September 22, 2017 7:39 PM ET

Healthcare Equipment and Supplies

Company Overview of Cellnovo Limited

Company Overview

Cellnovo Limited, a medical technology company, develops and markets mobile diabetes management systems. The company’s mobile diabetes management system includes insulin patch pumps, and activity monitors, as well as cellular enabled wireless touchscreen handsets with integrated blood glucose meters and automatic connectivity to the cloud. Its touchscreen headset device is used for monitoring blood glucose, insulin, carbohydrate intake, and intensity and timing of daily activity, as well as for automatically recording insulin, blood glucose, food, and exercise related information. The company markets its insulin patch pump systems via a direct sales force in the United Kingdom and France, as...

Ethos

Kings Road

Swansea,  SA1 8AS

United Kingdom

84 Employees

Phone:

44 20 3058 1250

Key Executives for Cellnovo Limited

CEO & Director
Total Annual Compensation: €210.1K
Compensation as of Fiscal Year 2016.

Cellnovo Limited Key Developments

Cellnovo Group Provides Update on 510(K) Submission for Clearance of the Cellnovo Diabetes Management System

Cellnovo Group provided an update regarding the review by the U.S. Food and Drug Administration (FDA) of the company’s 510(k) application for clearance of the Cellnovo Diabetes Management System. Cellnovo filed a 510(k), a premarket submission that is required before a medical device can be marketed in the US, with the FDA on November 16, 2016. On August 8, 2017, Cellnovo responded to an initial series of questions from the FDA relating to the application. Cellnovo can report that since this submission, the FDA has responded requesting further information to supplement that already provided by the Company. The company expects this new step will extend the previously expected timeline for clearance of the device in the U.S. and will continue to keep the market informed of progress.

Cellnovo Group Builds a Second Production Line for the Manufacture of its Insulin Cartridges

Cellnovo Group announced that it is building a second large-scale production line for the manufacture of its insulin cartridges. This announcement comes as the first production line, at a Flex facility in Austria, ramps up to full production capacity. The second production line, to be built in a Flex facility in Romania, will have the same annual production capacity as the first line, at 600,000 cartridges per year. The Flex facility in Romania was selected for its cost efficiencies, which will significantly reduce the overall cost of goods sold of company’s insulin cartridges. The completion of the project is expected in first half 2018.

Cellnovo Limited Presents at 10th DVFA Life Science Conference, Jun-13-2017

Cellnovo Limited Presents at 10th DVFA Life Science Conference, Jun-13-2017 . Venue: DVFA Center, Frankfurt am Main, Germany. Speakers: Eric Cohen, IR and Julian IR and Julian Shapley, CSO.

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