Researchers from the University of Utah and the University of Washington have developed self-assembling nanocages that are packaged within cell membranes and exported to travel from cell to cell, delivering therapeutics. The team’s work was published in Nature.

The drug delivery system is inspired by a mechanism used by viruses to spread their infectious materials among cells in a host’s body.”We’re shifting our perception from viruses as pathogens, to viruses as inspiration for new tools,” co-senior author Wesley Sundquist said in prepared remarks. Adding specific genetic code from viruses to the nanocages enabled them to undock from 1 cell, travel to another and dock there to empty its contents.

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

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BMP Medical today announced that it is the 1st plastics injection molding company to meet MedAccred guidelines and receive accreditation from the industry-managed supply chain accreditation program.

MedAccred’s accreditation program was created to enhance medical device quality and improve patient safety, BMP Medical said. The program requires that companies meet process-specific technical audit criteria and incorporate industry standards and best practices, along with OEM requirements.

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

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Researchers from Duke University have reconfigured the popular drug-delivery polymer, polyethylene glycol, to sidestep dangerous immune responses that have previously halted clinical trials at Duke. The team’s work was published in Nature Biomedical Engineering.

Polyethylene glycol, PEG, is a polymer that is found in toothpaste and cosmetics, but is often used in pharmaceuticals. It can be attached to active drugs in the bloodstream, thus slowing the body’s ability to clear them and lengthening the duration that the drug can be useful.

But because this polymer is so widely used, many people have developed antibodies to the polymer, which can cause allergic reactions when the PEG-modified drugs are introduced to the body. The team at Duke created an modified version of PEG that can avoid recognition by antibodies.

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

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Agilent Technologies (NYSE:A) said yesterday it opened a new $14.7 million technology center in Folsom, Calif.

The new 53,000 facility will add an additional 60 staff, the Santa Clara, Calif.-based company said, and will be adjacent to the company’s current facilities at 91 Blue Ravine Road.

“I am extremely pleased to see the completion of this additional space. This new facility expands Agilent’s capabilities for chromatography consumables and hardware, which are used in laboratories around the world and for critical health, safety and product quality decisions,” order fulfillment & supply chain prez Henrik Ancher-Jensen said in a press release.

The newly opened center will support the company’s Intuvo 9000 GC gas chromatography system, and will also include a customer applications laboratory and collaboration space as well as facilities for the company’s scientific consumables and supplies.

“We have always looked to Agilent for innovations that will allow those of us in the analytical laboratory to become more productive, to become more efficient and to provide higher quality data,” ESC Lab Sciences Corp prez Johnny Mitchell said in a prepared statement.

In September, Agilent said it priced a $300 million public offering of senior notes, with proceeds slated to repay its revolving credit facility.

The company said it looked to run offering under an automatic shelf registration statement, with notes set to mature in September 2026 at an annual interest rate of 3.05%.

Proceeds from the round are slated to repay amounts outstanding under its revolving credit facility and for general corporate purposes, according to a company press release. BNP Paribas Securities Corp, Citigroup Global Markets Inc. and Credit Suisse Securities LLC will act as joint book-running managers for the offer.

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Fisher & Paykel Healthcare (NZE:FPH) said last Friday that a German court overturned preliminary injunctions granted to ResMed (NYSE:RMD) in a patent infringement case filed in August.

With the overturned injunction, Fisher & Paykel said it has resumed sales of its Simplus full face mask, Eson nasal mask and Eson 2, which San Diego-based ResMed claimed infringed on its patents.

Fisher & Paykel shares have jumped on the news, rising 6.2% to close at $8.72. The company had previously lost more than 21% since ResMed filed legal action on August 18.

“We are pleased with the outcome of the first two hearings in these patent dispute proceedings and we remain confident in regards to future proceedings,” Fisher & Paykel CEO Lewis Gradon said in a press release.

Fisher & Paykel initiated the hostilities with an August 15 lawsuit in a California federal court, alleging that ResMed’s AirSense 10 and AirCurve 10 flow generators, ClimateLineAir heated air tubing and Swift mask line infringe 11 of its patents. The Auckland, N.Z.-based company moved to withdraw that suit the next day, but reserved the right to sue again, according to documents filed with the U.S. District Court for Central California.

On August 18, ResMed announced a responding barrage, with actions filed in another California federal court, plus Germany, New Zealand and the ITC. The lawsuit filed in the U.S. District Court for Southern California alleges that Fisher & Paykel’s Simplus full face mask, Eson nasal mask and Eson 2 nasal mask infringe 4 of ResMed’s patents and asks the court to invalidate its Down Under rival’s patents, find that it’s not infringing, or both.

ResMed sought an injunction from the ITC banning Fisher & Paykel from importing the allegedly infringing devices and claimed a win in Germany. The Munich District Court granted ResMed’s bid for a pair of preliminary injunctions stopping the sale of the Simplus, Eson and Eson 2 devices. In New Zealand the company is seekingto halt the manufacture and exportation of the devices, ResMed said.

Material from Reuters was used in this report.

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Skyline Medical said yesterday it closed a $2 million offering, with funds slated to support general corporate purposes.

The funds were raised through the sale of 756,999 units of common stock at $2.62 per share and 5-year warrants for 756,999 shares exercisable at 6 months at $4.46 per share.

Net proceeds from the round are expected to be $1.7 million, according to a press release. Dawson James Securities acted as the placement agent for the offering.

Last month, Skyline Medical said it won Health Canada approval for its Streamway medical fluid disposal device, launching it and its associated accessories in the region.

The Streamway System is an automated direct-to-drain medical fluid disposal system, the Minneapolis, Minn.-based company said.

Skyline Medical said that “a number of distributors” have shown interest in selling the Streamway in Canada, and that the company is currently in talks with them. The company expects to reach a deal within the coming weeks to distribute the product across 1,500 hospitals in all 13 Canadian provinces.

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A federal jury in Dallas today ordered Johnson & Johnson (NYSE:JNJ) and its subsidiary DePuy Orthopedics to pay more than $1 billion to 6 plaintiffs claiming to be injured by its Pinnacle metal-on-metal hip implants, according to the plaintiffs lawyers.

Jurors in the case found that the metal-on-metal pinnacle hip implants were designed defectively and that the companies failed to appropriately warn patients of the risks associated with the devices.

Plaintiffs in the case, 6 California residents implanted with the Pinnacle devices, claimed they experienced tissue death, bone erosion and other injuries as a result of the design flaws. The individuals also claimed that the devices were promoted as longer laster than ceramic or plastic material devices.

J&J and its DePuy Orthopedics subsidiary are facing approximately 8,400 lawsuits over the Pinnacle hip devices, with test cases being selected for trial. The outcomes of the test cases will help determine the remaining claims.

In July, J&J and DePuy Orthopedics asked a federal appeals court this week to expedite the appeal of its $151 million loss in a product liability lawsuit brought over its Pinnacle metal-on-metal hip implant.

In March, a Texas federal jury slapped DePuy Orthopaedics with a $500 million judgment in favor of a quintet of plaintiffs who blamed the Pinnacle implant for their injuries. After a 2-month trial, jurors found that the Ultamet metal-on-metal version of the Pinnacle hips were defectively designed and that DePuy failed to warn patients about the risks, awarding $130 million in total compensatory damages and $360 million in punitive damages. DePuy won the 1st bellwether trial in the MDL, in October 2014. The judge in the case in July slashed the award to roughly $151 million.

J&J’s bid for a stay was denied by Judge Ed Kinkeade of the U.S. District Court for Northern Texas, but the appeals court has yet to decide on a similar request. Johnson & Johnson also sought to delay a 3rd bellwether trial slated to commence in September.

In a July 12 filing with the U.S. Court of Appeals for the 5th Circuit, the company asked that court to speed its review of the appeal and asked that the 5 cases be consolidated into a single appeal.

In overturning the $500 million award in the 2nd bellwether, Kinkeade said he was compelled to reduce the verdict under a Texas state law limiting punitive damages according to a specific formula. Kinkeade also ruled that DePuy can’t delay the 3rd bellwether in the Pinnacle MDL; the company had asked the judge to give it enough time to appeal a $500 million jury verdict in the 2nd bellwether. DePuy wanted Kinkeade to pause the 3rd bellwether while the the U.S. Court of Appeals for the 5th Circuit considers its petition for a writ of mandamus.

Material from Reuters was used in this report.

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By Stewart Eisenhart, Emergo Group

For a second time, Brazilian medical device regulator ANVISA has extended a compliance deadline pertaining to INMETRO electronic safety certification for some medical device manufacturers.

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Boston Scientific (NYSE:BSX) and Neovasc (NSDQ:NVCN) announced a $75 million deal today for the Neovasc biological tissue business that makes components for Boston Scientific’s Lotus replacement heart valve.

The deal, slated to close by the end of the year, also includes a 15% stake in Neovasc, the companies said. Boston Scientific agreed to put up $67.9 million for the biotissue assets and to buy some 11.8 million shares of NVCN stock at 60¢ apiece, for a total of $7.1 million, Neovasc said.

The deal also gives Vancouver-based Neovasc a license to the biotissue assets and access to the plant used to make it so it can sell product to existing customers and use it in its own Tiara replacement heart valve program. That company said it plans to spend the cash on general corporate purposes, likely including its $91 million legal loss to EW subsidiary CardiAQ Valve.

The acquisition is not expected to affect Boston Scientific’s earnings in 2016 or 2017, the Marlborough, Mass.-based company said.

“We continually seek ways to optimize our manufacturing processes and enhance our product portfolio,” operations EVP Ed Mackey said in prepared remarks. “The vertically integrated operational capabilities resulting from this acquisition will strengthen our structural heart pipeline and immediately benefit our Lotus valve platform as we work to increase our market share in Europe and prepare for launch in the U.S., expected in late 2017.”

“Boston Scientific has been a long-term customer of Neovasc, having historically represented a sizable percentage of our tissue processing revenues,” added Neovasc CEO Alexei Marko. “As one of the world’s premier device companies, with a global cardio-vascular franchise, this investment in Neovasc enables continued development of our lead products, Reducer and Tiara, and strengthens our resolve to revolutionize how structural heart disease is treated.”

Late in October a federal judge in Massachusetts added $21 million to the $70 million Neovasc owes to CardiAQ in their spat over transcatheter mitral valve replacement technology. The jury in May found that Neovasc misappropriated trade secrets in developing the Tiara TMVR. Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014.

Last month Neovasc dodged an investor lawsuit brought after its share price plunged in the wake of the court rulings.

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Impel NeuroPharma Inc. said today that it closed a $36 million series C financing round to fund its pipeline of precision olfactory delivery (POD) intranasal devices. Life science firms venBIO, 5AM Ventures and Vivo Capital made investments in the round. Seattle-based Impel will get $21 million upfront and $15 million after it reaches development and business milestones.

Impel’s POD nasal devices are designed for improved bio-distribution, bio-availability and decreased dose-to-dose variability of small molecules and biologic drugs. The device delivers drugs to the upper nasal cavity, taking advantage of the vascular rich olfactory region and targeting the brain using the olfactory and trigeminal nerves. The company is developing combination products for migraine, Alzheimer’s and Parkinson’s disease. Impel said that it expects new indications will enter the clinic next year.

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

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Mylan (NSDQ:MYL) CEO Heather Bresch reportedly accepted “full responsibility” for the company’s EpiPen price hikes that sparked outrage over the past 2 months, but defended the company’s actions while blaming an opaque industry that she said was not built for consumer engagement. The CEO made her remarks at the Forbes Healthcare Summit in New York on Thursday.

“There are unintended consequences when the patient goes to the pharmacy counter and doesn’t know what the price will be,” Bresch said, according to Stat. “Transparency would improve this.”

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

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Exploitable cybersecurity flaws that could be fatal were found in 10 different implantable medical devices, according to a new report from a European research team.

Researchers at Belgium’s KU Leuven University examined 10 device, specifically implantable cardioverter defibrillators. The team used only commercial, off the shelf items and had no prior knowledge of the devices, but were able to break the device’s supposedly secure communications protocols.

Read the whole story at our sister site, Medical Design & Outsourcing.

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Despite reports this week that Actelion Pharmaceuticals (VTX:ATLN) rejected Johnson & Johson‘s (NYSE:JNJ) 2nd takeover bid, hedge funds are piling into the Swiss biotech firm, encouraged by Actelion’s silence on the matter.

The 2 companies have been engaged in informal talks for 2 months, according to Reuters, and the latest offer was pegged at 250 Swiss francs per share. J&J’s $270 billion bid for Actelion is tempting to shareholders, who would rather have the cash now than wait and bet on Actelion CEO Jean-Paul Clozel’s risky pipeline for therapeutics of rare diseases.

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

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Senseonics (NYSE:SENS) said today that it expanded its exclusive distribution agreement with Roche (PINK:RHHBY) for its implantable continuous glucose monitoring system for people with diabetes. The new agreement includes all of Europe, the Middle East and Africa, excluding Scandinavia, Finland and Israel.

According to the agreement, Germantown, Maryland-based Senseonics has given Roche exclusive rights to promote, market and sell the Eversense system in specified territories. Senseonics will still be responsible for product development, regulatory approval, quality management and manufacturing, while Roche will take over commercializing the system.

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

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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. Researchers uncover hackable ‘fatal flaws’ in defibrillators

Exploitable cybersecurity flaws that could be fatal were found in 10 different implantable medical devices, according to a new report from a European research team.

Researchers at Belgium’s KU Leuven University examined 10 device, specifically implantable cardioverter defibrillators. The team used only commercial, off the shelf items and had no prior knowledge of the devices, but were able to break the device’s supposedly secure communications protocols. Read more

4. Impel NeuroPharma closes $36m series C round for intranasal CNS treatments

Impel NeuroPharma Inc. said today that it closed a $36 million series C financing round to fund its pipeline of precision olfactory delivery (POD) intranasal devices. Life science firms venBIO, 5AM Ventures and Vivo Capital made investments in the round. Seattle-based Impel will get $21 million upfront and $15 million after it reaches development and business milestones.

Impel’s POD nasal devices are designed for improved bio-distribution, bio-availability and decreased dose-to-dose variability of small molecules and biologic drugs. The device delivers drugs to the upper nasal cavity, taking advantage of the vascular rich olfactory region and targeting the brain using the olfactory and trigeminal nerves. The company is developing combination products for migraine, Alzheimer’s and Parkinson’s disease. Impel said that it expects new indications will enter the clinic next year. Read more

3. Hedge funds betting on J&J after Actelion remains silent on takeover bid

Despite reports this week that Actelion Pharmaceuticals rejected Johnson & Johson‘s 2nd takeover bid, hedge funds are piling into the Swiss biotech firm, encouraged by Actelion’s silence on the matter.

The 2 companies have been engaged in informal talks for 2 months, according to Reuters, and the latest offer was pegged at 250 Swiss francs per share. J&J’s $270 billion bid for Actelion is tempting to shareholders, who would rather have the cash now than wait and bet on Actelion CEO Jean-Paul Clozel’s risky pipeline for therapeutics of rare diseases. Read more

2. Boston Scientific buys Neovasc’s biotissue biz for $75m

Boston Scientific and Neovasc announced a $75 million deal today for the Neovasc biological tissue business that makes components for Boston Scientific’s Lotus replacement heart valve.

The deal, slated to close by the end of the year, also includes a 15% stake in Neovasc, the companies said. Boston Scientific agreed to put up $67.9 million for the biotissue assets and to buy some 11.8 million shares of NVCN stock at 60¢ apiece, for a total of $7.1 million, Neovasc said. Read more

1. Jury levels $1B verdict against J&J’s DePuy Ortho in Pinnacle hip bellwether

A federal jury in Dallas today ordered Johnson & Johnson and its subsidiary DePuy Orthopedics to pay more than $1 billion to 6 plaintiffs claiming to be injured by its Pinnacle metal-on-metal hip implants, according to the plaintiffs lawyers.

Jurors in the case found that the metal-on-metal pinnacle hip implants were designed defectively and that the companies failed to appropriately warn patients of the risks associated with the devices. Plaintiff’s lawyer Mark Lanier said the $1.041 billion verdict included $32 million in compensatory damages and the remainder in punitive damages. Read more

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Executives from U.S. drugmakers such as Regeneron Pharmaceuticals (NSDQ:REGN) and Pfizer (NYSE:PFE) talked about the possible changes awaiting the industry under President-elect Donald Trump at the Forbes Healthcare Summit this week.

After he was elected, pharmaceutical stocks surged as investors concluded the threat of action on drug pricing had lessened. Trump has said he wants to repeal Obamacare, but hasn’t addressed the industry’s drug pricing problem that has largely dominated public discussion of pharmaceuticals in the past year.

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

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Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today that the FDA approved an expanded indication for its Evarrest fibrin sealant patch as an supplementary hemostat.

With the expanded indication, the patch can be used with manual compression as an adjunct to hemostasis in adult surgery patients, when standard surgical techniques to control bleeding such as suture or ligature are ineffective. The fibrin sealant patch uses biologics to rapidly stop problematic bleeding while a patient is undergoing surgery. The drug device reacts human thrombin and fibrinogen to form a fibrin clot, providing a structure for clot formation.

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

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Teleflex (NYSE:TFX) said today it will pay approximately $1 billion to acquire Vascular Solutions (NSDQ:VASC).

Through the deal, Teleflex will pick up all outstanding shares of Vascular Solutions at $56 per share, in cash. Boards of both companies have approved the deal, which is expected to close during the 1st half of 2017.

“We are extremely excited to announce this definitive agreement with Vascular Solutions, as it represents a significant step forward in our strategy. Vascular Solutions is a truly unique company with differentiated technologies serving the coronary and peripheral vascular markets. They have a demonstrated long-standing track record of delivering double-digit annual revenue growth, stemming from organically developed, patented products that address unmet clinical needs in high-value procedure categories. In addition, they have established a strong franchise focused on interventional cardiology and interventional radiology which complements Teleflex’s existing businesses. Importantly, while we believe Vascular Solutions has compelling growth opportunities as they continue to build their business with their existing product portfolio, we look forward to potential longer-term tailwinds as we benefit from their robust R&D pipeline and our international distribution network moving forward,” Teleflex CEO Benson Smith said in a press release.

Vascular Solutions, founded in 1997, produces more than 90 medical devices designed for minimally invsavie coronary and peripheral vascular procedures.

Teleflex said the acquisition of the company’s portfolio will “meaningfully accelerate” the growth of its vascular and interventional business and increase revenue as it allows entry into the coronary and peripheral vascular market.

“We are delighted with this combination, which will further improve our commitment to coronary and peripheral vascular care by providing greater access to our innovative product offerings for patients around the world, while offering our shareholders immediate value. We have tremendous respect for the Teleflex team, who share our commitment to patients and providers worldwide. We look forward to working closely with the Teleflex team to achieve a smooth transition,” Vascular Solutions CEO Howard Root said in prepared remarks.

“Similar to Vidacare and LMA, this transaction represents an opportunity to acquire a company that meets our key M&A objectives, which include obtaining a product portfolio that fits into our existing strategic business unit franchises and call points, thereby allowing for synergy generation; products that provide a superior clinical benefit to existing alternatives and a cost benefit to hospitals; long product life cycles that benefit from patent protection; and the ability to further improve our financial profile. This transaction also bolsters Teleflex’s leadership and management team with the additions of key members of the Vascular Solutions leadership team who will be instrumental in continuing to drive the business forward. For Teleflex shareholders, we expect this transaction to create value by generating attractive financial returns fueled by incremental revenue growth and accretion to our adjusted margins1 and adjusted earnings per share1 beginning in 2017,” CEO Smith said in a prepared statement.

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The Patent Trial and Appeal Board has thrown out Medtronic (NYSE:MDT) subsidiary Covidien‘s patent on electrosurgical shears in a spat between the company and Johnson & Johnson‘s (NYSE:JNJ) Ethicon Endo-Surgery subsidiary, according to court documents released this week.

The patent relates to a bipolar electrosurgical shearing instrument used to seal and cut blood vessels or vascular tissue, designed to use “both mechanical clamping action and electrical energy to coagulate, cauterize and/or seal tissue,” according to court documents.

The Board ruled in an inter partes review that Johnson & Johnson’s Ethicon subsidiary showed that, through combinations of earlier inventions and publications, the invention would have been obvious.

“We determine that Petitioner has met its burden of proving the unpatentability of claims 1-13 of the ‘536 patent by a preponderance of evidence,” board judges wrote.

The decision is the most recent in a long-running patent infringement war between Covidien and Johnson & Johnson’s Ethicon Endo-Surgery unit over surgical shears, which appeared to be over last month after the U.S. Supreme Court declined to review the case.

Covidien in August asked the Supremes to hear its appeal of a December 2014 decision by the U.S. Court of Appeals for the Federal Circuit, which overturned a $177 million award to Covidien in the U.S. District Court for Connecticut. There, Judge Janet Bond Arterton had ruled that Ethicon Endo-Surgery infringed surgical shears patents held by Covidien’s corporate predecessors, Tyco Healthcare and U.S. Surgical Corp.

The Federal Circuit vacated the damages award, ruling that an Ethicon prototype anticipated the Covidien devices “because Ethicon conceived of the prototype before Tyco’s January 1997 conception date and diligently reduced it to practice without abandoning, suppressing, or concealing it thereafter,” Chief Judge Sharon Prost wrote for the 3-judge appeals panel. “The district court improperly held that the Ethicon prototype could not be considered prior art … and erred in finding that the curved blade claims and dual [cam] claims would not have been obvious.”

The high court’s decision, in which Justice Samuel Alito did not take part, means the Federal Circuit decision stands.

The companies agreed earlier in November to bury most of the hatchet, agreeing to drop the case with each side bearing its own legal costs, except for the then-pending Supreme Court bid.

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German medical software company CompuGroup Medical has dropped its offer to pick up Belgian graphics group Agfa-Gevaert (EBR:AGFB), the companies said this week.

Neither company offered any reason as to why the negotiations had stopped.

CompuGroup Medical said it was looking to pick up Agfa-Gevaert, which makes medical IT products, in late October. The company said the buy which would bolster its software for doctors’ offices, pharmacies and hospitals; Agfa also has a portfolio of other products including X-ray machines.

The combined company would have annual sales of more than €3 billion ($3.3 billion). CompuGroup said it gave Agfa’s board a non-binding indication of interest but said it was not certain that it would end up making a firm offer.

Agfa, whose market value has shrunk by a third to €616 million this year, said its board would evaluate CompuGroup’s approach carefully.

CompuGroup has grown through a series of bolt-on acquisitions in recent years, most recently buying a majority in Vega, an Italian distributor of its software, last month.

Agfa, which in 2004 sold the eponymous camera film business that made it a household name, is active in the printing and medical imaging business. Its healthcare business accounts for about 40% of its €2.6 billion in annual revenue.

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