19:37 uur 12-06-2019

BIOCORP kondigt de CE IIb-goedkeuring van zijn Mallya-apparaat aan.

Regelgevend nieuws:

ISSOIRE, Frankrijk-(BUSINESS WIRE)-BIOCORP (Paris:ALCOR) (FR0012788065 – ALCOR / PEA-PME eligible), Frans bedrijf gespecialiseerd in de ontwikkeling en productie van medische hulpmiddelen en systemen voor de toediening van slimme geneesmiddelen, kondigt vandaag aan dat Mallya het CE 0459 keurmerk heeft verkregen als medische hulpmiddel klasse IIb.

Mallya is een slimme sensor die conventionele insulinepennen omzet in connected apparaten. Mallya registreert de belangrijkste behandelingsinformatie (geselecteerde dosis, datum en tijd van injectie) en stuurt deze naar een speciale mobiele toepassing. De app geeft de patiënt ook de mogelijkheid om een samenvattend rapport te bekijken van de doses die gedurende een bepaalde periode (tot 90 dagen) zijn geïnjecteerd. Dit apparaat laat een automatische registratie toe van de geïnjecteerde doses met de grootste nauwkeurigheid, waardoor er geen manuele logboeken meer nodig zijn.

BIOCORP Announces The CE IIb Approval of Its Mallya Device

Regulatory News:

ISSOIRE, France–(BUSINESS WIRE)– BIOCORP (Paris:ALCOR) (FR0012788065 – ALCOR / PEA‐PME eligible), French company specializing in the development and manufacturing of medical devices and smart drug delivery systems, today announces that Mallya has obtained the CE 0459 mark as medical device class IIb.

Mallya is a smart sensor that turns conventional insulin pens into connected devices. Mallya records the key treatment information (selected dose, date and time of injection) and sends it to a dedicated mobile application. The app also allows the patient user to view a summary report of doses injected over a period of time (up to 90 days). This device allows an automatic recording of the doses injected with the highest accuracy, removing the need of manual logbooks. Mallya fits perfectly with new usages of patients using Continuous Glucose Monitoring Systems or Connected Blood glucose systems.

Today, Mallya is the only device available in its category to be labeled CE medical device, class IIb. The main benefits it offers to patients and health professionals are:

– A patented concept, a device tested in several studies,
– Ease of installation and use does not disturb the usual use of the pen,
– Reliability of information collected and transmitted to the mobile app.

Mallya will be rolled out this fall, supported by BIOCORP commercial partners.

Founded in 2004 in Issoire (near Clermont-Ferrand), France, BIOCORP is a French company specializing in the development and manufacturing of medical devices and innovative drug delivery systems. It is listed as ‘Innovative Company’ by the French public investment bank Bpifrance. With over twenty years of experience and more than 30 manufactured products, BIOCORP is a key player in the industry, providing drug delivery solutions that meet the evolving needs of patients. Today, BIOCORP continues to innovate in medical plastics, its core business, and to market traditional devices (alternative to aluminum capsules, syringe and vial administration systems) that have been an important source of recurring income. Its solid expertise and capacity to innovate have allowed the company to develop new Internet-connected products, including MallyaTM, a smart cap for pen injectors that captures injection data and automatically transmits data to a mobile app, helping patients to manage their treatment. The company has a team of 45 employees. BIOCORP is listed on Euronext since July 2015 (FR0012788065 – ALCOR).
For more information, please visit www.biocorpsys.com
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