dijous, 31 de març del 2016

7 Pitfalls to Avoid in mHealth Web & App Design – White Paper

Updated-Xi-WP-Image-smAs medical and wellness devices converge, health care providers, mHealth companies, and device makers are facing a number of critical – and increasingly complex –  issues, including:

  • Ensuring that patients and HCPs actually use their apps and devices
  • Presenting potentially confusing – or alarming – data so that it is understandable and actionable
  • Unknowingly triggering the need for regulatory approval
  • Sharing and ownership of data, beyond HIPAA concerns

Understand the 7 common pitfalls in designing for mHealth, how to avoid them and moreover, what you SHOULD be doing to design for success.

Read this whitepaper to learn:

  • What each pitfall is and why it is imperative to avoid them
  • How to increase the odds of your product being used (spoiler: recognize that human nature poses innate obstacles to new developing new habits and behaviors)
  • How to recognize the greater possibilities that lie at the evolving frontier of Big Data integration

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MassDevice.com +5 | The top 5 medtech stories for March 31, 2016

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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

 

5. Newly developed exoskeleton mimics human knee

MassDevice.com news

Mechanical engineers from ETH Zurich have developed a prototype exoskeleton, the VariLeg, which they say more accurately mimics natural knee gait to give it an advantage on uneven terrain.

The newly developed prosthetic is designed to continuously change knee stiffness so it can adapt to irregular surfaces or obstacles, according to a Reuters report. Read more


4. Stryker takes its time with Mako’s Triathlon total knee

MassDevice.com news

Stryker is taking its time getting the Mako robot-assisted Triathlon total knee device on the market, despite having won FDA approval last August.

Admitting that the integration of Mako after the $1.7 billion acquisition in December 2013 was “messy,” CEO Kevin Lobo said Stryker isn’t planning to launch the total knee offering until 2017. Read more


3. AcuFocus raises $4m debt round

MassDevice.com news

AcuFocus, which makes the Kamra eye inlay for treating nearsightedness, said it raised nearly $4.1 million in a round of debt funding.

Irvine, Calif.-based AcuFocus said in a regulatory filing that the round included 16 unnamed investors. The company hopes to raise a total of $5 million, according to the filing. Read more


2. Medtronic wins expanded indication for Pillcam Colon 2

MassDevice.com news

Medtronic said today that the FDA granted an expanded indication for the Pillcam Colon 2 device it acquired along with Covidien last year.

The new indication covers the detection of colon polyps in patients with bleeding in the lower gastrointestinal tract who’s health is at risk from colonoscopy or mild sedation, but could tolerate them if the Pillcam device detects an abnormality. Read more


1. Biotech investor Steve Burrill to pay $6m, banned from trading

MassDevice.com news

Once-prominent biotech investor Stephen Burrill is barred from the securities industry and will pay nearly $6 million to settle SEC charges that he looted investment funds to cover losses in other businesses and pay for his lavish lifestyle.

Burrill and his firm Burrill Capital Management agreed to disgorge the $4.785 million prosecutors said Burrill siphoned off for personal use, plus a $1 million fine. The firm’s former chief legal officer, Victor Hebert, and former controller Helena Sen agreed to pay $185,000 and $90,000 civil fines, respectively. They are also barred from the securities industry, the SEC said. Read more

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Video: Researchers develop “bionic” heart patch

Researchers at the University of Tel Aviv had developed a proof-of-concept “bionic patch” designed to monitor and treat heart conditions in real time, according to a report from Reuters.

The patch features engineered, functional tissue integrated with electronics and is designed to give doctors new options for treating myriad heart problems.

Findings from the development of the heart were published in the journal Nature Materials this month.

“Well, this is the 1st time that engineered tissue, thick engineered tissue, functional tissues, are integrated with electronics to become cyborg tissues, meaning that there is integration of machine and living tissues,” Tal Dvir of Tel Aviv University told Reuters.

The newly developed heart patch is comprised of live, lab-grown heart tissue and nano-electronics embedded on a 3D printed scaffold, according to the report.

Researchers on the development team for the patch say it could offer an alternative to heart transplantation as the device can be used to release medications as well as to repopulate the defected area with cells that are capable of contraction.

The device can also monitor the heart and activate the organ as needed, as well as notifying physicians of potentially fatal problems in real time, according to the report.

“The patient is sitting in his house and not feeling well and the physician immediately sees the condition of the heart on his computer and can remotely activate the heart: can provide electrical stimulation, can release drugs. And if you really think about this technology, we don’t even need a physician because the cardiac patch can regulate its own function,” Dvir said.

Development of the heart patch is still years from commercial viability, the team said, with both animal trials and clinical trials in humans on the horizon.

Material from Reuters was used in this report.

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An Infographic: Comparing Drugs & Devices Trials

imarc-logoSeveral years ago, IMARC Research published a whitepaper outlining the differences between Drug and Medical Device clinical trials.  Since IMARC focuses primarily on medical device trials, we felt it was important to highlight the differences between the two trials.  It has proven to be one of our more popular whitepapers, so we have decided to offer everyone an infographic as a quick reference.

Understanding these similarities and appreciating the differences is important for clinical researchers who are involved in both drug and device trials.  Clearly, the process of getting a drug or device approved is different, but both require an ethical commitment combined with the proper controls and an understanding the differences – in the details – between drugs and devices.

So while the investigations of drugs and devices have their differences, by design these differences are intended to accomplish the game goal:  to safeguard those research participants while bringing safe and effective products to the market as quickly as possible.

Please take time to download IMARC’s  “Comparing Drugs & Devices: How are the Clinical Trials Regulated”

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Harvard Apparatus rebrands as Biostage

BiostageHarvard Apparatus Regenerative Technology (NSDQ:HART) said today it is rebranding as Biostage, Inc. and shifting its Nasdaq symbol to “BSTG”, effective April 1.

The company said the brand shift “reflects the company’s broad commitment and expertise in pioneering the development of bioengineered organ implants for the esophagus, bronchus and trachea.”

“The Biostage name change reflects the evolution of our focus from commercializing bioreactors and research tools to the pioneering development of bioengineered organ implants for the esophagus, bronchus, and trachea. We have changed our company name to Biostage to better communicate and differentiate our new Cellframe technology and strategic direction,” CEO Jim McGorry said in a press release.

Holliston, Mass.-based Biostage said the new name integrates both its biotechnology focus on implants that provide staging for the body’s innate healing utilizing its Cellframe technology platform.

The company’s Cellframe tech platform features biocompatible scaffolds that are seeded with a patient’s stem cells to create Cellspan implants for treating conditions of the esophagus, trachea and bronchus.

“Cellframe employs a process in which the patient’s own stem cells are taken from a simple adipose/fat tissue biopsy, the cells are first isolated, expanded and then seeded onto a proprietary biocompatible scaffold that mimics the natural dimensions of the damaged organ. After incubation in our proprietary bioreactor, the Cellspan implant is ready to be implanted. Cellspan implants are designed to deliver the necessary cues for triggering, guiding, and modulating the regenerative process,” McGorry said.

Biostage said it plans to file an investigational new drug app with the FDA in late 2016 as it seeks to initiate clinical trials of its tech pltform in humans. The company is expanding the preclinical testing of its Cellspan esophageal implants in collaboration with the Mayo Clinic to support its IND app.

“Biostage is the result of a nearly two-year corporate transformation that centered on people, research, and technologies. We put in place a deeply experienced management team and board of directors to effectively lead our team of cell biology experts, materials scientists, and engineers to develop and pursue a clearly-defined set of research, regulatory, and commercialization goals. Biostage has also expanded its research partnership base to cost-effectively add technology resources critical to our success. Collectively, these efforts allow Biostage to pursue a new approach to restoring function to damaged organs for patients who deserve better clinical solutions and improved outcomes,” McGorry said.

The company said it expects to update on its preclinical research collaborations in the middle of the 2nd quarter of 2016.

Last November, Jim McGorry, CEO of Biostage, said he’s ready to right the ship by expanding its regenerative trachea tech into both the bronchus and esophagus.

McGorry has been the CEO of Biostage for 4 months, and told the Boston Business Journal he’s preparing to turn the company’s stock slide around.

The reins were passed to McGorry from former CEO David Green earlier this year as the company said it was seeking a chief exec had the experience to guide the company through clinical trials and product launches.

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Stryker takes its time with Mako’s Triathlon total knee

Stryker Mako SurgicalStryker (NYSE:SYK) is taking its time getting the Mako robot-assisted Triathlon total knee device on the market, despite having won FDA approval last August.

Admitting that the integration of Mako after the $1.7 billion acquisition in December 2013 was “messy,” CEO Kevin Lobo said Stryker isn’t planning to launch the total knee offering until 2017.

“Stryker has never done this before,” he told MDDI. “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.'”

Hoping to avoid the problems Kalamazoo, Mich.-based Stryker ran into with its surgical navigation system, which caught on only in Australia, Lobo said the company is running a pair of clinical trials to study how surgeons use the robot-assisted surgery platform, he told the website.

“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,” Lobo explained. “We want to set the right expectation.”

“I’d rather take a year of deliberation so that when we launch, we launch with excellence,” he said.

Lobo said he’s confident that the Mako system will be competitive even as the Centers for Medicare & Medicaid Services launches the 5-year “Comprehensive Care for Joint Replacement” program at more than 800 hospitals next month. The program will bundle payments for hip and knee replacements from hospital admission to 90 days after discharge, covering “all related items and services” under Medicare Part A and Part B.

“I absolutely think Mako can win in a bundled payment environment,” Lobo 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.”

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He sold his first startup to Medtronic. Now he’s developing an even better technology to help monitor metabolic functions

Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly.  All interviews are conducted by Scott Nelson, Founder of Medsider and Partnership Lead at Touch Surgery.  We hope you enjoy them.

When most people think of the wearable space, devices like the Fitbit or the Apple Watch come to mind.  But over the past few years, there’s been a lot of development with respect to wearable devices that were designed for the traditional healthcare market.

Medtronic launched the SEEQ device.  Although implantable, St. Jude commercialized the CardioMEMS device.   And startups like AliveCor and AUM Cardiovascular have developed some innovative monitoring devices as well.

But there’s some major differences between consumer wearables (like the Fitbit) and wearable devices that are designed for remote monitoring within the traditional healthcare setting.  In order to get a better picture of this market, I recently interviewed Darrel Drinan, one of the prominent thought leaders within the wearable (remote monitoring) arena.

In this interview with Darrel Drinan, we cover his broad experience developing novel monitoring devices and what he’s learned along the way through deals with DARPA, Medtronic, and his new startup, BioRibbon Health.

The following conversation is based on an audio interview with Scott Nelson and Darrel Drinan.  Scott is the Founder of Medsider and leads partnerships at Touch Surgery.

Scott Nelson:  Let’s start with Corventis because it was affiliated with your accelerator, PhiloMetron. That was your first spin-out back in 2005, right?

Darrel Drinan: That’s correct. The origins of the research behind Corventis started back when we created PhiloMetron in 2001. DARPA funded us to develop patches for soldiers to monitor various physiological parameters and we were successful in doing that through 2003. We then started to focus on how we would commercialize it to the military and realized that was a significant challenge, so we looked at the healthcare applications and found the cardiovascular region market specifically to be the one that was going to be most receptive to the platform. And we met with Caufield and Byers first and they wanted to do a deal with Kleiner Perkins.  So we all got together and decided to create a spinout because at the time we had a bunch of different research projects in various categories and Kleiner and Perkins only wanted to focus on this cardiovascular application. So we created a company called Amigo Therapy, which was the first name, the undercover name, for Corventis, and closed the deal with those two groups in November of 2005.

Scott Nelson: And that’s what became Corventis, as we knew it, before the Medtronic acquisition.

Darrel Drinan: That is correct.

Scott Nelson: Corventis was acquired by Medtronic in 2014 for a reported 150 million. When you think about that acquisition, especially considering how well Medtronic is doing with the two devices (SEEQ and LINQ), how does that make you feel?

Darrel Drinan: Well, of course you’re always proud to be involved with a success, but as the old saying goes. successes have many parents and the failures are orphans. So we’re one of the many parents that created the Corventis spot but we weren’t the only group. There’s a great group of guys there in Minneapolis as well as in San Jose that did some of the heavy lifting on the application that ultimately led to Medtronic acquiring the company.

Scott Nelson: Before we go back to the pre-2005 era with Corventis and how that technology came to fruition, let’s talk about wearables in general because it’s certainly a hot space. Seems to be, if you keep up with the healthcare scene or medtech in general, there’s lots of investment, a lot of M&A activity. Even consumer brands like Apple and Under Armour are making significant investments in wearables. I think Fitbit’s IPO was last year in 2015, if my memory serves me right. So when you think about wearables, is the interest level justified?

Darrel Drinan:  Well, I think that a broad way to look at that is in the healthcare space, wearables are yet to emerge other than a couple of small applications such as diabetes and cardiovascular ECG monitoring. In the consumer side of the business, it’s a different approach, whereas life sciences typically have a very narrow vertical focus on an application. In the consumer side of the system like Fitbit, for example, or Jawbone, etc., they’re trying to reach a large, large audience and there’s very few applications that meet that size of an audience. And so they’ve started with fitness, and as we all see now that there are some challenges to that focus in terms of clinical efficacy, the relevance to using something, and then of course the device itself. The wristband devices are going to have some challenges picking up clinically-relevant parameters. So I think all of those will be constraints on the consumer side of the market.

I don’t believe the technology guys really understand healthcare, so they stuck with things that they do understand and fitness is one of them. So if you look at it in that context, I think there’s challenges in that market in terms of future growth opportunities, incremental value, price point, etc. Whereas in the healthcare market, it’s very clear there are needs. There are very clear opportunities, as I mentioned. When we look at the continuous glucose-sensing capabilities and mobile cardiac telemetry, like Corventis, are two of the early vertical applications and have very high value to not only the patient, but to the payer and the provider as well. So if you look at it in the context, the margins are obviously going to be higher in the healthcare side of the market.

Scott Nelson:  And when you think about the healthcare side of the market versus the consumer play, are there other areas that you think wearables will make a lot of sense or will make a big impact?

Darrel Drinan: Again, I think we should try to keep wearables in those two categories.  If you start to get into this middle category (or gray area), you know some people have talked about wearables for wellness or population health programs, you have to ask yourself, is the data clinically relevant and is it actionable? So on the fitness side, it’s self-actionable; you could do it yourself. Whereas in the healthcare side, you typically need a clinician of some sort to help you understand the value and begin monitoring it.

Darrel Drinan: I think an area that is severely underserved, but challenged in terms of a price point, is the weight loss category because weight loss or weight management is simply a behavioral issue. You need a diagnostic that tells you the problem.  And for the most part, the problem is very simple in terms of eating too much or exercising too little. So if you are able to monitor those two parameters, you probably could then create some type of effective interventions or behavioral modifications.  But the challenge to date has been on the calorie intake side, and that is the ability to determine how many calories a person has consumed.  It is very difficult to do because of compliance and estimation errors as well as the variance in what we eat. The calorie expenditure side is very clear and there are devices, including wristbands, that will get you to a certain level of accuracy that’s more than adequate. There’s a group that attempted to do that with a wrist-based device telling you how many calories you burn, but I think from what we’re reading, it looks like the values they’re providing to their customers are suspect in terms of how they’re actually measuring it through a wrist-based device.

With our next spinout, we spent the last six years developing algorithms and technology, patch technology, to actually measure that particular parameter, or calorie intake, and we’ve gotten it to what we call a “two-Snickers-bar” error and that’s more than adequate in the market right now. That’s not a cumulative error. That’s just an error. So on day one, most people burn between 2000 and 3000 calories a day and as a result, none of us are rapidly expanding or rapidly contracting. So on day two then, if you’re looking at it as a trend over time, you’re at 2000 to 4000 calories and so on and so forth.  So our error of a Snickers bar is well within the accuracy needs of the market to drive a behavioral change over a two-  to three-month period.  The whole premise of Weight Watchers is to count points that are assigned to a food group to give you the number of calories you consume. But if you take that responsibility away, just take that compliance component completely away, take the technique component completely away, and have the patient focus not on the counting of calories but on their behavior, suddenly you have a much more focused system and perhaps a far more effective system.

Scott Nelson: And that’s what you’re doing at BioRibbon Health today?

Darrel Drinan: At BioRibbon, we have 12 different families of parameters. It will be the most comprehensive monitoring platform in a single device out there today and it’ll be useful in both health and healthcare applications. So it could measure the usual suspects of heart rate, ECG,respiration, temperature, and motion.  But on top of that, we can monitor your body fat, lean mass, hydration, net weight, emotional status, calorie expenditure, calorie intake, net calorie balance, etc. And it’s in a small chest-worn patch that uses Bluetooth to go through your phone into the cloud.

Scott Nelson: Very cool. Sounds incredibly promising.  Before we dig into BioRibbon, let’s rewind the clock even further to earlier in your career.  Because I would imagine there were some key lessons you learned throughout your experiences at Gillette ThermoScan as well as the programs you were involved with at UCSD.

Darrel Drinan: Yeah, I think there are some that stand out in my mind through all of these programs, whether it’s my Gillette Braun days or the work we did at UCSD.  What I found consistently, and problematic, is that people were developing technology in absence of a focus on the problem, and that creates a number of problems as you move forward. So if you start with a clinical problem or a healthcare-related problem and understand it well and focus on that, your intellectual property portfolio is going to be far deeper because you’re going to identify not one, but many different potential solutions. Your IP is going to be broader and more robust.  You’ll be able to capture a field of use that is meaningful to the market and you’ll be better able to understand all of the challenges that others have had.

So when we were at Gillette, we were studying this category of body composition very heavily and we developed a mindset of, “Don’t drink your own Kool-Aid.”  That came from my design teams in San Diego and Germany. We started to do focus groups and the feedback we received was completely different from the device that we were developing. So I made my guys go to these focus groups and, for the most part, they were stunned because the market for those types of devices at the time was predominantly women who were making the purchase decisions. Within those focus groups, we were looking for specific feedback of why they would buy it and why they wouldn’t buy it.  And to be candid, some of the design options that we had to implement weren’t even in the same universe.  So drinking your own Kool-Aid is a huge problem. If you don’t talk to your customer, you very well could be developing your product for the wrong customer.

The other thing that we implemented at Gillette was a rule that if your end user had to do three things in a device, a diagnostic home-based device, your product would fail.  Those 3 things were technique, compliance, and knowledge.
So let me give you an example of that. Let’s look at a blood pressure cuff. On a wrist-based cuff, if you don’t have your wrist above your heart, you can have 10 points of mercury or more of air injected into the value. So as a result, you’re not going to have an accurate device.  That’s technique.

There’s a compliance component to that too.  If I’m a patient, and I have to remember to do this at 8 o’clock every day or 5 p.m. every day, I have to be mindful of that in order to be compliant.
The third component that makes blood pressure possible is people understand what normal is…120/80.  They don’t need to be taught this.

But a lot of these emerging categories don’t meet the rule of 3.  For example, let’s look at the headband device called Zeo. When that came out, there was a compliance issue in that you had to put it on. There was a technique issue because if you didn’t put it on the right spot of your forehead, it wouldn’t work. And third, they created a brand new value called a ZQ score, which was related to the quality of your sleep. People didn’t understand what a normal value was. So as a result, the device failed. They weren’t able to penetrate the market because the device didn’t meet the rule of 3.  And that’s a good example of how you can fail in the consumer side of the market.

However, with a prescriptive device, there’s a little bit more complication because you’re going to have somebody help you understand those values and guide you.  And I think with the way that digital health is going now with these automated feedback loops, it’s becoming more and more possible to create values based off data that the patient may or may not understand.

Scott Nelson: That’s great stuff. I’m going to nickname that the “Drinan rule of 3”.  In essence, what you’re saying is that you can’t ask the end user or the end customer to take three steps, especially if one of the steps forces them to learn something new altogether.  But when looking at the three issues that you mentioned, can you get away with two?  Or can you only really ask the end user to make one adjustment on their end?

Darrel Drinan:I think you can get away with only two of them. So how about standing on a bathroom scale? You understand what weight is, so there’s no education component. There is definitely a compliance component.  And there is potentially a technique component because if you rock around on the scales or you don’t have the scale properly on the floor, that could influence the reading of the scale.

Scott Nelson: I can see your point about why it’s not as big of a deal in the traditional healthcare setting because there’s a provider involved to sort of coach that patient along.  But it’s good advice for any product development team, even outside of consumer-based healthcare.  Once you’re asking a patient to do all three steps, that may present quite a few challenges even with a provider or coach to help out.

Let’s go back to your comment about focus groups.  You probably recall the famous Steve Jobs quote about focus groups.  It was something along the lines of not relying on focused groups when designing products because people don’t always know what they want.  So how do you go about balancing the feedback you get from focus groups in light of this fact?

Darrel Drinan: I think we should go back to the differences between a device for the consumer market vs. the healthcare market.  If you have a Steve Jobs that wants to create a market for a new solution, how do you get people to use that? Well, you have to tell them what the problem is that you’re solving for them. You also have to make it appealing. So the cool factor is a way to market that. “I have to have that. It’s cool.” Clothing is a good example. Do I really need a new shirt with a new logo? Perhaps not.  But if it’s part of the cool trend, then I think you can introduce it and solve a problem they didn’t know they had.
On the healthcare side, it’s a different animal. When you have diabetes, you have to solve it. Otherwise, you die. And so there is a clear difference on the healthcare side in that there is typically an urgent need. You’re bleeding, you have high blood pressure, your glucose is out of control, you’re obese, your hair is falling out, etc., etc.  There are so many and they’re very concisely defined.  That’s why the pharmaceutical side of the world is so narrowly focused on a drug where as medtech is narrowly focused on a problem.  When you go to the consumer side of the market, you have to create the demand for some of those needs. And that’s very, very challenging to do. I mean, how long has it taken the Internet to become such an integral part of our life that we can’t live without it?  25 years and trillions of dollars?  

Scott Nelson:  As we close out this interview, let’s focus on Corventis vs. BioRibbon.  At Corventis, it seemed like you really honed in on cardiac monitoring.  But with BioRibbon it seems like you’re expounding a lot further in terms of what you’re monitoring. So what did you learn at Corventis that you’re now applying to BioRibbon.

Darrel Drinan: Remember, when we started to commercialize the underlying technologies for Corventis in 2004, there was no iPhone. There was no iOS. There was no Android. The “cloud” wasn’t there.  Amazon Web Services didn’t exist. All of that exists now.  So now we can make it invisible. When talking about this, I often ask the question, “Do you really know if your phone is a CDMA or a GSM phone? Do you really care?”  Well, no.

I see the fitness market doing one thing, staying on the wrist.  Those companies will try to figure out if they can get any meaningful clinical data off of your wrist or those types of devices. But I think the healthcare wearable market is going vertical and those verticals are going to be very problem-focused like we talked about before with a particular solution in mind.  But to do that across a large population, you need many different sensors to mitigate variances in physiology, variances in use patterns, variances in body motion and what we call noise artifacts. So by adding more sensors to mitigate that noise, you now have the ability to provide a more robust value than a single-sensor platform such as the Corventis technology or even the MC10 stuff that they introduced at CES.  
In contrast, with our platform at BioRibbon, we’re able to provide all of that data so that new observations can be made on things that we never knew about. We have a number of different trials that will be utilizing the platform for things that we couldn’t have even imagined.  But the clinician or the researcher has said, “Hey, I need to figure out if this particular parameter has some influence on the underlying condition.”

I can’t go into too much detail, but I’ll give you an example. At around age 55 to 60, most humans lose their thirst complex. So they’re unable to tell whether or not they’re hydrated. Well, what are the clinical manifestations of that? Could it be the effectiveness of drugs when you take them if you’re chronically dehydrated or acutely dehydrated? Perhaps. Could that cause dizziness in elderly patients, ultimately resulting in them going to the hospital for an IV? Perhaps. So there’s a whole bunch of applications yet to be discovered.  
We’re not suggesting that someone look at all this data “naked” as we would call it. We’re developing what we call BioRibbon signatures and these are the combinations of different parameters as they’re correlated to a particular end point.  And those data points will allow an individual or a group of individuals to make decisions based on that data.  We think that’s going to address a huge market in an underserved population.  And that is the population that’s not in the hospital, but also isn’t healthy. It’s the unhealthy group that hasn’t visited the ER, are living with comorbidities that are driving the health expenditures in the US.

Scott Nelson: As a follow-up, when you think about product development and corresponding clinical trials at BioRibbon, contrast that to your experiences at Corventis.  Is there one thing you recall at Corventis that you’re doing differently at BioRibbon?  

Darrel Drinan: Yeah, I think the number of sensing parameters is going to be the difference between us and what Corventis is doing.  Same thing with Vital Connect and MC10.  This is a more complex platform because the data needed to mitigate beyond just positional changes, temperature changes, or seasonal changes.
For example, grandma’s heart rate is 62 in San Diego on Tuesday and she’s at 91 on Wednesday when she’s in Denver.  As it turns out, she went to fly to see her kids. How do I know that? Well, I have data from the device and the phone that I can calculate.  And I can mitigate any intervention if grandma is really traveling, or I can intervene if necessary.

Scott Nelson: Let’s now transition to the last 3, more personal questions. What’s your favorite nonfiction business book?

Darrel Drinan: The Lean Startup Series.  I think any of Steve Blank’s books are great.  If you’re an entrepreneur and you haven’t read them, you are going to fail. The concepts are not just close or nearly accurate.  No, they’re perfectly accurate.  They have such relevance to what I described early about the problem-focus, talk to your customer, don’t drink your Kool-Aid, etc. I think they’re brilliant.

Scott Nelson: Great.  And there is CEO or a business leader that you’re following right now?  Or one that really inspires you?

Darrel Drinan: In terms of a business leader, Steve Blank is pretty far up there on the pecking list of people that have solved some really, really, challenging problems.

Scott Nelson: Okay, last question. When thinking about your career in healthcare, what’s the one piece of advice that you’d tell your 30-year-old self if we had to rewind the clock that far?

Darrel Drinan: That’s a good question. I would say don’t drink your own Kool-Aid.  Don’t presume you understand the problem.  And don’t be enamored with technology for the purpose of technology because technology is hard.  But if you focus on a problem and you understand it, you’re more valuable.  Becoming an expert and then becoming a KOL in a particular category is very valuable. Being a generalist has marginal value.

I would also say the greatest percentage gain in value happens from creation to the first prototype or first in-human use. After that, it becomes a grind. So manufacturing stuff, hardware especially, is a really tough business.  You can’t be faint of heart to be in the hardware side of the business.

Scott Nelson: Darrel, thanks so much for your time.  It’s greatly appreciated!

 


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Medtronic wins expanded indication for Pillcam Colon 2

Medtronic's Pillcam Colon 2Medtronic (NYSE:MDT) said today that the FDA granted an expanded indication for the Pillcam Colon 2 device it acquired along with Covidien last year.

The new indication covers the detection of colon polyps in patients with bleeding in the lower gastrointestinal tract who’s health is at risk from colonoscopy or mild sedation, but could tolerate them if the Pillcam device detects an abnormality.

The vitamin-sized Pillcam is designed to provide images as it passes through the gastrointestinal tract after being swallowed. Covidien acquired its maker, Given Imaging, for $860 million in February 2014; Medtronic paid $50 billion for Covidien in January 2015.

The original Pillcam won FDA approval back in 2001; nods for later iterations came in 2013 for the Pillcam SB 3 and 2014 for the Pillcam colon.

“We are committed to the early detection and treatment of chronic GI diseases and cancers. We are pleased with the FDA’s decision to clear this expanded indication for PillCam Colon capsule which will provide access to more patients who can benefit from this technology,” early technologies president Vafa Jamali said in prepared remarks.

“The ability to offer PillCam Colon capsule to an expanded patient group represents a significant breakthrough in GI healthcare,” added Dr. Douglas Rex of the Indiana University School of Medicine. “The new indication allows gastroenterologists to provide their at-risk patients with a non-invasive and radiation free alternative to traditional colonoscopy.”

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Priorities – Teamwork to achieve common goals

FDA VoiceBy: Robert M. Califf, M.D.

With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success.

This is hardly surprising. FDA regulates about 20 percent of the nation’s economy and, given the vast number of options, it would be easy to get lost in an overwhelming swirl of activity. In fact, at times I have been (rightfully) accused of having an excessively lengthy to-do list! But my interactions with so many of the knowledgeable, dedicated, and mission-driven people here at FDA have helped foster a clear, realistic, and focused sense of priorities and have further heightened an already strong enthusiasm for helping this awesome organization reach these ambitious goals.

FDA makes decisions in a remarkably effective and responsible way. Guided by the lodestone of our mission to protect and promote the public health, and supported by the concerted efforts of dedicated and talented professionals who examine issues within team-based systems, FDA’s Centers that form the core of our organization are able to make an enormous number of decisions every day. The vast majority of these decisions, many of which are vital to the well-being of all Americans, are made possible by a system sustained by professionalism and a well-earned reputation for high-quality and impartial judgments—despite the fact that many decisions must ultimately disappoint (or at least not fully satisfy) one or more constituencies.

I strongly believe my most important responsibility during my time at FDA is to encourage and support a professional environment that enables our remarkably dedicated workforce to thrive and to reach its fullest potential. Dramatic advances in biotechnology and information sciences, as well as continuously accelerating trends toward globalization, are ushering in an era of rapid change. But amid this change, the key to success for the Agency in accomplishing its mission remains constant—sustaining and expanding our talented workforce and ensuring that we both hire the people we need for the future while we continue to enhance our environment to ensure that we retain existing staff. To that end, I will pursue a workforce initiative designed to 1) improve the hiring system, 2) ensure that the Agency has the best possible working conditions for staff, and 3) foster professional homes for the diverse professions that make up our teams so that we are able to recruit and retain them in a very competitive market.

My top programmatic priority will likely come as no surprise, given the astonishing changes that are currently rippling through society: we must do everything possible to rapidly adapt our national and global systems of evidence generation to meet the challenges and opportunities presented by technological advances. What does this mean? I’ve noticed that when high-quality evidence is available, FDA’s scientific decision making is often straightforward. But it can be particularly challenging for the Agency when it must make scientific decisions in the absence of optimal information. In such cases, opinions may carry greater weight, and there can be an increased likelihood of dissension both inside and outside of FDA, as well as a greater risk that we may fail to most fully protect or advance the welfare of patients and the public.

FDA is a science-based, science-led organization that focuses on the needs of patients and consumers; protecting their well-being is our charge as a public health agency. The state of the art as it pertains to understanding the needs and choices of patients and the public is progressing rapidly, and we must continue to keep pace by incorporating the best methods for taking patient preferences, experiences, and outcomes into account in every part of our work.

Biomedical science is nearing a tipping point where the amount of high-quality evidence available to support our decisions is likely to increase exponentially. As a nation, we have invested over $50 billion to provide an electronic health record (EHR) for almost every American. Further, computational storage capacity and analytical power are increasing by orders of magnitude from year to year. At the same time, the advent and wide diffusion of social media are enabling direct communication with patients and consumers on an unprecedented scale. When projects such as Sentinel and the National Medical Device Evaluation System are linked with the many complementary initiatives under way at our sister agencies and at organizations outside of the government, we can (and I believe in short order will!) build a robust foundation for a system in which both private and public sectors can produce much more useful knowledge at a fraction of the cost such efforts have previously required. Indeed, a major function of FDA is to support the continued development of an effective system for evidence generation, so that the private and academic sectors can make it happen.

Accordingly, FDA is thoroughly committed to working with the many partners in our ecosystem to help build and sustain an infrastructure that produces the high-quality scientific evidence needed to guide FDA’s decisions about the drugs, medical devices, tobacco products, and food products it’s charged with regulating, as well as the decisions that healthcare providers, patients, and consumers make about their health and well-being.

In addition to this overarching priority, a number of specific critical issues are on my front burner this morning and will remain there for the foreseeable future:

  • Pain. The present epidemic of opioid overdose deaths now exceeds deaths from automobile crashes. FDA cannot solve this problem on its own—and indeed, no single entity can—but we have a critical role to play, as described in our FDA Opioids Action Plan.
  • Tobacco product deeming. Much effort has gone into developing the framework for the approach to the regulation of the broad array of tobacco products. FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation over virtually all tobacco products, including electronic cigarettes, either all cigars or all but premium cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.
  • Implementation of the FDA Food Safety Modernization Act (FSMA). This statutory directive to transform the food safety system is well on its way to being implemented, with critical regulations issued and more to come. The effort involves the complex development of a new control and risk-based system that includes the entire chain of food safety. Effective implementation of this system will require the application of cutting-edge analytical and biological science, as well as the most modern approaches to human systems management.
  • Antimicrobial resistance. Concerns about the proliferation of multidrug-resistant pathogens, as well as the sustainability of the product pipeline needed to meet this threat, continue to grow. We have a major responsibility in the federal plan, one that will involve many parts of the Agency and require that we work with the broad ecosystem, both to ensure that appropriate antimicrobials are used appropriately on farms, and that novel antimicrobials are developed, approved, and used responsibly within a framework of effective stewardship.
  • Interagency effectiveness. When we consider our mission to protect and advance the public health, as well as our duty to balance benefit and risk for patients and consumers of medical products, much of our success can be enhanced by coordinated effort across government. We have therefore continued the FDA-NIH Joint Leadership Council and the FDA-CDC meetings, and also initiated similar discussions with CMS. The Biomarkers, Endpoints and other Tools (BEST) Resource offers a powerful example of the ability of FDA and NIH to contribute to solving scientific and regulatory issues together.
  • Precision Medicine. President Obama’s Precision Medicine Initiative represents more than just a project. Rather, it is a window that provides a clear view of the future for biomedicine and agriculture, a future in which powerful new technologies and methods allow the precise targeting of interventions using an array of genetic, genomic, biological, clinical, social, and environmental data according to the scale needed to achieve improved health outcomes.
  • Cross-Cutting Issues. There are a great many other issues (truthfully, the number reaches triple digits) on my list of concerns. But those issues that cut across the Agency, including optimizing our approach to combination products, medical countermeasures, and improving product labeling, will benefit most from my attention and support.

A single introductory blog post is not suited for giving details about priorities or individual programs. However, I hope I’ve conveyed my enthusiasm for the work at hand, as well as my confidence that we will be able to make real and lasting improvements in many critical areas. I promise that we will follow up with frequent updates, as fostering effective communication is itself an overarching priority of immense importance to me. So expect to hear from me again soon!

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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AcuFocus raises $4m debt round

AcuFocus Kamra inlayAcuFocus, which makes the Kamra eye inlay for treating nearsightedness, said it raised nearly $4.1 million in a round of debt funding.

Irvine, Calif.-based AcuFocus said in a regulatory filing that the round included 16 unnamed investors. The company hopes to raise a total of $5 million, according to the filing.

AcuFocus is backed by HealthCare Royalty Partners, SV Life Sciences, Versant Ventures, Carlyle Group, Accuitive Medical Ventures and Medtronic (NYSE:MDT). The company raised $21 million in September 2014, just before landing CE Mark approval in the European Union for the Kamra device, which is designed to be inserted into the cornea to treat presbyopia.

Kamra won FDA approval in April 2015 after a narrow win at an advisory panel hearing and has been implanted more than 1,000 times, according to AcuFocus.

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dimecres, 30 de març del 2016

Newly developed exoskeleton mimics human knee

Mechanical engineers from ETH Zurich have developed a prototype exoskeleton, the VariLeg, which they say more accurately mimics natural knee gait to give it an advantage on uneven terrain.

The newly developed prosthetic is designed to continuously change knee stiffness so it can adapt to irregular surfaces or obstacles, according to a Reuters report.

“Here with the Varileg we implemented the mechanical variable impedance, which is something special that no other exoskeleton has implemented at the moment. And the advantage of this is that we can mimic the human-like stiffness adaptation of the human knee and this also allows us to adapt to unexpected obstacles because we can say how stiff the knee should behave,” mechanical engineer Patrick Pfreundschuh said.

The group said it also plans on developing ‘smart crutches’ which will act as a control to adjust the device for different situations.

“On the crutches we will have several buttons and with these buttons he can decide where he’s going and also to change the modes; so we will have straight-walking mode, and stairs mode and sit-down mode. So he can change between the modes and then tell the device what it should do,” Pfreundschuh said.

The engineers said the proof-of-concept prototype is too bulky, but that they are working to build a new streamlined, lightweight version of the device.

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Precision Biopsy asks FDA to OK new ClariCore trial

Precision BiopsyPrecision Biopsy said today it submitted an application to the FDA seeking a go-ahead to expand the trial of its ClariCore prostate biopsy system into a new Transrectal Ultrasound and MR/Fusion arm.

The ClariCore system is designed for the spectral analysis of tissue samples during biopsies to “rapidly classify” tissue as normal or suspicious using an optical fiber and companion console designed to minimize the number of samples taken by up to 90%, the company said.

“We evaluated the ClariCore device in several of my patients during an operative procedure to remove the prostate, and came away highly impressed with the system. I support the clinical trials planned by Precision Biopsy, as its technology has the potential to significantly improve the diagnostic process for millions of patients who undergo biopsy procedures each year to monitor for prostate cancer, the second-most deadly cancer in men,” Dr. E. Crawford of the University of Colorado said in a press release.

All 3 arms of the company’s Cohort A clinical trial look to collect prostate tissue and associated optical responses to help develop the ClariCore System’s real-time tissue classification algorithm, the company said. A total of 200 patients are slated to be enrolled in the algorithm development trial.

“The ClariCore Optical Biopsy System offers the opportunity to minimize unnecessary coring and reduce costs. We look forward to furthering the development of our ClariCore system with the support and collaboration of these leaders in the medical community,” CEO Amir Tehrani said in prepared remarks.

“The expansion of our clinical testing at Precision Biopsy is a tribute to our team and the performance of the technology. We are thrilled to see this advance,” board member Dr. Omar Amirana said in a prepared statement.

Last October, Precision Biopsy said it raised $33.6 million in a new round of equity financing to support its ClariCore biopsy platform designed to provide prostate tissue classification during biopsy procedures.

Woodford Investment Management led the round, according to Aurora, Colo.-based Precision Biopsy, with investments from its parent company Allied Minds.

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Biotech investor Steve Burrill to pay $6m, banned from trading

Steve BurrillOnce-prominent biotech investor Stephen Burrill is barred from the securities industry and will pay nearly $6 million to settle SEC charges that he looted investment funds to cover losses in other businesses and pay for his lavish lifestyle.

Burrill and his firm Burrill Capital Management agreed to disgorge the $4.785 million prosecutors said Burrill siphoned off for personal use, plus a $1 million fine. The firm’s former chief legal officer, Victor Hebert, and former controller Helena Sen agreed to pay $185,000 and $90,000 civil fines, respectively. They are also barred from the securities industry, the SEC said.

The scandal began in 2013, when the fund’s managers allegedly discovered that Burrill, Hebert and Sen misappropriated some $18 million from the fund, according to a lawsuit filed in a California state court in 2014. Burrill resisted the board’s pressure to step down, but was officially ousted March 20, according to the lawsuit.

“Burrill spent his fund’s capital on whatever he pleased, and elevated his own interests above those of investors,” SEC enforcement chief Andrew Ceresney said. “Even though they are exempt from registration, venture capital advisers like Burrill have fiduciary obligations to their clients.”

Lawyers for Burrill and Sen did not immediately respond to requests for comment.

Michael Shepard, a lawyer for Hebert, said his client has been a lawyer for more than 50 years, and settled to put the investigation behind him.

Material from Reuters was used in this report.

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MassDevice.com +5 | The top 5 medtech stories for March 30, 2016

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

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

 

5. Trinity Medical picks up CasMed’s neonate disposables for $3m

MassDevice.com news

Trinity Medical Devices said yesterday that it paid $3.35 million for CAS Medical System‘s line of neonatal intensive care disposables.

The deal includes a an additional $400,000 milestone pegged to sales targets over the next 12 months, Parsippany, N.J.-based Trinity said. Read more


4. Court approves Nuo Therapeutics bankruptcy plan

MassDevice.com news

Wound care company Nuo Therapeutics said yesterday that a federal court in Delaware approved a bankruptcy plan that would either see it continue as an independent company or become 95% owned by lender Deerfield Management.

Gaithersburg, Md.-based Nuo filed for Chapter 11 bankruptcy protection in January, 2 years after raising $35 million from Deerfield. Formerly known as Cytomedix, the company makes the Aurix hematogel, which is designed to stimulate the body’s native mechanisms to heal wounds. Read more


3. FDA: Don’t use OxySure’s portable oxygen generator

MassDevice.com news

The FDA today released a safety letter warning against the use of OxySure Therapeutic’s Portable Emergency Oxygen System model 615.

The safety communication comes based on complaints of adverse events related to insufficient oxygen flow, re-breathing of exhaled gases, burns, bruising and exposure to chemicals. Read more


2. New Jersey appeals court upholds $11m pelvic mesh decision against J&J

MassDevice.com news

A New Jersey appeals court today upheld a $11.1 million jury award against Johnson & Johnson’s Ethicon subsidiary in a case concerning injuries caused by the company’s Prolift vaginal mesh.

The plaintiff in the case claimed the product caused debilitating nerve pain and said that better labeling and warnings could have prevented injuries. The plaintiff added that the product resulted in multiple complications which required intensive medical treatment and numerous operations, according to court documents. Read more


1. Retina Implant wins CE Mark for next-gen blindness implant

MassDevice.com news

Retina Implant said today that it won CE Mark approval in the European Union for the latest iteration of its subretinal implant for patients blinded by retinitis pigmentosa.

The Alpha AMS is the next-generation version of the Alpha IMS, which won CE Mark approval back in July 2013. The Reutlingen, Germany-based company said the new device increases the number of pixels from 1,500 to 1,600, claiming the title for most electrodes of any neuroprosthetic implant. Read more

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FDA: Cook Medical central venous cath recall is Class I

Cook MedicalThe FDA today labeled Cook Medical‘s recall of its central venous catheter and pressure monitoring sets and trays as Class I over issues with tip splitting and separation.

The devices being recalled are used to monitor pressure in a patient’s vein or artery, to sample blood and to administer drugs or fluids.

Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

The devices are being recalled over issues with device tips splitting or separating from the catheters due to a manufacturer error, which could allow the tip to enter a patients blood stream. Tips and pieces entering the blood stream could cause serious injury or death and requires medical interventions to extract, the FDA said.

The recall is for the Bloomington, Ind.-based company’s single lumen central venous catheter sets and trays, single lumen pressure monitoring sets and trays, femoral artery pressure monitoring catheter sets and trays and radial artery pressure monitoring catheter sets and trays, according to the FDA.

A total of 12,516 devices in the U.S. are being recalled, according to the FDA, manufactured between April 9, 2015 and October 22, 2015 and distributed between April 24, 2015 and October 23, 2015.

Cook Medical said it sent a letter to customers with the devices in January advising them to quarantine and return the affected products as soon as possible, and to report any adverse events.

Last February, Cook Medical expanded its Class I recall for beacon tip angiographic catheters to include additional lots, according to an FDA press release.

Cook Medical’s Beacon Tip Angiographic Catheters are used to inject contrast die into blood vessels in the heart to prepare for cardiac angiograms used to diagnose heart conditions.

The recall was initially filed in July over issues with tip splitting or separation of the device which can lead to the loss of function and separation that may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.

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FDA clears LED Dental’s Tuxedo dental radiography device

LED DentalLED Medical Diagnostics (TSX:LMD) said today its subsidiary LED Dental won FDA 510(k) clearance for its Tuxedo digital intraoral radiography system.

The Atlanta, Ga.-based company’s Tuxedo imaging platform consists of an intraoral sensor and image management software, and is designed as a digital replacement for analog dental film.

“We’re excited about bringing our own digital intraoral sensor system to market. This launch is consistent with our objectives to expand and diversify our imaging product portfolio with high margin imaging products and services,” CEO David Gane said in a press release.

LED Medical said the system produces “high-quality” intraoral radiographic images designed to integrate with most dental practice management systems.

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Xtant Medical wins FDA nod for spinal laminoplasty system

Xtant MedicalXtant Medical said today its X-Spine Systems subsidiary won FDA 510(k) clearance for its Xspan laminoplasty fixation system designed for use in the lower cervical and upper thoracic spine.

Spinal laminoplasty is a surgical procedure designed to remove pressure from the spinal cord through the restructuring of the lamina through a window or opening to allow the spinal canal to increase in size without losing stability or movement.

“We are very pleased to have received clearance for Xspan. This system will allow Xtant Medical to further differentiate itself from the competition and will better serve the growing needs of our surgeon partners,” CSO & exec veep Dr. David Kirschman said in prepared remarks.

Xtant Medical said its Xspan will be available to a “limited number of key surgeons” in the 2nd fiscal quarter of 2016 with a larger general release to follow later in 2016. The company said the worldwide market for laminoplasty is estimated to be $110 million “and growing”.

Earlier this month Xtant Medical said it won CE Mark approval in the European Union for its Aranax cervical plating system and and Irix-A stand alone anterior lumbar fusion device.

The company’s Aranax cervical plating system is distributed as a pre-sterilized, ready-to-use implant. The Irix-A stand alone anterior lumbar fusion device consists of an integrated titanium ring in a PEEK shell.

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Neovasc gains on Q4, 2015 results

Neovasc squeaks by Q2, positive on Tiara trialNeovasc (NSDQ:NVCN) shares are up today after the replacement heart valve maker posted its 4th-quarter and 2015 results yesterday, despite wider Q4 losses on a nearly -25% sales decline.

Vancouver-based Neovasc, which is looking to be the 1st to market with a transcatheter mitral valve implant, put up losses of -$7.4 million, or -11 per share, on sales of $2.2 million for the 3 months ended Dec. 31, 2015. Losses grew 10.0% and sales fell -24.7% compared with Q4 2014.

Full-year losses grew 55.6% to -$26.7 million,or -41,on sales growth of 90.1% to $9.9 million, compared with 2o14.

Neovasc is hoping its Tiara TMVR device will be the 1st such device to make it to market. The company also makes the Reducer device, which is designed to treat refractory angina.

“Our chief priority for 2016 is to complete all the necessary regulatory‎ and clinical activity to begin a CE Mark trial for Tiara, while continuing to expand Reducer’s commercial footprint in Europe,” CEO Alexei Marko said in prepared remarks.

“2016 will be our first full year of commercial sales for Reducer, and with distributors now in multiple European countries including Italy and Germany, we expect this base of business to grow,” added CFO Chris Clark. “As we continue transitioning revenue from our legacy businesses to our own proprietary products, our balance sheet remains very strong, entering 2016 with more than $55 million in cash.”

Neovasc added another patient to its clinical trial program for the Tiara device this year, taking the total to 12, and has “multiple” more patients scheduled for implantation, CEO Alexei Marko told analysts during a conference call yesterday. In January the company won FDA approval to add the 40mm size of the Tiara device to the trial, which could further accelerate enrollment.

The company plans to release data from the trial at the EuroPCR meeting in May, Marko said, according to a Seeking Alpha transcript. That will be an eventful month for the company, as the trial in a trade theft lawsuit brought by rival CardiAQ Valve Technologies (now a part of Edwards Lifesciences) is slated to go to trial May 2.

Investors, likely reacting to the increasing momentum for Tiara’s clinical program, sent NVCN shares up 2.4% to $4.32 apiece in mid-day trading today.

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Quantel Medical wins $3m contract with India Defense Dept.

Quantel MedicalOphthalmic device company Quantel Medical said today won a $3.4 million (EU €3 million) contract for ophthalmic laser equipment from India’s Ministry of Defense.

Through the deal, signed by the Directorate General of Armed Forces Medical Services, Quantel Medical is slated to provide 61 photocoagulator lasers for use in 53 military hospitals in India.

“Diabetes is extremely prevalent in India, affecting more than 62 million individuals, or about 7% of the adult population. It is well known that uncontrolled diabetes can be a precursor for the development of vision-related complications, including diabetic retinopathy and diabetic macular edema, both of which are very common in India. One study suggested that as many as 20% of individuals with diabetes in India are affected by diabetic retinopathy,” CEO Jean‐Marc Gendre said in a press release.

The French company said its 532 nm Supra with Suprascan laser platforms are designed to deliver “a number” of Multispot and MicroPulse patterns.

“This agreement will put an extremely powerful treatment option in the hands of physicians who treat patients with diabetic eye disease. It is a platform that can be adapted to use for other applications as well. Laser treatment of diabetes is in many cases as effective as medical treatment, and it is demonstrated to be much more cost effective,” CEO Gendre said in prepared remarks.

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Medtronic launches Nuro overactive bladder treatment

MedtronicMedtronic (NYSE:MDT) said today it launched its Nuro system designed for treating overactive bladder with symptoms of urinary urgency, urinary frequency and urge incontinence.

The Fridley, Minn.-based company said the device is designed to deliver percutaneous tibial neuromodulation treatment, a minimally invasive office-based procedure which provides a “measurable reduction” in urinary frequency or urinary incontinence.

“Many people with OAB are unsatisfied with current treatments and a significant number are not seeking treatment altogether. With the Nuro System, I can offer patients another option to restore bladder function and improve quality of life without the side effects of medication. This minimally invasive therapy targets the brain-bladder miscommunication and can help improve quality of life in a meaningful way,” Dr. Harriette Scarpero of Nashville, Tenn.’s Associated Urologists said in a press release.

The company’s Nuro system is designed to deliver electrical pulses to the tibial nerve via a needle placed in the skin near the ankle attached to a neurostimulator. The therapy is provided over 30 minute sessions weekly for 12 weeks and can extend further depending on physician prescription.

The most common side effect of treatments with the device are mild pain or skin inflammation at or near the stimulation site, Medtronic said.

“So many suffer from OAB and the majority are either not treated or not finding relief with other treatments, so Medtronic is pleased to offer another option along the care pathway. Our hope is that our expanding neuromodulation portfolio can help a broader range of patients get their lives back,” gastro/urology therapies prez & GM Linnea Burman said in a prepared statement.

Medtronic said that PTNM demonstrated significantly decresed numbers of incontinence episodes and voids per day, reduced number of urgency and urge incontinence episodes and increased voiding volume in clinical trials.

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Sensus Healthcare postpones IPO

Sensus HealthcareSensus Healthcare reportedly postponed its initial public offering today, after setting terms earlier this month with a midpoint raise of $20 million.

Boca Raton, Fla.-based Sensus makes the SRT-100 and SRT-100 Vision photon X-ray low-energy superficial radiotherapy systems for treating non-melanoma skin cancers, including basal cell and squamous cell carcinomas. The company said March 9 that it planned to float more than 1.8 million shares at $10 to $12 apiece, working out to a low-end raise of $18.2 million and a high end of $21.8 million.

A mere 8 IPOs have priced in 2016, all in the healthcare sector, according to Renaissance Capital, which 1st reported the Sensus tabling.

The SRT-100 system has U.S. 510(k) clearance, CE Mark approval in the European Union and approvals from the China Food & Drug Administration and Health Canada; Sensus claims more than 200 installed devices in 11 countries.

The company had planned to put $3 million of the IPO proceeds toward hiring new sales reps and a director of marketing, and another $3 million into R&D for new products and the further development of existing products. Some $2.7 million was to have gone toward paying a dividend to a former shareholders who elect not to convert their dividends into shares after the IPO, Sensus said at the time.

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Court approves Nuo Therapeutics bankruptcy plan

Nuo TherapeuticsWound care company Nuo Therapeutics (OTC:NUOT) said yesterday that a federal court in Delaware approved a bankruptcy plan that would either see it continue as an independent company or become 95% owned by lender Deerfield Management.

Gaithersburg, Md.-based Nuo filed for Chapter 11 bankruptcy protection in January, 2 years after raising $35 million from Deerfield. Formerly known as Cytomedix, the company makes the Aurix hematogel, which is designed to stimulate the body’s native mechanisms to heal wounds.

Nuo listed assets worth $19.2 million and debts of $13.1 million, including $834,144 owed to Arthrex, $70,486 owed to Sparton Medical Systems, $44,537 owed to Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Spine and $42,203 owed to Pfizer(NYSE:PFE). At the time the company said it planned to ask Deerfield for roughly $9 million worth of debtor-in-possession financing.

Yesterday Nuo said that the U.S. Bankruptcy Court for Delaware approved a 2-prong plan for its reorganization. The 1st scenario would see it raise at least $10.5 million by April 20. If it can’t raise the scratch by that deadline Nuo would become 95% owned by Deerfield under the 2nd scenario.

If the money can be raised, Nuo said it pledged to assign the rights to its license with Arthrex to Deerfield, which agreed to exchange the $6 million worth of debtor-in-possession financing advanced after Nuo’s bankruptcy filing for equity worth $29.3 million. If the 2nd scenario plays out, Nuop would also assign the Arthrex rights to Deerfield, plus 95% of its new stock.

“I am delighted that Scenario A affords our shareholders, as well as potentially others, the opportunity to participate in a recapitalized and reorganized Nuo,” acting CEO David Jorden said in prepared remarks. “Should we be successful in raising the necessary equity capital under Scenario A, then I believe the company will be well positioned to capitalize on the significantly increased Medicare reimbursement rate for Aurix available to wound care providers and facilities.”

Nuo also said it inked a deal with wound care clinic operator RestorixHealth to enroll 1,600 patients into coverage with evidence development studies based on the new, $1,411 reimbursement rate for Aurix therapy. Restorix would receive exclusive rights to Aurix in 20 to 30 geographies as part of the deal.

“We firmly believe Restorix is the right partner for Nuo with incentives for both of us properly aligned for efficient and effective patient enrollment in the CED protocols. We have significant confidence in Aurix as a valuable treatment choice and an important element of an advanced wound care product array. Without question, we need to see the CED process favorably concluded in order to fully unlock the product’s inherent commercial value,” Jorden said.

“While extraordinarily painful, the company’s cost structure is now significantly reduced. As such, the commercial revenues available to Nuo through its continued sales and marketing efforts in Veteran Affairs and other federal account facilities, in combination with the advantageous revenue opportunity available in the Restorix collaboration, can positively impact the company’s cash flow projections,” he said.

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Ex-AMO CEO Mazzo wants stay in insider trading case pending Supreme Court decision

Advanced Medical Optics (AMO)James Mazzo, the former Advanced Medical Optics CEO who was indicted 2 years ago, wants a federal judge to agree to a stay pending a U.S. Supreme Court decision this fall over issues he claims could affect the insider trading charges alleged in his case.

Mazzo was indicted in September 2014, stemming from Abbott‘s (NYSE:ABT) $2.8 billion acquisition of AMO in 2009. Prosecutors accused Mazzo of tipping close friend and neighbor Doug DeCinces about the deal. DeCinces, a former baseball player for the Baltimore Orioles, allegedly passed the information on to former teammate Eddie Murray, who agreed to settle his case for $358,000 but admitted no wrongdoing. (DeCinces agreed in 2011 to pony up $2.5 million (but admitted no guilt) to settle similar charges leveled by the SEC.)

In court filings this month, Mazzo argued that the Supreme Court’s upcoming decision in Salman v. United States “will directly and significantly affect the charges” against him. Salman, which is slated to be ready for oral argument before the high court in October, hinges on whether prosecutors must prove that a defendant benefitted from the alleged insider trading to make the charges stick.

“It also will materially affect the jury instructions, the evidentiary determinations, and a wide range of trial decisions by the defendants, the government, and the court. Although Mr. Mazzo has consistently demonstrated his readiness to begin trial, and to establish his innocence on the unfounded charges, Mr. Mazzo recognizes that this limited stay will contribute significantly to an orderly adjudication; will avoid unnecessary and wasteful proceedings and conserve judicial resources; will spare the parties significant unnecessary hardship and expense; and will serve the best interests of the court and the parties. The trial in this case could be promptly rescheduled after the Supreme Court issues its decision in Salman,” Mazzo argued, according to court documents.

Prosecutors countered that Mazzo’s motion “grossly overstates” the impact of Salman on his case and fails to establish sufficient hardships or waste of judicial resources “even under the erroneous civil standards he proposes,” according to the documents.

Mazzo’s motion also ignores the Speedy Trial Act and relies on a Louisiana federal court decision that doesn’t apply, the prosecutors argued.

Trial in the case is scheduled to begin July 19, unless Judge Andrew Guilford of the U.S. District Court for Central California agrees to stay the case. Last year Guilford denied prosecutors’ request to disqualify the law firm representing Mazzo, despite misrepresentations by a former lawyer for Skadden Arps Slate Meagher & Flom.

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