Business Wire

BIOCORP

Share
BIOCORP Announces The CE IIb Approval of Its Mallya Device

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 partners.

ABOUT BIOCORP
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
Follow us on Twitter @BIOCORPSystems

Contact:

BIOCORP Jacques Gardette CEO investisseurs@biocorp.fr

Éric Dessertenne Chief Operating Officer

Sylvaine DessardMarketing & Communication Director rp@biocorp.fr + 33 (0)6 88 69 72 85

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Access Advance Announces Major Growth in Its HEVC and VVC Patent Pools24.11.2025 16:10:00 CET | Press release

Access Advance LLC today announced significant expansions of both its HEVC Advance and VVC Advance Patent Pools during the second and third quarters of 2025, underscoring continued industry confidence in the company's balanced and transparent approach to video codec licensing. This growth follows the successful January 2025 launch of Access Advance's Video Distribution Patent ("VDP") Pool, demonstrating the company's expanding role in comprehensive video codec patent licensing solutions. Among the many highlights, Sharp Corporation joined the HEVC Advance Patent Pool as a Licensor, bringing valuable intellectual property assets to the pool's already extensive patent portfolio. Additionally, Huawei Technologies Co., Ltd., already an HEVC Advance Licensor and Licensee, expanded its collaboration with Access Advance by joining the VVC Advance Patent Pool as a Licensee. HP Inc. also expanded its license to include the VVC Advance Patent Pool after previously joining HEVC Advance in 2024, w

Microsize and Schedio Group to Acquire Lonza’s Micro-Macinazione Site in Switzerland24.11.2025 15:05:00 CET | Press release

Microsize, a leading CDMO specializing in particle size reduction and control technologies, today announced it has signed an agreement to acquire Micro-Macinazione (Mic Mac), a dedicated micronization facility in Monteggio, Switzerland, from Lonza. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124545344/en/ The agreement represents Microsize’s second acquisition from Lonza, following the successful 2022 divestment of its Quakertown, Pennsylvania site. In this transaction, Schedio Group – a Swiss-based provider of jet mills, isolators, spray dryers, and engineering services – is investing alongside Microsize to strengthen and localize its operational base in Europe, advancing a shared vision to lead the next generation of integrated particle engineering solutions. With more than 30 years of experience, Mic Mac has served the pharmaceutical industry with proven GMP-compliant jet milling and micronization capabilities for b

Hytera to Debut S1 E at PMRExpo 202524.11.2025 14:17:00 CET | Press release

Hytera, a leading global provider of critical communications technologies and solutions, today introduced the S1 E, a business-ready, palm-sized two-way radio designed specifically for the retail sector, expanding the portfolio of S Series and providing one more option for retail users to choose for their daily operations. The S1 E will make its debut at PMRExpo, the Europe's premier trade fair for secure, mission- and business-critical communication, taking place from November 25th to 27th, 2025, at Koelnmesse in Cologne, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124768341/en/ Hytera New Released Licence-free Analogue Business Radio S1 E Adhering to the S Series’ signature design language, the S1 E combines a stylish, modern, and minimalist aesthetic with practical functionality. Weighing under 85g, the S1 E provides all-day wearing comfort without tugging or weighing down uniforms. Key enhancements and sta

Merck Takes Patient-Directed Approach to Bring Innovation to the Treatment of Rare Neuromuscular Disorder, Generalized Myasthenia Gravis24.11.2025 14:00:00 CET | Press release

Cladribine capsules have the potential to be the first oral treatment for people living with rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia GravisCladribine capsules has received Fast Track designation and Orphan Drug Designation by the US FDAMerck has established an MG patient council to provide insights on how to best meet the needs of patients in the gMG rare disease community Merck, a leading science and technology company, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for cladribine capsules for the treatment of the rare, chronic autoimmune neuromuscular disorder, generalized Myasthenia Gravis (gMG). In June 2023, the FDA granted Orphan Drug Designation for cladribine capsules for the treatment of gMG. In addition, the Company is actively collaborating with patient organizations and Ad Scientiam, a medical technology company, to support a patient-directed approach to the future management of gMG. If approved

BENEFIT and Ant International Partner to Launch Alipay+ in Bahrain to Achieve Global E-Wallet Connectivity24.11.2025 13:04:00 CET | Press release

Partnership will integrate Alipay+ with BENEFIT, Bahrain’s national QR payment scheme, to enable all Bahraini merchants to accept cross-border digital payments from leading digital wallets and explore outbound payment capabilities. Both parties will explore developing next-generation digital payment framework to support Bahrain’s digital transformation journey. BENEFIT, the Bahraini innovator and a leading company in fintech and electronic financial transactions service, and Ant International, a leading global digital payment, digitisation and financial technology provider, headquartered in Singapore, have partnered to launch cross-border QR payments between Bahrain’s BENEFIT QR payment scheme and Ant International’s global wallet gateway, Alipay+, during 2026 to support the transition toward a more inclusive digital payments ecosystem. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251124405672/en/ (L-R): Hessa Husain, Depu

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye