Fortunately, GlySure had solid medical data to support the company’s developmental efforts. “What drew me to GlySure was this unique opportunity where the outcomes data already exist,” Jones says. “There was a seminal paper done in 2001 by Greet Van den Berghe that showed if you tightly control glucose you get these phenomenal outcomes—a 34% reduction in mortality and a near 50% reduction in sepsis, for example.” For hospitals these prospective outcomes result in “$1500 savings per patient in the U.S. and €2300 per patient in Europe,” he says.
 

Launched in 2006, GlySure is readying the commercial introduction of its continuous intravascular monitoring system for tight glycemic control in ICUs. Using an optical fluorescence sensor licensed from Beckman Coulter, the device could treat some 8 million patients annually, according to the company. The projected positive outcomes, estimated $2-billion market, and encouraging clinical test results have attracted $19.5 million in venture capital funds to GlySure.
 

A veteran of more than 20 years in the medical device industry, Jones was CEO of Tensys Medical from 2005 to 2008. At Tensys he oversaw the development of the first continuous, noninvasive blood pressure monitor. Before working at Tensys, Jones, who has a BS in molecular biophysics and biochemistry from Yale, spent nine years at Tyco’s Nellcor division, where he served most recently as vice president of marketing for pulse oximetry and critical care businesses. He also spent six years in sales and marketing management at BioGenex Laboratories.
 

On a “four-cities-in-five-days” business trip to the U.S. Jones called MDDI from his IP lawyer’s office in Minnesota before leaving for a Chicago visit with board members and a red-eye flight back to Oxfordshire. He discusses how GlySure benefited from the Indian clinical trials, the trend toward making devices that cut hospital costs, the developmental advantages of competition, the effect of the 2008 downturn, and related matters.
 

MDDI: In March GlySure announced the results of an ICU pilot trial in India. What do the results tell you about the company’s direction?
 

CJ: Those results are really the culmination of about 18 months of work we’ve done in intensive care. We now have over 106 patients trialed in the ICU. Those were the culmination of a lot of iterative developments that demonstrated the ability to monitor a diverse range of intensive care patients with different conditions—sepsis patients, cardiac patients, respiratory patients—and monitor them from admission through discharge.
 

Having done that, we’re now in the process of scaling up our manufacturing and finalizing the commercialization of the product. We were using some prototype systems in early pilot trials. Now we’re finalizing all the product integration and preparing for regulatory trials, with CE trials coming up this fall and discussions with FDA over the scope and nature of our U.S. regulatory trials. We hope to start those early in 2013.
 

MDDI: Your description touches on something that a lot of device companies are doing, which is seeking regulatory acceptance in Europe first. GlySure is based in the UK, obviously, but what are the pros and cons of getting a CE mark before tackling FDA approval in your view?

CJ: More and more you’re seeing a lot of medical device companies executing a Europe-first strategy because it is easier to get a CE mark these days than it is to get 510(k) or PMA clearance, depending upon the device you’re working with. For us we think it’s a huge advantage being on the ground in Europe already in that we don’t have to build any extra infrastructure there, we can do the trials in our backyard and get our feet wet in the market over there while we then build toward the U.S. FDA trials and ultimate U.S. commercialization of the product.
 

MDDI: Does it help that you get a CE mark first? Does FDA take that into account during regulatory scrutiny?
 

CJ: That’s an interesting question. I think it can help if you design your European studies correctly you can use them to answer questions that FDA may have and that data can be part of IDE or pre-IDE submissions when you’re discussing with FDA the nature of the U.S. trials. All that data you can present to and discuss with FDA that will ultimately help you reach agreement on what the U.S. trials should look like.
 

MDDI: Regarding the trials you did conduct, were there aspects that you found particularly challenging as far as the ICU patients you mentioned?
 

CJ: In terms of the trial design itself the most challenging aspect is that we have a device that monitors around the clock. It’s a continuous glucose sensor. If you’re going to run the device you then have to make a decision about whether you want to run the device 24/7 and have staff to do that during your trials or whether you just want to run it for 8 hours during the day and then turn it off and turn it back on the next day.
 

We really wanted to understand the performance of the device in a real-life, real-use situation, so we set up the trial where we were running the device and running the study 24 hours a day from admission to discharge in the ICU. We’re drawing blood to do comparative measurements throughout that time. Setting up the staffing and the management of the trial around the clock is a logistical challenge, and it would be much easier if you had to do one day shift. In the end you wind up with data that is much more representative of what you’re going to see when you’re running for 24 hours a day on patients with a commercialized product.
 

MDDI: Running the trial around the clock requires a bigger budget obviously.
 

CJ: Absolutely. It costs more money to run it that way.
 

MDDI: And you didn’t hesitate?
 

CJ: That’s part of the reason we ended up doing our early trials in India, because the costs were significantly lower there. You have to have all the same quality systems in place and all the same patient safety measures in place. The first volunteers we had for our testing were ourselves—our CTO, our chief chemist, and myself—so we knew the device was safe before we went into ICU testing.
 

Going over to India, we were able to do it at a lower cost, and the regulatory approval process was much faster, so we were able to save significant time and money by doing it overseas.
 

From here we’re gearing up to start our CE trials. We’re hoping to do those in Europe this fall, and if all goes well then we’ll be launching the device in Europe early in 2013 and at the same time we’re in discussions with FDA right now over U.S. trials. We’re hoping to define those this year so we can begin our FDA trials early next year.
 

MDDI: As far as your personal career path, what factors convinced you to move to the UK and GlySure?
 

CJ: I’ve spent my whole career in medical devices and diagnostics, and my last job in the U.S. was CEO of Tensys Medical, which developed a continuous, noninvasive blood-pressure monitor for use in operating rooms. That was a turnaround [operation]. We revamped the product, relaunched it, and managed to sell that company in 2008, so I was looking for my next opportunity.
 

During my career at Nellcor and then at Tensys the trend that I noticed more and more is that in order to get new technology out in the market it wasn’t enough to have something that was a little bit better or a little bit faster or a little bit easier to use. You needed to be able to show not only a clear, compelling clinical benefit but also to show hospitals how they could save costs. The whole health system is creaking against the cost pressures that it’s up against, and if you want a device to be adopted quickly these days you need to be able to show not only a benefit for the patient and clinicians but also the financial benefit to the hospital.
 

What drew me to GlySure was this unique opportunity where the outcomes data already exist. There was a seminal paper done in 2001 by Greet Van den Berghe that showed if you tightly control glucose you get these phenomenal outcomes—a 34% reduction in mortality and near 50% reduction in sepsis, for example—all of which turns into savings for the hospital that has been published in prospective outcomes data showing $1500 savings per patient in the U.S. and €2300 per patient in Europe. So, the fact is there was this huge pent-up demand that would enable hospitals to realize the benefits of tight glycemic control, and the opportunity existed to not only improve patient care to make the nurses’ jobs in the ICU easier but also to deliver hospitals the cost savings they needed.
 

It was that combination of sort of the Holy Grail of medical devices these days, which is both quality improvement and cost savings that convinced me it was an opportunity I wanted to be a part of.
 

MDDI: The company licensed the optical fluorescence technology from Beckman Coulter. How did the company work out that licensing agreement?
 

CJ: Our founder [Barry Crane] saw the opportunity, had deep experience in developing intravascular sensors, and was looking for a chemistry that was specific for glucose. This was one that he identified, and he approached Beckman Coulter. They are in many ways focused on the laboratory analyzer market, so it was a market that they were not going to pursue directly and we were able to negotiate a fairly standard medical device license with a royalty payment to enable us to have access to that technology for this market.
 

MDDI: How long is the agreement?
 

CJ: It was an exclusive license for the lifetime of the patents, and recently we were able to convert that into a purchase agreement where we bought the patents outright and now own them ourselves.
 

MDDI: So you’re at the IP attorney’s office. How is your IP portfolio doing?
 

CJ: Quite well. We just put out a press release a couple of weeks ago; we had a new patent of our own issue on our core calibration technology, which is essentially getting accurate measurements right at the point of care. As I said, in the past six months we’ve been able to finalize the purchase of that core IP from Beckman Coulter so those two things together have been some really nice progress for us on the IP front this year.
 

MDDI: GlySure has at least three device competitors with this capability for warding off hypoglycemia in ICU patients. From a business standpoint you talked about moving ahead this year and into next, how do you balance getting to market versus making sure you’re developing the very best product you can?
 

CJ: First of all, you’ve got to have product that is reliable, accurate, and safe. You can’t cut any corners on that. It’s just the classic truism you only get one chance to make a first impression. We’ve been developing this product with the target and goal of the ICU in mind and developing a product that is going to integrate easily and seamlessly into ICU practice.
 

For me this is a big market opportunity. It’s a [product] opportunity that clinicians have been [anticipating] for a decade now. My experience says in anything new it’s often useful to have multiple companies out there developing a market together, and collectively you can grow things faster than any one company can on its own. We’re quite confident that we’ve got the optimum solution for use in intensive care. It’s always a balance between trying to get there as quickly as possible and also making sure that you’ve got the right product when you come out. There’s no sense coming out too soon with a product that doesn’t make customers happy, so you’re much better off giving them something that is easy to use and accurate the first time around.
 

MDDI: One of the three main components in GlySure’s device is the sensor monitor. Can you elaborate on how long that runs?
 

CJ: There’s a standalone monitor. It’s a typical razor-razor blade system with a disposable patient-dedicated sensor because it’s a blood-contacting device. With the sensor itself…I think 106 hours is the longest patient we’ve been on, which has purely been a function of just how long patients have been in the ICU while we’ve been running the trials. We’re hopeful that we can extend it even farther than that. Our goal is to have a product that you can put into a patient and leave it throughout the duration of the patient’s stay in intensive care.
 

MDDI: Is that capability a major challenge or is it within reach?
 

CJ: I’m very confident it’s within reach. Our in vitro testing has shown the ability to monitor for five to seven days, so I believe it’s really a matter for us of finding the patients who are going to stay that long in the ICU and demonstrating what we can do. There’s been a lot of work in development going into the design of the sensor to allow it to be resident in the bloodstream without biofouling or thrombosis or clotting, but having done all that work we’re pretty confident we’re going to be able to continue to extend that time if we’ve got patients who stay in the ICU for longer and longer.
 

MDDI: Do you have a price point in mind for the product at this point?
 

CJ: It’s a little too early. We’re not on the market yet, so that’s not something that we’re talking about at the moment.
 

MDDI: But you’d have to design it with some sort of sweet spot in mind.
 

CJ: You always want to design it to keep the cost as low as possible so that you can offer a significant benefit to the hospital. We design it with cost in mind but we haven’t set the cost yet.
 

MDDI: GlySure has received about $19.5 million in venture capital funding since the launch. How would you describe the investment climate in Europe and the U.S. at the moment?
 

CJ: Ever since 2008 it’s fair to say it’s been challenging in both the U.S. and in Europe, and I think it’s also fair to say there’s probably more money available in the U.S. than there is anywhere else in the world right now. There is a very active start-up device and pharmaceutical community in Europe. There’s a lot of innovation going on over there, and there’s a lot of grants and government support. There is a building venture community in Europe, but it’s nowhere on the size, scale, or amount of funds in the U.S. right now.
 

MDDI: You mentioned that GlySure saved money by conducting clinical trials in India. Given the funding environment, what key decisions did you make to keep the project moving forward?
 

CJ: When I got to the company in 2008 it was right when the financial crisis was hitting. There was a very clear signal that the bar for investment had gone up, and people really wanted to see proof of concept and fundamentally see human data before doing follow-on investments. So for us part of the decision to go overseas was that the cost-per-patient [figure] was significantly lower in India than it was in Europe or in the U.S. The other was that the regulatory approval timelines and processes to begin a study were several months faster over in India, and every time we modified the product and went back to restart testing we saved that couple of months of regulatory time.
 

Over all, it probably saved us nine to 12 months of development time in being able to do our testing faster in India than we could have in either the U.S. or Europe at that early stage. It was absolutely critical to surviving the lean years when investment was very tight and getting to the point of having human proof of concept that enabled us to close that Series C round at the end of last year and bring some new investors into the company.
 

MDDI: What personal or professional adjustments did you have to make moving to a start-up from an established company?
 

CJ: It’s a classic trade-off. At a big established company you’ve got incredible resources at your fingertips to rely on. It’s one of resources versus speed and focus. You give up some of the resources, and you have to be much more efficient. But the benefit you have is the incredible power of focus in that you’ve got one project that everybody in the company is aligned around. That can allow you to do things much, much faster than at a large organization, where you may have resources but you’ve also got more layers of bureaucracy and approval and people to get aligned around decisions.
 

It is much more focused and faster to change direction, and in some ways I compare it to running an oil tanker versus running a speedboat. But you still have to learn to keep a light hand on the tiller. Just because you can make really rapid decisions doesn’t mean you want to do that all the time. You have to use that speed and nimbleness in the right way and keep it focused on the project and the outcomes you want.
 

MDDI: Broadly speaking, what differences in the business climate or mode of operating, if any, do you see between working in the U.S. and the UK?
 

CJ: You see many more similarities, I think, than differences. When it comes to commercialization there are big differences in the healthcare systems and the reimbursement and the way products are paid for. And there are obviously the big differences that we talked about in terms of the regulatory approval and CE versus FDA.
 

In terms of running a start-up, attracting people, and doing venture-based medical development, I was pleasantly surprised by the entrepreneurial nature of the culture and the country that I walked into and the number of resources that were available. So I’ve been very pleased. And from a business perspective I haven’t seen a lot of internal differences in the way companies, and start-ups in particular, operate.