London-based Cellnovo commercially launched its cellular-enabled diabetes management system and insulin pump this week in the UK. The company also launched a usability trial of its offering with 100 patients who have type 1 diabetes. The study will take place at "ten of the leading diabetes centers across the UK" according to the company and it and will include patients who are both adults and children. The device already has a CE Mark but has not yet secured FDA 510(k) clearance.
Cellnovo's diabetes management system, also called Cellnovo, includes an insulin pump that wirelessly connects to a touchscreen, cellular-enabled handheld glucose monitoring device. Last April DiabetesMine reported that "Cellnovo has actually been prepping and manufacturing for a couple years now, so they are ready to meet the demand" now that they have launched.
"The Cellnovo system provides us immediate access to the clinical status of all our patients on a single screen," stated Professor Stephen Greene of the University of Dundee, who is one of the people running the trial. "With accurate and current information we can identify and address problems immediately that, otherwise, might go unnoticed for months, contributing to excess cost and potentially tragic patient complications. In this clinical trial we will be the first to explore these new opportunities in diabetes patient management and hope to uncover new ways to improve and extend care, optimise workflow and drive cost efficiencies."
About a year ago Cellnovo announced a whopping $48 million second round of funding from Edmond de Rothschild Investment Partners (EdRIP), Forbion Capital Partners; Auriga Partners, NBGI Ventures, and Credit Agricole Private Equity. Return backers from the company’s first round of funding included Advent Venture Partners, HealthCare Ventures, and NESTA. Last September Cellnovo inked a deal with Johnson & Johnson company LifeScan that sees the startup embedding LifeScan glucometer technology into its mobile health offering. LifeScan made headlines in early 2009 when it appeared on-stage at the Apple Word Wide Developers Conference and showed off a prototype for a blood glucose meter that synched up to the then new iPhone 3G.
In a 2010 interview with the publication Invivo, Cellnovo’s CEO Bill Mckeon explained that: “If people understand Cellnovo as a device that sends data to a website, they are missing the point. If you had asked Steve Jobs at Apple about his new MP3 player called the iPod, and how it compares to other MP3 players, he might have said, ‘I am not making an MP3 player. I’m bringing entertainment into your life in a number of ways.’”
Here's how Cellnovo describes its opportunity: "Type 1 diabetes is routinely managed with pump technology throughout much of Europe and North America where 20-25 percent of patients gain benefit from therapy that mimics the body’s normal production of insulin. Yet the UK lags behind, with 96 percent of patients having to rely on multiple daily injections. By introducing a unique system that uses cellular data and touch screen technology, Cellnovo aims to eliminate the barriers to adoption of insulin pump therapy; simplifying and reducing the workload for doctors and nurses, while also improving the quality of insight and diabetes management achieved by patients."
Some great details about the system in this DiabetesMine article from last April.
More about the commercial launch and planned trial in the press release below:
PRESS RELEASE: February 08, 2012, LONDON, UK/BARCELONA, SPAIN -- Cellnovo today announced both the launch of the world's only mobile-connected diabetes management system, and the start of the largest usability trial ever to investigate insulin pump technology for patients with type 1 diabetes. The trial will also be the first in which all clinical data is captured remotely, in real-time; using the mobile data connectivity of the Cellnovo system.
Cellnovo's diabetes management system comprises an insulin pump that connects wirelessly to an intuitive 'app-based' touch-screen handset. The handset features an integral blood glucose monitor, an activity monitor and a mobile (GSM) data connection to a comprehensive web-based clinical management system.
Cellnovo patients will be able to track and manage their diabetes; securely sharing all clinical information through the web so that they, their doctors, nurses and family members can ensure sustained and effective diabetic control.
Principal Investigator of the Cellnovo usability trial, and world-leading authority on insulin pump therapy, Professor John Pickup of King's College London School of Medicine, remarked, "This clinical trial is not just the world's first with a mobile-connected insulin infusion system, it is also the first clinical trial in which the care team and patients can simultaneously observe and evaluate patient data in real-time, anywhere in the world."
Co-trialist, Dr Mark Evans of Addenbrookes Hospital in Cambridge, commented, "This technology represents a entirely new model for the management of diabetes and one that could be of direct and long-term financial benefit to the NHS. The effective management of diabetes requires masses of information. The more information we have, and the more rapidly we have it, the better job we can do of using our resources efficiently to prevent the devastating long-term complications of diabetes. The Cellnovo system is the world's first both to automate and deliver instantly the information we need – a task achieved through the thoughtful and thorough integration of consumer technology, such as wireless and cellular, with medical sensor and precision pump technologies."
Co-trialist, Professor Stephen Greene of the University of Dundee added, "The Cellnovo system provides us immediate access to the clinical status of all our patients on a single screen. With accurate and current information we can identify and address problems immediately that, otherwise, might go unnoticed for months, contributing to excess cost and potentially tragic patient complications. In this clinical trial we will be the first to explore these new opportunities in diabetes patient management and hope to uncover new ways to improve and extend care, optimise workflow and drive cost efficiencies."
William F. McKeon, Cellnovo Chief Executive Officer added, "The launch of the Cellnovo system marks a new era in medicine where mobile connectivity is routinely embedded in medical devices. We draw upon the convenience of mobile technology in so many aspects of our lives: email, photos, social networking and banking. It is now time that our most precious asset, our health, benefits from the real-time information flow that is made possible with an in-built mobile connection. We are moving into an era where our doctors will routinely detect health issues over the web, before they worsen; and where patients and family members have the peace of mind that dangerous and costly emergencies can be avoided as early signs are immediately spotted."
"The Cellnovo usability trial will be conducted in ten of the leading diabetes centers across the UK and will involve 100 patients, both adults and children. Such scale is unprecedented for a trial of insulin infusion technology and its usability." concluded Dr Reman McDonagh, Director of Clinical and Physician Relations for Cellnovo.
Type 1 diabetes is routinely managed with pump technology throughout much of Europe and North America where 20-25% of patients gain benefit from therapy that mimics the body’s normal production of insulin. Yet the UK lags behind, with 96% of patients having to rely on multiple daily injections. By introducing a unique system that uses cellular data and touch screen technology, Cellnovo aims to eliminate the barriers to adoption of insulin pump therapy; simplifying and reducing the workload for doctors and nurses, while also improving the quality of insight and diabetes management achieved by patients.
Type 1 diabetes affects 250,000 UK patients for whom the prospect of poor diabetic control can lead to blindness, nerve damage and death. Caring for diabetes accounts for 10% of the NHS budget, a significant proportion of which is focused on type 1, a growing challenge that affects 4% more UK patients each year. Type 1 diabetes can only be managed by the daily or constant administration of insulin, replacing the role of the pancreas that for these patients has become incapable of producing insulin, which is vital for the metabolism of carbohydrates.
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Notes for editors
Cellnovo is a mobile medical device company based in London, UK. The company was built by a seasoned group of veterans from both the medical device and mobile communications industries. Together, they have developed a mobile health system designed to reduce burden and provide more insight to people with diabetes, their healthcare teams and families.
The number of people with diabetes is estimated to double in the next twenty years, placing a tremendous strain on all healthcare systems throughout the world. The Cellnovo mobile diabetes management system is transformational in that it provides real-time access to patient data and the opportunity to streamline and improve care while at the same time reduce costs.
For more information, please visit www.cellnovo.com
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Daniel Beach Tel: + 44 (0) 7801 415143
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