Regen Lab Announces the Obtention of the New CE Certification Under Medical Device Regulation (EU MDR 2017/745) Validating the Safety and Performance of Its Proprietary Best-in-class PRP Solutions, Alone or Combined With Hyaluronic Acid
15.5.2023 15:00:00 EEST | Business Wire | Press release
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/
Contact information
Daphné Van Diermen
Chief Operating Officer
ddiermen@regenlab.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Donaldson Introduces Alpha-Pore™ Technology Platform for Extended Sterile Filtration Performance2.11.2026 16:35:00 EET | Press release
Donaldson Company, Inc. (NYSE: DCI), a leading worldwide manufacturer of innovative filtration products and solutions, today announced Alpha‑Pore™ technology, a next generation sterile filtration platform engineered to extend filter service life while maintaining critical process performance. Built for critical applications, Alpha‑Pore technology enables longer filter run time compared with competitive single- and dual-layer polyethersulfone (PES) membrane filters, while maintaining flow characteristics, sterility assurance, and process integrity.* The platform is designed to help manufacturers improve operational efficiency through fewer changeouts and more consistent performance over time. Engineered for Extended Performance Sterile filtration processes often require balancing run time with key performance parameters such as flow, differential pressure, and contaminant retention. Alpha‑Pore technology is designed to achieve all three. By optimizing pore structure and filter architect
Smartly Launches Intelligence Pro to Connect Campaign Planning, Performance and Incrementality2.11.2026 16:00:00 EET | Press release
Smartly, the AI-powered advertising technology company, today launched Intelligence Pro, a premium offering that brings together four capabilities to help marketers plan investment, understand true incrementality and determine where to spend their next dollar. Intelligence Pro connects causal inference models with planning tools to help marketers prove business impact and make faster decisions from increasingly complex data. “Marketing teams are inundated with data, but the challenge is identifying what signals are useful and turning them into a decision they can act on,” said Maxwell Tang, Chief Product Officer at Smartly. “Intelligence Pro brings forecasting, market context and state-of-the-art incrementality signals together to help marketers assess where to invest and what their media is contributing. As AI accelerates campaign execution, the quality of each decision matters more.” Intelligence Pro combines four capabilities within Smartly’s platform: Reach Planner helps teams comp
SBC Medical Forms Capital and Business Alliance with AtomicSoftware, Provider of the medicalforce Clinic Management Platform Used by 800+ Clinics in Japan2.11.2026 16:00:00 EET | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced that it entered into a capital and business alliance agreement on October 26, 2026, with AtomicSoftware Inc. (“AtomicSoftware”), the Tokyo-based provider of medicalforce, an all-in-one software-as-a-service (SaaS) platform for clinics. In connection with the alliance, SBC Medical has invested ¥600 million (approximately US$3.8 million) in AtomicSoftware’s Series C funding round. The two companies will co-develop AI features, beginning with a feature that supports physicians in preparing medical records. Key Highlights Proven platform: medicalforce is used by more than 800 clinics*1 in Japan, primarily self-pay clinics, with a clinic retention rate of 99.2%*2. Joint AI development: Features co-developed by the two companies will enhance medicalforce and be progressively incorpo
NetApp Completes Acquisition of PEAK:AIO to Accelerate Zettabyte-scale AI Deployments2.11.2026 15:00:00 EET | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that it completed the acquisition of PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. With this acquisition, NetApp can leverage metadata services and parallel namespace innovations to power the fastest storage on the planet, NetApp Novus, to support zettabyte-scale file systems for the most demanding workloads of AI clouds and GPU-as-a-service providers. For the best AI infrastructure economics, organizations need to keep GPU resources continuously supplied with data without bottlenecks. The acquisition advances NetApp’s strategy for the next phase of AI infrastructure by bringing PEAK:AIO’s metadata and parallel file system expertise together with NetApp ONTAP, giving customers a path to AI-scale storage that combines high concurrency and massive namespace growth with the resilience, security, and operational simplicity enterprises already trust
HistoSonics Receives Regulatory Approval in Singapore, Advancing Expansion Across Asia-Pacific2.11.2026 15:00:00 EET | Press release
HistoSonics today announced that the company has received market authorization from Singapore’s Health Sciences Authority (HSA) for its Edison® Histotripsy System (under the device name HistoSonics Histotripsy System), marking another significant milestone in the company’s continued international expansion and creating new opportunities to advance access to histotripsy throughout the Asia-Pacific region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261102090757/en/ HistoSonics Edison® Histotripsy System The Edison System is a novel, non-invasive, image-guided platform that uses the mechanical properties of focused ultrasound, known as histotripsy, to mechanically destroy and liquefy unwanted tissue and tumors. The technology offers a fundamentally new approach to tissue destruction without the need for invasive procedures, radiation, or thermal energy. The Edison System is currently authorized for the destruction of liver
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