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
CyrusOne Names John Hatem Chief Executive Officer to Accelerate its Global Digital Infrastructure Strategy30.7.2026 16:30:00 EEST | Press release
CyrusOne (the “Company”), a leading global data center owner, developer and operator, today announced the appointment of John Hatem as Chief Executive Officer and a member of the Company’s Board, effective immediately. As part of the Company’s long-term succession planning, Eric Schwartz, who successfully led CyrusOne through a period of significant expansion, is stepping down as CEO and will work together with Hatem to ensure a smooth transition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730005910/en/ John Hatem Hatem joined CyrusOne in 2011 and has held a series of increasingly senior roles across the business. He most recently served as President, responsible for global sales, global procurement, and design, engineering, and construction in the United States. His deep experience in data center design, development, and operations has helped transform CyrusOne into one of the world’s leading digital infrastructure p
Mary Kay Releases 2026 Sustainability Report Highlighting Transformative Progress Across Social, Economic, and Environmental Impact Globally30.7.2026 15:03:00 EEST | Press release
Mary Kay Inc., a leading global beauty company committed to sustainability and women’s empowerment, today released its 2026 Sustainability Report, outlining progress toward its 2030 goals and celebrating the 2025 and latest achievements that continue to drive positive change globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730240667/en/ Mary Kay's annual 2026 Sustainability Report highlights the company's decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in Mary Kay's mission of “enriching women’s lives” around the world. (Image Credit: Mary Kay Inc.) The annual report highlights Mary Kay’s decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in the company’s mission of “enriching women’s lives”
Veracode Launches “Veracode Marketplace”: A Curated Ecosystem of Elite Security Integrations Built for the AI-Powered Software Development Era30.7.2026 15:00:00 EEST | Press release
Veracode, the global leader in application risk management, today announced the launch of the Veracode Marketplace, a curated ecosystem that gives customers a single, trusted destination to discover, evaluate, and deploy third-party security integrations as an extension of the Veracode platform. The marketplace debuts with DryRun Security as its inaugural partner, delivering AI-native contextual analysis and verification to Veracode customers on day one. A New Standard for the AppSec Ecosystem The Veracode Marketplace enables security and engineering teams to extend their existing Veracode investment with validated, best-in-class integrations. Every partner is vetted for technical depth, product quality, and workflow fit. Integrations are anchored to Veracode findings for a unified audit trail, and every purchase goes through a single procurement path on a single contract, with a personalized support experience. “Application security has entered a new era, and no single vendor will sol
INNIO Awarded EcoVadis Platinum Medal for Fifth Consecutive Year30.7.2026 15:00:00 EEST | Press release
INNIO N.V. (Nasdaq: INIO) has been awarded the EcoVadis Platinum Medal, the highest recognition granted by the globally trusted provider of business sustainability ratings. This marks the fifth consecutive year that INNIO has achieved Platinum status since 2022. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730309718/en/ INNIO N.V. Awarded EcoVadis Platinum Medal for Fifth Consecutive Year In the latest assessment cycle, INNIO further improved its overall EcoVadis score compared to the previous year by introducing additional policies and further strengthening its sustainability management system. “This recognition is a strong validation of our sustainability strategy,” said Marcin Kawa, Vice President Sustainability at INNIO. “Achieving EcoVadis Platinum status for the fifth consecutive year shows that we have consistently delivered on our sustainability commitments and embedded responsible business practices throughout
Reply S.p.A: The Board of Directors Approves the Half-year Financial Report as of 30 June 202630.7.2026 14:52:00 EEST | Press release
Today, the Board of Directors of Reply S.p.A. [EXM, STAR: REY] approved the results as at 30 June 2026. Since the start of the year, the Group has recorded a consolidated turnover of €1,311.9 million which is an increase of 7.4% compared to the same period in 2025. All indicators are positive for the period. In the first half of 2026 consolidated EBITDA of €233.2 million compared to the €223.7 million recorded in 2025 and corresponds to 17.8% of turnover. EBIT, from January to June, was €189.7 million (€188.4 million in 2025), corresponding to 14.5% of turnover. Pre-tax profit, from January to June 2026, was €194.1 million (€179.4 million in 2025), corresponding to 14.8% of turnover. As regards the second quarter of 2026, the Group's performance was also positive, with consolidated turnover for the period of €667.0 million, up by 8.7% compared to 2025. EBITDA, from April to June 2026, amounted to €121.2 million, with EBIT of €94.6 and pre-tax profit of €94.3 million. As at 30 June 2026
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