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Articles from 2016 In March


How Genetically Engineered Maggots Could Heal Wounds

Research out of North Carolina State University shows that genetically engineered green bottle fly larvae secrete a human growth factor that could be used to promote cell growth and heal wounds.

Kristopher Sturgis

The recent proof-of-concept study was aimed at creating a new strain of genetically engineered green bottle fly (Lucilia sericata) larvae with enhanced wound-healing effects through the secretion of a human platelet-derived growth factor (PDGF-BB) that is known to stimulate cell growth and promote cell survival.

Rebecca J. Linger, post doctoral fellow in the department of entomology at NCSU and first author on the research, says that the larvae of green bottle flies was ideal after considering their history of clinical utility.

"Given their previous FDA approval and widely known clinical utility in treating not just diabetic ulcers, but over 20 additional medical conditions, Lucilia sericata larvae were by far the best model for our system," Linger says. "Secreted human proteins, including growth factors, have been expressed in silkworm (Bombyx mori), and several of these proteins have proven functional in the veterinary clinic."

Max Scott, a professor of entomology at the university and a corresponding author on the research, conceived of the study and says that controlling gene expression is crucial to engineering the desired results.

"The key to the technology is using the tetracycline transactivator to control gene expression," Scott said. "We realized we could use our technology to engineer Lucilia sericata with the aim of enhancing wound healing. We engineered Lucilia sericata to express PDGF-BB under the control of tetracycline transactivator. We envision that it should be possible to make engineered strains of Lucilia sericata that make a variety of growth factors that enhance wound healing and inhibit bacterial growth. We think this should be very cost-effective as maggots are cheap to rear."

Genetically engineered products continue to make their way into medicine as researchers explore gene and DNA modification to treat patients. Just last year a new startup was created to address hard-to-treat genetic disorders and diseases through the use of genetically engineered red blood cells. However, when it comes to using genetically modified green bottle fly larvae, Linger says one of the biggest obstacles is overcoming the negative connotations surrounding treatment with maggots.

"Some resistance to the concept of utilizing maggots as a treatment modality still exists," she says. "However, studies indicate that the majority of patients surveyed would undergo maggot therapy again, and would recommend it to other patients. Faster, more effective wound healing through genetically modified maggot therapy could further increase the popularity of maggot therapy."

Linger says that the using genetically engineered methods of treatment can provide a personalized drug regime and that maggot therapy could provide a panel of larvae expressing different factors that could be used for each individual wound based on specific wound characteristics -- and the benefits to the patient could be significant.

"Our system has the potential to provide a cheaper, more effective alternative to drug and antibiotic treatment, while avoiding the expense of synthetic growth factors, and the challenge of antibiotic resistance," Linger said. "Tailoring treatments to the specifics of individual patients is a concept that has already proven successful in medicine."

Linger says that one of the most important long-term goals in exploring the potentials of genetically engineered larvae is affordability. The group found that genetically modified insects can be mass produced in factories relatively cheaply, and they continue to explore ways to make the technology cheaper and more efficient.

"For example, my colleagues have developed a genetic pest control strategy that utilizes only the males of the insect species," Linger says. "We are currently developing a strain of the insect in which only the males survive beyond an early stage, thereby saving rearing facilities 50% on overall rearing costs, such as food and valuable rearing space. Also, my colleague Ying Yan suggests building new effector lines that coexpress different effector genes at the same time. These 'multi-purpose' larvae could promote wound healing by several mechanisms by secreting antimicrobial peptides and cell growth-promoting factors simultaneously, thereby increasing potential patient benefit."  

The group hopes to continue their research through the testing of technology on animal models. A rat wound healing model has already been developed, and could serve as an excellent model system for preclinical trials for the genetically engineered larvae.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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Researchers Find 1400 Software Vulnerabilities in Medical Supply System

Independent researchers have uncovered 1418 third-party software vulnerabilities in outdated but still used automated supply cabinet used to dispense medical supplies, according to a federal cybersecurity advisory.

Nancy Crotti


Pyxis
Security researchers found vulnerabilities in end-of-life versions of CareFusion's Pyxis SupplyStation system. 

Collaborating with CareFusion, researchers Billy Rios and Mike Ahmadi identified the vulnerabilities in end-of-life versions of CareFusion's Pyxis SupplyStation system, said the notice from the Industrial Control Systems Cyber Emergency Response Team(ICS-CERT). Ahmadi is scheduled to speak at MedTech Europe.

"These vulnerabilities could be exploited remotely," the advisory says. "Exploits that target these vulnerabilities are known to be publicly available."

Pyxis SupplyStation systems are automated cabinets that dispense medical supplies and can document usage in real time. They typically include a network of workstations, located in patient care areas throughout a facility and managed by the Pyxis SupplyCenter server, which links to the facility's existing information systems, according to ICS-CERT. The SupplyStation system is designed to provide access to supplies in "fail-safe mode" if the cabinet is rendered inoperable.

CareFusion will not provide a patch for these outdated systems, but has begun providing customers of end-of-life versions with an upgrade path. Those who choose not to upgrade can apply a series of compensating methods detailed in the advisory.

Information security professionals were not surprised at the researchers' findings, according to a report by SC Magazine.

John Smith, principal solution architect at Veracode, told SCMagazineUK.com thatmany new Internet of Things (IoT) devices pose a significant threat to healthcare.

 "Vulnerabilities will always be discovered in connected devices," Smith said. "The security of all IoT devices must be looked at holistically so that all devices, as well as their web and mobile applications, and back-end cloud services, are secure by default."

In February, hackers brought down medical devices and computing systems in a Los Angeles hospital for more than a week using ransomware,a form of malware that demands a payment before normal functioning is restored.  Hollywood Presbyterian Medical Center paid them $17,000 in bitcoin in response to a demand for more than $3.6 million to restore the records, according to the Los Angeles Times.

Researcher Ahmadi specializes in critical systems security - in which system failures can cause disastrous events that can lead to death.

"A heart is a vital organ and if it needs a pacemaker in order to survive, the pacemaker itself becomes as vital as the heart," Ahmadi said. "If you can find a vulnerability that can cause a failure, then it is actually a digital pathogen, the body doesn't differentiate anymore between a carbon-based virus and a digital one."

Note: A previous version of this article incorrecntly said that the security problems were related to infusion pumps. 

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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Democratizing Surgery: A Q&A With the CEO of Verb Surgical

Democratizing Surgery: A Q&A With the CEO of Verb Surgical

Arundhati Parmar

Late last year, Verb Surgical, a joint venture between Verily (formerly Google Life Sciences) and Johnson & Johnson's Ethicon division was formed with the intent to change the paradigm of robotic surgery established by pioneers like Intuitive Surgical.

The entrance of Google (now Alphabet) into any industry is noteworthy, and since March 2015, when the initial announcement was made, a flurry of articles has tried to divine from press releases, J&J's earnings calls, and interviews with former Google scientists, what exactly Verb Surgical has set out to do.

The name, by the way, very deliberately plays on the idea of action. Or actions that matter and empower surgeons, to be more precise.

Now, in a phone interview with Verb Surgical's CEO Scott Huennekens, previously the CEO of Volcano Corp., a picture begins to emerge about the Mountain View, CA, company.  Although many details are missing, it's clear that Verb is seeking not only to rewrite the rules of robotic surgery, but also alter the very definition of what surgery has come to mean.

The Q&A below has been edited for readability and clarity.

MD+DI: We've heard a lot of buzzwords about Verb Surgical - machine learning, analytics and advanced imaging. If I am a surgeon, what can I get from a Verb Surgical robot in the future that I am not getting today?

Huennekens: First of all, we think of us not as a robotics company but as a surgical platform company. If you think of open surgery as Surgery 1.0, minimally invasive surgery and laparoscopic surgery as Surgery 2.0, robotics surgery as 3.0, we really think that the next era is 4.0. We call it digital surgery and physicians call it digital surgery as well.

Instead of having robotics that is used in just 5% of procedures and it's like a mainframe computer, we're thinking of robotics like it's a PC. It's always there, it's always on.

So, it's lower cost, it's more accessible to you. And then in combination with that, there is advanced visualization and next generation technologies that start to give you differentiation of tissue. It could be the anatomy of the tissue, the tissue state or tissue type and surgeons start having information to inform their  decision-making.

They can also have that co-registered with current live imaging - whether its ultrasound, X-rays, or pre-operative imaging - and can start thinking about planning surgeries and executing them based upon this information.

Surgeons will also have advanced tools and instrumentation. So what you would have is all that information but not in its individual silos where Medtronic/ Covidien has these instruments and Karl Storze has this visualization and somebody else has a table and somebody else has robotics arms.

We want to eliminate silos and bring all these together in a seamless solution and then also have algorithms for decision-making.

I don't want to get into too many of the details that we are working on for competitive reasons, but the integration of all those components together and the solutions around procedures, is what we are looking to do.

You've heard of Moneyball and you may have even seen the movie. There's moneyball for baseball players. You may think of us as developing algorithms and information, so it's moneyball for surgeons.

In surgery, it's been a cottage industry so to speak where you had an apprentice who learned from a master and that's the way things evolved. So there is a lot of disparity of performance in surgeons. There's a lot of disparity in the way procedures are done. What we believe is you can use information and more standardized processes in surgery, just like any manufacturing process, to increase quality, lower cost and make the outcomes more uniform.

It's a long-winded answer but it kind of gives you the context of what we are looking to accomplish at Verb. 

MD+DI: Can you give an example of what kind of decision-making is possible with your advanced imaging and visualization capabilities when surgeons are using your robot?

Huennekens: It doesn't have to be with a robot. It can be an open surgery case, it can be a minimally-invasive surgery case with laparoscopic instruments or it can be robotic. You are going to be able to just look at an anatomy and it will tell you what the anatomy is.

You could tell perfusion versus non-perfusion. You can tell cancer cells versus non-cancer cells. Those are the things that we are working on and moving forward with whether it's just the visualization techniques or injectables that enhance the image as well. I don't want to get into too much detail in what we are doing there, but it's where things are headed.

MD+DI: You said these techniques can be used in open or minimally-invasive surgery, so are you saying that Verb could offer up a solution where hospitals might not need to buy a robot to get some of these other advantages?

Huennekens: I am saying it is a surgical platform, so if you have advanced imaging capability, you don't have to use robotic arms. The robotic arms are just tools. You can stick your endoscope in there and get visualization. You may want to do these things with laparoscopic instruments that are cheaper.

There are reasons you use robotics - dexterity and reach are among some. You may want to use them in an open case, where you have a deep region that you want to suture for which you want to use robotic arms than to reach in there and do by hand. We are saying why not?

Today robotics is a defined destination. It's not a tool. In our world, there are no robotic cases. There's open cases and minimally-invasive cases. You use what you need to do surgeries most effectively. Robotic instruments should be used in open cases or minimally-invasive cases.

MD+DI: I wanted to draw this distinction because so far, whenever people have talked about robotic surgery, it's always been minimally-invasive robotic surgery. You are broadening that term a little bit because you are saying robotic assistance can be easily used in open procedures too. Correct?

Huennekens: That's why we call it digital surgery. It's going to the future where all these procedures are digitized and computer-assisted. I think of it as computer-assisted surgery versus robotic. Robotics is one element of computer-assisted surgery or digital surgery.

MD+DI: But if a surgeon wanted to use a robot, Verb Surgical will have a robotic system in addition to all these other capabilities?

Huennekens: Absolutely. It's one of the key pillars. The pillars are: robotics, always there, always on; advanced imaging; machine learning, Big Data; and advanced instrumentation.

Ethicon Endo Surgery is a big leader in instrumentation and has a $6 to $7 billion sales franchise. Google is a world leader in Big Data and machine learning. They are also a world leader in optics, video and data analytics, and then you have robotics which is something that Verb is working on separately, but in a different form so that it's always available.

And then put an umbrella over all of that and we are saying we will be open platform. Intuitive Surgical's systems are closed. You have to buy the instruments from them. You have to buy the visualization.

We are saying if you pick up your cell phone and download an app, and you can use your app on your phone, we're willing to give people access to our platform under the right circumstances obviously. We have to respect regulatory requirements and such, but if someone has a set of pediatric instruments that would work, we'd be willing to grant them access under the right business relationship to our platform, as an example.

MD+DI: Maybe this is stretching it a little, but it's like you are building an App store for surgery like what Apple did with iPhone where other people can sort of plug and play?

Huennekens: That's right. It's not a stretch at all. What we are saying is that we want to have a broad open platform with multiple apps.

You asked, what's the physician going to have? Well, the physician will have choice. As long as there's an instrument that they want to use and that company is willing to work with us, they're going to be able to use it on our platform.

MD+DI: How big are your robots going to be in term of footprint? Can you give a percentage?

Huennekens: There's no percentage I can provide, but I can say it's not going to be this thousands-of-pounds system. It's going to be more between a mainframe and a PC, so it'll be much smaller and always on.

The surgeon console that allows surgeons to interface with the robot will be different as we move forward. I don't want to move into specifics, but Intuitive's surgeon console is a large system as well, and ours will be much different in form and function.

MD+DI: TransEnterix's CEO has criticized current robotic systems as having no feel because surgeons on the console don't know if they are touching soft tissue or bone. That company is developing robots with haptic feedback. Can you talk about what Verb Surgical is coming up with?


Huennekens: No, we're not touching upon that, no pun intended, at this time relative to what we are offering.

I can only say that we're looking at telling you what the tissue is and we think there's some interesting opportunities to improve on the touch and feel as well as the way you interact with your instruments.

MD+DI: Can you talk about cost?

Huennekens:  With Intuitive, you take a piece of a capital, which is a big part of the cost, and you amortize it. Then because the cost of the instruments and everything else is so prohibitive, it only gets used once a day, times 200 times a year, then your robots cost you over $1,000 every time you use it. If you use it four times a day, it costs you $250.

Our system will cost much less than Intuitive Surgical's. 

Also, with our system, you could use robotics in say two steps within a laparoscopic procedure where it makes sense for you to use them. Our system will be used in many more procedures, so it's worth it.

Our vision would be that it's less than $100 to use it. Maybe there will be a premium on a couple of instruments but you are talking about a couple of hundred dollars, not couple of thousand dollars.

We are leveraging J&J's $6 to $7 billion revenue in its surgical business and Medtronic is probably looking to do the same thing for Covidien's equally-sized surgical instrument business.

So it's a little bit different business model for us than Intuitive Surgical because you are talking about open, minimally-invasive cases and a broader tool set.

MD+DI An analyst recently said that Intuitive Surgical has such a head start that even with the heft of Google and J&J, Verb Surgical and others will not really be able to beat Intuitive. Do you agree?

Huennekens: No. Who do you think is our competitor? Now I get to ask you a question.

MD+DI: The status quo.

Huennekens: Yes, the status quo, non-use. So 95% of the market doesn't use a robotic solution and the Intuitive system doesn't address that 95%. We said for all the reasons why: from cost, to size, to set up time. You look at the global [Intuitive] footprint. It's not a solution.

So no, they are not a competitor. We want to have our system in every single OR. Every single OR in 10 years will be a digital surgery OR in the U.S., Europe, and Japan, and it will be starting to have an impact on the rest of the world as well.

There's a different future that exists because it's not selling a mainframe computer that costs $2.5 million. We're going to be selling a PC at a different price point.

If you look at the other businesses of Medtronic -- and I am not saying we will do this -- but they'll give away the capital, if hospitals buy enough instruments.

You go into Cleveland Clinic that's doing a $100 million-a-year in business with Medtronic, you think Medtronic won't provide 8 ORs with equipment that cost them $500,000 for the continuation of a $100 million-a-year contract for five years. Of course they will.

J&J has that kind of scale as well. J&J and Medtronic's robotics business model can be entirely different than the business model of Intuitive, which is dependent on the robot because the instruments aren't as big a deal or they don't have other businesses in open surgery and minimally-invasive surgery.

It's also difficult for TransEnterix and these other companies because they've got a chicken and an egg problem. 

MD+DI: Where are you in terms of product development and when can we see a surgical platform from Verb?

That's a question I get asked all the time. We're not answering that right now for competitive reasons. I am not trying to be coy or anything like that.

MD+DI: So you can't even say, in two years, three years, five years or whatever?

Huennekens: It will be before five years, I can tell you that.

MD+DI: What surgical procedures are you targeting?

We are moving forward with surgeries in urology, gynecology, general surgery and thoracic surgery. It's our objective to have multi-quadrant access and have a full assortment of procedures that we satisfy in those areas.

MD+DI: How is the joint venture structured?

Huennekens: We are consolidated in the financial statements of Alphabet, so that basically says that they have a slightly higher interest than J&J and there is an equity pool for employees.

MD+DI: How much money have you raised so far?

Huennekens: What we've said is from the money that J&J invested with SRI, [the company licensing robotic technology to Verb], what's been invested by J&J for instrument development and what's been invested by Google for development for all the other aspects of the project, plus what's funded, to commercialize this is a $250 million project.

Part of that has been spent. There's been a two plus, almost three-year development period during which J&J invested with SRI to develop a prototype robot. Now you've got ongoing investments that Google and J&J each company has been making. There's money that has been put into Verb to fully fund it to commercialization. The combination of all that is around $250 million.

MD+DI: Is there anything else you wish to add?

Huennekens: I would describe this as democratized surgery. We are on the verge of revolutionizing this market by bringing advanced robotics, advanced instruments, advanced imaging, machine learning, cloud and data computing, so it's a super exciting time.

Twenty-five years ago when I graduated business school, I worked for two years in general surgery. Then I worked 23 years in cardiac surgery and there were no billion-dollar markets when I started, but when I left, there were 15/16.

Coming back to general surgery after all this time, all that has changed is that laparoscopic surgery is a little bit further along and robots are used for prostate surgery and a little bit of gynecology. Part of the problem is technology costs.  Now, you've got the sun setting on a lot of IP from Intuitive and evolution of technology, so you've got new robotics companies that are coming into the field.

I think we are going to see a lot of change in the next five years and it's a $10 to $20 billion opportunity. I am less concerned about the dollars. This translates into the fact that we have the opportunity to impact 10 to 20 million surgeries.

[Images Credit: Verb Surgical]

Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected]  and on Twitter @aparmarbb

Get ready for Massachusetts Medtech Week and attend BIOMEDevice Boston, April 13-14 to stay on top of industry trends.

Biomarker Can Detect Concussions a Week Later

Biomarker Can Detect Concussions a Week Later

Traumatic brain injuries, including concussions, have gained widespread attention in recent years as their impact on athletes of all ages has been studied more closely. One common problem with concussions is that the classic symptoms like headaches, vomiting, and dizziness don't always show up right away.

Now, new research in trauma patients has shown that the glial fibrillary acidic protein (GFAP) biomarker can be found in the bloodstream for at least seven days following the head injury. The 584-patient study, "Time Course and Diagnostic Accuracy of Glial and Neuronal Blood Biomarkers GFAP and UCH-L1 in a Large Cohort of Trauma Patients With and Without Mild Traumatic Brain Injury," published in JAMA Neurology this week, showed that GFAP detected mild to moderate TBI  (MMTBI) as well as intracranial lesions seen on head CT scans and neurosurgical intervention out to seven days.

"We have so many diagnostic blood tests for different parts of the body, like the heart, liver and kidneys, but there's never been a reliable blood test to identify trauma in the brain," Linda Papa, MD, MSC, an emergency medicine physician at Orlando Health and lead author of the study, said in a media release. "We think this particular test could change that."

Get inspired to innovate during Massachusetts Medtech Week--register for BIOMEDevice Boston 2016, April 13-14.

GFAP and another biomarker, ubiquitin C-terminal hydrolase L1 (UCH-L1) were studied. Researchers found that although both biomarkers were found in the bloodstream an hour after the head injury, UCHL-L1 peaked at 8 hours after the trauma before declining quickly while GFAP peaked at 20 hours post-injury and declined more slowly over three days. 

The study authors wrote, "It is common for patients who have had a concussion or mild TBI not to seek immediate medical attention. Therefore, understanding the behavior of these biomarkers over days after injury is important for detection of injury in those who may only seek medical care several days after injury."

Traumatic brain injury has attracted attention from large players like NFL, GE, and Under Armour, which started the Head Health Challenge together in 2013 to incentivize work on the prevention, diagnosis, and treatment of brain injury.

[Image courtesy of ORLANDO HEALTH]

Biotech Investor Burrill to Pay Millions for Alleged Deception

G. Steven Burrill and his firm Burrill Capital Management will pay back nearly $5 million, on top of a $1 million fine, to settle SEC allegations of misappropriating funds.


G. Steven Burrill
G. Steven Burrill

Chris Newmarker and Brian Buntz

He was once one of the most influential investors in healthcare, having played an important role in establishing the biotech sector. Now G. Steven Burrill stands accused by the SEC of siphoning off up to $18 million from his funds to help pay his lavish lifestyle.

While not admitting or denying the wrongdoing, Burrill and his firm Burrill Capital Management agreed to disgorgement of $4.785 million in investor money that was allegedly misappropriated, as well as a $1 million penalty. Burrill will also be permanently barred from the securities industry under the agreement. 

Also settling were Burrill Capital Management's chief legal officer Victor A. Hebert and controller Helena C. Sen, who agreed to pay $185,000 and $90,000, respectively.

When it came to Burrill, misappropriated "prepaid expense" fees helped pay for family vacations to St. Barts and Paris, as well as jewelry, gifts, car service, and private jets.

"Even though they are exempt from registration, venture capital advisers like Burrill have fiduciary obligations to their clients that we will enforce. Burrill spent his fund's capital on whatever he pleased, and elevated his own interests above those of investors," Andrew Ceresney, director of the SEC's enforcement division, said in a news release

Even with the SEC case settled, Burrill faces a slew of lawsuits elsewhere, with the firm's accountant PriceWaterhouseCoopers also facing accusations.

The Burrill Life Sciences Capital Fund III LP claimed last year in a lawsuit filed in San Francisco County that PwC was complicit in Burrill's alleged fraud scheme.

"The Fund alleges that if PwC had conducted its audits objectively and in conformance with its professional obligations, PwC would have advised the fund's investors that Burrill's organization was paying itself millions of dollars in 'prepaid management fees' that the Burrill organization had not earned," the fund said in a recent updated complaint.  The document goes on to state that these "management fees" disguised embezzlement and that the fund ended up facing millions in damages as a result of PwC not reporting it. According to attorneys for the Fund, "The Fund has sued PwC alleging fraud, negligent misrepresentation, aiding and abetting, and professional negligence," it states.

PwC denies the charges and has filed cross-claims against the fund. The counterclaim asserted that the Burrill Fund was guilty of the following: breach of contract, breach of the covenant of good faith and fair dealing, negligent misrepresentation, contractual indemnification, and declaratory judgment on contractual indemnity. Furthermore, PwC's audit engagement clause had an indemnification clause that said in part: "In no event shall PricewaterhouseCoopers LLC be liable to the General Partner or the Partnership whether a claim be in tort, contract or otherwise, for any consequential, indirect, lost profit or similar damages relating to PricewaterhouseCoopers LLP's services."

The Fund had filed an order to strike PwC's counterclaim, which the court partially granted and partially denied. 

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker

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Former Abbott Exec Hopes to Stay Insider-Trading Trial

James Mazzo and his lawyers are arguing that a pending Supreme Court decision could set a precedent that would lessen the severity of the case against him.

Nancy Crotti

James MazzoFormer Advanced Medical Optics CEO James Mazzo has asked for a stay in his insider trading trial, pending a decision by the U.S. Supreme Court that could set a potential legal precedent in Mazzo's case.

Mazzo's trial is scheduled to start July 19 in U.S. District Court for the Central District of California in Santa Ana. The Justice Department had indicted Mazzo in September 2014, alleging that in 2009, Mazzo told his neighbor and vacation buddy, former Baltimore Orioles player Doug DeCinces, that Abbott Laboratories was about to buy Advanced Medical Optics for $2.8 billion. Then trading at $8 per share, Advanced Medical Optics' share price soared to $22 when news of the acquisition became public.

The acquisition was completed in 2009. Mazzo had retired from the company in 2012 amidst the allegations of insider trading.

But was what Mazzo allegedly did with his ballplayer buddy illegal? The Supreme Court might have something to say about that, according to Mazzo and his attorneys. They filed a motion last week asking for an indeterminate stay while the Supreme Court considers a Third Circuit Court of Appeals opinion in Salman v. United States.

The Supreme Court "will clarify the law" regarding a "core element" of the crimes he is charged with: whether Mazzo personally benefited from the alleged insider trading, the motion says. The Salmon case will decide whether a "gift" of information to a friend counts as insider trading, or whether there has to be personal gain on the part of the person providing the information.

The high court could render a decision in Salman as early as October, Mazzo argues. Granting the stay would also keep the district court from wasting its time in trying Mazzo under current law, as that law may be undone soon after, the motion says.

"Whatever path the Supreme Court takes, it will have a major impact on jury instructions, evidentiary decisions, and trial strategy, and it may well control whether the case (or certain charges) can proceed to trial at all," Mazzo's motion says.

Mazzo's motion "grossly overstate(s) the impact of the appeal in Salman on the issues in this case," the prosecution responded. It also fails to show that Mazzo would suffer hardship if the trial proceeds as scheduled, or that the trial would waste judicial resources, government attorneys said in their response." Defendant Mazzo also erroneously relies upon civil case law and a distinguishable district court order in a criminal case from another District," the prosecution added. Furthermore, the government stated that Mazzo's request "fails to even consider the Speedy Trial Act, 18 U.S.C. § 3161 et seq., requirements" and that it "relies upon a Louisiana district court order in a criminal case that is distinguishable."

Mazzo's indictment charges him with 13 counts of insider trading, 13 counts of tender offer fraud and one count of securities fraud. Each securities fraud count carries a maximum statutory sentence of 25 years in federal prison. Each of the insider trading and tender offer fraud counts in the indictment carries a maximum statutory sentence of 20 years. The money laundering counts each carry a maximum penalty of 10 years, according to the justice department.

Mazzo became head of Abbott Laboratories' Abbott Medical Optics after the acquisition until 2012. He is also a former board chair of trade organization AdvaMed.

A hearing on Mazzo's motion is scheduled for April 18.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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Origami Is Inspiring Minimally Invasive Surgical Advances

The traditional Japanese paper-folding art form has helped drive breakthroughs in everything from battery technology to foldable solar panels used in space. Now, it could be driving advances in robotic surgery.

Brian Buntz
Tiny forceps

Researchers at Brigham Young University (BYU; Provo, UT) have been working with NASA to use origami principles in spacecraft design. "Those who design spacecraft want their products to be small and compact because space is at a premium on a spaceship, but once you get in space, they want those same products to be large, such as solar arrays or antennas," says professor Spencer Magleby. "There's a similar idea here: We'd like something to get quite small to go through the incision, but once it's inside, we'd like it to get much larger."

The BYU researchers are working on using related origami techniques to fashion surgical tools that are so small they can be inserted into holes in the skin that can heal without sutures.

The university has licensed the technology to robotic surgery pioneer Intuitive Surgical.

Magleby, working with fellow BYU mechanical engineering professors Larry Howell and Brian Jensen, are working towards making surgery ever less invasive. "To that end, we're creating devices that can be inserted into a tiny incision and then deployed inside the body to carry out a specific surgical function," Howell said in a statement.

The surgical device industry had reached a point in which was becoming impossible to make surgical tools smaller using traditional instrumentation. But the BYU engineers were able to eliminate pin joints from some surgical instruments, using an origami-inspired design instead.  

"These small instruments will allow for a whole new range of surgeries to be performed--hopefully, one day manipulating things as small as nerves," Magleby notes in a release. "The origami-inspired ideas really help us to see how to make things smaller and smaller and to make them simpler and simpler."

One example of a device created by the researchers is robotically-controlled forceps that can fit inside a 3-mm hole.

The researchers are also working on a device known as D-Core, which is initially in a 2-D configuration but expands to become two rounded surfaces that can roll to simulate the interaction of spinal discs. The device can be made from a single material. The researchers have created versions from Tyvek, polycarbonate, polypropylene, and metallic glass.

The research is published in Mechanism and Machine Theory.

Image above from BYU.

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Stryker CEO: Why We Are Delaying Mako Total Knee Launch

Stryker CEO: Why We Are Delaying Mako Total Knee Launch

In an exclusive interview, Kevin Lobo explains why the Triathlon knee that was approved on the Mako robotics system last year is still not launched. 

Arundhati Parmar

After buying Mako Surgical in December 2013, Stryker has been busy bringing its hips and knees on the surgical robotics platform.

It has been a "messy integration" though the payoff is likely to be big, acknowledged Stryker's CEO, Kevin Lobo, in a recent interview with MD+DI. Stryker's total hip product and partial knee implant can be used on the Mako system, and in August 2015 FDA approved the use of Stryker's total knee - Triathlon - on the robotic system.

But the Kalamazoo, MI, medtech company is not launching the Mako knee until 2017, well over a year after the product's approval. 

"Stryker has never done this before by the way," Lobo said. "We've never had a product approved and then told the sales force you have to wait a year. We've never told our customers you have to wait a year."

That begs a question. Why?

The aim is to maximize the chance for success at launch, and right now not enough is known about how surgeons will use it, he said. That makes a launch risky. 

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History would suggest that is a wise move. Lobo pointed to the experience with the launch of Stryker's surgical navigation system, which has found traction in Australia but no where else."

"When it was launched, surgeons had a frustrating experience," he recalled. "They said, 'I got to do all this registration. It's slow. It's slowing me down,' and they just recoiled."

That is the exact reaction that Stryker wants to avoid with the launch of Triathlon on Mako. To gain experience regarding how surgeons would use it, Stryker is conducting two observational studies. Lobo declined to say how many patients will be involved,  noting that the trials are meant to arrive at training protocols for two surgeon cohorts.

"So we're trying to figure what's the training protocol for somebody who has never used a robot and what's the training protocol for someone who already has some robotic experience," he said. "[We want to know enough to say things like], 'You've never used a robot before, so for you it's going to take 6 cases to be proficient.' We want to set the right expectation."

The Mako robot is rumored to cost upwards of $1 million. That's expensive, but especially so at a time when certain geographic areas of the country are under CMS's bundled payment initiative that provides a fixed reimbursement amount for joint replacement spanning 72 hours before surgery through to 90 days after surgery.

One payment for a long episode of care will make hospital operators cost conscious, and while many, including Lobo believe that hospitals will look to cut costs in the recovery or post-acute care period, there may be some amount of pressure on device makers to cut costs of their products as well.

Despite that, Lobo thinks the expensive robotic system is well-suited to bundled payments because of strong clinical outcomes as well as repeatability and predictability of procedures.

"I absolutely think Mako can win in a bundled payment environment," he said. "We are going to show much less soft tissue disruption. Every surgeon is going to be able to do it the same way. we're going to have much more consistent, predictable outcomes and that's going to be enabled by a robot."

The bundled payment covers only 67 metropolitan statistical areas and goes into effect in April. Meanwhile Stryker will take the year gathering experience on the system for a big launch in 2017.

"Frankly, some of the people doing our observation are cynics of Mako, but they are world renowned key opinion leaders," Lobo said. "They are going to stand on the podium and when they speak, people are going to listen. I'd rather take a year of deliberation so that when we launch, we launch with excellence."

[Photo Credit: iStockphoto.com user BsWei]

Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected]  and on Twitter @aparmarbb

Genetic Testing Company Expands Offering, Adds Pediatric Focus

Genetic Testing Company Expands Offering, Adds Pediatric Focus

Marie Thibault

This week, genetic testing company Invitae announced a significant expansion of its panel offerings to cover more than 1000 genes. The expansion includes a focus on pediatrics, including pediatric immunology, rare diseases, and inherited metabolic conditions, as well as neuromuscular diseases. 

The expansion was launched a quarter earlier than originally expected and will be rolled out in several releases in the coming months, said Randy Scott, PhD, Invitae's CEO and cofounder, on a March 29 investor call.

Invitae is striving to offer comprehensive genetic testing through assays that cover hundreds of genes. The company already offers coverage for oncology, as well as some cardiovascular, neuromuscular, and rare diseases, but this latest expansion adds a pediatric focus to its services. 

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Scott explained the importance of affordable, relatively quick genetic testing for pediatric conditions:

"Until recently, pediatric and newborn clinicians and their patients were relegated to expensive testing with long turnaround times, often split across different labs, some of which offered only some of the genes required, which prevented many people from being able to benefit from a reasonably-priced, comprehensive test. Our intent is to put an end to diagnostic odysseys and ensure that patients and their families have access to testing they can afford."

Instead of several thousand dollars and pricing per gene, Invitae advertises a per-indication $1500 list price, a $950 price for institutions, distributors, and payers who contract with the company, and a $475 upfront patient price. The company will maintain this same pricing scheme for the expanded offering. On average, it takes three weeks to turn around test results.

In an interview last fallScott explained that economies of scale allow Invitae to offer flat test pricing, since the same assay is being run at far higher volumes in order to investigate a particular indication instead of an assay specific to one indication being run less frequently.

According to a company press release, the expansion includes testing for more than 30 neurological disorders such as muscular dystrophies and myopathies, more than 60 pediatric and rare diseases such as periodic fever syndromes and severe combined immunodeficiency, and inherited metabolic disorders.

"Newborn screening is one of the greatest public health initiatives; it is, however, a screening test. Confirmatory genetic testing can lead to a diagnosis more quickly and allow for timely initiation of effective therapies, accurate genetic counseling, recurrence risk assessment, and carrier testing for family members," said Olaf Bodamer, MD, PhD, associate chief genetics and genomics at Boston Children's Hospital, in the press release.

Invitae isn't stopping at over 1000 genes. Scott said the company plans to continue adding more genes to its offerings--planning to reach "most, if not all, 4000 [medically relevant] genes over the next 18 months"--and bundling tests to target various patient and customer populations. "For example, our newborn genetic testing program encompasses much of the content for carrier testing of healthy adults since many of the newborn metabolic disorders are recessive traits passed on by parents to their children," he said.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie

[Image courtesy of PRAISAENG/FREEDIGITALPHOTOS.NET]

Vaporized Peracetic Acid Sterilization Offers Alternative to EtO

With fewer safety risks and a faster turnaround time, VPA sterilization can allow medical device OEMs to sterilize product in house. 

Vicki Lanka 

(click image to enlarge)

Like all manufacturers, medical device companies are constantly looking for ways to optimize their production efficiency. Because patient safety and FDA compliance are top priorities, effective and dependable sterilization is a crucial part of the manufacturing process. However, many medical device manufacturers currently rely on off-site contract sterilization services that introduce inefficiencies, added costs, and risks into the production cycle.

Vaporized peracetic acid (VPA) sterilization, in which room-temperature VPA is injected into a pressurized chamber to eliminate surface contaminants, is changing that. Because this method allows for quick turnaround time and can be performed on an OEM's production floor, it offers device manufacturers an alternative to ethylene oxide (EtO) sterilization in some cases.
 

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VPA vs. EtO

Though still popular in the medical device industry, EtO sterilization has several drawbacks when compared with VPA methods. 

EtO facilities typically require infrastructure investment to comply with safety regulations, so EtO sterilization is typically performed on an off-site, contract basis. In order to make contract sterilization processes economically feasible, manufacturers must assemble large batches of product, which requires additional time, effort, and on-site storage space. Delivering pallets of this inventory to and from third-party sterilization facilities also adds significant logistics, transportation, and packaging costs, and it introduces the potential risk of delayed customer shipments. These issues can lead to delays and interruptions for manufacturers.

In contrast, VPA sterilization systems can be installed on an OEM's production floor and can handle disinfecting both small and large quantities of products more quickly than EtO--in a matter of hours versus days. Having an on-site, room-temperature VPA system allows medical device manufacturers to sterilize items in less time and with greater efficiency than is possible EtO. 

VPA sterilization systems can be relatively easy to install. The only factory floor space required for VPA sterilization systems is for the machines themselves. The machines have their own ventilation filtration systems built in, so no additional ventilation is required. Sterilization chambers can range in size from 417 L for small production batches up to 3000 L or more for large quantities. 

Another drawback of EtO is the fact that the process results in carcinogenic chemical residuals. Safety and environmental risks with VPA are lower because the process breaks down into carbon dioxide, oxygen, and water. Since it doesn't result in carcinogenic fumes, VPA also doesn't require a lengthy aeration period. As a result, the product does not have to leave the facility until it's ready for delivery to the customer.

VPA sterilization is also compatible with a broader range of materials used in medical device development than EtO sterilization. Thanks to its gentler, room-temperature process, VPA enables medical manufacturers to sterilize chemical and heat-sensitive materials that are off-limits with EtO. For example, copper, is not harmed by VPA. VPA can also be safely used with polystyrene materials, bioresorbable polymers including PLA and PLGA, polyacetals, nylon, various polyurethanes, and elastic polymers such as synthetic rubber. According to one study, the VPA process has been verified as compatible, safe, and effective for sterilizing 92 different materials.

Kaizen Analysis Shows VPA Efficiency Advantages

Many U.S. manufacturers have adopted the Japanese Kaizen philosophy of continuous improvement to evaluate and optimize their production processes. Kaizen is a successful method for developing a lean manufacturing culture and identifying cost savings and new efficiencies.

Minneapolis-based Medivators, which makes components to assist with endoscopic surgery, recently used Kaizen analysis to determine whether installing VPA sterilization on-site would improve its manufacturing efficiency for its endoscopy products in Conroe, TX. The company had previously worked with a contractor to sterilize its products via an EtO process. 

During a Kaizen review, the process improvement team completed a cost-benefit analysis of installing a 3000-L VPA machine on site. It determined that an in-line sterilization system would reduce processing time by as much as 70%.

Previously, Medivators had to build up inventory that was unnecessary and unusable until a truckload for EtO processing could be filled.  Once the company shipped the product off site, the facility would sterilize its devices and then ship them back. Medivators would then have to aerate the devices, as EtO is a potentially hazardous chemical that must be outgassed to a safe level before the product can be usable. 

When considering the entire sterilization process, the off-site EtO sterilization cycle time took between 10 and 12 days, and required a significant amount of square footage for pre- and post-sterilization inventory storage. With VPA, the sterilization and business intelligence validation steps would take one to three days.

Conclusion

VPA sterilization offers quick turnaround times and can be performed by OEMs in-house with equipment that is relatively easy to install. The process is free from carcinogenic chemical residuals found in EtO sterilization and is compatible with a broader range of materials. As medical device manufacturers look to cut costs and speed products to market while maintaining FDA compliance, VPA sterilization can provide another weapon in their arsenal.   

Vicki Lanka is the marketing manager for Revox Sterilization Solutions. Reach her at [email protected]