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
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/
Daphné Van Diermen
Chief Operating Officer
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
Verisign Reports Internet Has 354.0 Million Domain Name Registrations at the End of the First Quarter of 20238.6.2023 23:55:00 EEST | Press release
VeriSign, Inc. (NASDAQ: VRSN), a global provider of domain name registry services and internet infrastructure, today announced that the first quarter of 2023 closed with 354.0 million domain name registrations across all top-level domains (TLDs), an increase of 3.5 million domain name registrations, or 1.0%, compared to the fourth quarter of 2022.1,2 Domain name registrations also increased by 3.5 million, or 1.0%, year over year.1,2 The .com and .net TLDs had a combined total of 174.8 million domain name registrations in the domain name base3 at the end of the first quarter of 2023, an increase of 1.0 million domain name registrations, or 0.6%, compared to the fourth quarter of 2022. The .com and .net TLDs had a combined increase of 0.1 million domain name registrations, or 0.1%, year over year. As of March 31, 2023, the .com domain name base totaled 161.6 million domain name registrations, and the .net domain name base totaled 13.2 million domain name registrations. New .com and .net
Momcozy Introduces the Revolutionary M5 All-in-one Hands-free Breast Pump - Empowering Busy Moms with the Ultimate Maternity Solution8.6.2023 23:00:00 EEST | Press release
Momcozy, the esteemed maternity and baby brand favored by over two million moms worldwide, proudly unveils the revolutionary M5 all-in-one hands-free breast pump. Designed to provide the ultimate pumping experience for busy breastfeeding moms, this cutting-edge device showcases Momcozy's commitment to meeting the needs of mothers worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005079/en/ M5 All-in-one Handsfree Breast Pump (Graphic: Business Wire) Renowned for its position as a leader in the North American electric breast pump market, Momcozy distinguishes itself yet again with the M5 all-in-one hands-free breast pump. Driven by a user research team that believes in "cozy designs born from love" and strives to cater to customer needs, Momcozy has conducted extensive interviews with thousands of mothers over the past two years. The team's latest findings highlight "comfort" as the most frequently mentioned req
Mouser Electronics Explores the Intersection of Smart-Home Tech with Matter Protocol in Empowering Innovation Together Series8.6.2023 20:08:00 EEST | Press release
Mouser Electronics Inc., the industry's leading New Product Introduction (NPI) distributor with the widest selection of semiconductors and electronic components™, launches the next installment of their award-winning Empowering Innovation Together (EIT) series highlighting the Matter protocol. With this installment, Mouser brings together global technology experts from the Connectivity Standards Alliance (CSA) and industry-leading manufacturers to explore all aspects of Matter, from market introduction to design specifications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005018/en/ Matter: One protocol for them all. (Graphic: Business Wire) With its widespread industry support from leading semiconductor manufacturers, including NXP Semiconductors, Silicon Labs, STMicroelectronics, Schneider Electric, Texas Instruments, Infineon Technologies, Nordic Semiconductor and Microchip Technology Inc., Matter promises to revol
Edwards Lifesciences: Improving Patient Safety and Outcomes: EU-HYPROTECT Registry Demonstrates Reduced Time in Hypotension During Surgery Using Acumen HPI Software8.6.2023 19:30:00 EEST | Press release
Edwards Lifesciences today announced the results of the EU-HYPROTECT registry which indicates that using Acumen HPI software may help reduce the duration and severity of intraoperative hypotension in patients having non-cardiac surgery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005565/en/ (Graph: Business Wire) EU-HYPROTECT is a European multicenter prospective observational registry which included in its final analysis 702 patients scheduled for elective major non-cardiac surgery in 12 medical centers in 5 countries (France, Germany, Italy, Spain, UK). It is the first multicenter registry involving a predictive monitoring technology, establishing a large, prospectively collected data base on hypotension management in patients having non-cardiac surgery. All patients had intraarterial blood pressure monitoring with an arterial catheter and intraoperative Acumen HPI software. Both the duration and severity of intra
Mary Kay Celebrates Oceans Week by Reaffirming Partnership With the Nature Conservancy8.6.2023 19:02:00 EEST | Press release
Mary Kay is celebrating Ocean’s Week by reaffirming its decades-long partnership with The Nature Conservancy (TNC) to support ocean conservation and coral reef protection. Coral reefs, often referred to as the rainforests of the sea, cover less than 1% of the world’s surface area but support 25% of all marine life and over one billion people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230608005582/en/ Dr. Elizabeth McLeod, The Nature Conservancy’s Global Oceans Director, conducting research in Ulong Channel, Palau as part of the Super Reefs project, a collaborative effort to discover the secrets of “super reefs” with support from Mary Kay. (Credit: © Kip Evans/CCC Marketing) Because traditional reef conservation strategies have not been enough to counter the global loss of coral reefs, Mary Kay, a signatory to the UN Global Compact Sustainable Ocean Principles, is supporting experts from TNC, Woods Hole Oceanographic Ins
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