BIOCORP Obtains 510(k) FDA Clearance for Mallya®
07 December 2022 - 5:30PM
Business Wire
- Already CE marked, the FDA’s authorization reinforces BIOCORP's
technological leadership in the smart pens market.
- Supported by key players in the diabetes field (SANOFI, ROCHE,
and NOVO NORDISK), access to the American market opens up new
opportunities for industrial partnerships
Regulatory News:
BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME), a French
company specialized in the design, development, and manufacturing
of innovative medical devices, announced today that they have
received 510(K) clearance from the U.S. Food & Drug
Administration (FDA) to market Mallya, its smart medical device
that connects insulin pens.
Eric Dessertenne, CEO of BIOCORP, said: "This approval is a
major achievement for BIOCORP and all of our employees who have
been heavily involved in this regulatory process. This approval
marks a historic achievement for BIOCORP as it allows the
commercial launch of our Mallya device in the United States and
illustrates BIOCORP's ability to meet the highest regulatory
requirements. This news has been eagerly awaited by all our
industry partners to commercialize Mallya in the world's largest
diabetes market and we are delighted that U.S. patients will soon
be able to benefit from Mallya's services. This regulatory
milestone will have a positive impact on our sales outlook in 2023
and positions BIOCORP as a leader in the field of smart pens.”
The Mallya medical device is a smart sensor that is directly
attached to insulin pen injectors, making them connected devices.
Mallya automatically collects and records key treatment information
(selected insulin units, date, and time of injection) and transmits
it to a dedicated digital application. Mallya becomes the first
system approved in the U.S. capable of automatically connecting
different types of insulin & GLP-1 drugs, with an initial
version of Mallya compatible with SANOFI’s Solostar pen
injectors.
Mallya is already the only device in its class to be CE marked
as a Class IIb medical device. It offers the possibility to connect
to different types of injection pens and thus to follow a patient
in a multitherapy notably with a use of basal and rapid
insulin.
BIOCORP has already signed major partnerships in the field with
leaders of the diabetes space such as NOVO NORDISK, SANOFI AND
ROCHE Diabetes Care.
BIOCORP's 510K approval will accelerate the submission of
Mallya's future generations in the diabetes field and in other
therapeutic areas where the company has signed partnerships.
ABOUT BIOCORP
Recognized for its expertise in the development and manufacture
of medical devices and delivery systems, BIOCORP has today acquired
a leading position in the connected medical device market thanks to
Mallya. This smart sensor for insulin injection pens allows
reliable monitoring of injected doses and thus offers better
compliance in the treatment of patients with diabetes. Available
for sale from 2020, Mallya spearheads BIOCORP's product portfolio
of innovative connected solutions. The company has 80 employees.
BIOCORP is listed on Euronext since July 2015 (FR0012788065 –
ALCOR).
For more information, please visit www.biocorpsys.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20221206005937/en/
BIOCORP Sylvaine Dessard Senior Director Marketing &
Communication rp@biocorp.fr + 33 (0)6 88 69 72 85
Bruno ARABIAN Press Officer barabian@ulysse-communication.com
+33 (0)6 87 88 46 26
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