Glysure CEO Discusses Real-Time Glucose Monitoring Technology, ISO 13485 Certification and CE Mark

Glysure, a UK-based company developing a glucose monitoring system for use in hospital and intensive care, recently announced a significant company milestone with the achievement of ISO 13485 certification. The certification is an important step in securing CE Mark, and in turn entrance into a market that is said to be valued at nearly $1.5 BN.

As part of our expert series on the state of the industry, OneMedRadio spoke with Glysure CEO Chris Jones to discuss this recent news and learn about this unique technology. Jones also discussed trends in the industry affecting company growth and investment strategy, including reimbursement issues, evolving exit strategy, and the move away from normative medicine.

Click for the interview, and view the transcript below.

 

Matthew Margolis: OneMedRadio welcomes Chris Jones, CEO of GlySure, a UK-based company developing a glucose monitoring system for use in hospital and intensive care. Today, we’ll be discussing the company’s recent ISO 13485 certification, as well as the market opportunity in this space. So thank you for joining us, Chris.

Chris Jones: Good morning.

MM: Chris, can you give us a snapshot of GlySure? Give us the company mission, lead technology, brief history?

CJ: GlySure was founded to help ICU solve a couple of competing conflicting demands. It starts with the fact that insulin is one of the most dangerous drugs used in hospitals today. It has been number one on [the] Medmarx list of harmful medication errors in hospitals for over a decade now. At the same time, there has been a phenomenal amount of research on the subject of tight glycemic control, which was kicked off by a study by Greet Van Den Berghe that showed if you used intensive insulin therapy to tightly control glucose in intensive care, you get these phenomenal outcomes: 34% reduction in mortality, nearly 50% reduction in morbidity including rates of sepsis. So you now have this situation where hospitals have compelling data that says they should be using more insulin in ICU and yet the risks of doing that can be quite catastrophic.

The only way to do it safely is by frequently monitoring for glucose on an average of once an hour or more. The problem hospitals have and in particular intensive care, is that they don’t have the nursing resources to do a blood glucose measurement every hour on every patient in a ten-bed ICU. So they’re looking actively for better ways to safely implement intensive insulin therapy and to more easily and effectively monitor glucose. What we’ve done is we’ve developed a continuous intravascular glucose sensor that goes into the patient via their central venous catheter and gives the clinicians exactly what they want. Which is continuous glucose monitoring through the length of that patient’s stay in intensive care.

MM: So, catch us up on some recent news, of course this ISO 13485 certification? How does this fit in to your overall strategy?

CJ: This is a big step for us. It marks the completion of our quality management systems, and puts in place a key regulatory step that we need to have in order to begin our CE trial. We’ve been doing development testing in the ICU for the last two years now and we’ve tested over 120 patients. We’re just wrapping up those development trials right now and we’re expecting to begin our CE trial in the next quarter here. The ISO lays the foundation for us to be able to start those CE trials.

MM: So what was required of you? What did you have to demonstrate to achieve the ISO certification?

CJ: Fundamentally, it revolves around your quality management system and so we had five days of audits looking at not only the system but also how well we were following it and executing on it. That is looking at everything from our quality management systems to microbiology to product development. So it really cut across the entire organization.

MM: What is your immediate next step and do you have a timetable to achieving CE mark?

CJ: Right now, we are wrapping up the final V&V testing on the commercial versions of sensor and our hardware. We expect that to wrap up at the end of this month and then we’ll be looking to start our CE trials most likely sometime in May.

MM: Let’s shift gears and talk a little bit about market opportunity. In your opinion, is the blood glucose monitoring market crowded?

CJ: Our particular market is not crowded at all. There are a lot of technologies out there for doing intermittent measurements, but there is no technology on the market today that provides a continuous intravascular blood glucose measurement. So if you want to go and draw blood; send it down to the lab and wait 45 minutes, an hour, two hours for that data to come back- you can get a very accurate measurement. But what doesn’t exist today is at the bedside without requiring any additional nurse labor, the ability just to look up at a screen and see what the glucose value is. So this is in essence a brand new market in intensive care and looking at 8 to 10 million patients annually worldwide, adult ICU patients, we see this as a new $1.5B market opportunity.

The challenge is that if you look at survival rates in the ICU and if you compare them to blood glucose levels, average blood glucose, you see this U-shaped survival curve. What that means is that if blood glucose levels are very elevated then a patient has a higher risk of dying in the ICU. That risk comes down as you lower glucose levels and you bring them to normal. But the problem is, if you give too much insulin, and patient’s blood glucose goes too low; then all of a sudden that mortality and morbidity risk shoots up again. So you’ve got a very narrow sweet spot you’re trying to hit at a very high risk to the patient if they end up going too low in glucose. You’ve got to titrate the therapy very, very specifically to get the patient into the optimal range.

Today, the only way to do that is for the nurse to manually draw blood; run it on an analyzer, look at that result and then adjust the insulin. It takes a lot of time and they are very few hospitals that have the labor and the capacity to effectively implement the tight glycemic control targets.

MM: What data can you highlight from recent studies and relevant trials?

CJ: We’ve spent a lot of time testing this product in intensive care. A year ago, we published our first data at the Brussels Intensive Care Congress in March that showed summary from some of our pilot trials. We’re just now finalizing a trial on cardiac surgery patients, and we expect to be publishing that in the next couple of months. We’ve seen some fantastic data, the ability to monitor accurately across three to five days of a patient’s stay in intensive care to the standard that clinicians are looking for to be able to care for patients in the ICU. So we’re really excited about the data and looking forward to like getting out for people to look at.

MM: Can you give us some history of the financial structure of the company? Who you are your principal investors, and how was early round financing achieved?

CJ: The company was founded in 2006. It was founded by a technical team that had deep experience in developing continuous intravascular blood gas sensors. Sensors that were used in intensive care to monitor pH, PO2, and PCO2 continuously. The founder was able to go out and find the chemistry that he believed would be perfect for use in continuous glucose monitoring. The first round of financing, in 2006, was led by Amadeus Capital and Delta partners. Since then in the series C round, we were joined by Morning Side Ventures out of Boston. To date we’ve raised about 13 and a half million pounds total in funding.

MM: What seems to be the exit strategy for companies in your space?

CJ: I think that it probably is the same across almost everybody in medical devices these days. It’s no secret that the IPO market has really been closed for pre-revenue companies and in fact you know, almost requires 10 to 20 million in revenue to think about it significantly. More and more I think you’re seeing companies do corporate deals. There’s still a possibility that in a market like hours, which is a billion and a half dollars fundamentally untapped. I could see this being a very successful commercialization and the opportunity to do an IPO off of a nice attractive revenue base with a lot of growth behind it. Fundamentally, I think the statistics say probably 80% of exits these days are going through corporate acquisition as opposed to IPO.

MM: So talk a little bit about what trends you’re seeing in reimbursement for this market segment and how has that affected how you value and limit the cost to good sold?

CJ: For us we think that in the US in particular, this is likely to be included in the DRG. We don’t anticipate separate funding for continuous glucose monitoring in intensive care. So what we’ve been focusing on is the strong existing cost savings data. There’s data that shows from two prospective outcomes trials that the reduction in morbidity,  the reduction in the rates of sepsis and the reduction in the length of stay can save people between $1500 and $3000 per patient. So, I think when you look at those patient savings, compared to the expected cost of a sensor around $180 for the length of stay in ICU, you see the opportunity to drive a business really quite profitable and yet at the same time be able to offer hospitals not only improvements in quality, but also the ability to reduce their overall cost of care per patient. I think that’s really one of the things that makes this a unique opportunity and it’s what attracted me to the company, got me to leave California to come over to England was this unique opportunity to offer hospitals something that will benefit the patient, that will make the nurses lives easier in the ICU and will help the hospitals save cost as well.

MM: So last question, in your opinion, are we moving away from the concept of normative medicine and what applications may arise from this paradigm shift?

CJ: I’d agree absolutely that we’re moving away from that and if you look at glycemic control in intensive care, you’re seeing a lot of publications and a lot of debate over what the correct, or ideal levels of glucose control are. In fact, there’s published data that suggested depending upon whether you’re diabetic or not and also whether you’re a well controlled or an uncontrolled diabetic, you should vary the level of glucose that you’re targeting for that individual patient.

So I think we’re seeing more and more a move towards customized medicine where individual patient characteristics whether it’s the disease state that brings them in or whether it’s an underlying medical condition like diabetes or not, that is going to result in customizing and fine tuning a treatment that ultimately should improve outcomes for everybody overall.

I know that, you know, in some spaces particularly when you get into genetic testing, it can raise ethical implications. I think that they’re less significant when you’re looking at something like glucose and the intensive insulin therapy. But fundamentally, you know, my hope is that the move away from normative medicine and being able to better target therapies and treatments will help us improve the quality of care while also maintaining and managing the costs that are out there. Because one of the big challenges we’ve got, is that we’re in an age of incredible development and success in improving healthcare but along with that we’ve created incredible cost pressures on the developed world. So my hope is that as we move away from normative medicine, we get to more target individualized medicine, we can more customize care and more effectively use the healthcare dollars that we’ve got.

MM: That was a company snapshot with Chris Jones, CEO of GlySure, a UK-based company developing a glucose monitoring system for use in hospital and intensive care. With OneMed Radio, this is Matthew Margolis signing off.

 

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