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(April 20, 2017)
Study aimed at generating security & safety data for CE mark registration for Artificial Pancreas in 2018
Study results expected before end of 2017
PARIS--(BUSINESS WIRE)--Regulatory News:
Diabeloop, a privately held medical device company, developing an artificial pancreas system and Cellnovo Group (Paris:CLNV) (?Cellnovo CLNV:EN Paris) a medical technology company marketing the first mobile, connected, all-in-one diabetes management system, announce today the launch of a CE marking cross-over registration study for the Artificial Pancreas solution developed by Diabeloop using the Cellnovo pump.
Diabeloops artificial pancreas is a device enabling the complete automation of insulin delivery and uses information from a continuous blood glucose monitor (CGM) to calculate and deliver the optimal insulin dose to patients in real-time. The device has the potential to provide more accurate regulation of blood-sugar levels in insulin-dependent people with Type 1 diabetes, preventing hypoglycemic and hyperglycemic events and other long-term complications that may arise from diabetes.
Results of an initial 3-day cross-over clinical trial of the Diabeloop algorithm, paired with the Cellnovo pump in 36 patients at 9 centres showed positive outcomes and was presented by Diabeloop at the Advanced Technologies & Treatments for Diabetes (ATTD), February 15-18 in Paris, France.
Given the positive outcome of this first trial, Diabeloop is starting a CE marking 3-month cross-over registration study using the Cellnovo micro-pump and a CGM. The design of this new study is to compare the Diabeloop-Cellnovo device with other insulin pumps used with a CGM and a monitoring, in normal life conditions. This study will include 60 patients within 12 centres in France (Besançon, Caen, Evry, Grenoble, Lyon, Marseille, Montpellier, Nancy, Nantes, Reims, Strasbourg, Toulouse). The full results are expected before the end of the year.
This registration study, which has started with a pilot study, will be aimed at generating Security & Safety data for the purpose of obtaining a CE mark registration for the Diabeloop Artificial Pancreas combined with the Cellnovo System and a CGM in 2018.
Erik Huneker, Chief Executive Officer of Diabeloop, commented: ?We are very pleased with the progress our Artificial Pancreas system is making in collaboration with our partner Cellnovo. This Regulatory Clinical Study is designed to bring enough data from 12 centres to file for a CE Mark registration in 2018. We are proud to be developing an Artificial Pancreas technology that will considerably improve the quality of life of Type 1 diabetes patients.
Sophie Baratte, Chief Executive Officer of Cellnovo, commented: ?Alongside our French partner, Diabeloop, we have made significant progress in the development of this Artificial Pancreas solution and we remain confident in our ability to have this product available for patients in Europe in 2018. Our activities in this field should position Cellnovo as a major player in Artificial Pancreas.
Diabeloop aims to radically improve life for patients with Type 1 diabetes. Diabeloop will bring back peace of mind, reduce hypoglycemia and complications associated with Type 1 Diabetes. Diabeloop has been developed with the CERITD, a non-profit research & care organization focused on diabetes, the CEA LETI a leading French research institution, a group of 12 University Hospitals, patients and diabetologists; it is supported by the French Diabetes Association AFD. Diabeloop is currently raising capital to pursue its development.
For further information please visit www.diabeloop.fr, or follow @diabeloop
An independent medical technology company specialising in diabetes, Cellnovo has developed and markets the first mobile, connected, all-in-one diabetes management system that helps make life easier for patients. Compact, intuitive and entirely connected, Cellnovos insulin pump comprises a mobile touchscreen controller with an integrated blood-glucose meter. This unique device allows optimal management of insulin injections whilst ensuring extensive freedom of movement and peace of mind for patients. Thanks to the automatic transmission of data, it also allows the patients condition to be continually monitored by family members and healthcare professionals in real time. Cellnovo is currently participating in several major Artificial Pancreas projects with Diabeloop, TypeZero and Horizon 2020 to develop automated insulin delivery systems.
For further information please visit www.cellnovo.com-
About the Cellnovo Diabetes Management System
Compact, intuitive and entirely connected, Cellnovos insulin pump comprises a mobile touchscreen controller with an integrated blood-glucose meter. This unique device allows optimal management of insulin injections with drop-by-drop precision, whilst ensuring extensive freedom of movement and peace of mind for patients. Thanks to the automatic transmission of data, it also allows the patients condition to be continually monitored by family members and healthcare professionals in real time.
Cellnovo is listed on Euronext, Compartment C
ISIN: FR0012633360 Ticker: CLNV
Chief Executive Officer
Chief Executive Officer
Tristan Roquet Montégon, + 33 1 44 71 00 16
Media Relations in France
Nicolas Merigeau, + 33 1 44 71 94 98
Consilium Strategic Communications
Media Relations in United Kingdom
Chris Gardner, Chris Welsh, Laura Thornton
+44 20 3709 5700
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