REGEN-LAB
Regen Lab, a global commercial-stage medical technology company specializing in the research, development, registration, manufacturing and commercialization of proprietary tissue engineering products announces that its best-in-class medical devices REGENKIT®, CELLULAR MATRIX fig® and Arthrovisc® have obtained the CE certification under the EU Regulation 2017/745 on Medical Devices (MDR).
REGENKIT® is a preparation of Platelet-Rich Plasma (PRP), CELLULAR MATRIX fig®, a combination of PRP and Hyaluronic Acid (HA), and Arthrovisc®, HA filled syringes.
Based on the examination of its Quality Management System and Technical Documentation, these new CE certificates delivered to Regen Lab SA (EU authorized representative Regen Lab France SAS) by the notified body BSI are all valid for five years with a starting validity date on April 25, 2023, and an expiry date on April 24, 2028.
Imposed on all manufacturers and distributors operating in the European Union, the EU MDR 2017/745, applicable since May 26, 2021, in the European Union, is meant to mandatorily replace by 2028 the existing European Medical Device Directives (MDD 93/42/EEC). These EU regulations on medical devices aim at establishing a modern and more robust regulatory framework to protect public health and patient safety. This certification has considerably increased the amount of technical and clinical validation data required on medical devices across the EU, to address the need for a better traceability and transparency in safety.
In relation to the EU MDR certification of its products, Regen Lab successfully renewed its ISO13485:2016 and MDSAP certifications with a Quality Assurance System meeting the requirements of the European MDR EU 2017/745 Regulation in December 2022.
The certifications obtained reinforces Regenlab’s competitive position in the PRP market alone and in combination with HA.
Regen Lab autologous tissue engineering solutions are based on an extemporaneous preparation of PRP from the patient’s own blood and combined therapy (PRP combined with HA).
Regen Lab is a vertically integrated group with extensive R&D, regulatory and manufacturing expertise. To date, Regen Lab’s patented technologies* are available in over 90 countries worldwide and have been used to treat patients in various therapeutic areas (musculoskeletal, dermo-esthetics, wound care and urogenital) leading to the publication of over 200 clinical studies projects. The Company’s products are manufactured in the Group factories in Le Mont sur Lausanne (Switzerland), Brooklyn (New York, USA) since 2022, and in Les Ulis (Paris region, France) starting from Q3 of 2023.
More info about Medical Devices Regulation: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
About Regen Lab
Based in Mont-sur-Lausanne, Switzerland, Regen Lab is a global commercial-stage medical technology company specialized in the research, development, registration, manufacturing and commercialization of proprietary tissue engineering solutions. The Company's solutions are commercialized in more than 90 countries and generated total revenues of €40 million in 2022. The core technology of the Company focuses on the design of solutions for autologous platelet-rich plasma (PRP) based procedures, consisting in reinjecting the patient's own platelets into tissue lesions in order to stimulate tissue healing. The Company's original medical devices, commercialized primarily under the RegenKit brand, have been CE marked EU-MDR 2017/745 and approved by FDA and CFDA and are routinely used by physicians worldwide for the treatment of a wide variety of main indications currently including joint osteoarthritis, tendinopathies and dermo-esthetics. The Company's products are manufactured in the Group factories in Le Mont-sur-Lausanne (Switzerland), New York (USA) since Q3 2022 and Les Ulis (Paris region, France) starting Q3 2023, which the Company has built to meet its anticipated increasing demand for its new products.
More info about RegenLab: https://www.regenlab.com
*For a list of Regenlab’s patents see: https://www.regenlab.com/patents
Regenkit®, Cellular Matrix fig®, Arthrovisc, Regenlab®, Regenplasma®, Regencell®, RegenACR®, THT® are registered or pending trademarks of Regen Lab SA or RegenLab USA LLC.
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/20230515005412/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
Alpaca Raises $150 Million at a $1.15B Valuation to Build the Global Standard for Brokerage Infrastructure14.1.2026 13:00:00 CET | Press release
Alpaca appoints lead investor Drive Capital’s Co-Founder and Partner Chris Olsen to its board Alpaca, a global leader in brokerage infrastructure whose APIs empower partners like Kraken, SBI Securities, and Dime!, today announced it has raised a $150 million Series D led by Drive Capital that values the company at $1.15 billion. Drive Capital’s Co-Founder and Partner, Chris Olsen, will join Alpaca’s Board of Directors as part of the investment. The company also secured a $40 million line of credit, further strengthening its balance sheet as it continues to expand globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114225657/en/ Alpaca Raises $150 Million at a $1.15B Valuation to Build the Global Standard for Brokerage Infrastructure “Our mission is to open financial services to everyone on the planet,” said Yoshi Yokokawa, Co-Founder and CEO of Alpaca. “We are building the global standard for brokerage infrastructure
Sixth Street Raises €3.75 Billion for Third European Direct Lending Fund14.1.2026 12:30:00 CET | Press release
Sixth Street SLE III Hits Hard Cap, Reflecting Long-Term Strength as One of Europe’s Leading Private Capital Platforms Sixth Street, a leading global investment firm, today announced the final close of Sixth Street Specialty Lending Europe III (“SLE III” or “the Fund”), at its hard cap with €3.75 billion in total equity commitments. SLE III is Sixth Street’s third and largest dedicated fund focused on providing financing solutions for companies across Europe. The total investable capital for SLE III is expected to be approximately €7 billion, including anticipated leverage. “We are grateful to our long-term capital partners for their trust and commitment to our strategy as we continue to support European businesses at any point in their lifecycle, offering customized capital solutions delivered with speed and certainty,” said Michael Griffin, Co-Head of Sixth Street Global Direct Lending and Head of Europe Direct Lending. “This is a significant milestone for our European Direct Lending
500 Global Announces Promotion of Mei Chel Tan to Global Managing Partner14.1.2026 12:00:00 CET | Press release
Appointment reflects expanding demand for entrepreneurial ecosystem development and AI readiness across emerging markets. 500 Global, one of the world’s most active venture capital firms1, today announced the promotion of Mei Chel Tan to Global Managing Partner. Her appointment reflects both her leadership in expanding 500 Global’s footprint across high-growth regions and the accelerating AI transformation that is positioning nascent and emerging markets as central drivers of the next era of global growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114209489/en/ 500 Global announces promotion of Mei Chel Tan Mei Chel joined 500 Global in 2016 and was appointed Partner in 2023. Over the past decade, she has helped shape the firm’s expansion across Asia, Europe, Middle East and Africa — architecting the launch of early Asian investment funds and vehicles, leading market-entry strategies, developing national ecosystem di
Usercentrics Acquires MCP Manager to Bring Consent and Trust to AI14.1.2026 11:15:00 CET | Press release
Extending Privacy‑Led Marketing from websites and apps into AI workflows, so businesses can scale AI with much-needed oversight, auditability, and control Usercentrics, the global leader in Privacy-Led Marketing solutions, announced today it has acquired MCP Manager, a next-generation governance platform for the Model Context Protocol (MCP), built by a team with deep expertise in AI infrastructure. The acquisition makes Usercentrics the first major global market leader in data privacy solutions to extend consent and data guardrails into AI-driven workflows. The combined platform will deliver a unified Privacy-Led Marketing Suite that manages consent, preferences, and data governance across websites, apps, internal systems, and consumer-facing AI agents. Because these agents increasingly shape personalization and customer engagement, extending consent into real-time, model-driven interactions applies the same rigor that exists at data collection. This keeps experiences transparent, trus
Blue Shift Report Highlights Systemic Vulnerabilities Caused by the Hidden Cost of AI14.1.2026 10:00:00 CET | Press release
Arthur D. Little’s Blue Shift institute has published its latest report, AI’s Hidden Dependencies. This in-depth report, involving more than 50 experts, explores AI’s resource dependencies and the consequent direct systemic vulnerabilities for businesses and lays out strategic actions in response. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114966898/en/ Arthur D. Little’s Blue Shift Institute has published its latest report, AI’s Hidden Dependencies With AI’s adoption and usage expected to remain on its growth trajectory, so is its strain on resources. The report notably identifies three main areas of dependency: Environmental impacts, including emissions due to AI’s heavy energy usage and the manufacture of related hardware Energy supply, including increased electricity demand and strain on the grid Compute infrastructure, including supply chain choke points and dependencies on dominant providers As AI is now becomin
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