BIOCORP Announces The CE IIb Approval of Its Mallya Device

ISSOIRE, France–(BUSINESS WIRE)–#digitalhealth–Regulatory News:

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

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
us on Twitter @BIOCORPSystems


Jacques Gardette

Éric Dessertenne
Chief Operating Officer

Sylvaine DessardMarketing & Communication Director
33 (0)6 88 69 72 85