Abbott to close $25B St. Jude buy

Abbott (NYSE:ABT) said today that it plans to close its $25 billion buy of St. Jude Medical (NYSE:STJ) next Wednesday, Jan. 4, after receiving all necessary regulatory clearances for the deal.

Abbott touted the acquisition, saying it would position the combined entity to cover “nearly every area” of the cardiovascular market, holding onto the number 1 or 2 positions “across large and high-growth cardiovascular device markets.”

The combined company’s cardiovascular and neuromodulation portfolio has reported annual sales of approximately $8.7 billion, the companies said. Abbott expects the acquisition to be accretive, expecting 21¢ of accretion in 2017 and 29¢ in 2018.

“We continue to deliberately shape our business for long-term success by securing leadership positions in attractive markets and focusing on customer needs. This philosophy has served as the foundation for significant and sustainable value creation for our shareholders. The addition of St. Jude Medical creates one of the broadest medical device portfolios in the world and provides a steady stream of new technologies and therapies for many years to come,” Abbott CEO Miles White said in prepared remarks. “Customers today w ant partners who offer breakthrough technologies along with a broad portfolio of solutions to help them better care for their patients. Our powerful and complementary medical device portfolio and industry-leading new product pipeline will help us be that partner, uniquely positioning us to win in the marketplace.”

Just yesterday, anti-trust regulators in China granted conditional approval to the tie-up.

China’s Ministry of Commerce said the approval is conditioned on the sale of St. Jude’s small vessel closure device business; the companies would have 20 days from the close of their deal to execute the sale of the vascular closure unit and related assets, according to an online translation of the announcement.

Abbott and St. Jude have already arranged to sell off those assets and others to Terumo (TYO:4543) for approximately $1 billion. That deal calls for St. Jude to deal its Angio-Seal and Femoseal vascular closure assets, including a manufacturing plant in Puerto Rico; Abbott is due to divest the Vado steerable sheath it bought with the acquisition of Kalila Medical earlier this year.

The Chinese regulators said their review of that transaction found that the Terumo deal would fix their anti-trust concerns. Earlier this week, their U.S. counterparts agreed when the Federal Trade Commission likewise conditionally approved the deal.

Earlier this month, anti-trust regulators in India cleared the $25 billion tie-up, weeks after regulators in Europe cleared the deal.

Abbott has said it plans to pay for the deal with cash on hand and a $15.1 billion debt offering. The Abbott Park, Ill.-based healthcare giant floated $2.85 billion in 2.35% senior notes due in 2019; $2.85 billion in 2.9% notes due 2021; $1.5 billion in 3.4% notes due 2023; $3.0 billion in 3.75% notes due 2026; $1.65 billion in 4.75% notes due 2036; and $3.25 billion in 4.9% notes due 2046.

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Humacyte launches Phase II trial for artificial bypass graft in PAD

Humacyte said yesterday that it started a phase II trial of its human acellular vessel, Humacyl, as an artificial bypass graft in patients with peripheral arterial disease.

The non-randomized trial is slated to enroll 20 patients over the next year. Humacyl will be surgically implanted above the knee in the legs of PAD patients in the hopes of improving blood circulation. The goal of the study is to evaluate the vessel’s performance in the arterial bypass position and its efficacy at repairing human arterial blood vessels.

The Research Triangle Park, N.C.-based company’s phase II trial follows previous arterial trial surgeries at sites in Poland in 2013 that finished last year.

“The continuation of Humacyl’s Phase II clinical studies as a conduit for blood flow in a patient with Peripheral Arterial Disease marks a major milestone in the field of regenerative medicine,” Humacyte’s chief medical officer Dr. Jeffrey Lawson said in prepared remarks. “We are heartened by the fact that Humacyte is expanding its footprint by leveraging our 1st in class, bioengineered vessel for multiple vascular surgery applications – including patients that undergo hemodialysis and patients with peripheral vascular disease.”

Humacyte’s artificial blood vessel is also being evaluated in a Phase III clinical trial for use in patients with end stage renal disease. The trial enrolled 350 patients who are on hemodialysis and don’t qualify for a standard surgical treatment. In October last year, the company raised $150 million in a Series B financing round to fund the phase III trial.

“Over 8.5 million people in the United States suffer from peripheral arterial disease,” Dr. Michael Belkin, of Brigham and Women’s Hospital, added. “If the results of this clinical trial are positive, then this solution has the potential to serve as a new clinical option for the many patients that face the need for artery bypass surgery each year. We are pleased to be the first medical facility in the United States that is taking part in a key study that may lead to a meaningful impact on patients’ cardiovascular health.”

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BioCardia launches pivotal trial for CardiAmp heart failure treatment

BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S.

The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division.

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

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Nikon’s Optos, Google’s Verily ink deal for machine learning in retinal imaging

Nikon (TYO:7731) subsidiary Optos and Google (NSDQ:GOOG) unit Verily inked a deal this week to develop technologies for machine learning-enabled retinal imaging.

The deal calls for the companies will collaborate on improving the screening for diabetic retinopathy and diabetic macular edema, both among the leading causes of blindness worldwide.

The program combines Nikon’s leadership in optical engineering and precision manufacturing and Verily’s machine-learning technology to help healthcare providers diagnose the conditions, according to a press release.

In February 2015, Nikon paid $400 million to acquire Optos, marking the Japanese camera giant’s 1st foray into the medical sector. Optos is the market leader in retinal imaging and its ultra-widefield technology produces images that cover more than 80% of the retina, which is greater than any other device.

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FDA rejects Amphastar subsidiary’s Primatene Mist asthma inhaler

Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler.

The complete response letter from the federal watchdog told Armstrong Pharmaceuticals that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company conduct another human factor validation study to evaluate consumers’ ability to use the product without the help of a healthcare professional.

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

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Stealthy NeuroVasc Technologies raises $1m

Stealthy NeuroVasc Technologies said yesterday that it raised a $1 million funding round, taking it’s total raise since last year to nearly $2.5 million.

Laguna Hills, Calif.-based NeuroVasc is led by CEO Ev3 veteran Jianlu Ma, according to regulatory filings. According to the LinkedIn page of chairman Jeff Peters, the former Anulex Technologies CEO who’s also an Ev3 alum, NeuroVascular Technologies is developing an interventional neuroradiology technology to treat ischemic stroke.

The $1 million round included 3 unnamed investors, according to 1 of the filings. NeuroVascular Technologies reported raising $1.45 million in November 2015, from 4 unnamed investors.

Blockade Medical CEO David Ferrera, who was listed as a board member in the Nov. 18, 2015, filing, is not listed as a director in the most recent filing. That may be because of the acquisition earlier this year of Blockade by European medtech firm Balt International for an undisclosed amount.

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Apollo Endosurgery, Lpath close reverse merger

Apollo Endosurgery and Lpath (NSDQ:LPTN) said yesterday that they closed a reverse merger in which Apollo put another $29 million into the combined company.

Shares in the new company, which will adopt the Apollo Endosurgery name, are slated to begin trading today on the NASDAQ exchange under the APEN symbol. After a 1-for-5.5-share reverse split, there are about 10.7 million shares on the market, the company said, with Apollo investors owning a roughly 95.9% stake (including the $29 million investment by Apollo affiliates); Lpath owners have a 4.1% share.

“Apollo has an exciting product and technology portfolio from which to advance the interventional treatment of obesity through less invasive procedures. We are grateful for the continued confidence and support of Apollo’s stockholders as we take this next step in the development of our company,” Apollo CEO Todd Newton said in prepared remarks.

Major investors in the $29 million infusion include affiliates of PTV Healthcare Capital, H.I.G. BioHealth Partners, Remeditex Ventures, Novo A/S and CPMG, the companies said when they announced the deal in September.

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Provectus axes CEO Culpepper for expense account violations

Provectus Biopharmaceuticals Inc. (OTCQB:PVCT) said this week that its board of directors voted unanimously to terminate CEO and chief operating officer Peter Culpepper, after an internal investigation revealed that Culpepper violated the company’s expense account reimbursement policy.

The Knoxville, Tenn.-based company said it has established a search committee and is actively seeking a new CEO. In the meantime, Provectus president Timothy Scott will serve as interim CEO.

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

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Abbott’s $25B St. Jude Medical tie-up approved in China

Anti-trust regulators in China today granted conditional approval to the $25 billion tie-up of Abbott (NYSE:ABT) and St. Jude Medical (NYSE:STJ).

China’s Ministry of Commerce said the approval is conditioned on the sale of St. Jude’s small vessel closure device business; the companies would have 20 days from the close of their deal to execute the sale of the vascular closure unit and related assets, according to an online translation of the announcement.

Abbott and St. Jude have already arranged to sell off those assets and others to Terumo (TYO:4543) for approximately $1 billion. That deal calls for St. Jude to deal its Angio-Seal and Femoseal vascular closure assets, including a manufacturing plant in Puerto Rico; Abbott is due to divest the Vado steerable sheath it bought with the acquisition of Kalila Medical earlier this year.

The Chinese regulators said their review of that transaction found that the Terumo deal would fix their anti-trust concerns. Earlier this week, their U.S. counterparts agreed when the Federal Trade Commission likewise conditionally approved the deal.

Earlier this month, anti-trust regulators in India cleared the $25 billion tie-up, weeks after regulators in Europe cleared the deal.

Abbott has said it plans to pay for the deal with cash on hand and a $15.1 billion debt offering. The Abbott Park, Ill.-based healthcare giant floated $2.85 billion in 2.35% senior notes due in 2019; $2.85 billion in 2.9% notes due 2021; $1.5 billion in 3.4% notes due 2023; $3.0 billion in 3.75% notes due 2026; $1.65 billion in 4.75% notes due 2036; and $3.25 billion in 4.9% notes due 2046.

If the deal doesn’t go through by the end of next year, Abbott would have to redeem the 2019, 2023, 2026, 2036 and 2046 notes, but not the 2021 notes at a 101% premium plus interest, according to a regulatory filing.

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The future of cardiac MRI: 3D cine

The heart is a dynamic, beating organ, and until now it has been challenging to fully capture its complexity by magnetic resonance imaging (MRI). In an ideal world, doctors could create a 3-D visual representation of each patient’s unique heart and watch as it pumps, moving through each phase of the cardiac cycle. Andrew Powell, MD, Chief of the Division of Cardiac Imaging at Boston Children’s Hospital, and his physicist colleague Mehdi Hedjazi Moghari, PhD, have taken steps toward realizing this vision: 3D cine.

The standard cardiac MRI includes multiple 2D image slices stacked next to each other that must be carefully positioned  by the MRI technologist based on a patient’s anatomy. Planning the location and angle for the slices requires a highly-knowledgeable operator and takes time.

Powell and Moghari are working on a new MRI-based technology that can produce moving 3D images of the heart. It allows cardiologists and cardiac surgeons to see a patient’s heart from any angle and observe its movement throughout the entire cardiac cycle.

“It’s much easier to appreciate complex anatomy when you can see it in 3D cine instead of integrating lots of 2D slices in your mind,” says Powell.

Read the full post on Vector: The future of cardiac MRI: 3-D cine.

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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MassDevice.com +5 | The top 5 medtech stories for December 29, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.

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5. Alere sues CMS to reinstate its Arriva diabetes unit

Alere yesterday said that it’s suing to force the Centers for Medicare & Medicaid Services to reinstate its Arriva diabetes division’s enrollment, after the government health insurer yanked the accreditation last month over issues with an excess of claims submissions for deceased patients.

Arriva, which develops durable medical equipment for diabetic testing, was informed Oct. 12 that its Medicare enrollment would be revoked by CMS, which said at the time that Arriva submitted claims for 211 deceased patients. Alere attempted to appeal the determination, but the appeal was denied Nov. 2 and the group’s enrollment in CMS was revoked 2 days later. Read more

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4. Gates Foundation puts $140m into $206m round for Intarcia

Intarcia Therapeutics said today that it raised a $206m Series EE round and inked a deal with the Bill & Melinda Gates Foundation to fight HIV in emerging nations.

It’s the 2nd of 3 tranches in an ongoing round for Intarcia, which is developing a drug-delivery platform called Medici, a match-sized osmotic pump designed to be placed under the skin during an in-office procedure. The 1st tranche in September brought in $215 million. Read more

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3. Appeals court resuscitates Infuse lawsuit against Medtronic

A federal appeals court yesterday resuscitated a shareholders lawsuit accusing Medtronic of concealing for nearly 10 years the negative side effects of its Infuse bone growth protein.

The U.S. Court of Appeals for the 8th Circuit said a lower court judge was wrong to find that the plaintiffs sued too late, by waiting more than 2 years after learning of the alleged intent to defraud. The plaintiffs include institutional investors West Virginia Pipe Trades Health & Welfare Fund, Union Asset Management Holding AG and Employees’ Retirement System of Hawaii. Read more

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2. Minerva Surgical raises $16.7m for Aurora endometrial ablation device

Minerva Surgical reported a funding round worth $16.7 million and said it wants to raise $10 million more.

Redwood City, Calif.-based Minerva, founded in 2008, is developing technologies for treatment of abnormal uterine bleeding. Its flagship device is the Aurora endometrial ablation system, which targets and eliminates the endometrial lining in a procedure that takes as little as 4 minutes. The device won pre-market approval from the FDA in July 2015. Read more

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1. Medtronic’s Ev3 wins 2nd appeal in ex-rep’s whistleblower lawsuit

A federal appeals court last week dismissed a whistleblower lawsuit filed by a former sales rep for Medtronic subsidiary Ev3, ruling that the allegations weren’t strong enough to sustain a False Claims Act suit.

Whistleblower Jeffrey D’Agostino in October 2010 filed a qui tam lawsuit alleging that Ev3 violated the FCA by promoting its Onyx hydrogel blood blocker and Axium embolization coil for off-label uses. Judge Richard Stearns of the U.S. District Court for Massachusetts dismissed the suit in September 2014, ruling that D’Agostino failed to produce sufficient evidence to prove his allegations, after denying the plaintiff’s bid to file a 4th amended complaint. Read more

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Femasys raises $40m Series C for FemBloc permanent female contraception device

Femasys said earlier this month that it closed on a Series C round worth $40 million it plans to use on a pivotal trial of its FemBloc permanent female contraception device now that it has FDA approval for the study.

Atlanta-based Femasys said the round was arranged and led by Los Angeles-based investment bank Salem Partners, with “multiple institutional investors, family offices and a multibillion-dollar global medical device company” also contributing.

The company bills FemBloc as a non-surgical procedure that can be performed at the doctor’s office that’s designed to occlude the fallopian tubes.

“We are thrilled with the level of enthusiasm in this oversubscribed round of funding and grateful for the backing from our new and existing investors,” president & CEO Kathy Lee-Sepsick said in prepared remarks. “Their financial investment enables us to conduct and complete the FemBloc clinical plan, which will support our planned premarket approval application, and ultimately, our vision of improving the lives of women by providing access to an ideal permanent contraception solution that is safe and highly effective for women in the U.S. and worldwide.”

Femasys also said that it won an investigational device exemption from the FDA to conduct the pivotal study, it’s 1st clinical trial for the proposed indication for the complete FemBloc system.

“FemBloc is designed to fill the unmet need of a safe, permanent contraceptive method that can be easily implemented since it does not require specialized surgical skills or investment in costly surgical equipment,” clinical affairs vice president Dr. Mimi Zieman said. “This contrasts with current female sterilization options that have the inconvenience and risks associated with surgery and anesthesia for tubal ligation; and for hysteroscopic procedures – the challenge of placing the devices correctly, and concerns with long-term use.”

Femasys said Dechert served as legal counsel, with Baker Botts as investor counsel.

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Japan approves market return for NuVasive’s XLIF spinal fusion

NuVasive Inc. (NSDQ:NUVA) said today that it won approval from the Japanese Ministry of Health, Labor & Welfare for the return of instruments used in its eXtreme lateral interbody fusion procedure to the market in Japan.

San Diego-based NuVasive said instruments and components used in lateral access procedures are Class III devices in Japan, despite the fact that it’s XLIF dilator was originally approved in 2011 as a Class II device (additional sizes were approved in Japan in 2014, the company said). Surgeons there, who halted XLIF procedures while NuVasive sought a reclassification, will be able to resume during the 1st quarter next year, NuVasive said.

NuVasive said it agreed to provide additional training for surgeons with limited experience in XLIF and ensure that procedures are conducted at approved hospitals.

“We’ve worked diligently with the MHLW in obtaining the reclassified clearance for our dilators in Japan,” president & CEOO Jason Hannon said in prepared remarks. “Over 150,000 patients have been treated with XLIF around the world, of which 5,000 operations have taken place in Japan since 2013. As the industry leader in lateral procedures, we take our leadership responsibility seriously and have worked diligently with the MHLW to make XLIF available in Japan again. We thank the MHLW and our surgeon partners in Japan for supporting our efforts in keeping industry-leading innovation available to patients in need.”

NuVasive said it plans to issue its 2017 guidance next month at the annual J.P. Morgan Healthcare Conference in San Francisco.

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Alere sues CMS to reinstate its Arriva diabetes unit

Alere (NYSE:ALR) yesterday said that it’s suing to force the Centers for Medicare & Medicaid Services to reinstate its Arriva diabetes division’s enrollment, after the government health insurer yanked the accreditation last month over issues with an excess of claims submissions for deceased patients.

Arriva, which develops durable medical equipment for diabetic testing, was informed Oct. 12 that its Medicare enrollment would be revoked by CMS, which said at the time that Arriva submitted claims for 211 deceased patients. Alere attempted to appeal the determination, but the appeal was denied Nov. 2 and the group’s enrollment in CMS was revoked 2 days later.

Yesterday Alere said Arriva appealed to the CMS Administrative Law Judge and expects a hearing within 30 days and a decision within 3 months.

“We believe the recent action by CMS to remove Arriva from CMS billing is unlawful, arbitrary and capricious, and harmful to the more than 500,000 patients who depend on Arriva for these critical supplies. Our commitment to patients is unwavering, and because we are confident that this ruling will be overturned, Arriva is continuing to provide patients with the supplies they need as the appeals process proceeds. We are confident that Arriva is in compliance with CMS guidelines and look forward to an expeditious and favorable outcome for both Arriva and the hundreds of thousands of patients who depend on us. The number of purported instances cited by CMS is de minimis relative to the nearly 5.8 million total claims filed by Arriva during that same period,” the company said in a prepared statement.

Alere said it also filed a federal lawsuit to force CMS to stay the process and reinstate its billing number while its ALJ appeal is heard. A decision on Arriva’s motion to enjoin is expected by Jan. 5, 2017, the company said.

Alere has said that the 211 claims allegedly made for dead people made up less than 0.003% of its 5.7 million filed claims.

The Waltham, Mass.-based company is set to be acquired by Abbott (NYSE:ABT), but the $5.8 billion deal, announced in February, soon ran into trouble. A March 11 subpoena from the U.S. Justice Dept. sought documents on Alere’s dealings with 3rd-party distributors and foreign healthcare officials and the company was late in filing its full-year results for 2015.

Alere in April rejected a $50 million offer from Abbott to spike the merger and a few months later sued Abbott, looking to force its would-be acquirer to obtain all antitrust approvals required to complete the acquisition. In early September, Delaware Chancery Court Judge Sam Glasscock put the lawsuit on the fast track and urged the companies to try and talk things out; an attempt at mediation failed later that month.

And earlier this month, Abbott filed a lawsuit seeking to terminate the buyout, citing a “substantial loss in Alere’s value.”

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Gates Foundation puts $140m into $206m round for Intarcia

Intarcia Therapeutics said today that it raised a $206m Series EE round and inked a deal with the Bill & Melinda Gates Foundation to fight HIV in emerging nations.

It’s the 2nd of 3 tranches in an ongoing round for Intarcia, which is developing a drug-delivery platform called Medici, a match-sized osmotic pump designed to be placed under the skin during an in-office procedure. The 1st tranche in September brought in $215 million.

The Gates Foundation contributed some $140 million to the most recent round, Cambridge, Mass.-based Intarcia said; the 3rd round is slated to close during the 1st quarter next year.

“Thanks to tremendous financing progress, an even stronger shareholder base, our recent NDA submission in Type II diabetes, and now a groundbreaking relationship with the Bill & Melinda Gates Foundation, Intarcia is poised to open up a totally new category of important once- or twice-yearly treatment and prevention therapies for some of the world’s most serious chronic diseases − including those that disproportionately affect people with some of the greatest unmet needs,” chairman, president & CEO Kurt Graves said in prepared remarks. “Over the last 5 years, we have successfully brought to life the vision and promise of our disruptive Medici technology platform, and an expanding pipeline of novel therapeutics. With Medici, and each of our new once- or twice-yearly therapies, we’re aiming to solve some of the biggest unmet needs in the treatment and prevention of major chronic diseases that impact millions and millions of lives every day.

“We look forward to working with health and regulatory authorities in preparing to bring our 1st investigational medicine to patients with Type II diabetes next year. With our new strategic initiative in HIV prevention, we are also tremendously excited and humbled to work with an incredible organization as smart, forward-looking and purpose-based as the Bill & Melinda Gates Foundation,” Graves said.

Intarcia said the Gates investment involves an initial $50 million contribution for the HIV project, with another $90 million on the table in non-dilutive grants pegged to milestones for the program.

“There’s a vital need for an HIV/AIDS intervention that allows those at risk to incorporate prevention more easily into their daily lives. We feel optimistic about our partnership with Intarcia and the prospect of an implantable prophylactic device that could make a world of difference for people most in need,” added Gates Foundation CEO Sue Desmond-Hellmann.

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Appeals court resuscitates Infuse lawsuit against Medtronic

A federal appeals court yesterday resuscitated a shareholders lawsuit accusing Medtronic (NYSE:MDT) of concealing for nearly 10 years the negative side effects of its Infuse bone growth protein.

The U.S. Court of Appeals for the 8th Circuit said a lower court judge was wrong to find that the plaintiffs sued too late, by waiting more than 2 years after learning of the alleged intent to defraud. The plaintiffs include institutional investors West Virginia Pipe Trades Health & Welfare Fund, Union Asset Management Holding AG and Employees’ Retirement System of Hawaii.

The suit alleges that Medtronic executives misled investors about Infuse’s commercial prospects and safety profile; the complaint also alleges that Hawkins misled analysts about the prospects of a planned follow-on product called Amplify. The plaintiffs claim that investors bought Medtronic shares based on the misrepresentations and were subsequently injured when the stock dropped after Infuse’s safety issues came to light.

Approved in 2002 for use in spinal fusion surgery, Infuse at 1 point had annual sales of nearly $1 billion. The bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems. Medtronic has been accused of not only downplaying the product’s risks but also promoting it for off-label use.

Writing for the 8th Circuit’s 3-judge bench, Judge Raymond Gruender said it was not until a Spine Journal issue was published in June 2011 that reasonable shareholders might have inferred that problems with the company’s Infuse studies indicated an intent to defraud. Gruender also wrote that shareholders properly alleged that they relied on Medtronic’s alleged misconduct.

“Medtronic’s purported conduct would not merely assist or enable the physician-authors to deceive the market. Rather, Medtronic’s alleged conduct would deceive the market with the assistance of the physician-authors. A company cannot instruct individuals to take a certain action, pay to induce them to do it, and then claim any causal connection is too remote when they follow through. In this way, Medtronic’s alleged manipulative conduct directly caused the biased clinical trial results that the market relied upon,” he wrote.

Medtronic agreed to settle another shareholder lawsuit for $85 million in March 2012.

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Minerva Surgical raises $16.7m for Aurora endometrial ablation device

Minerva Surgical reported a funding round worth $16.7 million and said it wants to raise $10 million more.

Redwood City, Calif.-based Minerva, founded in 2008, is developing technologies for treatment of abnormal uterine bleeding. Its flagship device is the Aurora endometrial ablation system, which targets and eliminates the endometrial lining in a procedure that takes as little as 4 minutes. The device won pre-market approval from the FDA in July 2015.

According to a regulatory filing, Minerva raised its latest funding from 18 unnamed investors beginning Dec. 16. The company raised about $25.6 million in a prior round back in 2014 and added another $15 million early this year. The company has raised nearly $114 million since its inception, according to regulatory filings.

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Medtronic’s Ev3 wins 2nd appeal in ex-rep’s whistleblower lawsuit

A federal appeals court last week dismissed a whistleblower lawsuit filed by a former sales rep for Medtronic (NYSE:MDT) subsidiary Ev3, ruling that the allegations weren’t strong enough to sustain a False Claims Act suit.

Whistleblower Jeffrey D’Agostino in October 2010 filed a qui tam lawsuit alleging that Ev3 violated the FCA by promoting its Onyx hydrogel blood blocker and Axium embolization coil for off-label uses. Judge Richard Stearns of the U.S. District Court for Massachusetts dismissed the suit in September 2014, ruling that D’Agostino failed to produce sufficient evidence to prove his allegations, after denying the plaintiff’s bid to file a 4th amended complaint.

“While the [complaint] specifies 2 adverse incidents attributed to Onyx, any identification of the surgeons or facility involved is missing, any description of a monetary loss to the government is omitted, and there is no allegation that a claim for payment (false or otherwise) was presented to any government payer as a result of either of the alleged incidents,” Stearns wrote. “The conclusory allegation that ‘hundreds’ of similar incidents must have occurred and that some of these must have cost the government money is illustrative of the kind of opportunistic pleading that [Massachusetts law] is designed to prevent. Moreover, D’Agostino’s theory that ‘every claim paid by the government which involved the use of Onyx violated the FCA’ fits precisely in the legal-argument-disguised-as-fact category that the 1st Circuit flatly rejected.”

The U.S. Court of Appeals for the 1st Circuit revived the case in 2015 on the grounds that Stearns’ review of the 4th amended complaint move was to strict. But Stearns again found that the allegations fell short of the FCA’s pleading standards. D’Agostino appealed again, but the 1st Circuit affirmed Stearns, effectively putting an end to the case.

“The fact that [the Centers for Medicare & Medicaid Services] has not denied reimbursement for Onyx in the wake of D’Agostino’s allegations casts serious doubt on the materiality of the fraudulent representations that D’Agostino alleges,” Judge William Kayatta Jr. wrote for the 3-member appeals bench. “In any event, even if the alleged fraudulent representations were material as defined by the FCA, the elements of D’Agostino’s fraudulent inducement claims include not just materiality but also causation; the defendant’s conduct must cause the government to make a payment or to forfeit money owed.”

Similarly, Kayatta wrote, the FDA’s inaction on the Onyx and Axium products spiked D’Agostino’s claims.

“If the FDA would have approved Onyx notwithstanding the alleged fraudulent representations, then the connection between those representations to the FDA and a payment by CMS relying on FDA approval disappears,” he wrote. “The FDA’s failure actually to withdraw its approval of Onyx in the face of D’Agostino’s allegations precludes D’Agostino from resting his claims on a contention that the FDA’s approval was fraudulently obtained. To rule otherwise would be to turn the FCA into a tool with which a jury of 6 people could retroactively eliminate the value of FDA approval and effectively require that a product largely be withdrawn from the market even when the FDA itself sees no reason to do so.”

Covidien paid $2.6 million for vEv3 in July 2010; Medtronic acquired the assets when it bought Covidien for $50 billion in January 2015.

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NeuroMetrix raises $7m in private placement of preferred stocks, warrants

NeuroMetrix (NSDQ:NURO) said today that it entered into a definitive securities purchase agreement with an undisclosed investor for a private offering of 7,000 shares of Series E convertible preferred stock at $1,000 apiece, as well as warrants to purchase 10 million shares of common stock at an exercise price of ¢70 per share. The warrants will expire 5 years after the initial exercise date.

The Waltham, Mass-based company said it expects to receive $7 million in gross proceeds from the offering and that it will use the money to commercialize its over-the-counter wearable device for chronic pain relief.

NeuroMetrix also said it will not complete the public offering of units it made earlier in December, due to feedback from the Nasdaq stock market.

The company had previously expected to raise $26.5 million and planned to spend nearly $20 million from the offering to redeem 19,450 shares of Series D convertible preferred stock. NeuroMetrix also anticipated that it would retire 25 million warrants to purchase outstanding common stock.

In November, the company won CE Mark approval in the European Union for its Quell wearable pain relief device. NeuroMetrix pointed to recent studies that claimed 20-40% of adult Europeans suffer from chronic pain, costing the region $250 billion each year.

The company launched a pilot study of its device in September to evaluate Quell as a treatment for patients with fibromyalgia. NeuroMetrix is partnering with the Synovation medical group to conduct the study, according to the company.

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FDA warns batteries in medical carts associated with fires, explosions

The FDA issued a warning today to healthcare professionals regarding the safety hazards associated with battery-powered mobile medical carts. The federal watchdog said it has received numerous reports of hospital fires and explosions due to overheated equipment. Mobile medical carts, such as crash carts and medication dispensing carts, usually use high capacity lithium or lead acid batteries which last for many hours.

“Battery-powered mobile medical carts are used because of their convenience and utility. FDA has received medical device reports of hospital fires and other health hazards associated with batteries used in mobile medical carts and their chargers,” the FDA wrote. “These events, which range from smoke production and overheating to equipment fires and explosion, can occur with lithium, lead acid, and other types of batteries. Such hazards may result in equipment and facility damage, hospital evacuation or patient and staff injury.”

The organization wrote that it in several reports, firefighters had to bury mobile medical cart batteries to extinguish a fire because lithium battery fires are difficult to put out.

If a fire occurs, the FDA recommends that the healthcare professional immediately report the fire, unplug the cart and safely get it away from patients.

The FDA also said that healthcare professionals should regularly inspect batteries for signs of damage and vacuum to remove dust and lint around battery chargers. Keeping chargers or charging carts in confined spaces is not recommended, according to the federal watchdog.

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MassDevice.com +5 | The top 5 medtech stories for December 28, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. Precision Spine wins FDA 510(k) for AccuFit lateral plate system

Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability.

The Parsippany, N.J.-based company’s AccuFit lateral plate system consists of non-sterile, single use rigid plates designed to attach to the lateral portions of the vertebral body of the thoracolumbar spine with bone screws. Read more

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4. MiMedx enters legal spat with 2 former sales reps

MiMedx this month released information on lawsuits filed against and by the company involving 2 former sales reps.

The Marietta, Ga.-based company said it terminated the employees after finding that they had sold other company’s products “in violation of their contractual and common law duties to MiMedx.” Read more

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3. Endologix puts hold on AFX shipments over manufacturing issues

Endologix said today it is temporarily holding shipments of its AFX Endovascular abdominal aortic aneurysm system as it completes an investigation of manufacturing issues with the devices.

The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company. Read more

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2. Neovasc granted stay as it appeals $70m CardiAQ loss

Neovasc said today it won a stay of judgement as it looks to appeal a $70 million loss to mitral valve rival and Edwards Lifesciences subsidiary CardiAQ Valve.

The stay from the US District Court for the District of Massachusetts restricts CardiAQ from enforcing the money judgement “pending the outcome of the appeal,” the company said. Read more

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1. Abbott wins US antitrust approval for $25B St. Jude buy

The US Federal Trade Commission today granted approval to Abbott to complete its proposed $25 billion acquisition of St. Jude Medical.

The approval came with a caveat that the companies divest themselves of 2 cardiovascular medical device businesses – vascular closure devices and “steerable” sheaths. Read more

The post MassDevice.com +5 | The top 5 medtech stories for December 28, 2016 appeared first on MassDevice.

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Researchers develop nanodiscs to deliver personalized cancer therapy

Researchers from the University of Michigan have developed nanodiscs that deliver a customized therapeutic vaccine to treat colon and melanoma cancer in mice. The team’s work was published in Nature Materials.

“We are basically educating the immune system with these nanodiscs so that immune cells can attack cancer cells in a personalized manner,” senior author James Moon said in prepared remarks.

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

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OneMedNet, Vida Diagnostics partner to develop image sharing for pulmonologists

OneMedNet Corp. said today that it landed a collaboration deal with Vida Diagnostics Inc., to develop an image exchange and data sharing solution for diagnostic and therapeutic procedural workflows for pulmonologists.

According to the agreement, Vida will make an embedded VidaExchange data sharing solution using its VidaVision software and OneMedNet’s Beam network. The goal of the collaboration is to provide pulmonologists and other healthcare professionals with a mechanism to share images and studies for precision analysis.

“Precision healthcare requires precision informatics. We are delighted to be teaming up with OneMedNet to simplify pulmonologists’ access to advanced imaging analysis,” VIDA’s chief operating officer Sandra Stapleton said in prepared remarks. “The partnership enables integrated and streamlined procedural workflows, essential for higher-value precision care.”

The collaboration will extend to North America, Europe, and Australia, according to the companies.

“Our companies share an overlapping healthcare vision and our complimentary solutions blend seamlessly together, which certainly make for an ideal relationship,” OneMedNet’s VP of operations Catherine Forrester added. “We are pleased to expand our successful partnership program with yet another industry segment leader.”

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IntelGenx, Endo Ventures ink development and commercialization deal

IntelGenx (OTCQX:IGXT) said today that it inked a development and commercialization deal with pharmaceutical company Endo Ventures. According to the agreement, the 2 companies will develop a new product using IntelGenx’s VersaFilm drug delivery technology to bring to the market in the U.S.

Endo will have certain exclusive rights to market and sell the product in the U.S. and pay IntelGenx in upfront payments and future milestone payments of undisclosed amounts. Both companies will share the profits made from commercializing the product.

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

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NanoVibronix lands Health Canada nod for patch-based wound healing device

NanoVibronix (NSDQ:NVBXU) said today that it won approval from Health Canada to sell its WoundShield device in Canada. The Elmsford, N.Y.-based company has also won CE mark approval for the device in the European Union.

The WoundShield system is a patch-based ultrasound device that increases local capillary perfusion and tissue oxygenation to facilitate soft tissue regeneration, according to NanoVibronix. The company’s device uses low-frequency ultrasound waves to accelerate wound healing, prevent biofilms from forming and disrupt bacteria colonization.

NanoVibronix’s portfolio of devices, including WoundShield and PainShield, can be administered at home without the help of a medical professional.

“We are very pleased with Health Canada’s approval to sell the WoundShield in Canada,” CEO Brian Murphy said in prepared remarks. “We believe that the Canadian market represents an attractive opportunity for our WoundShield  system with more than 280 thousand patients suffering from persistent wounds, while diabetic foot ulcers are estimated to affect 25 percent of patients with diabetes. With chronic wounds affecting 5.7 million patients in the U.S., the total global wound device market is expected to reach $20 billion in 2016. WoundShield has also received a CE Mark for marketing clearance in Europe, where we are focusing on new sales and marketing initiatives. We will also pursue the necessary approvals to commence marketing in the U.S. Our strategy for selling WoundShield in the U.S. and Canada is to find a strong partner in the wound care market.”

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MiMedx touts Aetna reimbursement win for EpiFix implant

MiMedx (NSDQ:MDXG) said today that it won coverage from Aetna Inc. for its EpiFix allograft effective December 23rd. The insurance company classified EpiFix as “medically necessary” for the treatment of partial and full-thickness neuropathic diabetic foot ulcers when used in combination with standard diabetic ulcer care.

The non-viable cellular amniotic membrane allograft helps to regenerate soft tissue by delivering extracellular matris proteins, growth factors and other proteins found in amniotic tissue, according to MiMedx.

“We are very pleased to have received coverage from Aetna and with the significant progress we have made in gaining coverage for our allografts from both the commercial, as well as the federal and state payers,” chairman & CEO Parker Petit said in prepared remarks. “We believe we have substantial opportunities ahead as we continue to grow our advanced wound care products and broaden the other therapies and market sectors we serve with our allografts. Gaining coverage from all commercial payers has been a critical strategy for MiMedx. From our viewpoint, attainment of EpiFix coverage for the vast majority of the commercial covered lives has been a significant contributor to the success we have experienced in achieving and exceeding our growth projections.”

“The clinical efficacy and cost effectiveness of tissues and products are heavily scrutinized by the commercial health plans. It is clear to us that the evidence demonstrating that our allografts benefit their members clinically, as well as provide more cost effective care, has been a significant factor in our success in attaining coverage awards from insurers,” president & chief operating officer Bill Taylor added. “We know the positive clinical and economic impact our allografts have on their covered populations, and we are always pleased when health plans come to this same conclusion.”

This month, the Marietta, Ga.-based company published information about lawsuits filed against and by the company involving 2 former sales reps. The employees were terminated after MiMedx found they had sold other company’s products, violating their contracts. After the company fired the sales reps, MiMedx filed suits related to breaches in contract and the 2 employees soon returned fire, alleging that the company engaged in fraudulent business practices.

MiMedx said yesterday that preliminary findings of an investigation determined that the allegations against the company are “without merit”.

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Sanofi sues Nordisk over Tresiba marketing claims in U.S.

Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S. pharmacy benefit manager CVS Caremark in January and that patients should switch to Nordisk’s Tresiba.

CVS is replacing both Sanofi’s and Nordisk’s drugs with Eli Lilly’s Basaglar on its standard formulary, but Sanofi said that many health plans don’t follow CVS’s standard list and even those that do will probably continue to cover the company’s drugs.

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

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Biogen, Ionis win FDA approval for first spinal muscular atrophy drug

Biogen (NSDQ:BIIB) said last week that it won FDA approval for its spinal muscular atrophy treatment, Spinraza. The drug is the 1st treatment approved in the U.S. for spinal muscular atrophy, a progressive and often fatal genetic disease that causes muscle weakness in infants and toddlers.

The FDA previously granted Biogen’s application fast track designation and priority review, and Spinraza also received orphan drug designation.

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

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Managing medical device cybersecurity in the postmarket: At the crossroads of cyber-safety and advancing technology

By:  Suzanne B. Schwartz, M.D., M.B.A.

Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan.

Today, we’re pleased to announce that industry now has advice from FDA across this product continuum with the release of a final guidance on the postmarket management of medical device cybersecurity. It joins an earlier final guidance on medical device premarket cybersecurity issued in October 2014.

To understand why such guidance is so important for patients, caregivers and the medical device community, we need to take a step back and look at how cybersecurity fits into the medical device ecosystem.

In today’s world of medical devices that are connected to a hospital’s network or even a patient’s own Internet service at home, we see significant technological advances in patient care and, at the same time, an increase in the risk of cybersecurity breaches that could affect a device’s performance and functionality.

The best way to combat these threats is for manufacturers to consider cybersecurity throughout the total product lifecycle of a device. In other words, manufacturers should build in cybersecurity controls when they design and develop the device to assure proper device performance in the face of cyber threats, and then they should continuously monitor and address cybersecurity concerns once the device is on the market and being used by patients.

Today’s postmarket guidance recognizes today’s reality – cybersecurity threats are real, ever-present,  and continuously changing. In fact, hospital networks experience constant attempts of intrusion and attack, which can pose a threat to patient safety. And as hackers become more sophisticated, these cybersecurity risks will evolve.

With this guidance, we now have an outline of steps the FDA recommends manufacturers take to remain vigilant and continually address the cybersecurity risks of marketed medical devices. Central to these recommendations is FDA’s belief that medical device manufacturers should implement a structured and comprehensive program to manage cybersecurity risks. This means manufacturers  should, among other things:

• Have a way to monitor and detect cybersecurity vulnerabilities in their devices
• Understand, assess and detect the level of risk a vulnerability poses to patient safety
• Establish a process for working with cybersecurity researchers and other stakeholders to receive information about potential vulnerabilities (known as a “coordinated vulnerability disclosure policy”)
• Deploy mitigations (e.g., software patches) to address cybersecurity issues early, before they can be exploited and cause harm

This approach enables manufacturers to focus on continuous quality improvement, which is essential to ensuring the safety and effectiveness of medical devices at all stages in the device’s lifecycle.

In addition, it is paramount for manufacturers and stakeholders across the entire ecosystem to consider applying the National Institute of Standards and Technology’s (NIST) core principles for improving critical infrastructure cybersecurity: to identify, protect, detect, respond and recover. It is only through application of these guiding principles, executed alongside best practices such as coordinated vulnerability disclosure, that will allow us all to navigate this uncharted territory of evolving risks to device security.

This is clearly not the end of what FDA will do to address cybersecurity. We will continue to work with all medical device cybersecurity stakeholders to monitor, identify and address threats, and intend to adjust our guidance or issue new guidance, as needed.

Digital connections power great innovation—and medical device cybersecurity must keep pace with that innovation. The same innovations and features that improve health care can increase cybersecurity risks. This is why we need all stakeholders in the medical device ecosystem to collaborate to simultaneously address innovation and cybersecurity. We’ve made great strides but we know that cybersecurity threats are capable of evolving at the same pace as innovation, and therefore, more work must be done.

Learn More

For more information about medical device cybersecurity, visit the FDA’s Center for Devices and Radiological Health web page.

Suzanne B. Schwartz, M.D., M.B.A., is FDA’s Associate Director for Science and Strategic Partnerships, at the Center for Devices and Radiological Health

 

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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Z-Medica inks 3-year $3m QuickClot supply deal with NYPD

Hemostatic device developer Z-Medica said today it inked a 3 year, $2.7 million deal to supply the New York City Police department with QuickClot belt trauma kits.

The QuickClot belt trauma kit contains the company’s QuickClot combat gauze, a tourniquet, compression bandage and gloves for controlling bleeding in emergency situations, the Wallingford, Conn.-based company said.

“Our products have been battlefield tested and deployed with active military personnel in war zones for years. In the United States, QuikClot has become a standard product now used by law enforcement, emergency services and hospitals,” prez & CEO Stephen Fanning said in a press release.

Z-Medica touted the deal as the “largest standardization of advanced bleeding control kits ever deployed by a single city,” and expects training and deployment of the kits in early 2017.

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Neovasc granted stay as it appeals $70m CardiAQ loss

Neovasc (NSDQ:NVCN) said today it won a stay of judgement as it looks to appeal a $70 million loss to mitral valve rival and Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve.

The stay from the US District Court for the District of Massachusetts restricts CardiAQ from enforcing the money judgement “pending the outcome of the appeal,” the company said.

“‎Having this stay in place will allow our team to continue to advance both our Tiara and Reducer products and help patients in need. “‎2017 is shaping up to be an exciting time, with important clinical and development milestones expected throughout the year,” CEO Alexei Marko said in a press release.

As part of the stay, Neovasc said it will deposit $70 million into a joint escrow account and enter into a general security agreement related to remaining damages.

The company said it is “preparing to appeal the validity of the award” and the ruling on inventorship, and said the appellate process could take approximately a year to complete.

A Massachusetts federal jury in May awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device. Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014.

Last month, Neovasc narrowly avoided an investor lawsuit related to the loss. The $70 million ruling in May pushed NVCN shares down some -75% and prompted shareholder Sergio Grobler to file a purported class action lawsuit against Neovasc on behalf of Neovasc stock owners who bought from Neovasc’s January 2015 initial public offering to the date of the May 19 verdict. (The judge overseeing the CardiAQ Valve suit against Neovasc later added $21 million in damages for willfulness).

Neovasc moved to have the investor lawsuit dismissed, arguing that its statements that the CardiAQ Valve lawsuit was baseless and without merit were forward-looking and thus protected by the “safe harbor” created by the The Private Securities Litigation Reform Act of 1995.

Judge Richard Stearns of the U.S. District Court for Massachusetts agreed, finding that statements by Neovasc in regulatory filings, and by executives during earnings calls, were protected by the safe harbor provision.

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Endologix puts hold on AFX shipments over manufacturing issues

Endologix (NSDQ:ELGX) said today it is temporarily holding shipments of its AFX Endovascular abdominal aortic aneurysm system as it completes an investigation of manufacturing issues with the devices.

The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company.

The hold came only weeks after Endologix had the CE Mark approval for the AFX system suspended over reports of type III endoleaks associated with a previous-gen version of the device.

The Irvine, Calif.-based company expects the temporary hold to be lifted for some sizes “in the near future,” according to a press release.

“The temporary hold on AFX is not related to any reported events from physicians and we continue to see very good commercial clinical results with the latest versions of AFX and AFX2. The manufacturing issue was identified through our on-going product testing and we are proactively implementing the hold to ensure we always provide the safest possible products for patients. We believe we will be able to lift the hold on some sizes in the near future, with the timing for the remaining sizes dependent on the outcome of our investigation. In addition, the AFX manufacturing issue is unrelated to the manufacturing process for Nellix and Ovation, which continue to be available in approved markets,” CEO John McDermott said in a press release.

The company said it implemented “device and graft material improvements and updated instructions for use resulting in a substantial reduction in reported type III endoleaks.”

Endologix said it has received no reports of type III endoleaks with its next-gen AFX2 system, and anticipates reinstatement of CE Mark approval in the European Union for its AFX and AFX2 in January, 2017.

The company also said it will “share this information and additional background on improvements” to the systems in a letter to physicians during January.

Last month, Endologix saw shares dip approximately 25% after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms.

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Abbott wins US antitrust approval for $25B St. Jude buy

The US Federal Trade Commission today granted approval to Abbott (NYSE:ABT) to complete its proposed $25 billion acquisition of St. Jude Medical (NYSE:STJ).

The approval came with a caveat that the companies divest themselves of 2 cardiovascular medical device businesses – vascular closure devices and “steerable” sheaths.

The hurdle shouldn’t be too difficult for the companies, who have already arranged to sell off those specific cardiovascular assets to Terumo (TYO:4543) for approximately $1 billion.

The FTC said the divestiture would be required to keep the acquisition from causing “significant harm to competition in these 2 markets.”

The agency further ordered Abbott to notify it if it acquired lesion-assessing ablation catheter assets from Advanced Cardiac Therapeutics. Only St. Jude and 1 other company produce such technology, the FTC warned, and an acquisition of a new developer in the field could further eliminate additional competition.

The commission said its consent agreement on the matter will be open to public comment for 30 days before it decides whether or not to make it final.

Earlier this month, anti-trust regulators in India cleared the $25 billion tie-up.

In a Dec. 16 Twitter message, the Competition Committee of India said it “approves proposed combination between St Jude Medical and Abbott Laboratories; subject to voluntary remedies.”

Although the exact “voluntary remedies” required by CCI weren’t made clear, last month the European Commission’s decision on the deal required the divestiture of a pair of device lines: St. Jude must deal its Angio-Seal and Femoseal vascular closure assets, including a manufacturing plant in Puerto Rico, and Abbott must deal the Vado steerable sheath it bought with the acquisition of Kalila Medical earlier this year. Both assetts are slated to go to Terumo in their $1 billion deal.

The Indian approval came a handful of weeks after regulators in Europe cleared the deal.

Abbott has said it plans to pay for the deal with cash on hand and a $15.1 billion debt offering. The Abbott Park, Ill.-based healthcare giant floated $2.85 billion in 2.35% senior notes due in 2019; $2.85 billion in 2.9% notes due 2021; $1.5 billion in 3.4% notes due 2023; $3.0 billion in 3.75% notes due 2026; $1.65 billion in 4.75% notes due 2036; and $3.25 billion in 4.9% notes due 2046.

If the deal doesn’t go through by the end of next year, Abbott would have to redeem the 2019, 2023, 2026, 2036 and 2046 notes, but not the 2021 notes at a 101% premium plus interest, according to a regulatory filing.

Material from Reuters was used in this report.

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Precision Spine wins FDA 510(k) for AccuFit lateral plate system

Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability.

The Parsippany, N.J.-based company’s AccuFit lateral plate system consists of non-sterile, single use rigid plates designed to attach to the lateral portions of the vertebral body of the thoracolumbar spine with bone screws.

“As a system that utilizes a lateral approach, AccuFit helps bring about a full range of operative and postoperative benefits designed to optimize patient outcomes,” system developer Dr. Andrew Cappuccino said in prepared remarks.

The device is now indicated for use through a lateral or anterolateral surgical approach either above the bifurcation of the great vessels to treat thoracic and thoracolumbar spine instability, or through the anterior surgical approach below the bifurcation of the great vessels to treat lumbar and lumbarsacral spine instability.

“The AccuFit Lateral Plate System is an important addition to our growing portfolio of devices for use in the lateral approach to spine surgery and is designed to be used in conjunction with our MD-Vue Lateral Access System. The MD-Vue System is the only lateral retractor that offers a unique and patented nested 3-blade design, which prevents blade creep during insertion. Together, these lateral devices provide surgeons with a safe, reproducible approach designed to decrease OR time, shorten costly hospital stays and achieve efficient, positive patient outcomes,” COO Chris DeNicola said in a press release.

In September, Precision Spine said it won FDA 510(k) clearance for its its reform modular and hydroxyapatite coated pedicle screw systems.

The modular screw system is designed with a cobalt chrome tulip and proximal tapered triple lead thread designed to enhance pull-out strength and increase visibility, the company said.

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MassDevice.com +5 | The top 5 medtech stories for December 27, 2016

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. FDA approves Alcon’s AcrySof IQ ReStor intraocular lens

Novartis‘ eye care business, Alcon, said today that it won FDA approval for its AcrySof IQ ReStor multifocal toric intraocular lens. The lens treats presbyopia and pre-existing corneal astigmatism in adult patients undergoing cataract surgery.

The AcrySof IQ ReStor intraocular lens is already commercially available in the E.U., Australia, Canada, parts of Central and South America and Asia. Read more

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4. AtriCure warns on tip detachment risk with Cobra Fusion cardiac ablation device

AtriCure in September warned doctors of the risk that the tip of its Cobra Fusion cardiac ablation catheter could dislodge and separate from the device.

The Cobra Fusion device is designed to deliver both bipolar and monopolar energy to the ablation site. The device also uses suction to gently pulls tissue out of the path of circulating blood to eliminate the heat sink effect during both modalities, according to AtriCure’s website. Read more

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3. Cardinal Health pays $44 to settle DoJ case

Cardinal Health said today it reached a settlement with the US Department of Justice, paying $44 million to clear up civil penalties related to a 2012 case with the US Drug Enforcement Agency.

With the settlement, the company said that all related governmental organizations “have agreed to take no further administrative or civil action on these and related matters.” Read more

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2. Stryker’s Concentric Medical wins Class II FDA label for Trevo clot retrieval devices

The FDA announced it has relabelled Stryker subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II.

Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA. Read more

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1. EnteroMedics readies 1-for-70 reverse split

EnteroMedics said that its board declared a 1-for-70 reverse stock split effective Dec. 28, as part of the company’s plan to regain compliance with the NASDAQ exchange’s $1.00 minimum bid price.

ETRM shares closed at 49.2¢ apiece yesterday, down -0.8%. The stock was down another -1.2% today in pre-market trading to -48.6¢. Read more

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