Integra LifeSciences completes purchase of J&J’s Codman Neurosurgery

Integra LifeSciences, Codman NeuroIntegra LifeSciences (Nasdaq: IART) has completed its previously announced $1.045 billion purchase of Johnson & Johnson’s Codman Neurosurgery business, the companies announced today.

“The addition of Codman Neurosurgery expands our global leadership position by creating one of the broadest medical device portfolios in the neurosurgery market,” Peter Arduini, Integra’s president and CEO, said in a news release.

“Our planned investments in product innovation and global infrastructure will allow us to provide more healthcare solutions to surgeons and their patients worldwide,” Arduini said.

Integra in coming days will complete a previously announced $48 million divestiture of certain neurosurgery assets to Natus Medical (Nasdaq: BABY) that it needed to make to in order for the Codman buy to pass muster with the U.S. Federal Trade Commission and the National Markets and Competition Commission of Spain. The divestiture includes Integra’s global Camino ICP monitoring product line, U.S. rights relating to Integra’s fixed pressure shunts, and U.S. rights to Codman’s Duraform, standard EVD catheters and CSF collection systems.

“The Codman acquisition is transformational to Integra and creates significant long-term growth opportunities for our entire company,” Arduini said.

Johnson & Johnson (NYSE: JNJ) meanwhile said it remains dedicated to ischemic and hemorrhagic stroke treatment through its newly launched Cerenovus platform.

The post Integra LifeSciences completes purchase of J&J’s Codman Neurosurgery appeared first on MassDevice.

Novo Nordisk wins FDA nod for fast-acting mealtime insulin

NordiskNovo Nordisk (NYSE:NVO) said today that the FDA approved its Fiasp insulin aspart injection.

The fast-acting mealtime insulin is designed to improve glycemic control for adults with Type I and Type II diabetes. The injection can be taken at the start of a meal or within 20 minutes after starting a meal, Novo Nordisk reported.

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

The post Novo Nordisk wins FDA nod for fast-acting mealtime insulin appeared first on MassDevice.

EU launches full-scale probe into $54B Essilor-Luxotica merger

Luxottica, EssilorThe European Commission plans to investigate whether the €46 billion merger of Luxottica (NYSE:LUX) and Essilor (EPA:EI) could drive competitors away from the market or hike prices, according to Reuters.

The companies hold high-ranking positions in the ophthalmic lens and eyewear industries. Earlier this month, Luxottica and Essilor decided not to offer concessions in a preliminary review by antitrust authorities.

The agency said it plans to decide whether to clear the deal or not by February next year, but the two companies said they hope to close the merger at the end of this year.

“Both companies … will closely cooperate with the European Commission to fully demonstrate the rationale of the proposed combination,” they said in a joint statement, Reuters reported.

One concern that antitrust authorities have is that the merged company might encourage opticians to buy eyewear and lenses in packages. The Commission wants to ensure that Luxottica’s rivals have access to the lens market and Essilor’s rivals have access to the frames market.

“The final outcome will hinge to a large extent on concessions the two companies make to offset any foreclosure risks,” Luciano Di Via, head of antitrust affairs for Italy, told the newswire.

“Usually in situations such as this, behavioural remedies are requested, the commission may demand commitments from the two companies in terms of commercial practices, a request to sell certain assets is more unlikely.”

“Half of Europeans wear glasses and almost all of us will need vision correction one day,” European Competition Commissioner Margrethe Vestager told Reuters.

“We need to carefully assess whether the proposed merger would lead to higher prices or reduced choices for opticians and ultimately consumers.”

The merger is still waiting for clearance in the U.S., but it has been approved in India, Japan and New Zealand.

($1 = 0.8490 euros)

Material from Reuters was used in this report.

The post EU launches full-scale probe into $54B Essilor-Luxotica merger appeared first on MassDevice.

UPDATE: Abbott plans to close $5B Alere buyout next week

Abbott to acquire AlereUPDATED Sept. 29, 2017, with U.S. Justice Dept. news.

Abbott (NYSE:ABT) said today that it plans to close its once star-crossed merger with Alere (NYSE:ALR) next week, after U.S. and Canadian anti-trust regulators yesterday approved the deal subject to concessions.

Abbott agreed to divest a blood gas testing system to Siemens (NYSE:SI), which also agreed to buy two Alere facilities in Ottawa. Quidel (NSDQ:QDEL) Corp. is slated to buy Abbott’s heart function testing system business and an Alere facility in San Diego.

Abbott offered to acquire Alere in February 2016. After several snafus, the company finally agreed to purchase Alere for $5.3 billion – down from its initial $5.8 billion price tag. The deal is now slated to close Oct. 3, Abbott said.

“Creating the world’s leading point of care business will help Abbott meet the growing demand for fast, accurate and actionable information,” diagnostic products EVP Brian Blaser said in prepared remarks. “Combined with Abbott’s existing point-of-care business and its leading hand-held platform, i-Stat, we now have the broadest point of care testing portfolio to help improve care for patients in more parts of the world.”

Abbott said the Alere buyout should take its diagnostics revenues to about $7 billion annually.

Alere yesterday agreed to pay more than $13 million to settle SEC charges that it committed accounting fraud; today the Waltham, Mass.-based company said the U.S. Justice Dept. closed its probe into Alere’s dealings with third-party distributors and foreign healthcare officials without taking any action against Alere.

“We are pleased that this matter has been closed with no action taken against Alere,” the company said.

The post UPDATE: Abbott plans to close $5B Alere buyout next week appeared first on MassDevice.

KKR puts another $35m into Signostics parent company EchoNous

Signostics UscanPrivate equity giant KKR (NYSE:KKR) put another $235 million into EchoNous, the parent company of Signostics, for the second time in as many years.

The cash is earmarked for commercializing the Uscan ultrasound device, developing a vein-location device and an unnamed artificial intelligence-driven ultrasound project to market, Seattle-based EchoNous said. KKR put $35 million into the company back in November 2015.

“KKR has been a strong partner since our first investment round together, so we are very pleased to receive additional support from them as we build a world-class company dedicated to solving everyday problems in health care by fusing machine learning and miniaturized ultrasound,” EchoNous CEO Kevin Goodwin said in prepared remarks. “We are confident that with KKR’s continued investment, we will accelerate Uscan’s market share in hospitals across the country, bringing a series of highly innovative, intelligent and unique health care tools to those who need them.”

“EchoNous is approaching ultrasound with a unique, AI-driven focus that we believe will revolutionize the way this technology is used in patient care,” added chairman & KKR healthcare director Justin Sabet-Peyman. “The rapid adoption of Uscan demonstrates the company’s ability to execute on its innovative approach to ultrasound technologies, and we are excited about its ongoing development of new intelligent devices to improve health care.”

Back in 2015 Signostics said it planned to use the original $35 million to fuel its R&D program and pay for expanding its worldwide commercial footprint. The company’s Sonimage P3 won 510(k) clearance from the FDA in 2013; a new product is on tap for 2016, and Signostics said at the time that it was planning “a series of breakout advancements in ultrasound technology.”

Signostics drafted Goodwin in April 2015, following SonoSite’s $1 billion acquisition by Fujifilm Holdings (TSE:4901). The company said it shifted its corporate domicile and headquarters from Clovelly Park, Australia, to Kirkland, Wash., before consummating the deal with KKR.

The post KKR puts another $35m into Signostics parent company EchoNous appeared first on MassDevice.

Appeals court upholds Boston Scientific win over stent pioneer Jang

Boston ScientificA federal appeals court today upheld a Boston Scientific (NYSE:BSX) win over coronary stent pioneer Dr. David Jang.

The case dates back to 1999, when Jang won approval from the U.S. Patent & Trademark Office for a stent design featuring lateral struts. In 2002, Jang inked a deal worth up to $160 million to license the patents to Marlborough, Mass.-based Boston Scientific; Jang received $50 million up front, according to court documents, but only $10 million of the remaining $110 million in milestone payments.

Jang sued in 2005, alleging breach of contract and other claims. Boston Scientific filed a counterclaim in 2006 “denying any obligation to make additional contingent payments to Jang on the ground that that the accused stents did not infringe,” and thus were not covered under the deal with Jang, according to the documents.

Judge Virginia Phillips of the U.S. District Court for Central California initially ruled that the Boston Scientific stents did not infringe the Jang patents, shot down the breach of contract claim and decided the other claims in Boston’s favor. After Jang appealed, the Federal Circuit in 2012 vacated the ruling and remanded it to Phillips.

A Patent Office re-examination in 2013 found the Jang patents invalid, prompting Boston Scientific to argue that it shouldn’t be required to pay royalties on invalid patents. Phillips denied that bid for summary judgment, ruling that Jang has the right to demand royalties covering the time up until Boston Scientific asked for the re-examination, according to the documents. Boston appealed, asking the Federal Circuit to review the Phillips decision; the appeals court in September 2014 declined to hear the petition. At trial the jury sent up a split verdict, finding that Boston Scientific did not literally infringe the Jang patents but did infringe under the doctrine of equivalents. Phillips found in 2015 that Jang’s claims covered previous patents, triggering an ensnarement defense barring a patentee from asserting a scope of equivalency that would encompass, or ensnare, the prior art.

Jang moved for judgment as a matter of law on the jury’s finding of no literal infringement, but Phillips found enough evidence to support the verdict and rejected Jang’s bid for a new trial. Jang appealed that decision, arguing that a reasonable jury couldn’t have found no literal infringement because the undisputed facts showed otherwise and Boston Scientific’s non-infringement arguments were legally erroneous.

Today the U.S. Court of Appeals for the Federal Circuit upheld Phillips’ ruling, according to the documents.

The jury heard Dr. Jang’s theory of infringement and his supporting evidence but nevertheless found that the Express stent did not literally infringe. The district court did not fail to consider Dr. Jang’s theory of infringement and it correctly found substantial evidence to support the jury’s finding that the Express stent’s microelements do not literally meet the connecting-strut-column-related limitations,” the appeals court found. “Dr. Jang failed to persuade the district court that BSC’s non-infringement arguments were legally erroneous. We are similarly unpersuaded.”

The post Appeals court upholds Boston Scientific win over stent pioneer Jang appeared first on MassDevice.

Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem

Bigfoot BiomedicalBigfoot Biomedical‘s chief executive is excited about Abbott‘s (NYSE:ABT) latest regulatory win – and it’s not just because the two companies have an established partnership.

Yesterday, the FDA approved Abbott’s FreeStyle Libre Flash continuous glucose monitoring system. It’s the first device of its kind, allowing patients to track their blood glucose levels without the use of routine finger sticks.

“It’s a tremendous demonstration that the FDA understands the value of factory calibration and making usage of a sensor simpler and easier,” Bigfoot CEO Jeffrey Brewer told Drug Delivery Business News.

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

The post Why Bigfoot Biomedical’s CEO thinks the diabetes industry has a data problem appeared first on MassDevice.

Biolase seeks up to $12m with rights offering

BiolaseBiolase (NSDQ:BIOL) said today that it’s hoping to raise up to $12 million with a rights offering that’s already guaranteed to bring in $6 million.

The Irvine, Calif.-based dental laser maker said it hopes the offering will bring in at least $8 million, noting that affiliates of Larry Feinberg and Jack Schuler have each pledged to at least $3 million apiece. The exact pricing and number of shares involved have not been determined.

Last month Biolase posted a 134% increase in second-quarter net losses, which reach -$8.3 million, or -12¢ per share, on a -8.7% sales decline to $12.6 million compared with Q2 2016.

The post Biolase seeks up to $12m with rights offering appeared first on MassDevice.

Leerink fund raises $313m for HIT plays

Leerink Transformation PartnersA fund backed by investment bank Leerink Partners raised $313 million for investments in the health information technology sector.

Boston-based Leerink Transformation Partners said its first fund was significantly oversubscribed compared with the $250 million it initially sought to raise. Co-founder Todd Cozzens is a medical device industry veteran and former Sequoia Capital partner; Dr. Jared Kesselheim, a internist, spent 8 years at Bain Capital Ventures.

“We are distinctly positioned to help the best healthcare IT and services companies and their leaders accelerate their growth because of our differentiated backgrounds as founders, operators, clinicians, and investors,” Cozzens said in prepared remarks.

“We built a fund entirely focused on healthcare IT and services because of two key transformative tailwinds: The rapid adoption of information technology and the $3 trillion reimbursement shift underway from fee-for-service medicine toward value-based care,” Kesselheim added. “These drivers have created an unprecedented opportunity for disruption in a massive market whose complexity is best addressed by a fund with 100% sector focus.”

The inaugural fund also manages a $28 million pool, the Massachusetts Innovation Catalyst Fund, a $28 million fund, for backing Massachusetts-based companies.

“Massachusetts is home to some of the top hospitals and biopharmaceutical companies in the world and has abundant software engineering talent, so it is a natural geography to excel in developing healthcare IT businesses,” Kesselheim said. “We’re thrilled to build great local relationships and contribute to the Massachusetts healthcare ecosystem with the MICF.”

The post Leerink fund raises $313m for HIT plays appeared first on MassDevice.

LivaNova mulls sale for CRM biz

LivaNova (NSDQ:LIVN) said today that it’s considering a sale for its cardiac rhythm management business, tapping Barclays to shop the $250 million operation to potential buyers.

“As part of our ongoing efforts to position LivaNova for long-term success, we are sharpening our focus on the company’s areas of strength and market leadership. To that end, we are exploring options to realize the full value of the CRM Business Franchise,” CEO Damien McDonald said in prepare remarks. “The CRM business franchise is a global business and strong regional player with attractive assets, a robust pipeline and growth potential; however, it is no longer a strategic fit within LivaNova’s portfolio. The board and executive leadership team are committed to driving value for shareholders and customers and will continue to take actions that strengthen LivaNova’s position as a leading, innovative medical device company dedicated to extending and improving the lives of patients around the world.”

LivaNova’s CRM business put up sales of $249.1 million last year, the company said, adding that “there can be no assurances that the process of exploring strategic options for the CRM business franchise to maximize shareholder value will result in a transaction or that any transaction will be consummated.”

“The company has not set a timeline for completion of the review process, and it does not intend to disclose further developments unless or until a definitive decision has been reached by the company or the company has otherwise determined that further disclosure is appropriate or required,” LivaNova said.

LivaNova was formed by the $2.7 billion merger of Italy’s Sorin and Cyberonics in October 2015.

The post LivaNova mulls sale for CRM biz appeared first on MassDevice.