduce overall length of stay and lower readmission rates. The care pathway transformation solution is designed to support healthcare professionals and patients to have more informed relationships, leading to better health outcomes and lower costs for health systems. Together, we are addressing an acute need for some of the most costly chronic conditions,” Boston Scientific CEO Mike Mahoney said in a press release.

The platform will operate around pathway analytics, or how patients move through hospital systems, care management, monitoring how patients are diagnosed, treated and monitored, and patient engagement tracking, examining how patients are educated, monitored and communicated with during and after hospitalization, Boston Scientific said.

“Socio-economic changes are driving the market to move to value-based care, and new data-driven care transformation services are a great enabler of delivering high-quality healthcare at the right cost. Working together with Boston Scientific, we are able to bring to market digital capabilities and analytics-driven insights that focus on improving patient and economic outcomes,” Accenture senior managing director Anne O’Riordan said in prepared remarks.

Currently, the platform has been designed around patients with heart failure, but the companies said they plan to expand it to additional disease states.

During development, the companies worked with Sweden’s Karilinska University Hospital and Finland’s Tampere Heart Hospital to assess “current state of care delivery” for heart failure patients.

“The collaboration with Boston Scientific and Accenture exposed significant opportunities to increase provider collaboration and improve the quality of care that patients experience when coming to our hospital. For example, we identified a 25% unnecessary heart failure readmissions rate, and therefore a definite need for better care coordination, supported by modern technology and processes that can decrease overall costs,” Tampere Heart Hospital CEO Dr. Kari Niemelä said in a prepared statement.

The companies plan to offer the solution to hospitals in the U.K. and Scandanavia, with pilot projects planned for Europe and the U.S.

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Abbott’s Q4 sales, earnings slide

Abbott (NYSE:ABT) today reported 4th-quarter sales and earnings declines but still managed to beat Wall Street’s consensus earnings forecast by a penny.

The Abbott Park, Ill.-based healthcare giant posted profits of $767 million, or 51¢ per share, on sales of $5.19 billion for the 3 months ended Dec. 31, 2015, for a bottom-line slide of -15.2% on a -3.1% sales decline compared with Q4 2014.

But adjusted to exclude 1-time items, earnings per share were 62¢, coming in just ahead of the 61¢ expectation on The Street.

Full-year profits rose 7.2% to $3.26 billion, or $2.92 per share, on sales growth of 0.8% to $20.41 billion, compared with 2014. Adjusted EPS were $2.15, exactly in line with analysts’ consensus forecast.

“In 2015, we achieved top-tier sales and earnings growth despite a challenging currency environment,” chairman & CEO Miles White said in prepared remarks. “Our underlying performance continues to be strong.”

Abbott said it expects to post adjusted EPS of $2.10 to $2.20 this year; 1st-quarter adjusted EPS are pegged at 38¢ to 40¢.

ABT shares slid -5.5% to $38.25 apiece today in early trading.

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Vascular Flow Technologies raises $14.3m

Vascular Flow Technologies said today it raised $14.3 million (£10 million) through multiple rounds of financing to support research & development, strategic joint development and out-licensing agreements with industry partners.

The funding round consisted of 2 tranches; a $10 million (£7 million) loan note restructuring into Series A ordinary preference shares and a $4.3 million (£3 million) Series B financing round led by an undisclosed family office and joined by international and individual angel investors, the company said.

The U.K.-based company will use the funds as it shifts its focus towards operating as a technology transfer business, applying its Spiral Laminar Flow technology to vascular and endovascular devices. VFT said it will support the application through the use of computational fluid dynamics and finite element analysis.

“The realignment of the business supports VFT’s natural evolution from an innovative medical devices company, through to a tech transfer business. The £10 million secured in this investment round will make a significant impact on the transition, and allow us to continue to work with the key players in the sector to apply SLF technology to address unmet clinical needs in vascular and endovascular markets. In addition, the financing will enable us to build further clinical and health economic evidence for SLF technology,” CEO Bill Allan said in a press release.

The SLF technology is designed to replicate natural blood flow and eliminate the turbulent blood flow associated with diseased vessels and standard prosthetic vascular grafts, VFT said. The company has “a number” of clinical trials underway in the U.S. and Europe aiming to examine long-term clinical and economic outcomes of the technology.

The company’s new business model will focus on collaborative work, with current collaborations including work in stents and hemodialysis access catheters.

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HeartWare spikes Valtech Cardio deal, settles proxy war

HeartWare International (NSDQ:HTWR) today backed out of its acquisition of Israeli replacement heart valve maker Valtech Cardio and settled a proxy war with activist investor Engaged Capital.

“HeartWare’s decision last fall to acquire Valtech represented a unique opportunity to bring together 2 complementary portfolios for substantial, high-growth markets and create a broad technology pipeline for the treatment of patients with heart failure,” president & CEO Doug Godshall said in prepared remarks. “While we continue to believe Valtech’s portfolio of mitral and tricuspid interventional tools holds tremendous promise, HeartWare finds itself in a different set of circumstances than when we first entered into the agreement.”

Godshall said Framingham, Mass.-based HeartWare will focus on getting its next-generation MVAD program back on line and pursue a destination therapy indication for its HVAD device. Both are left ventricular assist devices designed to treat patients with heart failure.

“By stepping away from the acquisition, all of our resources will be dedicated to strengthening our existing business to put the company in the best position to take advantage of the significant opportunities within our ventricular assist device portfolio. We recognize from our discussions with shareholders over the past several weeks that they, too, share our enthusiasm for the strength of our core VAD franchise, and we look forward to realizing this value together,” Godshall said. “This decision does not, in any way, reflect a lack of enthusiasm for Valtech or the mitral and tricuspid valve opportunities, and we wish Valtech all the best in advancing their company to the next level.”

The move means HeartWare must make a $30 million convertible promissory note to Valtech.

In a separate release, HeartWare said it settled its beef with activist investor Engaged Capital by agreeing to jointly select an additional independent director for HeartWare’s board and setting up a business strategy committee.

“We have maintained an open dialogue with Engaged Capital over the last several months, and following recent, constructive discussions, we are pleased to have reached an agreement with them,” Godshall said. “We look forward to working collaboratively to select a new, highly qualified, independent director who will bring a complementary perspective and further strengthen our Board of Directors.”

“We are pleased to have reached an amicable resolution with HeartWare following the termination of the Valtech transaction. We appreciate the steps the company has taken today to maintain focus on its core ventricular assist device business,” added Engaged Capital principal & chief investment officer Glenn Welling. “We invested in HeartWare because we are confident in the strength of HeartWare’s core VAD business and in the significant opportunity for growth within the global mechanical circulatory support market. We believe HeartWare’s VAD franchise is significantly undervalued and that additional objective, financial perspectives represented on the Board can help support HeartWare’s efforts to drive growth and enhance shareholder value.”

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2016: The year of diversity in clinical trials

By: Robert M. Califf, M.D.

Controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains for FDA is ensuring that research participants are representative of the patients who will use the medical product.

Moving from the result of a clinical trial to applying it in practice is complex. But it’s generally agreed that the composition of the population enrolled in a trial should help FDA reviewers, clinicians, or policy makers to have confidence that the trial results will apply to future practice.

Furthermore, a wide range of people should have the opportunity to participate in trials, both for access to new therapies and to have the chance to contribute to better treatment of everyone, an important altruistic goal for many Americans.

Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials. A substantial body of literature has documented this under-representation in recent years, particularly for women in some cardiovascular trials and general inclusion of black/African-American and minority participants in clinical trials. In response to these concerns, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, giving FDA direction to evaluate this issue and take action.

FDA has responded in multiple ways, including the creation of Drug Trials Snapshots that give the public readouts of the demographic profile of people participating in clinical trials for approved drugs. While progress has been made, we’ve learned from this program that we still have work to do. An evaluation of the Snapshots since the program began more than a year ago shows that some groups, especially ethnic and racial groups, aren’t always well represented in clinical trials.

These data are critical, because certain groups of patients may respond differently to therapies. For example, studies for a recently approved schizophrenia drug found that one side effect – the urge to move constantly – was seen more often in black/African-American patients. Two important classes of blood pressure drugs were found to work less well in black patients. And a drug for heart failure works very well in black patients but not in white patients. We also have seen labeling changes due to differences in dosing requirements between men and women, such as the recent labeling change with a sleep medication. These few examples show the importance of improving diversity in clinical trials, so medical products are safe and effective for everyone.

Increasing diversity in clinical trials is a priority for FDA. To that end, in 2016, the Agency is planning a variety of activities to push for greater inclusion, including more minority participation. For example:

• FDA’s Office of Minority Health has developed a variety of tools to support clinical trial participation, including collaboration with the National Library of Medicine to help consumers and patients find clinical trials, educational materials on trials, as well as a multi-media campaign highlighting the importance of clinical trial participation. These materials are designed to urge those underrepresented in clinical trials to find out more information, and consider enrolling.
• FDA’s Office of Women’s Health launched its Diverse Women in Clinical Trials initiative. Developed in collaboration with the National Institute of Health’s Office of Research on Women’s Health, this multipronged effort will raise awareness and share best practices about clinical research design, recruitment, and subpopulation analyses.
• Our biostatisticians, trial design experts, and quantitative scientists will continue to work with the research community to develop methods to refine our approach to the conduct and analysis of trials to provide the best estimates of treatment effects for diverse populations.
• We will continue our commitment to include patient advocacy groups to engage patients in clinical trial design, feedback and evaluation from a patient’s perspective. By engaging patients early in the trial design process, feasibility and participation may be improved.
• Finally, our Office of External Affairs plans to publish a consumer update describing what it is like to participate in a clinical trial and encouraging the public to enroll in trials, if possible.

As mentioned above, these activities – and, indeed, the Snapshot program itself – were conceived as part of FDA’s response to Section 907 of FDASIA. This provision directed FDA to conduct an inventory of how well various population groups were being represented in clinical trials of FDA-regulated medical products and whether these data were publicly reported. Once that was done, FDA was directed to develop an action plan, which we published in August 2014. And we’ve been diligently working toward implementation and sustainability ever since.

As you heard from Barb Buch, M.D., Associate Director for Medicine at CBER, earlier this month, the public meeting at the end of next month will continue the dialogue with important stakeholders –like you – to continue this momentum.

And there’s more to come.

We want to make 2016 the year of more diversity in clinical trials. But we can’t do it alone. Stay tuned in the coming months for how we can work together to make this critical goal a reality.

Robert M. Califf, M.D., is FDA’s Deputy Commissioner for Medical Products and Tobacco

 

 

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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Johnson & Johnson to pay $120m in 1st mesh settlement

Johnson & Johnson (NYSE:JNJ) is making the 1st move in settling thousands of lawsuits from women who claim the company’s vaginal-mesh inserts caused organ damage and serious pain, paying $120 million to settle the 1st 2,000 to 3,000 suits, according to Bloomberg.

The company still faces over 40,000 suits related to vaginal meshes, and its unsure how much the company will owe for each case, as average payouts will vary.

“From time to time we have appropriately agreed to resolve some cases. We will not discuss the terms, nor discuss our ongoing litigation strategy,” J&J spokesperson Ernie Knewitz told Bloomberg in an emailed statement.

The settlement is the 1st for J&J and its Ethicon unit, though the company has reportedly set aside an undisclosed reserve for those claims.

J & J faces the most cases of all the medical device companies being charged in the over 100,000 suits, which includes Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR).

Earlier this month, A federal appeals court upheld a $2 million loss for Bard in a product liability lawsuit brought over its Avaulta pelvic mesh.

A jury awarded plaintiff Donna Cisson $250,000 in compensatory damages and $1.75 million in punitive damages back in August 2013, in 1 of the 1st of thousands of federal lawsuits to go to trial over pelvic mesh implants. The devices are designed to treat female urinary incontinence and pelvic organ prolapse.

Earlier in January the FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review.

The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through its pre-market approval process for transvaginal POP procedures. The moves do not apply to mesh used in other indications, including stress urinary incontinence and abdominal POP repair, the FDA said.

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MassDevice.com +3 | The top 3 medtech stories for January 27, 2016

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

 

3. St. Jude Medical’s Q4 profits cut in half

Fourth-quarter profits for St. Jude Medical were off more than 50%, the medical device company said today, as its $3 billion acquisition of Thoratec put a $179 million hit on the bottom line.

Little Canada, Minn.-based St. Jude posted profits of $113 million, or 39¢ per share, on sales of $1.45 billion for the 3 months ended Jan. 2, for a bottom-line slide of -53.9% on sales growth of 0.6%. Read more

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2. Bidding war heats up for Toshiba Medical

A bidding war for Toshiba subsidiary Toshiba Medical is reportedly heating up among a slew of private equity players and rival corporations.

Toshiba, which said last month that it’s seeking outside investors to buy a stake in the healthcare business amid laying off nearly 7,000 workers, wants to focus on its core nuclear energy and chip businesses. Read more

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1. Judge boots Boston Scientific counterfeit mesh case to the FDA

A federal judge booted a purported class-action racketeering lawsuit filed against Boston Scientific, accusing the medical device maker of illegally smuggling counterfeit resin made in China to make pelvic mesh.

The lawsuit was filed Jan. 12 in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse. Read more

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Edwards invests in Fogarty Institute

The Fogarty Institute for Innovation said today it received a grant from Edwards Lifesciences (NYSE:EW) to support its medical technology innovation and Lefteroff Internship programs.

The programs help support next generation life sciences companies by supporting individuals, other programs and early stage ideas, the Institute said.

“We are grateful to Edwards Lifesciences Foundation for their continued support and for sharing our passion to improve patient care. Their funds will help our medical startups continue to develop their innovative technologies, projected to improve and/or save the lives of nearly 10 million people worldwide. They will also help us expand our thriving internship program, which provides invaluable real world, on-the-job experience for young people who are just starting to explore the world of cardiac surgery and medical technology,” Fogarty Institute CEO Ann Fyfe said in a press release.

Edwards has invested approximately $500,000 in the Fogarty Institute’s programs over the years to support future medical innovators, and has operated as the manufacturer for the Fogarty family of vascular products, the Institute said.

“We are excited to partner with the Fogarty Institute to inspire new innovation in medical technology that will help underserved patients. As a convening point for global innovation, the Fogarty Institute is a strong partner for programs that inspire and guide students and startups that will create the next generation of devices seeking to lower healthcare costs and improve patients’ quality of life,” Edwards global corporate giving exec director Amanda Fowler said in prepared remarks.

The Fogarty Institute’s innovation program has hosted and worked with 20 medical device startups and mentored several international companies, with 6 startups successfully spun off to date.

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Natus Medical shares jump on Q4, FY2015 EPS beat

Natus Medical (NSDQ:BABY) saw shares jump slightly after reporting Q4 and FY2015 earnings that beat the Street, with revenue numbers just squeaking under expectations.

Pleasanton, Calif.-based Natus Medical Inc reported profits of $8.5 million, or 26¢ per share, on sales of $100 million for the 3 months ended December 31. That amounts to an 18.3% bottom-line slide as sales grew 6.4%, compared with the same period last year.

Adjusted to exclude 1-time items, profits were up 29.8% from 2014 at $17 million, and earnings per share were 51¢. Analysts on Wall Street were expecting an adjusted EPS of 46¢, 5¢ lower than Natus reported for the quarter.

The company narrowly missed revenue expectations from the street, as they were looking for an extra $100,000 from Natus.

For the year, Natus reported profits of $37.9 million, or $1.14 per share, on sales of $375.9 million.

The company saw a 16.6% bottom-line gain on sales growth of 5.6% compared with its fiscal year 2014.

After excluding 1-time items, net income was $51.4 million and earnings per share were $1.55. Analysts on Wall Street were looking for an adjusted EPS of $1.50, which the company topped by 5¢. Revenue for the year was slightly off Street expectations, looking for $376 million.

Shares today have risen 2.38% in response, trading at $37.83 as of 12:00 p.m. EST.

“2015 was truly a great year for Natus.  4th quarter revenues hit $100 million for the first time in our history and our annual non-GAAP earnings per share grew 23%.  Our profit margins set record levels during the quarter and the full year as we achieved non-GAAP gross margins of 63.9% for the quarter and 62.6% for the year.  Our non-GAAP operating margin was 20.3% during the quarter and 19.0% for the year, clearly exceeding our 2015 annual goal of 18%. As previously announced, the revenue shortfall in the quarter versus our guidance was due to a delay in our Venezuela order. As we enter 2016, I remain extremely optimistic about our new service initiatives: Peloton, GND and NicView.  They all have tremendous revenue and profitability growth potential over the coming years. We also expect organic growth in both our core neurology and newborn care business units giving 2016 the potential to be another exciting year at Natus,” CEO Jim Hawkins said in prepared remarks.

Natus laid out expectations for the next quarter and fiscal year 2016. The company expects revenue between $96.5 and $97.5 million and non-GAAP earnings per share of 34¢ to 35¢ for the 1st quarter of 2016.

For the fiscal year 2016, Natus expects revenue between $445 and $450 million and non-GAAP earnings per share between $1.84 and $1.88.

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Minnetronix raises $20m

Minnetronix said yesterday it raised $20 million in equity capital through a minority investment from Altaris Capital Partners.

The investment marks the 1st time Minnetronix has raised outside equity since its founding 20 years prior.

“Our team at Minnetronix is passionate about improving patients’ lives. We’ve developed technologies large and small through the years and are seeing a growing need for innovative technologies in underserved areas that tend to be overlooked because they aren’t multi-billion dollar markets. We believe this is an important business niche, and the investment by Altaris will help us accelerate our mission to develop and deliver devices that benefit patients and the physicians who care for them. Altaris, which has tremendous experience in building medtech companies, will be a valuable partner to us as we work to grow our proprietary technologies and therapies, including our groundbreaking cerebrospinal fluid treatment platform for treating life-threatening neurological diseases,” CEO Rich Nazarian said in a press release.

Minnetronix develops electronic and electromechanical devices for the medical device industry. The company has developed tech and products for the cardiovascular, oncology, pulmonary, neurology and wound care markets, the St. Paul, Minn.-based company said.

“We are delighted to partner with Minnetronix. We were attracted to Minnetronix’ track record of serving the development and manufacturing needs of its medical device customers, their deep understanding of the medical device industry, and their innovative approach to developing proprietary technologies and products,” Altaris Capital Partners managing director George Aitken-Davies said in prepared remarks.

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Greatbatch wins $37.5m patent infringement suit with AVX

Greatbatch (NYSE:GB) said yesterday it won $37.5 million in damages after a jury in the U.S. District Court for the District of Delaware ruled in its favor during a patent infringement case between Greatbatch and AVX.

Greatbatch filed the patent infringement complaint in April 2013, alleging that AVX infringed on patents related to filtered feedthrough assemblies used in implantable pacemakers and cardioverter defibrillators.

“Greatbatch is committed to challenging willful and deliberate patent infringement and to taking all steps necessary to ensure that our intellectual property is protected. I want to express my sincere appreciation for the time and careful attention the court and the jury gave this important case,” Greatbatch CEO Thomas Hook said in a press release.

With the ruling, the jury upheld the validity of 2 asserted patents, and 2 additional patents that AVX had challenge, Greatbatch said.

In response, AVX said it is reviewing the verdict and “consulting with its legal advisors on what action AVX may take in response,” according to a press release posted today.

Earlier this month, the Patent Trial and Appeal Board said it instituted an inter partes review of a pacemaker patent from Greatbatch, siding with challenger AVX corp that its initial decision overlooked a key argument.

AVX was granted a request for a rehearing from the same 3-judge panel that denied it last August.

The panel stated that the 1st decision was erroneous and that in consideration of the request and expert testimony, it overlooked AVX’s argument for why Greatbatch’s patent is obvious and anticipated.

The board’s rehearing determined that 10 of AVX’s multiple claims would be reviewed and were likely invalid. The board was divided on the case, with dissenting judge Elizabeth Roesel  saying that “the majority errs by relying upon argument and evidence that are not presented in the petition.”

The patent undergoing AIA review, number 7,327,553, is 1 of 5 being examined in a trial between the companies that began Monday in Delaware.

AVX challenged a separate Greatbatch patent in December, but the board ruled that all AVX’s claims were invalid.

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MEPS Real-Time expands staff, headquarters

RFID inventory management company MEPS Real-Time said it is adding to its sales, marketing, product management and engineering team, as well as expanding its Carlsbad, Calif.-based headquarters nearly 40%.

MEPS Real-Time developed and produces the Intelliguard RFID pharmaceutical inventory tracking system, which includes kit and tray management, inventory management and vendor managed inventory systems, the company said.

“Our expansion will help us to better serve the healthcare market, as we work directly with clients to maximize their RFID investment, from kit and tray management, to high-value inventory storage in controlled temperature cabinets. I’m confident our new hires will round out our already impressive team and allow us to meet the growing needs of the market, as well as the high demand for our solutions,” CEO Shariq Hussain said in a press release.

The company said it has appointed new sales directors for the Central, South and Northern U.S. regions, promoted Valerie Fritz to marketing veep and added Paula Dycaico as product management director.

The company said it added senior project engineer and technical support staff positions, and is in the process of recruiting implementation, quality assurance, product management, marketing and software personnel.

This article originally appeared on MassDevice.com’s sister site, Medical Design & Outsourcing.

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Velano Vascular wins FDA nod for new blood draw device

Velano Vascular said today that it won 510(k) clearance from the FDA for a new iteration of its needle-free blood draw device.

San Francisco-based Velano, which raised a $5 million Series A round in February 2015, won its 1st FDA nod for the device last year.

The new clearance covers a pair of modifications to the device aimed at in-patient blood draws: A clamp for use with syringe draws and a revised indication for use that removes a limitation on when the device can be used with in-dwelling peripheral IV catheters, Velano said.

“We rapidly implemented and pursued FDA clearance for these modifications based on input from patients and medical professionals who are using and systematically assessing our blood-draw technology,” co-founder & CEO Eric Stone said in prepared remarks. “These enhancements reflect our customer-centric approach to introducing our technology into medical practice, both in terms of product enhancements and clinical use patterns.”

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Admedus inks exclusive distro deal with Coroneo

Admedus (ASX:AHZ) said today it inked an exclusive distribution agreement with Coroneo to sell its Extra aortic annuloplasty ring ing and other heart valve surgery instruments in Germany and the U.K.

Canada-based Coroneo’s Extra aortic ring is designed to repair aortic valves by supporting dystrophic aortic tissue and a downsized dilated valve annulus to restore proper cusp contact.

“This is a very exciting partnership for Coroneo, as we continue to expand the global reach of our unique products. We believe the Coroneo range is synergistic with CardioCel and Admedus’ work in this space, as we both provide surgeons with specialized implantable devices and instruments to facilitate the repair and reconstruction of dysfunctional heart valves,” Coroneo CEO Anthony Paolitto said in a press release.

Admedus said the Extra aortic ring is complimentary to the company’s own CardioCel bio-scaffolds, which are regenerative tissue patches designed for cardiac and vascular repairs and reconstructions and promote autologous growth. Sales of the Extra aortic ring will operate through Admedus’ existing sales and marketing infrastructure.

“We are very pleased to have signed this agreement with Coroneo as it expands our product portfolio in the cardiovascular space, as well as adding to our ongoing sales growth and generating increased revenue from our existing in-house resources. Admedus is pleased to add additional products into the sales and marketing product portfolio and we will continue to look for further complementary products as the Company continues to grow,” Admedus CEO Lee Rodne said in prepared remarks.

The agreement comes with an option to extend the partnership to other regions outside Germany and the U.K. in the future. The companies will launch Coroneo products in the U.K. and Germany in April this year.

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