BIOCORP
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221206005937/en/
About Business Wire
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
3Degrees Welcomes David Dines to Board of Directors11.12.2025 17:00:00 CET | Press release
3Degrees, a global leader in renewable energy and climate solutions, is pleased to announce the appointment of David Dines to its Board of Directors, effective December 8, 2025. Dines brings more than four decades of leadership experience across global energy, commodities, financial services, transportation, and industrial markets. He served on the executive team as Chief Financial Officer and Corporate Senior Vice President at Cargill, Inc., the largest privately held company in the United States, where he oversaw enterprise-wide financial strategy, capital deployment, and financial performance. During his 29-year career at Cargill, Dines led multiple global businesses, played key roles in major technology and process transformations, and was a member of Cargill’s Commodity Risk, Financial Risk, and Process, Data, and Technology Committees. “We are thrilled to welcome David to the 3Degrees board,” said Philippe Vedrenne, CEO, 3Degrees. “He has an exceptional command of financial stewa
ITC Infotech wins PTC Partner Network Award for FY25 in the PLM Category11.12.2025 15:40:00 CET | Press release
ITC Infotech’s DxP Services earns recognition for its strong PLM expertise, unwavering commitment to delivering customer value, and strategic collaboration with PTC to drive innovation through SaaS-led offerings and accelerate digital transformation for customers. ITC Infotech, a leading global technology services and solutions provider, has been awarded the PTC Partner Network Award for FY25 in the Product Lifecycle Management (PLM) category. This prestigious recognition, awarded to a single partner globally, celebrates excellence in deploying Enterprise PLM software, enabling global and cross-functional teams to effectively manage product data and providing a trusted system for product information. The award underscores ITC Infotech’s leadership in PLM-led digital transformation, as well as its strategic alignment with PTC’s Intelligent Product Lifecycle vision, which helps customers build a structured product data foundation that serves as the backbone for AI-driven transformation.
1X Announces Strategic Partnership to Make up to 10,000 Humanoid Robots Available to EQT’s Global Portfolio11.12.2025 15:00:00 CET | Press release
1X, the AI and robotics company behind NEO, the first ready-to-ship humanoid robot, today announced a strategic partnership with EQT, one of the world’s largest private equity firms and an investor in 1X through EQT Ventures. The partnership marks the beginning of what could become a large-scale commercial rollout of general-purpose humanoid robots across multiple industries. Together, 1X and EQT have a shared intent to facilitate the rollout of up to 10,000 humanoids across EQT’s global portfolio companies between 2026 and 2030, with any potential implementation decision ultimately taken by each portfolio company. The partnership represents an early step in bringing humanoid robotics into mainstream commercial use. Through this collaboration, EQT’s portfolio companies will gain early access to 1X’s commercial production capacity and integration expertise, giving early adopters a first-mover advantage in addressing structural workforce transformation. The partnership will focus on high
Texas Card House to Host World Series of Poker® Circuit in 202611.12.2025 15:00:00 CET | Press release
Exclusive partnership brings the World Series of Poker to Texas for the first time. The World Series of Poker (WSOP) has announced that Texas will join its exclusive ranks as an official stop on the 2026 Circuit Tour for the first time in history. Through an exclusive partnership with Texas Card House, the iconic WSOP Circuit will be hosted in Austin, at TCH Social from April 23rd to May 4th 2026. TCH Social is one of the Texas-based company’s flagship locations featuring up to 70 poker tables, a full-service restaurant, craft cocktails, and an upscale atmosphere. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211428594/en/ Texas Card House Social Austin, the first-ever Texas venue to welcome the WSOP Circuit. During the event, Texas will become the center of the professional poker universe. Players from around the world will compete at the Texas Card House in Austin to claim a championship WSOP Circuit ring, enormous pri
Nexo Acquires Buenbit in Major Expansion Across Latin America11.12.2025 15:00:00 CET | Press release
The acquisition combines Nexo’s comprehensive award-winning product portfolio with Buenbit’s CNV-registered operations and strong local expertise.Global digital assets leader Nexo establishes Buenos Aires as its Latin American hub, supporting long-term investment and partnerships across Argentina, Peru, and Mexico.Buenbit clients to gain access to Nexo’s full suite of products, top-tier security, and personalized client care. Nexo, the premier digital asset platform with $11 billion in assets under management, today announced its acquisition of Buenbit, one of Latin America’s most trusted and fastest-growing crypto platforms. This strategic transaction marks a milestone in Nexo’s global scaling, uniting the company’s advanced liquidity infrastructure and high-yield products with Buenbit’s deep local expertise and strong customer base. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251211358777/en/ The acquisition combines Ne
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