Cellnovo Provides an Update on Its Partnership with Diabeloop for the Development of an Artificial Pancreas Solution

Regulatory News:

Cellnovo Group ("Cellnovo” or the "Company” – CLNV: EN Paris) (Paris:CLNV), a medical technology company marketing the first mobile, connected, all-in-one diabetes management system today provides an update on its partnership with Diabeloop SA for the development of an artificial pancreas solution.

Following the positive results of an initial clinical study carried out in 2016, Diabeloop and CERIDT, a non-profit research and care organisation focused on diabetes, launched a clinical study in April 2017 aimed at obtaining the CE mark registration for an artificial pancreas system. The study was undertaken by Diabeloop by combining their proprietary algorithm with Cellnovo’s insulin pump. As recently announced, the first arm of this study is now completed and the second arm is scheduled to start by the end of 2017.

The first arm of this study, for which full data will not be published until the completion of the study, reports very positive feedback from patients and investigator sites. It also allowed the identification of modifications required to adapt the Cellnovo pump to specific constraints linked to continuous regulation of the delivered insulin dose, which results in pump operating conditions that differ from standard operations. In collaboration with Diabeloop, Cellnovo’s teams have developed a software solution to ensure complete compatibility of the Cellnovo pump with the Diabeloop algorithm, thus allowing the system to function optimally. However, the necessary modifications are subject to regulatory procedures, which have resulted in delays that prohibit the optimised Cellnovo pump from being used in the second arm of the clinical study.

In parallel with this clinical study, Cellnovo and Diabeloop will continue their partnership in order to be able to offer an artificial pancreas solution that is 100% French.

Erik Huneker, Chief Executive Officer of Diabeloop, comments: "We are very satisfied with the progress made by our Artificial Pancreas system with the Cellnovo pump. The initial feedback from patients and investigation centers has already been very positive and confirms the high expectations for our system. Our partner, Cellnovo, is working closely with our teams on the important work of ensuring compatibility of their pump with our algorithm. Once the regulatory approval of the modifications has been acquired, Cellnovo and Diabeloop will complete the clinical evaluation of the Diabeloop-Cellnovo system in order to obtain a CE marking in 2018.”

Sophie Baratte, Chief Executive Officer of Cellnovo, comments: "The unique characteristics of our insulin pump, associated with the algorithm developed by Diabeloop, make this artificial pancreas solution a major innovation for patients with type 1 diabetes. In collaboration with the Diabeloop teams, we are doing everything to make this artificial pancreas solution available to patients in 2018.”

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About Cellnovo (Euronext: CLNV)

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, Cellnovo’s 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 patient’s 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 more information go to www.cellnovo.com

About the Cellnovo Diabetes Management System

Compact, intuitive and entirely connected, Cellnovo’s insulin pump comprises a mobile touchscreen controller with a 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 patient’s condition to be continually monitored by family members and healthcare professionals in real time.

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